<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04451772</url>
  </required_header>
  <id_info>
    <org_study_id>M20-186</org_study_id>
    <secondary_id>2020-001690-72</secondary_id>
    <nct_id>NCT04451772</nct_id>
  </id_info>
  <brief_title>A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State</brief_title>
  <official_title>A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation&#xD;
      of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib&#xD;
      given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body,&#xD;
      in participants who completed study M19-130. This study will assess the change in disease&#xD;
      symptoms.&#xD;
&#xD;
      ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus&#xD;
      Erythematosus (SLE). This study is &quot;double-blinded&quot;, which means that neither the trial&#xD;
      participants nor the study doctors will know who will be given which study drug. Study&#xD;
      doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a&#xD;
      different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260&#xD;
      participants will be enrolled in the study in approximately 100 sites worldwide.&#xD;
&#xD;
      Participants will receive the following for up to 56 weeks:&#xD;
&#xD;
      Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once&#xD;
      daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in&#xD;
      M19-130 will continue to receive the same treatment in this study. Participants who were&#xD;
      receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms&#xD;
      in this study.&#xD;
&#xD;
      Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and&#xD;
      Upadacitinib Dose B&#xD;
&#xD;
      There may be higher burden for participants in this trial compared to their standard of care.&#xD;
      Participants will attend monthly visits during the course of the study at a hospital or&#xD;
      clinic. The effect of the treatment will be checked by medical assessments, blood tests,&#xD;
      checking for side effects and completing questionnaires.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Anticipated">December 28, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 28, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>Through Week 108</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Achievement of Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4</measure>
    <time_frame>Through Week 104</time_frame>
    <description>SRI is a composite responder index based on improvement in disease activity without worsening of the overall condition or the development of significant disease activity in new organ systems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achievement of British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA)</measure>
    <time_frame>Through Week 104</time_frame>
    <description>BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Steroid Burden</measure>
    <time_frame>Baseline of M19-130 (Week 0) Through Week 104</time_frame>
    <description>Steroid Burden is measured as milligrams (mg) of prednisone-equivalent administered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Flares Per Patient-Year (Respectively and Overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) flare index (SFI)</measure>
    <time_frame>Through Week 104</time_frame>
    <description>SELENA SLEDAI flare index defines (mild, moderate or severe) SLE flares using the SLEDAI-2K score, disease activity scenarios, treatment changes, and Physician's Global Assessment of Disease Activity.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Systemic Lupus Erythematosus (SLE)</condition>
  <arm_group>
    <arm_group_label>Part 1: Elsubrutinib Dose A and Upadacitinib Dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Elsubrutinib Dose A and Upadacitinib Dose A once daily (QD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Elsubrutinib Dose A and Upadacitinib Dose B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Elsubrutinib Dose A and Upadacitinib Dose B QD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3: Elsubrutinib Dose A and Upadacitinib Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Elsubrutinib Dose A and Upadacitinib placebo QD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 4: Elsubrutinib Placebo and Upadacitinib Dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Elsubrutinib placebo and Upadacitinib Dose A QD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Elsubrutinib</intervention_name>
    <description>Oral; Capsule</description>
    <arm_group_label>Part 1: Elsubrutinib Dose A and Upadacitinib Dose A</arm_group_label>
    <arm_group_label>Part 2: Elsubrutinib Dose A and Upadacitinib Dose B</arm_group_label>
    <arm_group_label>Part 3: Elsubrutinib Dose A and Upadacitinib Placebo</arm_group_label>
    <other_name>ABBV-105</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Elsubrutinib</intervention_name>
    <description>Oral; Capsule</description>
    <arm_group_label>Part 4: Elsubrutinib Placebo and Upadacitinib Dose A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Upadacitinib</intervention_name>
    <description>Oral; Tablet</description>
    <arm_group_label>Part 1: Elsubrutinib Dose A and Upadacitinib Dose A</arm_group_label>
    <arm_group_label>Part 2: Elsubrutinib Dose A and Upadacitinib Dose B</arm_group_label>
    <arm_group_label>Part 4: Elsubrutinib Placebo and Upadacitinib Dose A</arm_group_label>
    <other_name>ABT-494</other_name>
    <other_name>RINVOQ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Upadacitinib</intervention_name>
    <description>Oral; Tablet</description>
    <arm_group_label>Part 3: Elsubrutinib Dose A and Upadacitinib Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Completed Study M19-130 (i.e., the randomized controlled trial of elsubrutinib,&#xD;
             upadacitinib, and ABBV-599 [elsubrutinib/upadacitinib] combination or matching&#xD;
             placebo) and will not have developed any laboratory or clinical discontinuation&#xD;
             criteria as defined in that study.&#xD;
&#xD;
          -  On stable background treatment for SLE throughout the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active, chronic, or recurrent viral, or bacterial infection.&#xD;
&#xD;
          -  Active tuberculosis (TB)&#xD;
&#xD;
          -  History of gastrointestinal (GI) perforation, diverticulitis, or a significantly&#xD;
             increased risk for GI perforation per investigator assessment.&#xD;
&#xD;
          -  Participant require vaccination with live vaccine during study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AZ Arthritis and Rheumotology Research, PLLC /ID# 227833</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032-9306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wallace Rheumatic Studies Center, LLC /ID# 224374</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valerius Medical Group &amp; Research Center /ID# 223922</name>
      <address>
        <city>Los Alamitos</city>
        <state>California</state>
        <zip>90720-5402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Bay Rheumatology Medical /ID# 225493</name>
      <address>
        <city>San Leandro</city>
        <state>California</state>
        <zip>94578</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital /ID# 245087</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis &amp; Rheumatic Disease Specialties /ID# 227828</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Research /ID# 233192</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRIS Research and Development, LLC /ID# 227814</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deerbrook Medical Associates /ID# 227330</name>
      <address>
        <city>Vernon Hills</city>
        <state>Illinois</state>
        <zip>60061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qualmedica Research, LLC /ID# 227817</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714-0805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Rheumatology and Bone Research /ID# 225479</name>
      <address>
        <city>Wheaton</city>
        <state>Maryland</state>
        <zip>20902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center /ID# 222505</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215-5400</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>June DO, PC /ID# 221841</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health/NYU School of Medicine /ID# 245088</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016-2772</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>STAT Research, Inc. /ID# 221840</name>
      <address>
        <city>Vandalia</city>
        <state>Ohio</state>
        <zip>45377-9464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny Health Network Research Institute /ID# 245086</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Ramesh Gupta /ID# 225524</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekton Research, Inc. /ID# 224411</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accurate Clinical Management /ID# 225509</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SW Rheumatology Res. LLC /ID# 225485</name>
      <address>
        <city>Mesquite</city>
        <state>Texas</state>
        <zip>75150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carilion Clinic /ID# 227832</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 222569</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>1426</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Interzonal General de Agudos General Jose de San Martin /ID# 221893</name>
      <address>
        <city>La Plata</city>
        <state>Buenos Aires</state>
        <zip>1900</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CER Instituto Medico /ID# 223175</name>
      <address>
        <city>Quilmes</city>
        <state>Buenos Aires</state>
        <zip>1878</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aprillus Asistencia e Investigacion /ID# 221890</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <state>Ciuadad Autonoma De Buenos Aires</state>
        <zip>1046</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto CAICI S.R.L /ID# 221892</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Medicas Tucuman /ID# 221888</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <state>Tucuman</state>
        <zip>4000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigaciones Clinicas Tucuman /ID# 221889</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <state>Tucuman</state>
        <zip>4000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Research Unit Sunshine Coast /ID# 221816</name>
      <address>
        <city>Maroochydore</city>
        <state>Queensland</state>
        <zip>4558</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emeritus Research /ID# 223027</name>
      <address>
        <city>Camberwell</city>
        <state>Victoria</state>
        <zip>3124</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre /ID# 221814</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Sveti Ivan Rilski /ID# 223358</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Sveti Ivan Rilski /ID# 223359</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital /ID# 222950</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital /ID# 222851</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huashan Hospital, Fudan University /ID# 222929</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Xinjiang /ID# 222928</name>
      <address>
        <city>Urumqi</city>
        <zip>830001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Integral de Reumatologia del Caribe Circaribe SAS /ID# 221879</name>
      <address>
        <city>Barranquilla</city>
        <state>Atlantico</state>
        <zip>80002</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 221884</name>
      <address>
        <city>Bogota</city>
        <state>Cundinamarca</state>
        <zip>110221</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Preventive Care Sas /Id# 221881</name>
      <address>
        <city>Chia</city>
        <state>Cundinamarca</state>
        <zip>250001</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthy Medical Center SAS /ID# 221882</name>
      <address>
        <city>Zipaquira</city>
        <state>Cundinamarca</state>
        <zip>250252</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitaria Bolivari /ID# 221880</name>
      <address>
        <city>Medellin</city>
        <zip>050034</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 222963</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 222964</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont /ID# 222480</name>
      <address>
        <city>Debrecen</city>
        <state>Hajdu-Bihar</state>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 222479</name>
      <address>
        <city>Veszprém</city>
        <state>Veszprem</state>
        <zip>8200</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 221919</name>
      <address>
        <city>Cona</city>
        <state>Ferrara</state>
        <zip>44124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chukyo Hospital /ID# 223398</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>457-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Nagoya Medical Center /ID# 222397</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>460-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Occupational and Environmental Health, Japan /ID# 222499</name>
      <address>
        <city>Kitakyushu-shi</city>
        <state>Fukuoka</state>
        <zip>807-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima Red Cross Hospital &amp; Atomic-bomb Survivors Hospital /ID# 222393</name>
      <address>
        <city>Hiroshima-shi</city>
        <state>Hiroshima</state>
        <zip>730-8619</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Asahikawa Medical Center /ID# 222394</name>
      <address>
        <city>Asahikawa-shi</city>
        <state>Hokkaido</state>
        <zip>070-8644</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EIRAKU Internal Medicine Clinic /ID# 222385</name>
      <address>
        <city>Kagoshima-shi</city>
        <state>Kagoshima</state>
        <zip>890-0063</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>Tohoku University Hospital /ID# 222392</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>9808574</zip>
        <country>Japan</country>
      </address>
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  </location>
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    <facility>
      <name>Shinshu University Hospital /ID# 222395</name>
      <address>
        <city>Matsumoto-shi</city>
        <state>Nagano</state>
        <zip>390-8621</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
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    <facility>
      <name>Saitama Medical Center /ID# 222389</name>
      <address>
        <city>Kawagoe-shi</city>
        <state>Saitama</state>
        <zip>350-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital /ID# 222498</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital /ID# 221897</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RM Pharma Specialists S.A de C.V. /ID# 221915</name>
      <address>
        <city>Mexico City</city>
        <state>Ciudad De Mexico</state>
        <zip>03100</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 221913</name>
      <address>
        <city>Mexico City</city>
        <state>Ciudad De Mexico</state>
        <zip>11850</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morales Vargas Centro de Investigacion S.C. /ID# 221912</name>
      <address>
        <city>Leon</city>
        <state>Guanajuato</state>
        <zip>37000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Integral en Reumatologia S.A de C.V /ID# 221914</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44160</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Estudios de Investigación Básica y Clínica, S.C. /ID# 221910</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44690</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Care &amp; Research SA de CV /ID# 221911</name>
      <address>
        <city>Mérida</city>
        <state>Yucatan</state>
        <zip>97070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore Hospital /ID# 221850</name>
      <address>
        <city>Takapuna</city>
        <state>Auckland</state>
        <zip>0622</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 221860</name>
      <address>
        <city>Wroclaw</city>
        <state>Dolnoslaskie</state>
        <zip>51-685</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. /ID# 224430</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>31-011</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 221859</name>
      <address>
        <city>Poznan</city>
        <state>Wielkopolskie</state>
        <zip>61-545</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MTZ Clinical Research Powered by Pratia /ID# 224431</name>
      <address>
        <city>Warszawa</city>
        <zip>02-172</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GCM Medical Group PSC /ID# 224394</name>
      <address>
        <city>San Juan</city>
        <zip>00917-3104</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mindful Medical Research /ID# 222513</name>
      <address>
        <city>San Juan</city>
        <zip>00918-3756</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HUA - Txagorritxu /ID# 221992</name>
      <address>
        <city>Vitoria</city>
        <state>Alava</state>
        <zip>01009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 221995</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Basurto /ID# 221999</name>
      <address>
        <city>Bilbao</city>
        <state>Vizcaya</state>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Galdakao /ID# 221996</name>
      <address>
        <city>Galdakao</city>
        <state>Vizcaya</state>
        <zip>48960</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario A Coruna - CHUAC /ID# 221993</name>
      <address>
        <city>A Coruna</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre /ID# 221994</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de Valme /ID# 221997</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario y Politecnico La Fe /ID# 221998</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital /ID# 221747</name>
      <address>
        <city>Taichung City</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital /ID# 221748</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital /ID# 221745</name>
      <address>
        <city>Taipei City</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University Hospital /ID# 227653</name>
      <address>
        <city>Taipei City</city>
        <zip>11031</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hosp /ID# 221746</name>
      <address>
        <city>Taipei City</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linkou Chang Gung Memorial Hospital /ID# 222469</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guys and St Thomas NHS Foundation Trust /ID# 221863</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manchester University NHS Foundation Trust /ID# 221861</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Bulgaria</country>
    <country>China</country>
    <country>Colombia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Canada</country>
    <country>Netherlands</country>
  </removed_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>January 16, 2023</last_update_submitted>
  <last_update_submitted_qc>January 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Systemic Lupus Erythematosus</keyword>
  <keyword>ABBV-599</keyword>
  <keyword>ABBV-105</keyword>
  <keyword>ABT-494</keyword>
  <keyword>Elsubrutinib</keyword>
  <keyword>Upadacitinib</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Upadacitinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04451772
org study id: M20-186
secondary id: 2020-001690-72
nct id: NCT04451772
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation
      of multiple organ systems. This study will evaluate how well elsubrutinib and upadacitinib
      given alone or as the ABBV-599 combination (elsubrutinib/upadacitinib) works within the body,
      in participants who completed study M19-130. This study will assess the change in disease
      symptoms.

      ABBV-599 is an investigational drug being developed for the treatment of Systemic Lupus
      Erythematosus (SLE). This study is "double-blinded", which means that neither the trial
      participants nor the study doctors will know who will be given which study drug. Study
      doctors put the participants into 1 of 4 groups called treatment arms. Each group receives a
      different treatment. Adult participants with a diagnosis of SLE will be enrolled. Around 260
      participants will be enrolled in the study in approximately 100 sites worldwide.

      Participants will receive the following for up to 56 weeks:

      Participants will receive oral elsubrutinib capsules and/or oral upadacitinib tablets once
      daily for up to 56 weeks. Participants who were receiving elsubrutinib and/or upadacitnib in
      M19-130 will continue to receive the same treatment in this study. Participants who were
      receiving placebo in M19-130 will be re-randomized to one of the 2 combination treatment arms
      in this study.

      Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A Arm 2: Elsubrutinib Dose A and
      Upadacitinib Dose B

      There may be higher burden for participants in this trial compared to their standard of care.
      Participants will attend monthly visits during the course of the study at a hospital or
      clinic. The effect of the treatment will be checked by medical assessments, blood tests,
      checking for side effects and completing questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Adverse Events
time frame: Through Week 108
description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
measure: Achievement of Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
time frame: Through Week 104
description: SRI is a composite responder index based on improvement in disease activity without worsening of the overall condition or the development of significant disease activity in new organ systems.
measure: Achievement of British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA)
time frame: Through Week 104
description: BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.
measure: Change in Steroid Burden
time frame: Baseline of M19-130 (Week 0) Through Week 104
description: Steroid Burden is measured as milligrams (mg) of prednisone-equivalent administered.
measure: Number of Flares Per Patient-Year (Respectively and Overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLE Disease Activity Index (SLEDAI) flare index (SFI)
time frame: Through Week 104
description: SELENA SLEDAI flare index defines (mild, moderate or severe) SLE flares using the SLEDAI-2K score, disease activity scenarios, treatment changes, and Physician's Global Assessment of Disease Activity.
arm group label: Part 1: Elsubrutinib Dose A and Upadacitinib Dose A
arm group type: Experimental
description: Participants will receive Elsubrutinib Dose A and Upadacitinib Dose A once daily (QD).
arm group label: Part 2: Elsubrutinib Dose A and Upadacitinib Dose B
arm group type: Experimental
description: Participants will receive Elsubrutinib Dose A and Upadacitinib Dose B QD.
arm group label: Part 3: Elsubrutinib Dose A and Upadacitinib Placebo
arm group type: Experimental
description: Participants will receive Elsubrutinib Dose A and Upadacitinib placebo QD.
arm group label: Part 4: Elsubrutinib Placebo and Upadacitinib Dose A
arm group type: Experimental
description: Participants will receive Elsubrutinib placebo and Upadacitinib Dose A QD.
intervention type: Drug
intervention name: Elsubrutinib
description: Oral; Capsule
arm group label: Part 1: Elsubrutinib Dose A and Upadacitinib Dose A
arm group label: Part 2: Elsubrutinib Dose A and Upadacitinib Dose B
arm group label: Part 3: Elsubrutinib Dose A and Upadacitinib Placebo
other name: ABBV-105
intervention type: Drug
intervention name: Placebo for Elsubrutinib
description: Oral; Capsule
arm group label: Part 4: Elsubrutinib Placebo and Upadacitinib Dose A
intervention type: Drug
intervention name: Upadacitinib
description: Oral; Tablet
arm group label: Part 1: Elsubrutinib Dose A and Upadacitinib Dose A
arm group label: Part 2: Elsubrutinib Dose A and Upadacitinib Dose B
arm group label: Part 4: Elsubrutinib Placebo and Upadacitinib Dose A
other name: ABT-494
other name: RINVOQ
intervention type: Drug
intervention name: Placebo for Upadacitinib
description: Oral; Tablet
arm group label: Part 3: Elsubrutinib Dose A and Upadacitinib Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
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country: Argentina
country: Australia
country: Bulgaria
country: China
country: Colombia
country: Germany
country: Hungary
country: Italy
country: Japan
country: Korea, Republic of
country: Mexico
country: New Zealand
country: Poland
country: Puerto Rico
country: Spain
country: Taiwan
country: United Kingdom
country: United States
country: Canada
country: Netherlands
responsible party type: Sponsor
mesh term: Lupus Erythematosus, Systemic
mesh term: Upadacitinib
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
ipd url: https://vivli.org/ourmember/abbvie/