<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/NCT03827798</url>
  </required_header>
  <id_info>
    <org_study_id>CCFZ533H12201BC</org_study_id>
    <nct_id>NCT03827798</nct_id>
  </id_info>
  <brief_title>Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa</brief_title>
  <official_title>A Randomized, Subject and Investigator Blinded, Placebo-controlled and Multi-center Platform Study, to Assess Efficacy and Safety of Different Investigational Drugs in Patients With Moderate to Severe Hidradenitis Suppurativa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to assess preliminary efficacy and safety of CFZ533,&#xD;
      LYS006, MAS825 , LOU064 and VAY736 in patients with moderate to severe hidradenitis&#xD;
      suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate&#xD;
      clinical profile for further clinical development.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 27, 2019</start_date>
  <completion_date type="Anticipated">October 23, 2026</completion_date>
  <primary_completion_date type="Anticipated">October 23, 2026</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>Hidradenitis Suppurativa Clinical Response (HiSCR)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Proportion of patients achieving clinical response after 16 weeks of treatment</description>
  </primary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Anticipated">245</enrollment>
  <condition>Hidradenitis Suppurativa</condition>
  <arm_group>
    <arm_group_label>CFZ533</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>s.c.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LYS006</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>p.o.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to CFZ533</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo (s.c.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to LYS006</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo (p.o.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MAS825</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>s.c.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to MAS825</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo (s.c.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LOU064 25mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>p.o.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LOU064 100mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>p.o.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to LOU064</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo p.o.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VAY736</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>s.c.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to VAY736</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo (s.c.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CFZ533</intervention_name>
    <description>s.c.</description>
    <arm_group_label>CFZ533</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to CFZ533</intervention_name>
    <description>s.c.</description>
    <arm_group_label>Placebo to CFZ533</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LYS006</intervention_name>
    <description>p.o.</description>
    <arm_group_label>LYS006</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to LYS006</intervention_name>
    <description>p.o.</description>
    <arm_group_label>Placebo to LYS006</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MAS825</intervention_name>
    <description>s.c.</description>
    <arm_group_label>MAS825</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to MAS825</intervention_name>
    <description>s.c.</description>
    <arm_group_label>Placebo to MAS825</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LOU064 25mg</intervention_name>
    <description>p.o.</description>
    <arm_group_label>LOU064 25mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LOU064 100mg</intervention_name>
    <description>p.o.</description>
    <arm_group_label>LOU064 100mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to LOU064</intervention_name>
    <description>p.o.</description>
    <arm_group_label>Placebo to LOU064</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VAY736</intervention_name>
    <description>s.c.</description>
    <arm_group_label>VAY736</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to VAY736</intervention_name>
    <description>s.c.</description>
    <arm_group_label>Placebo to VAY736</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with moderate to severe HS based on the number of lesions, fistulae and&#xD;
             anatomical areas involved&#xD;
&#xD;
          -  Minimal body weight of 50 kg&#xD;
&#xD;
          -  Able to communicate well with the investigator and understand and comply with the&#xD;
             requirements of the study, and the ability and willingness to conduct study visits as&#xD;
             per the study schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of other investigational drugs at the time of screening or before&#xD;
&#xD;
          -  Women physiologically capable of becoming pregnant, unless they are using highly&#xD;
             effective methods of contraception&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria may apply&#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_contact>
    <last_name>Novartis Pharmaceuticals</last_name>
    <phone>1-888-669-6682</phone>
    <email>novartis.email@novartis.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Novartis Pharmaceuticals</last_name>
    <phone>+41613241111</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Orange Park</city>
        <state>Florida</state>
        <zip>32073</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033-0850</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Wien</city>
        <zip>A 1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Prague</city>
        <state>Prague 1</state>
        <zip>11000</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Copenhagen NV</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Roskilde</city>
        <zip>4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Antony</city>
        <zip>92160</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lyon</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Marseille Cedex 05</city>
        <zip>13885</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rouen Cedex</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Darmstadt</city>
        <zip>64297</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Halle (Saale)</city>
        <zip>06108</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Koeln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Schwerin</city>
        <zip>19055</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Budapest</city>
        <zip>1085</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pecs</city>
        <zip>7623</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Szeged</city>
        <zip>H 6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kopavogur</city>
        <zip>201</zip>
        <country>Iceland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Valencia</city>
        <state>Comunidad Valenciana</state>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Manises</city>
        <state>Valencia</state>
        <zip>46940</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Granada</city>
        <zip>18012</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <zip>35010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28031</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Iceland</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hidradenitis suppurativa, acne inversa, platform study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hidradenitis Suppurativa</mesh_term>
    <mesh_term>Hidradenitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
  </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/NCT03827798
org study id: CCFZ533H12201BC
nct id: NCT03827798
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The main purpose of this study is to assess preliminary efficacy and safety of CFZ533,
      LYS006, MAS825 , LOU064 and VAY736 in patients with moderate to severe hidradenitis
      suppurativa and to determine if CFZ533, LYS006, MAS825, LOU064 and VAY736 have an adequate
      clinical profile for further clinical development.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Hidradenitis Suppurativa Clinical Response (HiSCR)
time frame: 16 weeks
description: Proportion of patients achieving clinical response after 16 weeks of treatment
arm group label: CFZ533
arm group type: Experimental
description: s.c.
arm group label: LYS006
arm group type: Experimental
description: p.o.
arm group label: Placebo to CFZ533
arm group type: Placebo Comparator
description: Matching placebo (s.c.)
arm group label: Placebo to LYS006
arm group type: Placebo Comparator
description: Matching placebo (p.o.)
arm group label: MAS825
arm group type: Experimental
description: s.c.
arm group label: Placebo to MAS825
arm group type: Placebo Comparator
description: Matching placebo (s.c.)
arm group label: LOU064 25mg
arm group type: Active Comparator
description: p.o.
arm group label: LOU064 100mg
arm group type: Active Comparator
description: p.o.
arm group label: Placebo to LOU064
arm group type: Placebo Comparator
description: Matching placebo p.o.
arm group label: VAY736
arm group type: Experimental
description: s.c.
arm group label: Placebo to VAY736
arm group type: Placebo Comparator
description: Matching placebo (s.c.)
intervention type: Drug
intervention name: CFZ533
description: s.c.
arm group label: CFZ533
intervention type: Drug
intervention name: Placebo to CFZ533
description: s.c.
arm group label: Placebo to CFZ533
intervention type: Drug
intervention name: LYS006
description: p.o.
arm group label: LYS006
intervention type: Drug
intervention name: Placebo to LYS006
description: p.o.
arm group label: Placebo to LYS006
intervention type: Drug
intervention name: MAS825
description: s.c.
arm group label: MAS825
intervention type: Drug
intervention name: Placebo to MAS825
description: s.c.
arm group label: Placebo to MAS825
intervention type: Drug
intervention name: LOU064 25mg
description: p.o.
arm group label: LOU064 25mg
intervention type: Drug
intervention name: LOU064 100mg
description: p.o.
arm group label: LOU064 100mg
intervention type: Drug
intervention name: Placebo to LOU064
description: p.o.
arm group label: Placebo to LOU064
intervention type: Drug
intervention name: VAY736
description: s.c.
arm group label: VAY736
intervention type: Drug
intervention name: Placebo to VAY736
description: s.c.
arm group label: Placebo to VAY736
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
phone: 1-888-669-6682
email: novartis.email@novartis.com
last name: Novartis Pharmaceuticals
phone: +41613241111
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Austria
country: Belgium
country: Czechia
country: Denmark
country: France
country: Germany
country: Hungary
country: Iceland
country: Netherlands
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Hidradenitis Suppurativa
mesh term: Hidradenitis
mesh term: Antibodies, Monoclonal
sharing ipd: Undecided
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com