<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/NCT04444466</url>
  </required_header>
  <id_info>
    <org_study_id>UP0086</org_study_id>
    <secondary_id>2019-002981-12</secondary_id>
    <nct_id>NCT04444466</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants</brief_title>
  <official_title>A First-In-Human, Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB Biopharma SRL</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UCB Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess safety, tolerability and pharmacokinetics (PK) of oral&#xD;
      UCB8600.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Study was only open for recruitment of Healthy Study Participants (Part A) prior to&#xD;
      termination and did not enroll any patient population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    internal company decision; not safety related&#xD;
  </why_stopped>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">August 2, 2021</completion_date>
  <primary_completion_date type="Actual">August 2, 2021</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>Cohort design</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>This is an investigator- and participant-blind study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>From Baseline (Day 1) until the End of Study (up to Day 42)</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event is characterized according to the intake of the study medication.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The maximum plasma concentration (Cmax) of a single dose UCB8600</measure>
    <time_frame>Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose</time_frame>
    <description>Cmax: Maximum observed plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum plasma concentration (tmax) of a single dose UCB8600</measure>
    <time_frame>Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose</time_frame>
    <description>tmax: Time to maximum observed plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The area under the curve (AUC) of a single dose UCB8600</measure>
    <time_frame>Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose</time_frame>
    <description>AUC0-infinity: Area under the plasma concentration time curve from time 0 to infinity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The maximum plasma concentration (Cmax) of multiple doses UCB8600</measure>
    <time_frame>Plasma samples will be taken on Day 1, 9 and 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose</time_frame>
    <description>Cmax: Maximum observed plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum plasma concentration (tmax) of multiple doses UCB8600</measure>
    <time_frame>Plasma samples will be taken on Day 1, 9 and 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose</time_frame>
    <description>tmax: Time to maximum observed plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The area under the curve (AUCtau) over a dosing interval on Day 1 of multiple doses UCB8600</measure>
    <time_frame>Plasma samples will be taken on Day 1 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose</time_frame>
    <description>AUCtau: Area Under the Curve over a dosing interval</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The area under the curve (AUCtau) over a dosing interval on Day 9 of multiple doses UCB8600</measure>
    <time_frame>Plasma samples will be taken on Day 9 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose</time_frame>
    <description>AUCtau: Area Under the Curve over a dosing interval</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The area under the curve (AUCtau) over a dosing interval on Day 14 of multiple doses UCB8600</measure>
    <time_frame>Plasma samples will be taken on Day 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose</time_frame>
    <description>AUCtau: Area Under the Curve over a dosing interval</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy Study Participants</condition>
  <condition>Chronic Spontaneous Urticaria</condition>
  <arm_group>
    <arm_group_label>UCB8600</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants randomized to this arm will receive various single doses and multiple doses of UCB8600 administered to various cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Study participants randomized to this arm will receive various single doses and multiple doses of Placebo administered to various cohorts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>UCB8600</intervention_name>
    <description>Study participants will receive UCB8600 in a pre-specified sequence during the Treatment Period.</description>
    <arm_group_label>UCB8600</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Study participants will receive Placebo in a pre-specified sequence during the Treatment Period matching UCB8600.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>PBO</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Applicable to Parts A-D&#xD;
&#xD;
          -  Participant must be 18 to 65 years of age inclusive, at the time of signing the&#xD;
             informed consent&#xD;
&#xD;
          -  Participants who are overtly healthy (in the opinion of the investigator) as&#xD;
             determined by medical evaluation including medical history (any chronic and acute&#xD;
             illness), physical examination, vital signs, 12-lead electrocardiogram (ECG), and&#xD;
             laboratory screening tests at the Screening Visit&#xD;
&#xD;
          -  Body weight 45 kg or greater and body mass index (BMI) within the range 19 and 30&#xD;
             kg/m^2 (inclusive)&#xD;
&#xD;
        Part B-specific&#xD;
&#xD;
          -  Study participants must have a Screening serum immunoglobulin E (IgE) of ≥30 kU/L and&#xD;
             ≤700 kU/L for inclusion in Cohort 1 through Cohort 4a and &gt;700 kU/L for inclusion in&#xD;
             Cohort 4b&#xD;
&#xD;
          -  Study participants must be documented to be sensitized to at least 1 common&#xD;
             aeroallergen confirmed by (skin prick test (SPT) at Screening)&#xD;
&#xD;
        Part C-specific&#xD;
&#xD;
          -  Study participants must have a diagnosis of chronic spontaneous urticaria (CSU)&#xD;
             diagnosed by a dermatologist, allergist or clinical immunologist and have persistent&#xD;
             symptoms most days of the week for the last 6 weeks despite regular use of an H1&#xD;
             antihistamine according to the EAACI/GA²LEN/EDF/WAO guideline&#xD;
&#xD;
          -  Study participants must have a documented 7-day Urticaria Assessment Score (UAS7)&#xD;
             score of 16 or above and an 7-day Itch Severity Score (ISS7) of 8 or above at Visit 2&#xD;
             (Day -1, Admission)&#xD;
&#xD;
          -  Study participants must have a Screening serum immunoglobulin E (IgE) of ≥30 kU/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Applicable to Parts A-D&#xD;
&#xD;
          -  Participant has any (acute or chronic [including severe acute respiratory syndrome&#xD;
             coronavirus 2 (SARS-CoV-2) infection]) medical or psychiatric condition that, in the&#xD;
             opinion of the investigator, could jeopardize or would compromise the study&#xD;
             participant's ability to participate in this study&#xD;
&#xD;
          -  Study participant has 12-lead electrocardiogram (ECG) with changes considered to be&#xD;
             clinically significant (eg, QT interval corrected using Fridericia's formula (QTcF)&#xD;
             &gt;450 msec , left bundle branch block, or evidence of myocardial ischemia) at the&#xD;
             Screening Visit or Day -1 (Admission)&#xD;
&#xD;
          -  A history of additional risk factors for Torsades de pointes (TdP) (eg, heart failure,&#xD;
             hypokalemia, family history of Long QT Syndrome)&#xD;
&#xD;
          -  Study participant has a history of atopy, allergic rhinitis, urticaria, angioedema,&#xD;
             asthma, food allergies, or anaphylaxis&#xD;
&#xD;
          -  Study participant has a known hypersensitivity to any components of the study&#xD;
             medication or comparative drugs as stated in this protocol&#xD;
&#xD;
          -  Study participant has a history of drug allergy or other allergy that, in the opinion&#xD;
             of the investigator or UCB Study Physician, contraindicates his/her participation&#xD;
&#xD;
          -  Study participants with evidence of helminthic parasitic infection as evidenced by&#xD;
             stools being positive for a pathogenic organism according to local guidelines. All&#xD;
             participants will be screened at Screening. If stool testing is positive for&#xD;
             pathogenic organism, the participants will not enter Treatment Period and will not be&#xD;
             allowed to rescreen&#xD;
&#xD;
          -  Study participant has received prescription or nonprescription medicines (including&#xD;
             over-the-counter medicines and herbal and dietary supplements [including St John's&#xD;
             Wort]) that have been taken within 14 days prior to Screening. Drugs that are strong&#xD;
             or moderate inhibitors or inducers of cytochrome P450 (CYP)3A4 and/or P-glycoprotein&#xD;
             (Pgp) are prohibited&#xD;
&#xD;
          -  The use of concomitant medications that prolong the QT/QTc interval&#xD;
&#xD;
          -  Study participant has donated more than 500 mL of blood or blood products within 90&#xD;
             days prior to Admission (Day -1) or plans to donate blood during the study (20 weeks&#xD;
             post Screening)&#xD;
&#xD;
          -  Study participant has consumed any grapefruit, grapefruit juice, grapefruit-containing&#xD;
             products, or star fruit within 14 days prior to administration of UCB8600&#xD;
&#xD;
        Part B-specific&#xD;
&#xD;
          -  Study participant has:&#xD;
&#xD;
               1. a history of angioedema, severe asthma, severe food allergies, or anaphylaxis&#xD;
&#xD;
               2. a personal or family history of cardiomyopathy&#xD;
&#xD;
          -  A Screening forced expiratory volume (FEV1) &lt;80% predicted (highest of 3)&#xD;
&#xD;
          -  Study participant has:&#xD;
&#xD;
               1. Allergen immunotherapy, also known as desensitization or hyposensitization at a&#xD;
                  maintenance licensed dose (depending on the type of immunotherapy [subcutaneous&#xD;
                  or sublingual]) for ≥3 months prior to Screening and then throughout the study&#xD;
&#xD;
               2. Severe positive reaction to Screening skin prick test&#xD;
&#xD;
          -  Topical or systemic corticosteroids, including high dose oral (&gt;5 mg prednisolone), in&#xD;
             the past 14 days prior to Screening and throughout the study&#xD;
&#xD;
          -  Topical immunosuppressants in the past 14 days prior to Screening and throughout the&#xD;
             study&#xD;
&#xD;
          -  Tricyclic antidepressants, prescription antihistamines, over-the-counter&#xD;
             antihistamines, and heartburn medications in the past 14 days prior to Admission&#xD;
&#xD;
          -  Systemic immunosuppressants such as azathioprine, methotrexate, cyclosporine, and&#xD;
             mycophenolate mofetil in the past 4 weeks prior to Screening and throughout the study&#xD;
&#xD;
          -  Biologics such as omalizumab for the past 6 months prior to Screening and throughout&#xD;
             the study&#xD;
&#xD;
        Part C-specific&#xD;
&#xD;
          -  Study participant has:&#xD;
&#xD;
               1. a history of angioedema, severe asthma, severe food allergies, or anaphylaxis&#xD;
&#xD;
               2. a personal or family history of cardiomyopathy&#xD;
&#xD;
          -  Study participants with a serum IgE level of &gt;1000 kU/L&#xD;
&#xD;
          -  A screening FEV1 &lt;80% predicted (average of 3)&#xD;
&#xD;
          -  Allergen immunotherapy, also known as desensitization or hyposensitization at a&#xD;
             maintenance licensed dose (depending on the type of immunotherapy [subcutaneous or&#xD;
             sublingual]) for ≥3 months prior to Screening and then throughout the study&#xD;
&#xD;
          -  Topical or systemic corticosteroids, including high dose oral (&gt;5 mg prednisolone), in&#xD;
             the past 14 days prior to Screening and throughout the study&#xD;
&#xD;
          -  Topical immunosuppressants in the past 14 days prior to Screening and throughout the&#xD;
             study&#xD;
&#xD;
          -  Systemic immunosuppressants such as azathioprine, methotrexate, cyclosporine, and&#xD;
             mycophenolate mofetil in the past 4 weeks prior to Screening and throughout the study&#xD;
&#xD;
          -  Biologics such as omalizumab for the past 6 months prior to Screening and throughout&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>UCB Cares</last_name>
    <role>Study Director</role>
    <affiliation>001 844 599 2273 (UCB)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Up0086 001</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>July 15, 2022</last_update_submitted>
  <last_update_submitted_qc>July 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy study participants</keyword>
  <keyword>UCB8600</keyword>
  <keyword>Phase 1</keyword>
  <keyword>Chronic spontaneous urticaria</keyword>
  <keyword>CSU</keyword>
  <keyword>IgE</keyword>
  <keyword>Atopic participants</keyword>
  <keyword>Urticaria</keyword>
  <keyword>UCB</keyword>
  <keyword>Food Effect (Part D)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urticaria</mesh_term>
    <mesh_term>Chronic Urticaria</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.</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/NCT04444466
org study id: UP0086
secondary id: 2019-002981-12
nct id: NCT04444466
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to assess safety, tolerability and pharmacokinetics (PK) of oral
      UCB8600.
The Study was only open for recruitment of Healthy Study Participants (Part A) prior to
      termination and did not enroll any patient population.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cohort design
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: This is an investigator- and participant-blind study.
measure: Incidence of treatment-emergent adverse events (TEAEs)
time frame: From Baseline (Day 1) until the End of Study (up to Day 42)
description: An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event is characterized according to the intake of the study medication.
measure: The maximum plasma concentration (Cmax) of a single dose UCB8600
time frame: Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose
description: Cmax: Maximum observed plasma concentration
measure: Time to maximum plasma concentration (tmax) of a single dose UCB8600
time frame: Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose
description: tmax: Time to maximum observed plasma concentration
measure: The area under the curve (AUC) of a single dose UCB8600
time frame: Plasma samples will be taken predose on Day 1 and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216 hours postdose
description: AUC0-infinity: Area under the plasma concentration time curve from time 0 to infinity
measure: The maximum plasma concentration (Cmax) of multiple doses UCB8600
time frame: Plasma samples will be taken on Day 1, 9 and 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
description: Cmax: Maximum observed plasma concentration
measure: Time to maximum plasma concentration (tmax) of multiple doses UCB8600
time frame: Plasma samples will be taken on Day 1, 9 and 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
description: tmax: Time to maximum observed plasma concentration
measure: The area under the curve (AUCtau) over a dosing interval on Day 1 of multiple doses UCB8600
time frame: Plasma samples will be taken on Day 1 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
description: AUCtau: Area Under the Curve over a dosing interval
measure: The area under the curve (AUCtau) over a dosing interval on Day 9 of multiple doses UCB8600
time frame: Plasma samples will be taken on Day 9 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
description: AUCtau: Area Under the Curve over a dosing interval
measure: The area under the curve (AUCtau) over a dosing interval on Day 14 of multiple doses UCB8600
time frame: Plasma samples will be taken on Day 14 at: predose, 0.5, 1, 2, 3, 6, 12, 24 hours postdose
description: AUCtau: Area Under the Curve over a dosing interval
arm group label: UCB8600
arm group type: Experimental
description: Study participants randomized to this arm will receive various single doses and multiple doses of UCB8600 administered to various cohorts.
arm group label: Placebo
arm group type: Placebo Comparator
description: Study participants randomized to this arm will receive various single doses and multiple doses of Placebo administered to various cohorts.
intervention type: Drug
intervention name: UCB8600
description: Study participants will receive UCB8600 in a pre-specified sequence during the Treatment Period.
arm group label: UCB8600
intervention type: Other
intervention name: Placebo
description: Study participants will receive Placebo in a pre-specified sequence during the Treatment Period matching UCB8600.
arm group label: Placebo
other name: PBO
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: UCB Cares
role: Study Director
affiliation: 001 844 599 2273 (UCB)
facility: 
country: Bulgaria
responsible party type: Sponsor
mesh term: Urticaria
mesh term: Chronic Urticaria
sharing ipd: No
ipd description: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.