A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B)

Last updated: April 24, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Skin Wounds

Allergies & Asthma

Eczema (Atopic Dermatitis - Pediatric)

Treatment

UCB1381

Placebo

Clinical Study ID

NCT05277571
UP0110
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants with atopic dermatitis. Efficacy will be assessed following repeat intravenous dosing versus placebo in study participants with atopic dermatitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Part A Healthy study participants

  • Participant must be 18 to 55 years of age inclusive at the time of signing theinformed consent form (ICF)

  • Participant must be overtly healthy as determined by medical evaluation includingmedical history, physical examination, laboratory tests, and cardiac monitoring

  • Participant has a body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive)

  • Participant can be male or female and must agree to use contraception

Part B Participants with moderate to severe Atopic dermatitis (AtD)

  • Participant must be 18 to 65 years of age inclusive at the time of signing the ICF

  • Participant has moderate or severe AtD that has been present for at least 12 monthsprior to initiating the study (signing of the ICF) and with:

  • A validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline

  • An Eczema Area and Severity Index (EASI) score of ≥14 at Screening and ≥16 atBaseline

  • Pruritis Numerical Rating Scale (NRS) ≥3 at Screening and Baseline

-≥10 % body surface area (BSA) of AtD involvement at Screening and Baseline

  • Either documented recent history (within 6 months before the Screening Visit) ofinadequate response to treatment with topical medications (regular use of topicalcorticosteroids [TCS] or topical calcineurin inhibitors [TCIs]) or when topicaltreatments are confirmed to be otherwise medically inadvisable (eg, because ofimportant side effects or safety risks)

  • Participant has a BMI within the range 18 to 35 kg/m2 (inclusive)

Exclusion

Exclusion Criteria:

Part A Healthy study participants

  • Participant has a history or presence of any medical or psychiatric condition,physical examination finding, laboratory test result, electrocardiogram (ECG), orvital sign that, in the opinion of the investigator, could significantly alter theabsorption, metabolism, or elimination of drugs; constitute a risk when taking thestudy intervention; or interfere with the interpretation of data

  • Participant has a known hypersensitivity to any components of the investigationalmedicinal product (IMP) or other biologic drugs (including humanized monoclonalantibodies (mAbs)), clinically significant drug allergies, or history of severeadverse reactions after drug administration

  • Participant has a past history of inflammatory bowel disease (includes Crohn'sdisease and ulcerative colitis)

  • Participant has previously been randomized in this study

  • Participant has participated in another study of an IMP or has received any biologicagent (such as mAbs, including marketed drugs and including biologic agents thattarget interleukin (IL)-13 or IL-22) within the 30 days prior to Screening or 5half-lives (whichever is longer), if this information can be validated by theinvestigator

Part B Participants with moderate to severe AtD

  • Participant has a history or presence of any medical or psychiatric condition,physical examination finding, laboratory test result, electrocardiogram (ECG), orvital sign that, in the opinion of the investigator, could significantly alter theabsorption, metabolism, or elimination of drugs; constitute a risk when taking thestudy intervention; or interfere with the interpretation of data

  • Participant has a known hypersensitivity to any components of the IMP or otherbiologic drugs (including humanized mAbs), clinically significant drug allergies, orhistory of severe adverse reactions after drug administration

  • Participant has a past history of inflammatory bowel disease (includes Crohn'sdisease and ulcerative colitis)

  • Participant has had pharmaceutically active topical therapies for AtD (includingmild topical corticosteroids (TCS)) within 2 weeks of the Baseline Visit (corticosteroids, cyclosporin or other calcineurin inhibitors [eg, tacrolimus,pimecrolimus])

  • Participant has received phototherapy or systemic non-biologic therapies for AtDwithin 4 weeks of the Baseline Visit (including moderate/strong corticosteroids,cyclosporine A or other calcineurin inhibitors, mycophenolate mofetil, azathioprine,methotrexate, or any alternative medicine for AtD, eg, traditional Chinese medicine)

  • Participant has previously used a biologic that affects IL-13 or IL-22 pathways, orany JAK inhibitor (including marketed and/or experimental treatments), within 30days or 5 half-lives (whichever is longer) of the Baseline Visit. Previous use ofbiologics affecting IL-13 or IL-22 pathways is only accepted if treatment wasstopped due to reasons other than inadequate efficacy and safety (eg, administrativereasons, poor convenience, poor access to drug)

  • Participant has received any prescription or nonprescription medicines, includingover the counter remedies and herbal and dietary supplements (other than vitaminswithin recommended daily dose limits) within 14 days (or 5 half-lives of therespective drug, whichever is longer) prior to the Baseline Visit, other thancontraceptives (oral, implant, or intrauterine devices) or occasional use ofanalgesics such as paracetamol (acetaminophen, with or without caffeine, with amaximal dose of 4g/day and 10g/14 days) or intranasal corticosteroids for seasonalrhinitis or inhaled bronchodilators and low dose inhaled corticosteroids for mildasthma. In case of uncertainty, the UCB Development Physician should be consulted

  • Participant has previously been randomized in this study

  • Participant has participated in previous studies with a biologic that affects IL-13or IL-22 pathways, or any JAK inhibitor (including marketed and/or experimentaltreatments), within 30 days or 5 half-lives (whichever is longer) of the BaselineVisit. Previous use of biologics affecting IL-13 or IL-22 pathways is only acceptedif treatment was stopped due to reasons other than inadequate efficacy and safety (eg, administrative reasons, poor convenience, poor access to drug)

  • Participant has participated in another study of an IMP within 30 days or 5half-lives (whichever is longer) of the Baseline Visit or is currently participatingin another study of an IMP

Study Design

Total Participants: 273
Treatment Group(s): 2
Primary Treatment: UCB1381
Phase: 1/2
Study Start date:
March 07, 2022
Estimated Completion Date:
October 01, 2025

Connect with a study center

  • Up0110 117

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • Up0110 125

    Beverly Hills, California 90212
    United States

    Site Not Available

  • Up0110 101

    Glendale, California 91206
    United States

    Site Not Available

  • Up0110 126

    Lake Forest, California 92630
    United States

    Site Not Available

  • Up0110 116

    Los Angeles, California 90045
    United States

    Site Not Available

  • Up0110 121

    Northridge, California 91324
    United States

    Site Not Available

  • Up0110 123

    Sherman Oaks, California 92866
    United States

    Site Not Available

  • Up0110 126

    Tustin, California 92780
    United States

    Site Not Available

  • Up0110 127

    Valencia, California 91355
    United States

    Site Not Available

  • Up0110 108

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Up0110 103

    DeLand, Florida 32720
    United States

    Site Not Available

  • Up0110 102

    Miami, Florida 33147
    United States

    Site Not Available

  • Up0110 109

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Up0110 106

    Ocala, Florida 34471
    United States

    Site Not Available

  • Up0110 102

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • Up0110 103

    Seminole, Florida 33777
    United States

    Site Not Available

  • Up0110 105

    Tampa, Florida 33613
    United States

    Site Not Available

  • Up0110 111

    College Park, Georgia 30349
    United States

    Site Not Available

  • Up0110 112

    Normal, Illinois 61761
    United States

    Site Not Available

  • Up0110 118

    West Lafayette, Indiana 47906
    United States

    Site Not Available

  • Up0110 114

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Up0110 107

    New York, New York 10029-6501
    United States

    Site Not Available

  • Up0110 129

    New York, New York 10075
    United States

    Active - Recruiting

  • Up0110 124

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Up0110 104

    Oklahoma City, Oklahoma 73170
    United States

    Site Not Available

  • Up0110 119

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • Up0110 120

    Dallas, Texas 75231
    United States

    Site Not Available

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