Phase
Condition
Skin Wounds
Allergies & Asthma
Eczema (Atopic Dermatitis - Pediatric)
Treatment
UCB1381
Placebo
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Up0110 117
North Little Rock, Arkansas 72117
United StatesSite Not Available
Up0110 125
Beverly Hills, California 90212
United StatesSite Not Available
Up0110 101
Glendale, California 91206
United StatesSite Not Available
Up0110 126
Lake Forest, California 92630
United StatesSite Not Available
Up0110 116
Los Angeles, California 90045
United StatesSite Not Available
Up0110 121
Northridge, California 91324
United StatesSite Not Available
Up0110 123
Sherman Oaks, California 92866
United StatesSite Not Available
Up0110 126
Tustin, California 92780
United StatesSite Not Available
Up0110 127
Valencia, California 91355
United StatesSite Not Available
Up0110 108
Clearwater, Florida 33765
United StatesSite Not Available
Up0110 103
DeLand, Florida 32720
United StatesSite Not Available
Up0110 102
Miami, Florida 33147
United StatesSite Not Available
Up0110 109
Miami Lakes, Florida 33014
United StatesSite Not Available
Up0110 106
Ocala, Florida 34471
United StatesSite Not Available
Up0110 102
Saint Petersburg, Florida 33705
United StatesSite Not Available
Up0110 103
Seminole, Florida 33777
United StatesSite Not Available
Up0110 105
Tampa, Florida 33613
United StatesSite Not Available
Up0110 111
College Park, Georgia 30349
United StatesSite Not Available
Up0110 112
Normal, Illinois 61761
United StatesSite Not Available
Up0110 118
West Lafayette, Indiana 47906
United StatesSite Not Available
Up0110 114
Minneapolis, Minnesota 55455
United StatesSite Not Available
Up0110 107
New York, New York 10029-6501
United StatesSite Not Available
Up0110 129
New York, New York 10075
United StatesActive - Recruiting
Up0110 124
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Up0110 104
Oklahoma City, Oklahoma 73170
United StatesSite Not Available
Up0110 119
Philadelphia, Pennsylvania 19103
United StatesSite Not Available
Up0110 120
Dallas, Texas 75231
United StatesSite Not Available
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