A Phase 1/2A, Randomized, Placebo-Controlled, Single-Ascending Dose (Part A, Participant- and Investigator-Blind) and Repeat-Dose (Part B, Participant-, Investigator-, and Sponsor-Blind) 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)
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.
⁃ Part A Healthy study participants
• Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)
• Participant must be overtly healthy as determined by medical evaluation including medical 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 months prior 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 at Baseline
• 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) of inadequate response to treatment with topical medications (regular use of topical corticosteroids \[TCS\] or topical calcineurin inhibitors \[TCIs\]) or when topical treatments are confirmed to be otherwise medically inadvisable (eg, because of important side effects or safety risks)
• Participant has a BMI within the range 18 to 35 kg/m2 (inclusive)