CompletedPhase 1/2

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)

United States109 participantsStarted 2022-03-07

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 B…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidents of treatment-emergent adverse events (TEAEs) from Baseline through the End of Study (EOS) Visit (Week 12) in Part A

Timeframe: From Baseline up to Week 12 in Part A

Incidents of treatment-emergent serious adverse events (TESAEs) from Baseline through the EOS Visit (Week 12) in Part A

Timeframe: From Baseline up to Week 12 in Part A

Incidents of TEAEs from Baseline through the EOS Visit (Week 22) in Part B

Timeframe: From Baseline up to Week 22 in Part B

Incidents of TESAEs from Baseline through the EOS Visit (Week 22) in Part B

Timeframe: From Baseline up to Week 22 in Part B

≥75% improvement vs Baseline (Yes/No) in Eczema Area and Severity Index score (EASI75) at Week 12 in Part B

Timeframe: From Baseline up to Week 12 in Part B

Trial details

NCT IDNCT05277571

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-17

View on ClinicalTrials.gov More Atopic Dermatitis trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidents of treatment-emergent adverse events (TEAEs) from Baseline through the End of Study (EOS) Visit (Week 12) in Part A

Timeframe: From Baseline up to Week 12 in Part A

Incidents of treatment-emergent serious adverse events (TESAEs) from Baseline through the EOS Visit (Week 12) in Part A

Timeframe: From Baseline up to Week 12 in Part A

Incidents of TEAEs from Baseline through the EOS Visit (Week 22) in Part B

Timeframe: From Baseline up to Week 22 in Part B

Incidents of TESAEs from Baseline through the EOS Visit (Week 22) in Part B

Timeframe: From Baseline up to Week 22 in Part B

≥75% improvement vs Baseline (Yes/No) in Eczema Area and Severity Index score (EASI75) at Week 12 in Part B

Timeframe: From Baseline up to Week 12 in Part B