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Compensation: Varies

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273 Participants Needed

UCB1381 for Eczema

Recruiting at 25 trial locations

Overseen ByUCB Cares

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: UCB Biopharma SRL

Must be taking: Topical corticosteroids

Must not be taking: Biologics, JAK inhibitors

Disqualifiers: Inflammatory bowel disease, others

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called UCB1381 to see if it is safe and well-tolerated when given through a vein or under the skin. The study includes both healthy individuals and those with atopic dermatitis, a condition causing red, itchy skin. The drug likely works by calming the immune system to reduce skin inflammation.

Will I have to stop taking my current medications?

Yes, participants must stop taking certain medications before joining the trial. Specifically, those with atopic dermatitis must stop using topical therapies for 2 weeks and systemic therapies for 4 weeks before the study starts. Other medications, except for some exceptions like contraceptives and occasional pain relievers, must be stopped 14 days before the study.

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273 (UCB)

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-55 with a BMI of 18-30 kg/m2, and adults aged 18-65 with moderate to severe atopic dermatitis (AD), a BMI of 18-35 kg/m2, and certain severity scores. Participants must not have used specific treatments recently or have conditions that could affect the study.

Inclusion Criteria

Your body mass index (BMI) is between 18 and 30.

I have had severe skin eczema for over a year, not better with usual creams.

I agree to use birth control during the study.

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Exclusion Criteria

Part B Participants with moderate to severe Atopic dermatitis (AtD) must not have participated in another study of an IMP within 30 days or 5 half-lives (whichever is longer) of the Baseline Visit or is currently participating in another study of an IMP

Part B Participants with moderate to severe Atopic dermatitis (AtD) must not have a history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, electrocardiogram (ECG), or vital sign that, in the opinion of the investigator, could significantly alter the absorption, metabolism, or elimination of drugs; constitute a risk when taking the study intervention; or interfere with the interpretation of data

I have moderate to severe Atopic dermatitis and haven't been in studies for IL-13 or IL-22 or JAK inhibitors recently.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single-Ascending Dose (Part A)

Participants receive a single dose of UCB1381 or placebo intravenously or subcutaneously to assess safety and tolerability

12 weeks

Multiple visits for dosing and monitoring

Repeat-Dose (Part B)

Participants with moderate to severe atopic dermatitis receive repeated doses of UCB1381 or placebo intravenously to assess safety, pharmacokinetics, and efficacy

22 weeks

Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

UCB1381

Trial Overview The safety and effects of UCB1381 are being tested in two parts: Part A tests single doses on healthy participants; Part B tests repeated doses on those with AD compared to placebo. The focus is on how well it works for AD after multiple doses.

How Is the Trial Designed?

12Treatment groups

Experimental Treatment

Placebo Group

Group I: UCB1381 dosing regime 9 in Part BExperimental Treatment1 Intervention

Participants will be randomized to receive repeated doses UCB1381 intravenously (iv).

Group II: UCB1381 dosing regime 8 in Part AExperimental Treatment1 Intervention