UCB1381 for Eczema

Recruiting at 25 trial locations

Overseen By UCB 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

Compensation: Varies

Number of Visits: Unknown

273 Participants Needed

Trial Summary

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.

Research Team

UCB Cares

Principal Investigator

001 844 599 2273 (UCB)

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: UCB1381 dosing regime 9 in Part B Experimental Treatment 1 Intervention

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

Group II: UCB1381 dosing regime 8 in Part A Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose UCB1381 intravenously (iv).

Group III: UCB1381 dosing regime 7 in Part A Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose UCB1381 intravenously (iv).

Group IV: UCB1381 dosing regime 6 in Part A Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose UCB1381 subcutaneously (sc).

Group V: UCB1381 dosing regime 5 in Part A Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose UCB1381 subcutaneously (sc).

Group VI: UCB1381 dosing regime 4 in Part A Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose UCB1381 intravenously (iv).

Group VII: UCB1381 dosing regime 3 in Part A Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose UCB1381 intravenously (iv).

Group VIII: UCB1381 dosing regime 2 in Part A Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose UCB1381 intravenously (iv).

Group IX: UCB1381 dosing regime 1 in Part A Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose UCB1381 intravenously (iv).

Group X: Placebo iv Arm Part A Placebo Group 1 Intervention

Participants will be randomized to receive a single dose of placebo iv to maintain the blinding.

Group XI: Placebo sc Arm Part A Placebo Group 1 Intervention

Participants will be randomized to receive a single dose of placebo sc to maintain the blinding.

Group XII: Placebo iv Arm Part B Placebo Group 1 Intervention

Participants will be randomized to receive repeated doses of placebo iv to maintain the blinding.

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven