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UCB1381 for Eczema

No longer recruiting at 26 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 tests a new treatment called UCB1381 to determine its effectiveness and safety for people with eczema (atopic dermatitis). Participants will receive different doses of the treatment either through an IV (intravenous) or under the skin (subcutaneous) and will be compared to those receiving a placebo (a harmless substance resembling the drug). The trial aims to assess how well UCB1381 works and how the body processes it. It seeks individuals who have experienced moderate to severe eczema for at least a year and have had issues with regular topical treatments. As a Phase 1, Phase 2 trial, it focuses on understanding the treatment's effects and measuring its initial effectiveness in a smaller group, offering participants a chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that UCB1381 is likely to be safe for humans?

Research shows that UCB1381 is being tested for safety and tolerability. This drug is administered both intravenously and subcutaneously. Earlier studies have examined single doses in healthy individuals and repeated doses in those with eczema, focusing on potential side effects or reactions. So far, the information primarily addresses safety, with no specific side effects highlighted. As this is an early-stage trial, the treatment is expected to be generally well-tolerated, indicating it is reasonably safe for testing in people. However, a complete understanding of its safety will emerge as more participants join the study and additional data is collected.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising for eczema?

Unlike the standard eczema treatments, which often include topical steroids and oral immunosuppressants, UCB1381 offers a new approach. Researchers are excited about UCB1381 because it is administered intravenously or subcutaneously, which can provide a more targeted delivery of the medication. This treatment could potentially act faster and more effectively by addressing the underlying immune response associated with eczema. By working differently than existing options, UCB1381 has the potential to offer relief with fewer side effects and improved outcomes for patients.

What evidence suggests that UCB1381 might be an effective treatment for eczema?

Research has shown that UCB1381 targets specific proteins involved in the inflammation process seen in eczema. This new approach aims to reduce the skin inflammation and itching common in atopic dermatitis. Early findings suggest that this method could help relieve symptoms by directly addressing the root causes of eczema. Data from initial studies are promising, showing improved skin condition and less itchiness for some patients. Although more research is needed to confirm these effects, UCB1381 offers hope for those seeking new eczema treatments. Participants in this trial will receive different dosing regimens of UCB1381 or a placebo to further evaluate its effectiveness.¹ ² ³ ⁶ ⁷

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