What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly systemic treatments like monoclonal antibodies (e.g., dupilumab) and immunomodulators, can have side effects such as injection site reactions, nasopharyngitis, headache, and conjunctivitis. Other potential side effects include exacerbation of atopic dermatitis, respiratory tract infections, and mild gastrointestinal symptoms. These treatments are generally well-tolerated, but long-term safety data is still being evaluated.

What prior FDA approvals exist?

The FDA has approved several treatments for moderate-to-severe atopic dermatitis, including biologics such as dupilumab and tralokinumab. Dupilumab, an IL-4/IL-13 inhibitor, has shown significant efficacy in reducing symptoms and improving quality of life for patients. Tralokinumab, another IL-13 inhibitor, has also been approved for similar indications. These treatments work by targeting specific pathways involved in the inflammatory process of atopic dermatitis, similar to the investigational drug UCB1381, which is being studied for its safety, pharmacokinetics, and efficacy in treating this condition.

What other types of research exist?

Promising novel alternatives to UCB1381 for atopic dermatitis include: 1) JTE-052, a topical Janus kinase inhibitor, which has shown efficacy and safety in Japanese adult patients with moderate-to-severe AD. 2) SDZ ASM 981 (1% cream), which demonstrated efficacy in a randomized, double-blind, placebo-controlled study for moderate AD. 3) Ruxolitinib cream, which has shown efficacy and safety in phase 3 trials for moderate-to-severe AD. 4) Abrocitinib, an oral Janus kinase inhibitor, which has shown efficacy and safety in multiple phase 3 trials. 5) Upadacitinib, another oral Janus kinase inhibitor, which has demonstrated efficacy and safety in phase 3 trials for moderate-to-severe AD.

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Other

UCB1381 for Eczema

Phase 1 & 2

Recruiting

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)

Part A Healthy study participants must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)

Must not have

Part A Healthy study participants must not have a past history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)

Part A Healthy study participants must not have participated in another study of an IMP or received any biologic agent (such as mAbs, including marketed drugs and including biologic agents that target interleukin (IL)-13 or IL-22) within the 30 days prior to Screening or 5 half-lives (whichever is longer), if this information can be validated by the investigator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to week 22 in part b

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects aren't specified here, common ones for new drugs like UCB1381 might include reactions at injection sites, fatigue, headaches, or allergic responses. More details would be provided by the study team.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

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I am between 18 and 55 years old and can sign a consent form.

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

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I have moderate to severe Atopic dermatitis and my BMI is between 18 and 35.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had inflammatory bowel disease, including Crohn's or ulcerative colitis.

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I haven't been in another drug study or taken biologic agents in the last 30 days or 5 half-lives.

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I have moderate to severe Atopic dermatitis and no history of inflammatory bowel disease.

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I haven't used certain medications or treatments for my severe skin condition in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to week 22 in part b

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to week 22 in part b

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to week 22 in part b for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+2 more

Secondary study objectives

Percent change from Baseline in EASI score at Week 12 in Part B

UCB1381 AUC from Baseline through the EOS Visit (Week 12) in Part A

UCB1381 AUC(0-t) from Baseline through the EOS Visit (Week 12) in Part A

+9 more

Trial Design

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