What is galvokimig studying for atopic dermatitis?

Galvokimig is being studied to understand how different doses affect adults with moderate-to-severe atopic dermatitis. The research aims to evaluate its safety, how the drug works in the body, and its impact on eczema symptoms. This study is sponsored by UCB Biopharma SRL and helps explore treatment options for this chronic skin condition.

Who may be eligible for this atopic dermatitis clinical trial?

Adults aged 18 years or older with moderate-to-severe chronic atopic dermatitis lasting at least one year may be eligible. Participants must have certain severity scores and a history of inadequate response to topical treatments or be unable to use them safely. This study is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this atopic dermatitis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to attending visits may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07277660

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating Galvokimig in Adults With Moderate to Severe Atopic Dermatitis

Led by UCB Biopharma SRL · Updated on 2026-06-05

160

Participants Needed

Research Sites

42 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating how different doses of galvokimig compare with a placebo in adults with moderate-to-severe atopic dermatitis, a chronic skin condition. This Phase 2 study aims to understand the relationship between the dose given and its effects on the condition, focusing on safety, how the drug moves through and acts in the body, and its overall impact on the disease. Participants will be randomly assigned to receive one of three different doses of galvokimig or a placebo during the initial treatment period. After 16 weeks, participants will either continue on the same dose or switch to a modified dose based on the study plan. Galvokimig and placebo are given as injections, and the study is designed to be double-blind, meaning neither participants nor researchers know who receives which treatment during the initial phase. During the study, participants will be regularly evaluated for changes in their eczema severity, itch intensity, and overall response to treatment using specific scales like the Eczema Area and Severity Index EASI and Peak Pruritus Numerical Rating Scale PP-NRS. Safety is closely monitored through reports of adverse events up to week 58. The study lasts at least 16 weeks with ongoing assessments to track treatment effects and safety over time.

CONDITIONS

Brief Title

A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participant must be aged 18 years or older at the time of signing informed consent
Diagnosis of chronic atopic dermatitis for at least 1 year according to American Academy of Dermatology criteria
Validated Investigator Global Assessment (vIGA) score of 3 or higher at Screening and Baseline
Eczema Area and Severity Index (EASI) score of 16 or higher at Screening and Baseline
Peak Pruritus Numerical Rating Scale (PP-NRS) score of 4 or higher at Screening and Baseline
Atopic dermatitis involvement of at least 10% body surface area at Screening and Baseline
Documented history within 6 months prior to Screening of inadequate response to topical treatments or topical treatments medically inadvisable, and candidate for systemic therapy

You will not qualify if you...

Any medical or psychiatric condition, lab test result, physical exam finding, or ECG signal that poses risk or interferes with study participation
Active skin conditions that could confuse atopic dermatitis diagnosis or assessment, including scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, or active allergic or irritant contact dermatitis
Personal or first-degree family history of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
History of chronic, recurrent, or serious infections within 6 months prior to Baseline
Meeting tuberculosis exclusion criteria
Prior treatment with galvokimig
Safety issues causing discontinuation of interleukin-13 biologic treatments like dupilumab, tralokinumab, or lebrikizumab
Use of systemic therapies (other than biologics), topical therapies, or other atopic dermatitis treatments within 4 weeks prior to Baseline
Use of biologic agents within 3 months prior to Baseline

Research Team

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