Galvokimig for Atopic Dermatitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called galvokimig for individuals with moderate-to-severe atopic dermatitis, a type of eczema that causes itchy and inflamed skin. The main goal is to compare different doses of galvokimig to a placebo (a non-active substance) in managing symptoms. Participants should have had atopic dermatitis for at least a year, affecting a significant part of their body, and have tried topical treatments without success to join this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
Yes, you will need to stop taking all systemic and topical treatments for atopic dermatitis at least 4 weeks before the study starts. If you are on biologic agents, you must stop them at least 3 months before the study begins.
Is there any evidence suggesting that galvokimig is likely to be safe for humans?
Research has shown that galvokimig has been tested for safety in people with moderate-to-severe atopic dermatitis, a skin condition that causes itching and redness. An 18-week study found that participants generally tolerated galvokimig well, with most side effects being mild to moderate. Serious side effects were rare, and no life-threatening problems were reported. This suggests that the treatment is reasonably safe for humans. However, as with any medication, individuals may experience different reactions. Always consult a healthcare provider before joining a trial.12345
Why do researchers think this study treatment might be promising for atopic dermatitis?
Most treatments for atopic dermatitis, like topical steroids or calcineurin inhibitors, work by reducing inflammation on the skin's surface. But Galvokimig works differently, targeting specific immune pathways involved in the body's inflammatory response, potentially providing a more focused and effective approach to managing symptoms. Researchers are excited about Galvokimig because it might offer a new hope for patients who don't respond well to existing treatments, and its unique mechanism could mean fewer side effects compared to traditional therapies. Additionally, Galvokimig might offer longer-lasting relief, reducing the need for frequent applications typical of current treatments.
What evidence suggests that galvokimig might be an effective treatment for atopic dermatitis?
Research has shown that galvokimig may help treat moderate-to-severe atopic dermatitis, a type of skin condition. In earlier studies, over 60% of patients experienced significant improvement, with their skin problems reducing by at least 75%. Specifically, one study found that 64.9% of patients improved this much, compared to only 12.3% of those who took a placebo (a pill with no active medicine). This trial will evaluate different doses of galvokimig, and these findings suggest that galvokimig could be a promising option for people dealing with this skin issue.13467
Who Is on the Research Team?
UCB Cares
Principal Investigator
001 844 599 22733
Are You a Good Fit for This Trial?
Adults over 18 with moderate-to-severe atopic dermatitis can join this trial. They must have a certain severity score, affected body surface area, and a history of poor response to topical treatments or reasons they can't use them.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Intervention
Participants receive a predefined Galvokimig dose or placebo for 16 weeks
Continuation
Participants continue on the same or a modified dose of Galvokimig or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Galvokimig
Trial Overview
The study is testing different doses of Galvokimig against a placebo in adults with atopic dermatitis to see how effective it is and what the safety profile looks like.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Placebo Group
Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
Participants will receive matching placebo during Initial Intervention Period. After week 16 participants will continue on the same or a dose galvokimig.
Find a Clinic Near You
Who Is Running the Clinical Trial?
UCB Biopharma SRL
Lead Sponsor
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
Citations
UCB announces successful first-in-patient trial for ...
More than 60% of patients achieved at least a 75% improvement in skin lesions: A median of 64.9% of patients treated with galvokimig versus 12.3% with ...
NCT07277660 | A Dose-ranging Study to Evaluate the ...
A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis.
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ddw-online.com
ddw-online.com/ucb-publishes-new-data-on-clinical-trials-for-galvokimig-36506-202509/UCB publishes new data on clinical trials for galvokimig
“The study showed that many patients achieved the stringent EASI75 and EASI90 outcomes at Week 12 with galvokimig in this early-stage trial,” ...
247 A first-in-patient 18-week study of galvokimig ...
Primary endpoints were ≥75% improvement from baseline in Eczema Area and Severity Index (EASI75) response rate at week 12 and incidence of treatment-emergent ...
Galvokimig Achieves High EASI Scores in Pilot Study
Galvokimig showed significant efficacy in a Phase 1/2a trial, with 64.9% achieving EASI75 at week 12 versus 12.3% in the placebo group. The ...
galvokimig in moderate-to- severe atopic dermatitis (AD) ...
Data from first-in-patient 18-week study of galvokimig, a ... 18-week safety results of galvokimig from the UP0089 study in ...
UCB announces successful first-in-patient trial for ...
More than 60% of patients achieved at least a 75% improvement in skin lesions: A median of 64.9% of patients treated with galvokimig versus ...
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