160 Participants Needed

Galvokimig for Atopic Dermatitis

Recruiting at 9 trial locations
UC
Overseen ByUCB Cares
Prior Safety DataThis treatment has passed at least one previous human trial

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?

UC

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

I am 18 years old or older.
My skin condition is severe, as rated by a doctor.
My eczema is severe, with an EASI score of 16 or more.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Intervention

Participants receive a predefined Galvokimig dose or placebo for 16 weeks

16 weeks

Continuation

Participants continue on the same or a modified dose of Galvokimig or placebo

42 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

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?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Galvokimig Arm 3Experimental Treatment1 Intervention
Group II: Galvokimig Arm 2Experimental Treatment1 Intervention
Group III: Galvokimig Arm 1Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

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

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.

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 ...