In short
Galvokimig is an investigational medicine being studied for adults with moderate to severe atopic dermatitis. It is given as an injection under the skin (subcutaneously). One Phase 2 trial with 164 participants is currently authorised to test whether galvokimig is safe and whether it works compared with placebo.
Key points
- Galvokimig is an investigational medicine, not yet authorised for general use.
- It is being studied in adults with moderate to severe atopic dermatitis.
- The only registered trial is a Phase 2 study with 164 participants.
- The trial is authorised and compares galvokimig with a placebo injection.
- The main measure is the EASI-75 response at week 16, which shows how much the eczema has improved.
- Galvokimig is given as a subcutaneous injection.
What is galvokimig?
Galvokimig is an investigational medicine being developed by UCB Biopharma. It has not yet received marketing authorisation and is available only within clinical trials. The full name of the substance is galvokimig, and it is being studied for its potential to treat atopic dermatitis, a long-lasting skin condition that causes itching and inflamed patches of skin.
How does galvokimig work?
The available sources do not describe the exact mechanism of action of galvokimig. The trial is designed to evaluate its efficacy, safety, pharmacokinetics, and pharmacodynamics in adults with moderate to severe atopic dermatitis. Pharmacokinetics means how the body absorbs, distributes, and removes the drug, while pharmacodynamics describes what the drug does to the body.
Which conditions is it studied for?
- Atopic dermatitis — a chronic inflammatory skin disease that causes dry, itchy, and inflamed skin. Galvokimig is being studied in adults with the moderate to severe form of this condition.
How is galvokimig given?
Galvokimig is given as a subcutaneous injection, which means it is injected into the layer of tissue just under the skin. The trial record lists a dose of 00 mg, which indicates that the specific dose was not reported in the register and is being investigated as part of the dose-ranging study design. The placebo used in the trial is a 0.9% sodium chloride solution for injection, also given subcutaneously.
What do the clinical trials show?
One Phase 2 trial is registered for galvokimig. The study is a multicentre, randomised, double-blind, placebo-controlled, parallel-group, dose-ranging trial. It has a planned enrolment of 164 adult participants with moderate to severe atopic dermatitis. The trial is currently authorised, meaning it has received regulatory approval to begin. According to a supplementary source, the trial is active and no longer recruiting participants.
The main outcome measure is the percentage of participants who achieve an EASI-75 response at week 16. EASI stands for Eczema Area and Severity Index, and an EASI-75 response means that a participant's eczema severity score has improved by at least 75% compared with the start of the trial. The study also aims to evaluate the dose-response relationship of galvokimig compared with placebo after 16 weeks of treatment.
The trial is sponsored by UCB Biopharma and is known by the acronym PossibILity.
What side effects are known?
The available sources do not report specific side effects of galvokimig. As an investigational medicine, its safety profile is still being evaluated in the ongoing Phase 2 trial.