Galvokimig dose-ranging for adults with moderate-to-severe atopic dermatitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Moderate to Severe Atopic Dermatitis

Phase 2 Interventional UCB Pharma · NCT07277660

This trial tests different doses of galvokimig versus placebo to see if it reduces symptoms in adults with moderate-to-severe atopic dermatitis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years and up
SexAll
SponsorUCB Pharma Industry-sponsored
Drugs / interventionsdupilumab, tralokinumab, lebrikizumab
Locations57 sites (Oceanside, California and 56 other locations)
Trial IDNCT07277660 on ClinicalTrials.gov

What this trial studies

This Phase 2 dose-ranging trial compares multiple doses of galvokimig with placebo in adults who have moderate-to-severe atopic dermatitis. Eligible participants meeting severity thresholds (vIGA ≥3, EASI ≥16, PP-NRS ≥4, and ≥10% BSA) and with inadequate response to topical therapies will be assigned to receive galvokimig or placebo and followed over time. The study collects measures of symptom relief, skin lesion improvement, itch scores, and drug pharmacokinetics/pharmacodynamics, alongside safety monitoring. Results will be used to define the dose–response relationship and inform selection of doses for later studies.

Who should consider this trial

Good fit: Adults aged 18 or older with chronic moderate-to-severe atopic dermatitis who meet vIGA ≥3, EASI ≥16, PP-NRS ≥4, have ≥10% BSA involvement, and have had an inadequate response to topical treatments are the intended participants.

Not a fit: Patients with mild atopic dermatitis, children under 18, those who respond well to topical therapy, or those with contraindications to the investigational drug are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, galvokimig could offer a new systemic option that reduces inflammation and itch and improves skin clearance for adults with moderate-to-severe atopic dermatitis.

How similar studies have performed: Other biologic and JAK-inhibitor therapies for atopic dermatitis have shown clear clinical benefits, but galvokimig is a newer agent with limited public Phase 2 data so far.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Participant must be aged greater than or equal (≥)18 years at the time of signing the informed consent
* Participant has chronic atopic dermatitis (AtD) (according to American Academy of Dermatology Consensus Criteria) that has been present for at least ≥1 year prior to initiating the study (ie, signing of the informed consent form \[ICF\]) and with:

  1. validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline
  2. Eczema Area and Severity Index (EASI) score ≥16 at both Screening and Baseline
  3. Peak Pruritus Numerical Rating Scale (PP-NRS) score of ≥4 at both Screening and Baseline
  4. ≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline
  5. Documented recent history (within 6 months prior to Screening) of inadequate response to treatment with topical medications, or study participants for whom topical treatments are otherwise medically inadvisable (eg, due to important side effects or safety risks) and who are candidates for systemic therapy

Exclusion Criteria:

* Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study
* Active dermatologic conditions that may confound the diagnosis of AtD or would interfere with assessment of treatment, such as but not limited to scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, active allergic or irritant contact dermatitis
* Presence or family history (first degree) of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)
* History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline (including herpes zoster) as judged by the investigator
* Participants are not permitted to enroll into the study if they meet tuberculosis (TB) exclusion criteria
* Previous treatment with galvokimig
* Participant has relevant safety events to one or more interleukin (IL)-13 biologic response modifiers (ie, dupilumab, tralokinumab and lebrikizumab) that resulted in discontinuation and change of treatment
* All systemic therapies (other than biologics), topical therapies and other treatments for AtD must be discontinued at least 4 weeks prior to Baseline
* Treatment with biologic agents must discontinued at least 3 months prior to baseline

Where this trial is running

Oceanside, California and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Atopic DermatitisGalvokimig,UCB9741
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.