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Clinical Trials in the UK / NCT07277660
Recruiting Phase 2

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

NCT07277660 · tracked via the Priya Life Science UK tracker
Sponsor
UCB Biopharma SRL
Phase
Phase 2
Started
2025-12-29
Last updated
2026-09-11

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

GalvokimigPlacebo

Galvokimig: Drug: Galvokimig Pharmaceutical form: Solution for injection

Placebo: Drug: Placebo Pharmaceutical form: Solution for injection

Study summary

The purpose of the study is to evaluate the dose-response relationship of galvokimig compared with placebo in study participants with moderate-to-severe atopic dermatitis (AtD).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (68)

FacilityCityRegionStatus
Atd002 52021 Oceanside California Active Not Recruiting
Atd002 52008 Santa Monica California Active Not Recruiting
Atd002 52013 Boca Raton Florida Active Not Recruiting
Atd002 52007 Miami Florida Active Not Recruiting
Atd002 52003 Miami Florida Active Not Recruiting
Atd002 52015 Savannah Georgia Active Not Recruiting
Atd002 52017 Chicago Illinois Active Not Recruiting
Atd002 52018 Wheaton Illinois Active Not Recruiting
Atd002 52012 New Albany Indiana Active Not Recruiting
Atd002 52014 Bowling Green Kentucky Active Not Recruiting
Atd002 52001 Troy Michigan Recruiting
Atd002 52009 Troy Michigan Active Not Recruiting
Atd002 52010 Omaha Nebraska Active Not Recruiting
Atd002 52022 New York New York Active Not Recruiting
Atd002 52020 The Bronx New York Active Not Recruiting
Atd002 52019 Philadelphia Pennsylvania Active Not Recruiting
Atd002 52005 Dallas Texas Active Not Recruiting
Atd002 52016 Frisco Texas Active Not Recruiting
Atd002 52011 Frisco Texas Active Not Recruiting
Atd002 52004 Sugar Land Texas Active Not Recruiting
Atd002 41004 Lovech Bulgaria Active Not Recruiting
Atd002 41001 Pleven Bulgaria Active Not Recruiting
Atd002 41007 Plovdiv Bulgaria Active Not Recruiting
Atd002 41002 Sevlievo Bulgaria Active Not Recruiting
Atd002 41003 Sofia Bulgaria Recruiting
Atd002 41005 Sofia Bulgaria Active Not Recruiting
Atd002 41006 Sofia Bulgaria Active Not Recruiting
Atd002 51002 Edmonton Canada Active Not Recruiting
Atd002 51006 Hamilton Canada Active Not Recruiting
Atd002 51007 Toronto Canada Active Not Recruiting
Atd002 51003 Vancouver Canada Active Not Recruiting
Atd002 42002 Náchod Czechia Active Not Recruiting
Atd002 42001 Prague Czechia Active Not Recruiting
Atd002 42003 Prague Czechia Active Not Recruiting
Atd002 42004 Prague Czechia Active Not Recruiting
Atd002 42005 Prague Czechia Active Not Recruiting
Atd002 43001 Bad Bentheim Germany Active Not Recruiting
Atd002 43005 Dresden Germany Recruiting
Atd002 43002 Frankfurt Germany Recruiting
Atd002 43004 Leipzig Germany Active Not Recruiting

+ 28 more sites — see the full list on the official registry below.

More UCB Biopharma SRL trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07277660 on ClinicalTrials.gov ↗ ← All trials in the UK