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Clinical Trials in Germany / NCT07277660
Active, not 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 Germany tracker
Phase
Phase 2
Started
2025-12-29
Last updated
2026-09-22

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

Galvokimig →Placebo

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
Atd002 52008 Santa Monica California
Atd002 52013 Boca Raton Florida
Atd002 52007 Miami Florida
Atd002 52003 Miami Florida
Atd002 52015 Savannah Georgia
Atd002 52017 Chicago Illinois
Atd002 52018 Wheaton Illinois
Atd002 52012 New Albany Indiana
Atd002 52014 Bowling Green Kentucky
Atd002 52001 Troy Michigan
Atd002 52009 Troy Michigan
Atd002 52010 Omaha Nebraska
Atd002 52022 New York New York
Atd002 52020 The Bronx New York
Atd002 52019 Philadelphia Pennsylvania
Atd002 52005 Dallas Texas
Atd002 52016 Frisco Texas
Atd002 52011 Frisco Texas
Atd002 52004 Sugar Land Texas
Atd002 41004 Lovech Bulgaria
Atd002 41001 Pleven Bulgaria
Atd002 41007 Plovdiv Bulgaria
Atd002 41002 Sevlievo Bulgaria
Atd002 41003 Sofia Bulgaria
Atd002 41005 Sofia Bulgaria
Atd002 41006 Sofia Bulgaria
Atd002 51002 Edmonton Canada
Atd002 51006 Hamilton Canada
Atd002 51007 Toronto Canada
Atd002 51003 Vancouver Canada
Atd002 42002 Náchod Czechia
Atd002 42001 Prague Czechia
Atd002 42003 Prague Czechia
Atd002 42004 Prague Czechia
Atd002 42005 Prague Czechia
Atd002 43001 Bad Bentheim Germany
Atd002 43005 Dresden Germany
Atd002 43002 Frankfurt Germany
Atd002 43004 Leipzig Germany

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

More UCB Biopharma SRL trials in Germany

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 Germany