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NCT07277660PHASE2Recruiting

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

UCB Biopharma SRL

Start Date

12/29/2025

Completion Date

3/6/2028

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

BIOLOGICAL

Galvokimig

DRUG

Placebo

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Conditions

Atopic Dermatitis

Locations

Atd002 52021

Oceanside, California 92056

United States

Atd002 52008

Santa Monica, California 90403

United States

Atd002 52013

Boca Raton, Florida 33486

United States

Atd002 52007

Miami, Florida 33126

United States

Atd002 52003

Miami, Florida 33133

United States

Atd002 52015

Savannah, Georgia 31419

United States

Atd002 52017

Chicago, Illinois 60611

United States

Atd002 52018

Wheaton, Illinois 60189

United States

Atd002 52012

New Albany, Indiana 47150

United States

Atd002 52014

Bowling Green, Kentucky 42104

United States

Atd002 52001

Troy, Michigan 48084

United States

Atd002 52009

Troy, Michigan 48084

United States

Atd002 52010

Omaha, Nebraska 68144

United States

Atd002 52022

New York, New York 10029-6574

United States

Atd002 52020

The Bronx, New York 10455

United States

Atd002 52019

Philadelphia, Pennsylvania 19114

United States

Atd002 52005

Dallas, Texas 75230

United States

Atd002 52016

Frisco, Texas 75033

United States

Atd002 52011

Frisco, Texas 75034

United States

Atd002 52004

Sugar Land, Texas 77479

United States

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

Atd002 43003

Lübeck,

Germany

Atd002 43007

Mahlow,

Germany

Atd002 44003

Budapest,

Hungary

Atd002 44001

Debrecen,

Hungary

Atd002 21001

Habikino,

Japan

Atd002 21002

Nagasaki,

Japan

Atd002 21007

Nagoya,

Japan

Atd002 21005

Sakai,

Japan

Atd002 21008

Sapporo,

Japan

Atd002 21004

Tachikawa-shi,

Japan

Atd002 21006

Yokohama,

Japan

Atd002 45011

Chorzów,

Poland

Atd002 45001

Katowice,

Poland

Atd002 45003

Krakow,

Poland

Atd002 45007

Krakow,

Poland

Atd002 45010

Krakow,

Poland

Atd002 45014

Krakow,

Poland

Atd002 45004

Lodz,

Poland

Atd002 45013

Lodz,

Poland

Atd002 45005

Sosnowiec,

Poland

Atd002 45009

Tarnów,

Poland

Atd002 45002

Warsaw,

Poland

Atd002 45006

Warsaw,

Poland

Atd002 45008

Wroclaw,

Poland

Atd002 46004

London,

United Kingdom

Atd002 46007

London,

United Kingdom

Atd002 46003

Salford,

United Kingdom

Atd002 46006

Sheffield,

United Kingdom