RecruitingPhase 2NCT07277660

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


Sponsor

UCB Biopharma SRL

Enrollment

160 participants

Start Date

Dec 29, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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:
  • validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline
  • Eczema Area and Severity Index (EASI) score ≥16 at both Screening and Baseline
  • Peak Pruritus Numerical Rating Scale (PP-NRS) score of ≥4 at both Screening and Baseline
  • ≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline
  • 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 Criteria8

  • 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
  • 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

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Interventions

BIOLOGICALGalvokimig

Drug: Galvokimig Pharmaceutical form: Solution for injection

DRUGPlacebo

Drug: Placebo Pharmaceutical form: Solution for injection


Locations(23)

Atd002 52008

Santa Monica, California, United States

Atd002 52013

Boca Raton, Florida, United States

Atd002 52007

Coral Gables, Florida, United States

Atd002 52003

Miami, Florida, United States

Atd002 52015

Savannah, Georgia, United States

Atd002 52017

Chicago, Illinois, United States

Atd002 52018

Wheaton, Illinois, United States

Atd002 52012

New Albany, Indiana, United States

Atd002 52014

Bowling Green, Kentucky, United States

Atd002 52001

Troy, Michigan, United States

Atd002 52009

Troy, Michigan, United States

Atd002 52010

Omaha, Nebraska, United States

Atd002 52020

The Bronx, New York, United States

Atd002 52019

Philadelphia, Pennsylvania, United States

Atd002 52005

Dallas, Texas, United States

Atd002 52016

Frisco, Texas, United States

Atd002 52011

Frisco, Texas, United States

Atd002 52004

Sugar Land, Texas, United States

Atd002 51006

Hamilton, Canada

Atd002 51007

Toronto, Canada

Atd002 21005

Sakai, Japan

Atd002 21008

Sapporo, Japan

Atd002 21004

Tachikawa-shi, Japan

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NCT07277660


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