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

Last updated: March 26, 2026
Sponsor: UCB Biopharma SRL
Overall Status: Active - Recruiting

Phase

2

Condition

Atopic Dermatitis

Dermatitis, Atopic

Eczema (Atopic Dermatitis)

Treatment

Galvokimig

Placebo

Clinical Study ID

NCT07277660
ATD002
2025-522578-35
U1111-1326-9886
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Participant must be aged greater than or equal (≥)18 years at the time of signingthe informed consent

  • Participant has chronic atopic dermatitis (AtD) (according to American Academy ofDermatology Consensus Criteria) that has been present for at least ≥1 year prior toinitiating the study (ie, signing of the informed consent form [ICF]) and with:

  1. validated Investigator Global Assessment (vIGA) score ≥3 at Screening andBaseline

  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 andBaseline

  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 inadequateresponse to treatment with topical medications, or study participants for whomtopical treatments are otherwise medically inadvisable (eg, due to importantside effects or safety risks) and who are candidates for systemic therapy

Exclusion

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 takingthe study intervention; or interfere with the interpretation of data and couldjeopardize or would compromise the study participant's ability to participate inthis study

  • Active dermatologic conditions that may confound the diagnosis of AtD or wouldinterfere with assessment of treatment, such as but not limited to scabies,seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, active allergic orirritant contact dermatitis

  • Presence or family history (first degree) of inflammatory bowel disease (includesCrohn's disease and ulcerative colitis)

  • History of chronic or recurrent infections, or a serious or life-threateninginfection within the 6 months prior to the Baseline (including herpes zoster) asjudged 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 biologicresponse modifiers (ie, dupilumab, tralokinumab and lebrikizumab) that resulted indiscontinuation and change of treatment

  • All systemic therapies (other than biologics), topical therapies and othertreatments 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

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Galvokimig
Phase: 2
Study Start date:
December 29, 2025
Estimated Completion Date:
March 06, 2028

Connect with a study center

  • Atd002 51006

    Hamilton,
    Canada

    Active - Recruiting

  • Atd002 51007

    Toronto,
    Canada

    Active - Recruiting

  • Atd002 51007

    Toronto 6167865,
    Canada

    Site Not Available

  • Atd002 21005

    Sakai,
    Japan

    Active - Recruiting

  • Atd002 21005

    Sakai 1853195,
    Japan

    Site Not Available

  • Atd002 21008

    Sapporo,
    Japan

    Active - Recruiting

  • Atd002 21008

    Sapporo 2128295,
    Japan

    Site Not Available

  • Atd002 21004

    Tachikawa-shi,
    Japan

    Active - Recruiting

  • Atd002 52008

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Atd002 52008

    Santa Monica 5393212, California 5332921 90404
    United States

    Site Not Available

  • Atd002 52013

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Atd002 52007

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Atd002 52003

    Miami, Florida 33133
    United States

    Active - Recruiting

  • Atd002 52015

    Savannah, Georgia 31419
    United States

    Active - Recruiting

  • Atd002 52015

    Savannah 4221552, Georgia 4197000 31419
    United States

    Site Not Available

  • Atd002 52017

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Atd002 52018

    Wheaton, Illinois 60189
    United States

    Active - Recruiting

  • Atd002 52017

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Atd002 52012

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Atd002 52012

    New Albany 4262045, Indiana 4921868 47150
    United States

    Site Not Available

  • Atd002 52014

    Bowling Green, Kentucky 42104
    United States

    Active - Recruiting

  • Atd002 52014

    Bowling Green 4285268, Kentucky 6254925 42104
    United States

    Site Not Available

  • Atd002 52001

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Atd002 52009

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Atd002 52001

    Troy 5012639, Michigan 5001836 48084
    United States

    Site Not Available

  • Atd002 52009

    Troy 5012639, Michigan 5001836 48084
    United States

    Active - Recruiting

  • Atd002 52010

    Omaha, Nebraska 68144
    United States

    Active - Recruiting

  • Atd002 52010

    Omaha 5074472, Nebraska 5073708 68144
    United States

    Site Not Available

  • Atd002 52020

    The Bronx, New York 10455
    United States

    Active - Recruiting

  • Atd002 52020

    The Bronx 5110266, New York 5128638 10455
    United States

    Site Not Available

  • Atd002 52019

    Philadelphia, Pennsylvania 19114
    United States

    Active - Recruiting

  • Atd002 52019

    Philadelphia 4560349, Pennsylvania 6254927 19114
    United States

    Site Not Available

  • Atd002 52005

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Atd002 52011

    Frisco, Texas 75034
    United States

    Active - Recruiting

  • Atd002 52016

    Frisco, Texas 75033
    United States

    Active - Recruiting

  • Atd002 52004

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • Atd002 52005

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • Atd002 52011

    Frisco 4692559, Texas 4736286 75034
    United States

    Active - Recruiting

  • Atd002 52016

    Frisco 4692559, Texas 4736286 75033
    United States

    Site Not Available

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