Recruiting
Phase 2

Galvokimig

Sponsor:

UCB Biopharma SRL

Code:

NCT07277660

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Galvokimig

Placebo

Study Details

Brief 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).

Conditions

Atopic Dermatitis

Study ID

NCT07277660

Start date

Dec 29, 2025

Status verified date

Aug, 2026

Completion date

Mar 6, 2028

Anticipated

Primary completion date

May 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Galvokimig Arm 1

Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.

experimental: Galvokimig Arm 2

Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.

experimental: Galvokimig Arm 3

Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.

placebo comparator: Placebo

Participants will receive matching placebo during Initial Intervention Period. After week 16 participants will continue on the same or a dose galvokimig.

Interventions

Galvokimig

Drug: Galvokimig Pharmaceutical form: Solution for injection

Placebo

Drug: Placebo Pharmaceutical form: Solution for injection

Primary outcome measure

  • Percentage of participants with Eczema Area and Severity Index (EASI)75 response at Week 16 [ Time Frame: Week 16 ]

Central Contacts and Locations

Locations

Atd002 52017

Recruiting

Chicago, Illinois, United States, 60657

Atd002 52001

Recruiting

Troy, Michigan, United States, 48084

More Information

Sponsor

UCB Biopharma SRL

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Atopic Dermatitis
  • Galvokimig,
  • UCB9741

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UCB Biopharma SRL on 2026-08-27.