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

NCT ID: NCT07277660

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-03-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Galvokimig

Intervention Type: BIOLOGICAL

Drug: Galvokimig Pharmaceutical form: Solution for injection

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.

Group Type: EXPERIMENTAL

Galvokimig

Intervention Type: BIOLOGICAL

Drug: Galvokimig Pharmaceutical form: Solution for injection

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.

Group Type: EXPERIMENTAL

Galvokimig

Intervention Type: BIOLOGICAL

Drug: Galvokimig Pharmaceutical form: Solution for injection

Placebo

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

Group Type: PLACEBO_COMPARATOR

Galvokimig

Intervention Type: BIOLOGICAL

Drug: Galvokimig Pharmaceutical form: Solution for injection

Placebo

Intervention Type: DRUG

Drug: Placebo Pharmaceutical form: Solution for injection

Interventions

Galvokimig

Drug: Galvokimig Pharmaceutical form: Solution for injection

Intervention Type: BIOLOGICAL

Placebo

Drug: Placebo Pharmaceutical form: Solution for injection

Intervention Type: DRUG

Other Intervention Names

UCB9741

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 22733

Central Contacts

UCB Cares

Role: CONTACT

ucbcares@ucb.com

+18445992273

UCB Cares

Role: CONTACT

UCBCares@ucb.com

0018445992273

Other Identifiers

2025-522578-35

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1326-9886

Identifier Type: OTHER

Identifier Source: secondary_id

ATD002

Identifier Type: -

Identifier Source: org_study_id