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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

A dose-ranging study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of galvokimig in adult study participants with atopic dermatitis

Sasamoto Hiroshi

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo

CTR-JRCT.UCBJapan@ucb.com

Global Clinical Development Japan

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo

+81-3-6864-7587

CTR_SCC_UCBJapan@UCB.com

Recruiting

Feb. 20, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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:
a. validated Investigator Global Assessment (vIGA) score >= 3 at Screening and Baseline
b. Eczema Area and Severity Index (EASI) score >= 16 at both Screening and Baseline
c. Peak Pruritus Numerical Rating Scale (PP-NRS) score of >= 4 at both Screening and Baseline
d. >= 10% body surface area (BSA) of AtD involvement at both Screening and Baseline
e. 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

- 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 ability of study participant 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 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

Both

Atopic dermatitis

- Galvokimig Arm 1, Arm 2 and 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:
Participants will receive matching placebo during Initial Intervention Period. After week 16 participants will continue on the same or a dose galvokimig.

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

Dec. 18, 2025

Yes

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

USA/Bulgaria/Canada/Czech Republic/Germany/Hungary/Poland/UK