A study to learn if galvokimig is safe and works in adults with moderate to severe atopic dermatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UCB Biopharma

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

30 Mar 2026 → ongoing

Decision date (initial)

2026-03-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

UCB Biopharma SRL

External identifiers

EU CT number

2025-522578-35-00

WHO UTN

U1111-1326-9886

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety, Pharmacodynamic

To evaluate the dose-response relationship of galvokimig compared with placebo administered sc in study participants with moderate-to-severe AtD after 16 weeks of study intervention

Secondary objectives 2

1. To evaluate the efficacy of galvokimig administered sc compared with placebo on additional efficacy measures in study participants with moderate-to-severe AtD after 16 weeks of study intervention
2. To investigate the safety and tolerability of galvokimig administered sc in study participants with moderate-tosevere AtD

Conditions and MedDRA coding

Atopic Dermatitis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Participant must be aged greater than or equal (≥)18 years at the time of signing the informed consent
2. 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

Exclusion criteria 9

1. 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
2. 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
3. Presence or family history (first degree) of inflammatory bowel disease (includes Crohn’s disease and ulcerative colitis)
4. 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
5. Participants are not permitted to enroll into the study if they meet tuberculosis (TB) exclusion criteria
6. Previous treatment with galvokimig
7. 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
8. All systemic therapies (other than biologics), topical therapies and other treatments for AtD must be discontinued at least 4 weeks prior to Baseline
9. Treatment with biologic agents must discontinued at least 3 months prior to baseline

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of participants with Eczema Area and Severity Index (EASI)75 response at Week 16

Secondary endpoints 4

1. Percentage of Participants with validated Investigator Global Assessment (vIGA) response at Week 16
2. Change from Baseline in weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16
3. Incidence of Treatment-Emergent (TE) Adverse Events (AE)
4. Incidence of TE Serious Adverse Events (SAEs)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UCB Biopharma

Sponsor organisation

UCB Biopharma

Address

Researchdreef 60

City

Anderlecht

Postcode

1070

Country

Belgium

Scientific contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Public contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Third parties 13

Locations

5 EU/EEA countries · 38 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 78 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications