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

June 4, 2026 updated by: UCB Biopharma SRL

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bulgaria
      • Lovech, Bulgaria
        • Recruiting
        • Atd002 41004
      • Pleven, Bulgaria
        • Recruiting
        • Atd002 41001
      • Plovdiv, Bulgaria
        • Recruiting
        • Atd002 41007
      • Sevlievo, Bulgaria
        • Recruiting
        • Atd002 41002
      • Sofia, Bulgaria
        • Recruiting
        • Atd002 41005
      • Sofia, Bulgaria
        • Recruiting
        • Atd002 41006
  • Canada
      • Hamilton, Canada
        • Recruiting
        • Atd002 51006
      • Toronto, Canada
        • Recruiting
        • Atd002 51007
  • Czechia
      • Náchod, Czechia
        • Recruiting
        • Atd002 42002
      • Prague, Czechia
        • Recruiting
        • Atd002 42001
      • Prague, Czechia
        • Recruiting
        • Atd002 42004
      • Prague, Czechia
        • Recruiting
        • Atd002 42005
  • Germany
      • Bad Bentheim, Germany
        • Recruiting
        • Atd002 43001
      • Dresden, Germany
        • Recruiting
        • Atd002 43005
      • Frankfurt, Germany
        • Recruiting
        • Atd002 43002
      • Leipzig, Germany
        • Recruiting
        • Atd002 43004
      • Lübeck, Germany
        • Recruiting
        • Atd002 43003
      • Mahlow, Germany
        • Recruiting
        • Atd002 43007
  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Atd002 44003
      • Debrecen, Hungary
        • Recruiting
        • Atd002 44001
  • Japan
      • Habikino, Japan
        • Recruiting
        • Atd002 21001
      • Nagasaki, Japan
        • Recruiting
        • Atd002 21002
      • Nagoya, Japan
        • Recruiting
        • Atd002 21007
      • Sakai, Japan
        • Recruiting
        • Atd002 21005
      • Sapporo, Japan
        • Recruiting
        • Atd002 21008
      • Tachikawa-shi, Japan
        • Recruiting
        • Atd002 21004
      • Yokohama, Japan
        • Recruiting
        • Atd002 21006
  • Poland
      • Chorzów, Poland
        • Recruiting
        • Atd002 45011
      • Katowice, Poland
        • Recruiting
        • Atd002 45001
      • Krakow, Poland
        • Recruiting
        • Atd002 45003
      • Krakow, Poland
        • Recruiting
        • Atd002 45007
      • Krakow, Poland
        • Recruiting
        • Atd002 45014
      • Krakow, Poland
        • Recruiting
        • Atd002 45010
      • Lodz, Poland
        • Recruiting
        • Atd002 45013
      • Sosnowiec, Poland
        • Recruiting
        • Atd002 45005
      • Tarnów, Poland
        • Recruiting
        • Atd002 45009
      • Warsaw, Poland
        • Recruiting
        • Atd002 45002
      • Warsaw, Poland
        • Recruiting
        • Atd002 45004
      • Warsaw, Poland
        • Recruiting
        • Atd002 45006
      • Wroclaw, Poland
        • Recruiting
        • Atd002 45008
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Atd002 46004
      • London, United Kingdom
        • Recruiting
        • Atd002 46007
      • Salford, United Kingdom
        • Recruiting
        • Atd002 46003
      • Sheffield, United Kingdom
        • Recruiting
        • Atd002 46006
  • United States
    • California
      • Oceanside, California, United States, 92056
        • Recruiting
        • Atd002 52021
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Atd002 52008
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Atd002 52013
      • Coral Gables, Florida, United States, 33134
        • Recruiting
        • Atd002 52007
      • Miami, Florida, United States, 33133
        • Recruiting
        • Atd002 52003
    • Georgia
      • Savannah, Georgia, United States, 31419
        • Recruiting
        • Atd002 52015
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Atd002 52017
      • Wheaton, Illinois, United States, 60189
        • Recruiting
        • Atd002 52018
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Atd002 52012
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Recruiting
        • Atd002 52014
    • Michigan
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Atd002 52001
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Atd002 52009
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Atd002 52010
    • New York
      • New York, New York, United States, 10029-6574
        • Recruiting
        • Atd002 52022
      • The Bronx, New York, United States, 10455
        • Recruiting
        • Atd002 52020
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Recruiting
        • Atd002 52019
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Atd002 52005
      • Frisco, Texas, United States, 75034
        • Recruiting
        • Atd002 52011
      • Frisco, Texas, United States, 75033
        • Recruiting
        • Atd002 52016
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Atd002 52004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: Galvokimig
Drug: Galvokimig Pharmaceutical form: Solution for injection
Other Names:
  • UCB9741
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.
Biological: Galvokimig
Drug: Galvokimig Pharmaceutical form: Solution for injection
Other Names:
  • UCB9741
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.
Biological: Galvokimig
Drug: Galvokimig Pharmaceutical form: Solution for injection
Other Names:
  • UCB9741
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.
Biological: Galvokimig
Drug: Galvokimig Pharmaceutical form: Solution for injection
Other Names:
  • UCB9741
Drug: Placebo
Drug: Placebo Pharmaceutical form: Solution for injection

What is the study measuring?

Primary Outcome Measures

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

The EASI is a validated scoring system that grades the physical signs of atopic dermatitis/eczema.

The severity of each clinical sign is scored as: 0=None to 3=Severe.
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with validated Investigator Global Assessment (vIGA) response at Week 16
Time Frame: Week 16
The vIGA score is using descriptors that best describe the overall appearance of the lesions at a given time point. Assessment: vIGA 0=clear to 4=severe
Week 16
Change from Baseline in weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16
Time Frame: Baseline and Week 16
The PP-NRS is a single item patient-reported outcome (PRO) measure assessing the worst itch in the last 24 hours. It will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Baseline and Week 16
Incidence of Treatment-Emergent (TE) Adverse Events (AE)
Time Frame: Up to Week 58
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention until 8 weeks after final administration.
Up to Week 58
Incidence of TE Serious Adverse Events (SAEs)
Time Frame: Up to Week 58

An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed:

  • Results in death
  • Is life-threatening
  • Requires inpatient hospitalization or prolongation of existing hospitalization
  • Results in persistent or significant disability/incapacity
  • Is a congenital anomaly/birth defect
  • Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
Up to Week 58

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma SRL

Investigators

  • Study Director: UCB Cares, 001 844 599 22733

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2025

Primary Completion (Estimated)

May 17, 2027

Study Completion (Estimated)

March 6, 2028

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATD002
  • 2025-522578-35 (Registry Identifier: CTIS (EU))
  • U1111-1326-9886 (Other Identifier: Universal Trial Number (UTN))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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