A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis
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
3 other identifiers
interventional
160
9 countries
50
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2025
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2025
CompletedFirst Posted
Study publicly available on registry
December 11, 2025
CompletedStudy Start
First participant enrolled
December 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 6, 2028
April 24, 2026
April 1, 2026
1.4 years
December 2, 2025
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants with Eczema Area and Severity Index (EASI)75 response at 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 Outcomes (4)
Percentage of Participants with validated Investigator Global Assessment (vIGA) response at Week 16
Week 16
Change from Baseline in weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16
Baseline and Week 16
Incidence of Treatment-Emergent (TE) Adverse Events (AE)
Up to Week 58
Incidence of TE Serious Adverse Events (SAEs)
Up to Week 58
Study Arms (4)
Galvokimig Arm 1
EXPERIMENTALParticipants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
Galvokimig Arm 2
EXPERIMENTALParticipants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
Galvokimig Arm 3
EXPERIMENTALParticipants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
Placebo
PLACEBO COMPARATORParticipants will receive matching placebo during Initial Intervention Period. After week 16 participants will continue on the same or a dose galvokimig.
Interventions
Drug: Galvokimig Pharmaceutical form: Solution for injection
Eligibility Criteria
You may qualify if:
- 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:
- validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline
- Eczema Area and Severity Index (EASI) score ≥16 at both Screening and Baseline
- Peak Pruritus Numerical Rating Scale (PP-NRS) score of ≥4 at both Screening and Baseline
- ≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Atd002 52021
Oceanside, California, 92056, United States
Atd002 52008
Santa Monica, California, 90404, United States
Atd002 52013
Boca Raton, Florida, 33486, United States
Atd002 52007
Coral Gables, Florida, 33134, United States
Atd002 52003
Miami, Florida, 33133, United States
Atd002 52015
Savannah, Georgia, 31419, United States
Atd002 52017
Chicago, Illinois, 60611, United States
Atd002 52018
Wheaton, Illinois, 60189, United States
Atd002 52012
New Albany, Indiana, 47150, United States
Atd002 52014
Bowling Green, Kentucky, 42104, United States
Atd002 52001
Troy, Michigan, 48084, United States
Atd002 52009
Troy, Michigan, 48084, United States
Atd002 52010
Omaha, Nebraska, 68144, United States
Atd002 52020
The Bronx, New York, 10455, United States
Atd002 52019
Philadelphia, Pennsylvania, 19114, United States
Atd002 52005
Dallas, Texas, 75230, United States
Atd002 52016
Frisco, Texas, 75033, United States
Atd002 52011
Frisco, Texas, 75034, United States
Atd002 52004
Sugar Land, Texas, 77479, United States
Atd002 41004
Lovech, Bulgaria
Atd002 41001
Pleven, Bulgaria
Atd002 41002
Sevlievo, Bulgaria
Atd002 41005
Sofia, Bulgaria
Atd002 41006
Sofia, Bulgaria
Atd002 51006
Hamilton, Canada
Atd002 51007
Toronto, Canada
Atd002 42002
Náchod, Czechia
Atd002 42001
Prague, Czechia
Atd002 42004
Prague, Czechia
Atd002 42005
Prague, Czechia
Atd002 43004
Leipzig, Germany
Atd002 43007
Mahlow, Germany
Atd002 44003
Budapest, Hungary
Atd002 21001
Habikino, Japan
Atd002 21007
Nagoya, Japan
Atd002 21005
Sakai, Japan
Atd002 21008
Sapporo, Japan
Atd002 21004
Tachikawa-shi, Japan
Atd002 21006
Yokohama, Japan
Atd002 45003
Krakow, Poland
Atd002 45007
Krakow, Poland
Atd002 45014
Krakow, Poland
Atd002 45005
Sosnowiec, Poland
Atd002 45009
Tarnów, Poland
Atd002 45002
Warsaw, Poland
Atd002 45004
Warsaw, Poland
Atd002 45006
Warsaw, Poland
Atd002 45008
Wroclaw, Poland
Atd002 46004
London, United Kingdom
Atd002 46003
Salford, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 22733
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2025
First Posted
December 11, 2025
Study Start
December 29, 2025
Primary Completion (Estimated)
May 17, 2027
Study Completion (Estimated)
March 6, 2028
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.