A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis
Galvokimig: Drug: Galvokimig Pharmaceutical form: Solution for injection
Placebo: Drug: Placebo Pharmaceutical form: Solution for injection
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Percentage of participants with Eczema Area and Severity Index (EASI)75 response at Week 16 — 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.
Trial sites (68)
Facility
City
Region
Status
Atd002 52021
Oceanside
California
Active Not Recruiting
Atd002 52008
Santa Monica
California
Active Not Recruiting
Atd002 52013
Boca Raton
Florida
Active Not Recruiting
Atd002 52007
Miami
Florida
Active Not Recruiting
Atd002 52003
Miami
Florida
Active Not Recruiting
Atd002 52015
Savannah
Georgia
Active Not Recruiting
Atd002 52017
Chicago
Illinois
Active Not Recruiting
Atd002 52018
Wheaton
Illinois
Active Not Recruiting
Atd002 52012
New Albany
Indiana
Active Not Recruiting
Atd002 52014
Bowling Green
Kentucky
Active Not Recruiting
Atd002 52001
Troy
Michigan
Recruiting
Atd002 52009
Troy
Michigan
Active Not Recruiting
Atd002 52010
Omaha
Nebraska
Active Not Recruiting
Atd002 52022
New York
New York
Active Not Recruiting
Atd002 52020
The Bronx
New York
Active Not Recruiting
Atd002 52019
Philadelphia
Pennsylvania
Active Not Recruiting
Atd002 52005
Dallas
Texas
Active Not Recruiting
Atd002 52016
Frisco
Texas
Active Not Recruiting
Atd002 52011
Frisco
Texas
Active Not Recruiting
Atd002 52004
Sugar Land
Texas
Active Not Recruiting
Atd002 41004
Lovech
Bulgaria
Active Not Recruiting
Atd002 41001
Pleven
Bulgaria
Active Not Recruiting
Atd002 41007
Plovdiv
Bulgaria
Active Not Recruiting
Atd002 41002
Sevlievo
Bulgaria
Active Not Recruiting
Atd002 41003
Sofia
Bulgaria
Recruiting
Atd002 41005
Sofia
Bulgaria
Active Not Recruiting
Atd002 41006
Sofia
Bulgaria
Active Not Recruiting
Atd002 51002
Edmonton
Canada
Active Not Recruiting
Atd002 51006
Hamilton
Canada
Active Not Recruiting
Atd002 51007
Toronto
Canada
Active Not Recruiting
Atd002 51003
Vancouver
Canada
Active Not Recruiting
Atd002 42002
Náchod
Czechia
Active Not Recruiting
Atd002 42001
Prague
Czechia
Active Not Recruiting
Atd002 42003
Prague
Czechia
Active Not Recruiting
Atd002 42004
Prague
Czechia
Active Not Recruiting
Atd002 42005
Prague
Czechia
Active Not Recruiting
Atd002 43001
Bad Bentheim
Germany
Active Not Recruiting
Atd002 43005
Dresden
Germany
Recruiting
Atd002 43002
Frankfurt
Germany
Recruiting
Atd002 43004
Leipzig
Germany
Active Not Recruiting
+ 28 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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