Phase
Condition
Atopic Dermatitis
Dermatitis, Atopic
Eczema (Atopic Dermatitis)
Treatment
Galvokimig
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be aged greater than or equal (≥)18 years at the time of signingthe informed consent
Participant has chronic atopic dermatitis (AtD) (according to American Academy ofDermatology Consensus Criteria) that has been present for at least ≥1 year prior toinitiating the study (ie, signing of the informed consent form [ICF]) and with:
validated Investigator Global Assessment (vIGA) score ≥3 at Screening andBaseline
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 andBaseline
≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline
Documented recent history (within 6 months prior to Screening) of inadequateresponse to treatment with topical medications, or study participants for whomtopical treatments are otherwise medically inadvisable (eg, due to importantside effects or safety risks) and who are candidates for systemic therapy
Exclusion
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 takingthe study intervention; or interfere with the interpretation of data and couldjeopardize or would compromise the study participant's ability to participate inthis study
Active dermatologic conditions that may confound the diagnosis of AtD or wouldinterfere with assessment of treatment, such as but not limited to scabies,seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, active allergic orirritant contact dermatitis
Presence or family history (first degree) of inflammatory bowel disease (includesCrohn's disease and ulcerative colitis)
History of chronic or recurrent infections, or a serious or life-threateninginfection within the 6 months prior to the Baseline (including herpes zoster) asjudged 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 biologicresponse modifiers (ie, dupilumab, tralokinumab and lebrikizumab) that resulted indiscontinuation and change of treatment
All systemic therapies (other than biologics), topical therapies and othertreatments 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 Design
Connect with a study center
Atd002 51006
Hamilton,
CanadaActive - Recruiting
Atd002 51007
Toronto,
CanadaActive - Recruiting
Atd002 51007
Toronto 6167865,
CanadaSite Not Available
Atd002 21005
Sakai,
JapanActive - Recruiting
Atd002 21005
Sakai 1853195,
JapanSite Not Available
Atd002 21008
Sapporo,
JapanActive - Recruiting
Atd002 21008
Sapporo 2128295,
JapanSite Not Available
Atd002 21004
Tachikawa-shi,
JapanActive - Recruiting
Atd002 52008
Santa Monica, California 90404
United StatesActive - Recruiting
Atd002 52008
Santa Monica 5393212, California 5332921 90404
United StatesSite Not Available
Atd002 52013
Boca Raton, Florida 33486
United StatesActive - Recruiting
Atd002 52007
Coral Gables, Florida 33134
United StatesActive - Recruiting
Atd002 52003
Miami, Florida 33133
United StatesActive - Recruiting
Atd002 52015
Savannah, Georgia 31419
United StatesActive - Recruiting
Atd002 52015
Savannah 4221552, Georgia 4197000 31419
United StatesSite Not Available
Atd002 52017
Chicago, Illinois 60611
United StatesActive - Recruiting
Atd002 52018
Wheaton, Illinois 60189
United StatesActive - Recruiting
Atd002 52017
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Atd002 52012
New Albany, Indiana 47150
United StatesActive - Recruiting
Atd002 52012
New Albany 4262045, Indiana 4921868 47150
United StatesSite Not Available
Atd002 52014
Bowling Green, Kentucky 42104
United StatesActive - Recruiting
Atd002 52014
Bowling Green 4285268, Kentucky 6254925 42104
United StatesSite Not Available
Atd002 52001
Troy, Michigan 48084
United StatesActive - Recruiting
Atd002 52009
Troy, Michigan 48084
United StatesActive - Recruiting
Atd002 52001
Troy 5012639, Michigan 5001836 48084
United StatesSite Not Available
Atd002 52009
Troy 5012639, Michigan 5001836 48084
United StatesActive - Recruiting
Atd002 52010
Omaha, Nebraska 68144
United StatesActive - Recruiting
Atd002 52010
Omaha 5074472, Nebraska 5073708 68144
United StatesSite Not Available
Atd002 52020
The Bronx, New York 10455
United StatesActive - Recruiting
Atd002 52020
The Bronx 5110266, New York 5128638 10455
United StatesSite Not Available
Atd002 52019
Philadelphia, Pennsylvania 19114
United StatesActive - Recruiting
Atd002 52019
Philadelphia 4560349, Pennsylvania 6254927 19114
United StatesSite Not Available
Atd002 52005
Dallas, Texas 75230
United StatesActive - Recruiting
Atd002 52011
Frisco, Texas 75034
United StatesActive - Recruiting
Atd002 52016
Frisco, Texas 75033
United StatesActive - Recruiting
Atd002 52004
Sugar Land, Texas 77479
United StatesActive - Recruiting
Atd002 52005
Dallas 4684888, Texas 4736286 75230
United StatesSite Not Available
Atd002 52011
Frisco 4692559, Texas 4736286 75034
United StatesActive - Recruiting
Atd002 52016
Frisco 4692559, Texas 4736286 75033
United StatesSite Not Available

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