Psoriasis Clinical Trial
A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis
Summary
The purpose of this study is to evaluate the efficacy and safety of bermekimab in participants with moderate to severe atopic dermatitis (AD).
Eligibility Criteria
Inclusion Criteria:
Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECGs) performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
Have atopic dermatitis (AD) for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history
Have a history of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable (example [eg], due to important side effects or safety risks)
Be considered, in the opinion of the investigator, a suitable candidate for dupilumab (DUPIXENT) therapy according to their country's approved DUPIXENT product labeling
Have an eczema area and severity index (EASI) score greater than or equal (>=) to 16 at screening and at baseline
Have an investigator global assessment (IGA) score >=3 and involved body surface area (BSA) >=10 percent (%) at screening and baseline
Exclusion Criteria:
Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months
Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis), or has been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months before screening
Has or has had herpes zoster within the 2 months before screening
Has a history of being human immunodeficiency virus (HIV) antibody-positive, or tests positive for HIV at screening
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There are 42 Locations for this study
Los Angeles California, 90025, United States
Santa Ana California, 92705, United States
Orange Park Florida, 32073, United States
Tampa Florida, 33613, United States
Rolling Meadows Illinois, 60008, United States
Indianapolis Indiana, 46256, United States
Warren Michigan, 48088, United States
East Windsor New Jersey, 08520, United States
New York New York, 10029, United States
Columbus Ohio, 43215, United States
Pittsburgh Pennsylvania, 15213, United States
Johnston Rhode Island, 02919, United States
Arlington Texas, 76011, United States
Pflugerville Texas, 78660, United States
San Antonio Texas, 78213, United States
Webster Texas, 77598, United States
Norfolk Virginia, 23502, United States
Spokane Washington, 99202, United States
Calgary Alberta, T2J 7, Canada
Markham Ontario, L3P 1, Canada
Mississauga Ontario, L4Y 4, Canada
Niagara Falls Ontario, L2H 1, Canada
Montreal Quebec, H2H2B, Canada
Quebec , G1V 4, Canada
Bad Bentheim , 48455, Germany
Berlin , 10789, Germany
Frankfurt/ Main , 60590, Germany
Hamburg , 20537, Germany
Hamburg , 22391, Germany
Hannover , 30625, Germany
Langenau , 89129, Germany
Mahlow , 15831, Germany
Obihiro-shi , 080-0, Japan
Osaka Fu , 593-8, Japan
Sapporo , 060-0, Japan
Czestochowa , 42-20, Poland
Lodz , 90-24, Poland
Osielsko , 86031, Poland
Warszawa , 02-95, Poland
Warszawa , 02962, Poland
Wroclaw , 50566, Poland
Wrocław , 51-68, Poland
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