Last updated 8 days ago
A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis
180 patients around the world
Available in Argentina, United States, Brazil
Janssen Research & Development, LLC
15Research sites
180Patients around the world
This study is for people with
Dermatitis
Atopic dermatitis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening.Meets all the following disease activity criteria.Chronic atopic dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to screening visit.Eczema area and severity index (EASI) score greater than or equal to (>=) 16 at the screening and Week 0.Validated investigator global assessment for atopic dermatitis (vIGA-AD) score >= 3 at screening and Week 0.>= 10% body surface area (BSA) of AD involvement at screening and Week 0.Documented history (within 6 months before screening) of either inadequate response or inadvisability to medicated topical treatments for AD or inadequate response to systemic therapies (within 12 months before screening).Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.If willing to participate in the substudy, must sign a separate ICF for the corresponding substudy (or substudies).Willing and able to comply with scheduled visits, treatment plan, laboratory tests, lifestyle restrictions, and other study procedures.
- History of substance abuse or alcohol abuse within 1 year before screening.In the investigator's opinion, any clinically significant results from the 12-lead ECG, chemistry, hematology, or urinalysis laboratory tests obtained at the screening visit that would affect interpretation of study data or the participant's safety in the study.Known or suspected immunodeficiency, including history of invasive opportunistic infections.Previously received JNJ-95597528.Has known hypersensitivity or intolerance to JNJ-95597528 or its excipients or to any biologic medication or known allergies, or clinically significant reactions to murine, chimeric, monoclonal antibodies (mAbs), or antibody fragments.
Sites
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Recruiting
DOM Centro de Reumatología - CABA
Recruiting
InAER - Investigaciones en Alergia y Enfermedades Respiratorias - CABA, Buenos Aires
Recruiting
Instituto de Investigaciones Clínicas Córdoba
Recruiting
Centro de Investigaciones Médicas Tucumán
Recruiting
Instituto Médico de Alta Complejidad San Isidro IMACSI
Recruiting
Centro Respiratorio Infantil S.A. - Rosario
Recruiting
Derma Internacional S.A.
Recruiting
Mautalen - Salud e Investigación - CABA
Recruiting
Centro de Investigaciones Clínicas-CIC-IESR
Recruiting
StudyREADY-AD
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Atopic dermatitis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07230860
