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A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis
A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis

NCT07230860

Active Not RecruitingPhase 2

Sponsor: Janssen Research & Development, LLC

Conditions: Dermatitis, Atopic

Interventions: JNJ-95597528, Placebo

Countries: United States, Argentina, Brazil, Canada, China, Germany, Japan, Poland

The purpose of this study is to assess how well JNJ-95597528 works compared to placebo in participants with moderate to severe atopic dermatitis (AD).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

* 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: a. Chronic atopic dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to screening visit; b. Eczema area and severity index (EASI) score greater than or equal to (\>=) 16 at the screening and Week 0; c. validated investigator global assessment for atopic dermatitis (vIGA-AD) score \>= 3 at screening and Week 0; d. \>= 10% body surface area (BSA) of AD involvement at screening and Week 0; e. 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

Exclusion criteria:

* 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
Locations (62)
  • Fountain Valley, California, United States
  • Los Angeles, California, United States
  • Santa Ana, California, United States
  • Miami, Florida, United States
  • Rolling Meadows, Illinois, United States
  • Indianapolis, Indiana, United States
  • Detroit, Michigan, United States
  • Fargo, North Dakota, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • CABA, Argentina
  • Córdoba, Argentina
  • Rosario, Argentina
  • Rosario, Argentina
  • San Miguel de Tucumán, Argentina
  • Curitiba, Brazil
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • Santo André, Brazil
  • Santo André, Brazil
  • São Paulo, Brazil
  • Calgary, Alberta, Canada
  • Ajax, Ontario, Canada
  • + 32 more on CT.gov