Evaluating JNJ-95475939 for treating moderate to severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness of JNJ-95475939 compared to a placebo in individuals suffering from moderate to severe atopic dermatitis. Participants must have a documented history of chronic atopic dermatitis and meet specific severity criteria, including a minimum EASI score and body surface area involvement. The study will involve administering the investigational drug alongside a placebo to determine its impact on symptoms and overall skin condition.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Chronic Atopic Dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to the screening visit
* Eczema Area and Severity Index (EASI) score greater than and equal to (\>=) 16 at the screening and baseline visits
* Validated investigator global assessment for AD (vIGA-AD) score \>= 3 at the screening and baseline visits
* \>= 10% body surface area (BSA) of AD involvement at the screening and baseline visits
* Baseline Peak Pruritus Numeric(al) Rating Scale (PP-NRS) average score of \>=4
* Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, or inadequate response to systemic therapies (within 12 months before screening)
* Participant has applied a moisturizer at least once daily for at least 7 days before the baseline visit

Exclusion criteria:

* Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents (eg, severe ocular surface disease, dupilumab-associated facial redness) inhibiting IL-4Rα, IL-4, and/or IL-13 signaling (eg, dupilumab, lebrikizumab, or tralokinumab)
* Participant is pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study
* Active skin disease other than AD including eczema herpeticum, molluscum contagiosum, impetigo, psoriasis or has any other ongoing significant skin condition including skin infections, that, according to the investigator, could interfere with efficacy assessments
* Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, or history of recurrent eczema herpeticum
* History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, untreated latent tuberculosis), recurrent urinary tract infection, fungal infection, mycobacterial infection, or open, draining, or infected skin wounds, or ulcers.
* Diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization
* Had major surgery (eg, requiring general anesthesia and hospitalization), within 8 weeks before screening, or will not have fully recovered from surgery, or has such surgery planned during the time the participant is expected to participate in the study

Where it's running

• First OC Dermatology
  Fountain Valley, California, United States Recruiting
• Hamilton Research LLC
  Alpharetta, Georgia, United States Recruiting
• Dawes Fretzin Clinical Research Group LLC
  Indianapolis, Indiana, United States Recruiting
• Indiana Clinical Trial Center
  Plainfield, Indiana, United States Recruiting
• Optima Research
  Boardman, Ohio, United States Recruiting
• Oregon Medical Research Center
  Portland, Oregon, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• 611 in Chinese children with moderate to severe atopic dermatitis

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• First-in-human test of DCY636 in healthy adults and in people with moderate to severe atopic dermatitis

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• Camoteskimab in adults with moderate-to-severe atopic dermatitis

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• Testing 611 for moderate to severe atopic dermatitis in Chinese adolescents

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• Abrocitinib for moderate-to-severe atopic dermatitis after inadequate response to biologics

  This study will try abrocitinib in adolescents and adults (≥12 years) with moderate-to-severe atopic dermatitis who didn't respond to or couldn't tolerate up to two biologic treatments to see how it works in routine care.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.