Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Fountain Valley, California and other locations
Dates
study started
study ends around
Principal Investigator
by April W. Armstrong, MD, MPH
Headshot of April W. Armstrong
April W. Armstrong

Description

Summary

The purpose of this study is to evaluate how well JNJ-95475939 works as compared to placebo in participants with moderate to severe atopic dermatitis.

Official Title

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of JNJ-95475939 for the Treatment of Participants With Moderate to Severe AD

Keywords

Dermatitis, Atopic, Atopic Dermatitis, Dermatitis, Dupilumab, JNJ-95475939

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • First OC Dermatology accepting new patients
    Fountain Valley California 92708 United States
  • Oregon Medical Research Center accepting new patients
    Portland Oregon 97201 United States

Lead Scientist at UCLA

  • April W. Armstrong, MD, MPH
    Dr. April Armstrong is Professor and Chief of Dermatology at University of California Los Angeles (UCLA). She oversees and leads the dermatology division, including managing clinical operations and promoting research and education. She also serves as Co-Director for Network Resources at the UCLA Clinical and Translational Research Institute.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
Links
Sign up for this study
ID
NCT06881251
Phase
Phase 2 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated