DUPLEX-AD

• Research type

  Research Study

• Full 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 Atopic Dermatitis

• IRAS ID

  1011362

• Contact name

  Elena BOLAÑOS CASCALES

• Contact email

  GCOUKSubmissions@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2024-517814-13

• ISRCTN Number

  ISRCTN16314965

• Research summary

  Atopic dermatitis (AD) is a common inflammatory skin condition which causes itchy, dry, red skin. Biologically, AD is characterized by Type-2 immune response dysregulation and skin barrier disruption worsened by the itch-scratch cycle.
  JNJ-95475939 blocks the two important biological pathways (called Interleukin-4 [IL-4]/IL-13 and IL-31*) involved in the Type-2 inflammation and itch-scratch cycle of AD.
  *IL-4, IL-13 and IL-31 are proteins that regulate immune responses.
  In this study, researchers want to learn how well JNJ-95597528 works as compared to placebo and a comparator in participants with moderate to severe AD.

  Participants aged 18 years or older with moderate to severe AD.

  The study consists of 3 periods:
  1.
  Screening period (up to 5 weeks): Eligible participants will be screened for participation in study.
  2.
  Treatment period (up to 24 weeks): Participants will be randomly (by chance) assigned in
  Collection of non-PRF data for local registries - Template version 5.0 Page 8 of 13
  one of the
  5 treatment groups:
  Group A: Dupilumab Dose regimen 1 administered subcutaneously (SC; under the skin) for 24 weeks.
  Group B: JNJ-95475939 Dose regimen 1 SC for 24 weeks.
  Group C: JNJ-95475939 Dose regimen 2 SC for 24 weeks.
  Group D: JNJ-95475939 Dose regimen 3 SC for 24 weeks.
  Group E: Placebo SC for 12 weeks, then switch to JNJ-95475939 Dose regimen 1 SC for another 12 weeks
  3.
  Follow-up period (up to 8 weeks): Participants will be followed up to monitor their health.
  Safety assessments will include physical examinations, body weight, vital signs, 12-lead ECG, pregnancy testing, clinical laboratory tests, and monitoring of adverse events and serious adverse events. The overall duration of the study is up to 37 weeks.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  25/LO/0053

• Date of REC Opinion

  21 Feb 2025

• REC opinion

  Further Information Favourable Opinion