Iconic Ascend: JNJ2113 compared to Placebo and Ustekinumab in patients with psoriasis

• Research type

  Research Study

• Full title

  A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis.

• IRAS ID

  1011110

• Contact name

  Elena Bolanos Cascales

• Contact email

  GCOUKSubmissions@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International N.V.

• Eudract number

  2024-515706-77

• ISRCTN Number

  ISRCTN56487896

• Research summary

  Plaque psoriasis is a skin disease that causes red, scaly, & sometimes painful and itchy patches on the skin.
  Targeting interleukin-23 (IL-23)* to prevent it from binding to its receptor** is a highly validated approach for treating moderate to severe psoriasis. The study drug, JNJ-77242113, is a medicine that blocks the IL-23 receptor by binding to it. By blocking the effects of IL-23, inflammation is reduced thus preventing disease from getting worse.
  *A specific type of protein involved in inflammation.
  **A protein that binds to specific molecule.
  The purpose of this study is to check how well JNJ-77242113 works compared to placebo (does not contain any active medication) in participants with moderate to severe plaque psoriasis.
  Who can participate?
  Participants greater than or equal to (>=)12 years with moderate to severe plaque psoriasis.
  What does the study involve:
  Participants enrolled into 2 cohorts:
  Cohort A: Never received systemic therapy or have received systemic therapy but have discontinued for reasons other than those mentioned in Cohort B.
  Cohort B: Received systemic therapy but responded poorly, have not tolerated or have been advised not to take.
  Study includes:
  1. Screening Period (Up to 5 Weeks)
  2. Treatment Period: Participants to be randomly assigned into arms:
  JNJ-77242113:
  JNJ-77242113 from Week 0 to Week 104
  Matching placebo for ustekinumab at Weeks 0,4 & 16
  Placebo:
  Matching placebo for JNJ-77242113 from Week 0 to Week 16
  Matching placebo for ustekinumab at Weeks 0, 4 & 16
  JNJ-77242113 from Week 16 to Week 104
  Ustekinumab:
  Ustekinumab at Weeks 0, 4 & 16
  Matching placebo for JNJ-77242113 from Week 0 to Week 28
  JNJ-77242113 from Week 28 to Week 104.
  3. Safety follow-up Period: Up to 4 weeks after treatment completion/discontinuation

  Safety assessments include monitoring of adverse events, laboratory tests, electrocardiograms,
  physical examinations, vital signs, & patient-reported health questionnaires.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  25/NE/0041

• Date of REC Opinion

  13 Mar 2025

• REC opinion

  Further Information Favourable Opinion