ICONIC-PsA 2

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced Participants with Active Psoriatic Arthritis

• IRAS ID

  1010955

• Contact name

  ELENA BOLAÑOS CASCALES

• Contact email

  GCOUKSubmissions@its.jnj.com

• Sponsor organisation

  Janssen Cilag International NV

• Eudract number

  2024-517284-23

• ISRCTN Number

  ISRCTN16757143

• Clinicaltrials.gov Identifier

  Nil known

• Research summary

  Active psoriatic arthritis (PsA) is a chronic disease that causes joint pain and swelling. Patients may also have red patches on their skin. Psoriatic arthritis can affect any joint in the body, including fingers, toes, knees, and the spine. This can make it harder to move around and do everyday tasks.

  Drugs that prevent interleukin IL-23* from binding to its receptor** may be an effective way to disease control. The study drug, JNJ-77242113, is a medicine designed to target the IL-23 receptor and block IL-23 from binding to it.
  *A specific type of protein involved in inflammation.
  **A protein that binds to specific molecule

  In this study researchers want to check how well JNJ-77242113 works when compared to placebo (does not contain any active medication) in participants with PsA.

  Participants aged 18 years or older with PsA can participate.

  This study is a 52-week main study with a 52-week blinded long term extension (LTE). At Week 0, participants will be randomly (by chance) assigned to one of the 3 treatment arms:
  o Group I: JNJ-77242113 Dose 1 once daily.
  o Group II: JNJ-77242113 Dose 2 once daily.
  o Group III: Placebo once daily. At Week 16, participants will cross-over to receive Dose 1 or Dose 2 JNJ-77242113 once daily.
  The main study will consist of:
  • Screening Period (Up to 5 weeks)
  • Placebo-controlled period (Up to 16 weeks)
  • Blinded active-treatment period (up to 36 weeks)
  • Safety follow-up visit (4 weeks after last dose of study treatment)
  All participants that complete the main study will have the option to participate in the 52-week blinded LTE period (48 weeks of active treatment plus 4 weeks of safety follow-up).
  Safety assessments include monitoring of adverse events (AEs), vital sign measurement, participant and investigator reported questionnaires, and blood tests. All side effects will be recorded till the study ends (approximately up to 2 years).

• REC name

  Wales REC 5

• REC reference

  24/WA/0371

• Date of REC Opinion

  8 Jan 2025

• REC opinion

  Further Information Favourable Opinion