Trial intelligence / Profile preview

Icotrokinra in Active Psoriatic Arthritis

NCT06807424Phase 3

Key facts

Status
Active, not recruiting
Start
Jan 2025
Primary completion
Feb 2027
Countries
24
Modality
Peptides
Conditions
psoriatic arthritis (PsA)
01

Overview

Phase 3, randomised, double-blind trial of icotrokinra in psoriatic arthritis (PsA) (3 arms), sponsored by Janssen Pharmaceutical. Primary endpoint: American College of Rheumatology 20 Response at 16 weeks. Started Jan 2025; status: active, not recruiting.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • Group I: Icotrokinra Dose 1

    Participants receive icotrokinra Dose 1.

  • Group II: Icotrokinra Dose 2

    Participants receive icotrokinra Dose 2.

  • Group III: Placebo

    Participants receive placebo matched to icotrokinra, crossing over to icotrokinra at Week 16.

03

Who it enrols

Participants must have active psoriatic arthritis despite previous use of a non-biologic DMARD, apremilast, or a biologic agent. They must also have active plaque psoriasis or nail changes consistent with psoriasis.

04

Endpoints

Primary

  • American College of Rheumatology 20 Response

Secondary

  • Psoriatic Area and Severity Index 75 Response

  • Psoriatic Area and Severity Index 90 Response

  • Psoriatic Area and Severity Index 100 Response

  • Investigator Global Assessment Psoriasis Score

  • American College of Rheumatology 50 Response

  • American College of Rheumatology 70 Response

  • Health Assessment Questionnaire-Disability Index

  • 36 Item Short Form Survey Physical Component Summary

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