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Johnson & Johnson announces ICOTYDE® (icotrokinra) delivers significant improvement in psoriatic arthritis disease activity among biologic-naive patients with once-daily targeted oral peptide

JNJ
  • Johnson & Johnson announced positive Phase 3 ICONIC-PsA 1 study results for ICOTYDE (icotrokinra) in biologic-naïve adults with active psoriatic arthritis, presented at the American College of Rheumatology Convergence 2026.
  • ICOTYDE met its primary endpoint at Week 16, with 58% of patients achieving an ACR20 response compared to 41% for the placebo group.
  • At Week 16, 29% of ICOTYDE-treated patients achieved an ACR50 response and 13% achieved an ACR70 response, versus 16% and 5% respectively for placebo.
  • Among patients with qualifying skin involvement at Week 16, 57% of ICOTYDE recipients achieved clear or almost clear skin (IGA 0/1) compared to 14% for placebo, and 37% achieved a PASI 90 score compared to 6% for placebo.
  • Efficacy data through Week 24 showed continued improvement, with 69% of patients achieving ACR20, 40% achieving ACR50, and 18% achieving ACR70.
  • At Week 24, 64% of patients with qualifying baseline skin involvement achieved clear or almost clear skin, and 56% achieved a PASI 90 score.
  • Safety findings through Week 24 were consistent with the established profile of ICOTYDE, with no new safety signals identified.
  • ICOTYDE is a first-in-class, once-daily oral peptide that targets the IL-23 receptor to address both joint inflammation and skin lesions associated with psoriatic arthritis.
  • The study population consisted of biologic-naïve adults, and participants in the placebo group who remained on treatment crossed over to receive ICOTYDE at Week 16.
  • ICOTYDE is currently approved in the U.S. for moderate-to-severe plaque psoriasis but is not yet approved for psoriatic arthritis.
  • The drug is being developed pursuant to a collaboration between Protagonist Therapeutics and Johnson & Johnson, with J&J holding exclusive worldwide rights for development beyond Phase 2.
  • Additional Phase 3 studies are underway to evaluate ICOTYDE for biologic-experienced psoriatic arthritis, ulcerative colitis, and Crohn's disease.
Company
Johnson & Johnson
Keywords
Johnson & Johnson