Johnson & Johnson announced positive Phase 3 results for ICOTYDE (icotrokinra) in biologic-naive adults with active psoriatic arthritis, presented as a late-breaking poster at the American College of Rheumatology Convergence 2026 on November 7, 2026.

Key Highlights

  • Primary endpoint met: 58% of patients receiving ICOTYDE 200 mg achieved an ACR20 response at Week 16, compared with 41% receiving placebo.
  • ACR50 and ACR70 responses: 29% of ICOTYDE patients achieved ACR50 and 13% achieved ACR70, versus 16% and 5% for placebo, respectively, at Week 16.
  • Skin improvement: Among patients with qualifying skin involvement, 57% receiving ICOTYDE achieved clear or almost clear skin (IGA 0/1) versus 14% on placebo, and 37% achieved PASI 90 versus 6% on placebo.
  • Week 24 ACR20: Response rates continued to increase numerically, with 69% of ICOTYDE patients achieving ACR20 by Week 24.
  • Safety profile: Safety data through Week 24 were consistent with the established safety profile of ICOTYDE, with no new safety signals identified.
  • Regulatory status: According to the filing, ICOTYDE is not approved for the treatment of active psoriatic arthritis; it is currently approved in the U.S. only for moderate-to-severe plaque psoriasis.

ICONIC-PsA 1 Phase 3 Findings: Joint and Skin Outcomes Through Week 24

Johnson & Johnson (NYSE:JNJ) disclosed Phase 3 results from the ICONIC-PsA 1 study (NCT06878404), a randomized, double-blind, placebo-controlled trial evaluating once-daily oral icotrokinra in biologic-naive adults with active psoriatic arthritis. According to the filing, the study met its primary endpoint: a significantly higher proportion of patients receiving ICOTYDE 200 mg achieved an ACR20 response compared with placebo (58% vs. 41%) at Week 16. The filing notes that at Week 16, participants in the placebo group who were still on study treatment crossed over to receive ICOTYDE.

The filing further reported that numerically higher proportions of ICOTYDE patients also achieved ACR50 (29% vs. 16%) and ACR70 (13% vs. 5%) at Week 16. Among patients with qualifying skin involvement, 57% receiving ICOTYDE achieved an IGA score of 0/1 versus 14% on placebo, and 37% achieved PASI 90 versus 6% on placebo. Response rates continued to increase numerically through Week 24, with 69% achieving ACR20, 40% achieving ACR50, and 18% achieving ACR70. Among patients with qualifying baseline skin involvement, 64% achieved IGA 0/1 and 56% achieved PASI 90 by Week 24.

According to the filing, ICOTYDE is described as the first and only targeted oral peptide designed to precisely block the IL-23 receptor. The filing states that ICOTYDE was jointly discovered pursuant to a license and collaboration agreement between Protagonist and Johnson & Johnson, with Johnson & Johnson retaining exclusive worldwide rights to develop and commercialize compounds from the research. The company noted that these results are being presented as a late-breaking poster at ACR Convergence 2026, and that forward-looking statements are subject to the company's cautionary language.

What Was Disclosed

Johnson & Johnson disclosed Phase 3 clinical trial data for ICOTYDE in active psoriatic arthritis, reporting ACR20, ACR50, ACR70, and skin response rates at Week 16 and Week 24, along with a safety summary showing no new signals through Week 24.