Johnson & Johnson (J&J) has announced positive results from its Phase 3 ICONIC-PsA 1 study evaluating Icotyde (icotrokinra) in biologic-naïve adults with active Psoriatic Arthritis (PsA). The investigational therapy met the primary endpoint, with 58 percent of patients receiving Icotyde achieving an American College of Rheumatology 20 (ACR20) response at Week 16, compared with 41 percent receiving placebo.
Icotyde is a targeted oral peptide designed to selectively block the interleukin-23 (IL-23) receptor. The therapy demonstrated improvements across joint and skin disease measures, with safety findings consistent with its established safety profile and no new safety signals identified. The results are being presented as a late-breaking poster at the American College of Rheumatology (ACR) Convergence 2026.
The study also reported numerically higher ACR50 and ACR70 response rates among patients receiving Icotyde. At Week 16, 29 percent achieved ACR50 and 13 percent achieved ACR70, compared with 16 percent and 5 percent, respectively, in the placebo group.
Improvements in skin symptoms were also observed among patients with qualifying skin involvement. Around 57 percent of patients receiving Icotyde achieved clear or almost clear skin, measured through the Investigator's Global Assessment (IGA 0/1), compared with 14 percent receiving placebo. Additionally, 37 percent achieved a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90), compared with 6 percent in the placebo group.
Treatment responses continued to increase numerically through Week 24. At this time point, 69 per cent of patients receiving Icotyde achieved ACR20, 40 percent achieved ACR50 and 18 percent achieved ACR70. Among patients with qualifying baseline skin involvement, 64 percent achieved clear or almost clear skin, while 56 percent achieved PASI 90. Safety findings through Week 24 remained consistent with the established safety profile, with no new safety signals reported.
According to Johnson & Johnson, the findings highlight the potential of Icotyde as an oral treatment option for people living with psoriatic arthritis, a chronic immune-mediated inflammatory disease affecting the joints and skin. The condition can cause joint pain, stiffness and swelling, along with skin lesions associated with plaque psoriasis. Studies indicate that nearly 30 percent of people with plaque psoriasis also develop psoriatic arthritis.
The company is evaluating Icotyde through additional Phase 3 clinical programmes. The ICONIC-PsA 2 study is assessing its efficacy and safety in biologic-experienced and biologic-naïve adults with active psoriatic arthritis. Other Phase 3 studies are evaluating the therapy in patients with moderate-to-severe plaque psoriasis, including ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2.
Additional clinical investigations are underway to assess Icotyde in moderately to severely active ulcerative colitis and Crohn's disease through the ICONIC-UC and ICONIC-CD studies, respectively.
Icotyde is currently approved in the United States for treating moderate-to-severe plaque psoriasis in adults and paediatric patients aged 12 years and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. Its evaluation in psoriatic arthritis and other inflammatory conditions is ongoing.
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