J&J's Icotyde meets Phase 3 goal in psoriatic arthritis

Johnson & Johnson said on November 7, 2026 that its once-daily oral peptide Icotyde (icotrokinra) met the primary endpoint of a Phase 3 trial in adults with active psoriatic arthritis who had not previously taken a biologic drug. The findings are scheduled as a late-breaking poster at ACR Convergence 2026 on Tuesday, November 10, from 10:30 a.m. to 12:30 p.m. The abstract page does not state a time zone.

Icotyde is a peptide taken by mouth that blocks the IL-23 receptor. J&J said it is approved in the United States for moderate-to-severe plaque psoriasis in adults and in patients 12 and older who weigh at least 40 kg, and that it is not approved for psoriatic arthritis. The U.S. Food and Drug Administration cleared it for plaque psoriasis in March 2026, as we reported when the UK later approved the same use (report).

The trial

ICONIC-PsA 1 (NCT06878404) is a randomized, double-blind, placebo-controlled study sponsored by Janssen Research & Development, a Johnson & Johnson company. ClinicalTrials.gov lists actual enrollment of 552, matching the ACR abstract. People were randomized 5:5:5:3 to once-daily oral icotrokinra at the abstract’s “200 mg” or “400 mg” arms, to placebo, or to ustekinumab given as a safety reference arm with no formal statistical comparisons.

A parallel Phase 3 trial, ICONIC-PsA 2 (NCT06807424), is testing the drug in both biologic-experienced and biologic-naive adults with active psoriatic arthritis. ClinicalTrials.gov lists that study as active, not recruiting, with 813 people enrolled. J&J’s November 7 release does not include those results.

Week 16: the primary endpoint

The primary endpoint was the share of patients reaching ACR20, a 20% improvement on a composite of joint counts and other disease-activity measures, at week 16. On the “200 mg” arm, 58% reached ACR20, versus 41% on placebo (p of 0.002), according to both J&J and the abstract. The “400 mg” arm reached 52%, with a p of 0.052, which the abstract does not treat as statistically significant. The abstract says that arm showed “no additional benefit beyond the 200mg dose.”

On “200 mg” versus placebo, ACR50 was 29% versus 16% (nominal p of 0.004) and ACR70 was 13% versus 5% (nominal p of 0.015). The abstract says those p-values are nominal. It also notes that multiplicity-controlled testing of secondary endpoints required both dose groups to be statistically significant first, which the “400 mg” ACR20 comparison was not. In the “400 mg” group, ACR50 was 23% and ACR70 was 10%.

Among patients with qualifying skin involvement, 57% on Icotyde reached clear or almost clear skin (IGA 0/1), versus 14% on placebo (nominal p under 0.001). The abstract reports that 57% versus 14% figure for both the “200 mg” and “400 mg” arms. J&J also reported that 37% reached PASI 90, versus 6% on placebo (nominal p under 0.001), among patients with qualifying skin involvement. The company’s release does not break the PASI 90 figure out by dose.

Week 24 and safety

At week 16, placebo patients still on treatment were reassigned to Icotyde. J&J said response rates on “200 mg” continued to rise numerically through week 24, to ACR20 of 69%, ACR50 of 40% and ACR70 of 18%.

Adverse event rates through week 16 were 44% on “200 mg”, 52% on “400 mg”, 41% on placebo and 51% on ustekinumab, the abstract reported. Both J&J and the abstract said no new safety signals were identified through week 24.

What is not known

• Longer follow-up. Public results stop at week 24. The abstract says ustekinumab remains a safety reference arm through week 52, with no formal comparisons.
• ICONIC-PsA 2. Results from the larger parallel trial have not been reported.
• A PsA filing. J&J’s release does not say when, or whether, the company will ask regulators to add psoriatic arthritis to Icotyde’s label.
• PASI 90 by dose. J&J reported an overall PASI 90 rate and did not publish a breakdown for the “200 mg” and “400 mg” arms in the release.

This story summarizes a company press release and a meeting abstract. It is not medical advice.