Johnson & Johnson's ICOTYDE Meets Primary Endpoint in Phase 3 Psoriatic Arthritis Trial

Johnson & Johnson (NYSE:JNJ) announced that its investigational treatment ICOTYDE (icotrokinra) achieved the primary endpoint in a Phase 3 clinical trial involving adults with active psoriatic arthritis who had not previously received biologic therapies.

The ICONIC-PsA 1 study evaluated the efficacy and safety of ICOTYDE at a dose of 200 mg administered once daily. At Week 16, 58% of patients receiving the treatment achieved an ACR20 response, compared with 41% of patients receiving placebo.

ACR20 is a clinical measure indicating at least a 20% improvement in tender and swollen joint counts, alongside other measures of disease activity.

The results were presented in a late-breaking poster at the American College of Rheumatology Convergence 2026 meeting.

Phase 3 Trial Reports Improvements in Joint Symptoms

The ICONIC-PsA 1 trial assessed several measures of treatment response among adults with active psoriatic arthritis who had not previously been treated with biologic medicines.

At Week 16, 58% of patients treated with ICOTYDE achieved an ACR20 response, compared with 41% in the placebo group, meeting the study’s primary endpoint.

The trial also evaluated higher thresholds of clinical improvement.

An ACR50 response, representing at least a 50% improvement in the relevant measures of disease activity, was achieved by 29% of patients receiving ICOTYDE, compared with 16% of those receiving placebo.

An ACR70 response, indicating at least a 70% improvement, was recorded in 13% of patients treated with ICOTYDE, versus 5% in the placebo group.

These findings provided additional information about the extent of joint symptom improvement observed during the first 16 weeks of treatment.

ICOTYDE Shows Improvements in Psoriasis Skin Symptoms

The study also examined changes in skin symptoms among participants who met the criteria for baseline psoriasis involvement.

At Week 16, 57% of ICOTYDE-treated patients in this subgroup achieved clear or almost clear skin, according to the Investigator’s Global Assessment measure.

The corresponding response rate among patients receiving placebo was 14%.

The trial also assessed improvement using the Psoriasis Area and Severity Index (PASI).

A PASI 90 response, indicating at least a 90% improvement in psoriasis severity, was achieved by 37% of patients receiving ICOTYDE, compared with 6% of patients receiving placebo.

The results indicate that the treatment was associated with improvements in both joint and skin manifestations of psoriatic arthritis during the placebo-controlled assessment period.

Clinical Responses Continue to Increase Through Week 24

Johnson & Johnson reported that response rates continued to increase during the subsequent assessment period.

By Week 24, 69% of patients receiving ICOTYDE had achieved an ACR20 response, compared with 58% at Week 16.

The proportion achieving ACR50 increased to 40%, while 18% reached the ACR70 threshold.

Skin-related outcomes also improved over the longer assessment period.

Among patients with qualifying psoriasis involvement at baseline, 64% achieved clear or almost clear skin at Week 24.

Additionally, 56% of patients in this subgroup achieved a PASI 90 response.

The Week 24 findings provide further information about treatment responses over time. The supplied results did not include corresponding Week 24 placebo response rates.

Safety Findings Consistent With Established Profile

Johnson & Johnson stated that the safety data collected through Week 24 were consistent with ICOTYDE’s established safety profile.

The company reported that no new safety signals were identified during the assessment period.

ICOTYDE is not currently approved for the treatment of psoriatic arthritis.

However, the medicine has received US regulatory approval for moderate-to-severe plaque psoriasis in adults and paediatric patients aged 12 years and older who weigh at least 40 kilograms.

The Phase 3 results relate to a separate potential indication and do not represent regulatory authorisation for use in psoriatic arthritis.

Johnson & Johnson Holds Worldwide Commercial Rights

ICOTYDE was jointly discovered by Johnson & Johnson and Protagonist Therapeutics.

Under the companies’ development arrangement, Johnson & Johnson holds exclusive worldwide rights to develop and commercialise the medicine.

The ICONIC-PsA 1 results add clinical data concerning the potential use of icotrokinra in patients with active psoriatic arthritis who have not previously received biologic treatments.

The company has not provided a regulatory submission timetable for the psoriatic arthritis indication in the supplied announcement.

Clinical Development Outlook

The Phase 3 ICONIC-PsA 1 trial met its primary endpoint, with ICOTYDE demonstrating higher ACR20 response rates than placebo at Week 16.

The study also reported improvements in more stringent joint response measures and psoriasis skin outcomes, with additional increases in response rates through Week 24.

Johnson & Johnson reported no new safety signals during the 24-week assessment period.

The findings provide additional clinical evidence for ICOTYDE in psoriatic arthritis, although the medicine remains unapproved for this indication.

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