Oral JNJ-2113 Demonstrates Efficacy in Phase 3 Trials for Moderate-to-Severe Psoriasis

Key Insights

• JNJ-2113 (icotrokinra), an oral IL-23 receptor antagonist, showed significant skin clearance in phase 3 ICONIC-LEAD trial compared to placebo for moderate-to-severe psoriasis.
• The ICONIC-TOTAL study also met its primary endpoint, demonstrating JNJ-2113's efficacy in treating psoriasis affecting special areas like the scalp, genitals, hands, and feet.
• Safety data from both trials were consistent with previous phase 2 studies, with comparable adverse event rates between JNJ-2113 and placebo groups.

Johnson & Johnson and Protagonist Therapeutics have announced positive topline results from the phase 3 ICONIC-LEAD and ICONIC-TOTAL trials evaluating JNJ-2113 (icotrokinra), an oral peptide designed to selectively block the interleukin (IL)-23 receptor, in patients with moderate-to-severe plaque psoriasis. The studies demonstrated significant efficacy and a favorable safety profile, positioning JNJ-2113 as a potential best-in-class oral agent for psoriasis treatment.

ICONIC-LEAD Trial Results

The ICONIC-LEAD study, involving 684 participants, compared JNJ-2113 to placebo. The co-primary endpoints were a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and an Investigator's Global Assessment (IGA) score of 0 or 1 with at least a 2-grade improvement. At week 16, 64.7% of participants on JNJ-2113 achieved IGA scores of 0/1, while 49.6% achieved PASI 90, compared to 8.3% and 4.4% on placebo, respectively. By week 24, 74.1% of subjects reported IGA scores of 0/1 and 64.9% achieved PASI 90.

ICONIC-TOTAL Trial Results

The ICONIC-TOTAL trial assessed 311 individuals with psoriasis affecting special areas such as the scalp, genital area, and/or hands and feet. The study met its primary endpoint of IGA 0/1 at week 16, demonstrating the medication’s efficacy in these difficult-to-treat areas.

Safety Profile

Safety data from the ICONIC-LEAD study aligned with earlier phase 2 FRONTIER trials, with comparable adverse event rates between JNJ-2113 (49.3%) and placebo (49.1%) at Week 16.

Future Development

Protagonist Therapeutics and Johnson & Johnson plan to initiate a phase 3 program for JNJ-2113 in psoriatic arthritis (ICONIC-PsA). Results from the phase 3 ICONIC-ADVANCE 1 and 2 studies, comparing JNJ-2113 against placebo and deucravacitinib, are expected in 2025. A potential psoriasis NDA submission is also anticipated.

Dinesh V. Patel, PhD, president and CEO of Protagonist, expressed enthusiasm for JNJ-2113, highlighting its potential as a once-daily oral treatment offering significant skin clearance and demonstrated tolerability.