Icotrokinra Demonstrates Efficacy in Adolescents and Adults With Moderate to Severe Psoriasis in ICONIC-LEAD Phase 3 Study

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Johnson & Johnson shared today positive topline data from a subgroup analysis of its phase 3 ICONIC-LEAD study.¹

The results, presented at the ongoing World Congress of Pediatric Dermatology (April 8-11; Buenos Aires, Argentina), demonstrated the efficacy of icotrokinra (JNJ-2113) in patients aged 12 years and older with moderate to severe plaque psoriasis.

This subgroup analysis marks the first time a systemic psoriasis therapy has been evaluated for efficacy and safety in adolescents and adults concurrently within a single phase 3 study framework.

Icotrokinra, which targets the interleukin-23 (IL-23) receptor pathway, is being developed as a once-daily oral therapy.

About the ICONIC-LEAD Trial

The ICONIC-LEAD study (NCT06095115) is a large-scale, randomized, placebo-controlled phase 3 trial designed to evaluate the safety and efficacy of icotrokinra in 684 participants aged 12 years and older.²

Participants were randomized to receive icotrokinra (n=456) or placebo (n=228). The study’s co-primary endpoints included achieving Investigator’s Global Assessment (IGA) 0/1 with at least a 2-grade improvement from baseline and PASI 90 at Week 16. Among the total participants, 66 were adolescents.

High Skin Clearance Rates by Week 16

Among adolescent participants aged 12 years and older, those treated with icotrokinra experienced substantial clinical improvements by week 16 of the study.

Specifically, 84.1% of adolescents achieved a score of 0 or 1 (clear or almost clear) on the IGA scale, compared to 27.3% of those receiving placebo. Additionally, 70.5% reached PASI 90 (at least a 90% improvement in the Psoriasis Area and Severity Index), versus 13.6% in the placebo group.

These early results suggest a rapid onset of action with icotrokinra.

Continued Improvement Through Week 24

By week 24, clinical outcomes among adolescent patients on icotrokinra continued to improve. In total, 86.4% achieved IGA 0/1 (clear or almost clear skin), while 88.6% reached PASI 90.

Furthermore, 75% achieved complete skin clearance (IGA 0) and 63.6% achieved PASI 100, indicating total lesion resolution.

These figures point to icotrokinra’s durability and deepening clinical response over time.

Favorable Safety Profile With Fewer Adverse Events

In terms of tolerability, the study found that icotrokinra maintained a favorable safety profile. By week 16, 50% of adolescents in the treatment group experienced at least one adverse event, compared to 73% of those in the placebo group. No new or unexpected safety concerns emerged.

Expert Insights

Lawrence Eichenfield, MD, who presented the findings and is chief of pediatric and adolescent dermatology at Rady Children’s Hospita in San Diego, California, emphasized the importance of advancing therapeutic options for younger patients.

“Data from the phase 3 ICONIC LEAD subgroup analysis demonstrate impressive efficacy rates, showing the promise of this novel therapeutic option in the treatment of adolescents with moderate to severe plaque psoriasis who’ve often not yet received an advanced therapy,” Eichenfield said in a news release.¹ “Young patients with plaque psoriasis face unique challenges due to the visible and uncomfortable nature of the disease, making effective treatment options that align with their needs and preferences all the more important.”

Liza O’Dowd, MD, vice president and immunodermatology disease area lead at Johnson & Johnson Innovative Medicine, echoed this sentiment, adding that the inclusion of adolescents in pivotal trials reflects a broader commitment to addressing unmet needs in underserved populations.

“Adolescents living with moderate to severe plaque psoriasis shouldn’t have to wait for effective treatments options that have the potential to deliver completely clear skin, which is the driving force for studying this younger population as part of the pivotal ICONIC program,” O’Dowd said.¹ “These data underscore the promise of next-generation therapies and the potential for icotrokinra to offer adolescents with moderate to severe plaque psoriasis the unique combination of a favorable safety profile and complete skin clearance in a once-daily pill.”

References

1. Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin and demonstrate favorable safety profile in a once daily pill. News release. Johnson & Johnson. April 10, 2025. Accessed April 10, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-75-of-adolescents-with-plaque-psoriasis-achieved-completely-clear-skin-and-demonstrate-favorable-safety-profile-in-a-once-daily-pill
2. A study of JNJ-77242113 in adolescent and adult participants with moderate to severe plaque psoriasis (ICONIC-LEAD). ClinicalTrials.gov. Updated April 2, 2025. Accessed 10, 2025. https://clinicaltrials.gov/study/NCT06095115