Icotrokinra Demonstrates Promise in Phase 3 ICONIC-LEAD and ICONIC-ADVANCE for Plaque Psoriasis

At the 2025 American Academy of Dermatology (AAD) Annual Meeting, Johnson & Johnson (J&J) shared findings from its phase 3 ICONIC-LEAD clinical trial program evaluating icotrokinra (JNJ-2113) in adults and adolescents aged 12 years and older with moderate to severe plaque psoriasis.¹

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The latest data, presented as a late-breaking abstract at the meeting, demonstrate the ability of the oral peptide, which blocks the interleukin(IL)-23 receptor, to achieve high rates of skin clearance while maintaining a favorable safety profile.

Additionally, J&J announced it has initiated a new phase 3, head-to-head study to compare icotrokinra with ustekinumab. The ICONIC-ASCEND study represents a milestone as the first study aimed at demonstrating the clinical superiority of an oral pill versus and injectable biologic.¹

ICONIC-LEAD: Promising Efficacy and Safety Results

Results of the ICONIC-LEAD (NCT06095115) study² demonstrated robust efficacy, with 65% of patients achieving an Investigator’s Global Assessment (IGA) score of 0/1 (clear or almost clear skin) and 50% attaining Psoriasis Area and Severity Index (PASI) 90 at week 16. These outcomes significantly outperformed placebo (8% and 4%, respectively).

At week 24, icotrokinra continued to show improvements in skin clearance:

• 74% achieved IGA 0/1
• 65% reached PASI 90
• 46% attained complete skin clearance (IGA 0)
• 40% achieved PASI 100

Furthermore, the safety profile of icotrokinra remained comparable to placebo, with adverse events occurring in 49% of patients in both groups. No new safety signals were identified.

ICONIC-ADVANCE 1 & 2: Superiority Over Deucravacitinib

In addition to ICONIC-LEAD, topline results from the phase 3 ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) trials^3-4 confirmed that icotrokinra met its co-primary endpoints of IGA 0/1 and PASI 90 at week 16 compared to placebo.

Additionally, the investigational drug demonstrated superiority over deucravacitinib, an existing oral treatment, at weeks 16 and 24.

Expert Insights

Robert Bissonnette, MD, a leading investigator in the ICONIC-LEAD study, emphasized the importance of these findings.

"People living with moderate-to-severe plaque psoriasis are seeking options that balance efficacy, safety and ease of use," Bissonnette, chairman at Innovaderm Research in Montreal, said in a news release.¹ "These study results are promising, and show the potential for treatment with icotrokinra to offer patients the unique combination of complete skin clearance and a favorable safety profile in a once daily pill."

References

1. Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis. News release. Johnson & Johnson. March 8, 2025. Accessed March 11, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-potential-to-set-a-new-standard-of-treatment-in-plaque-psoriasis
2. A study to compare JNJ-2113 with ustekinumab in adult participants with moderate-to-severe plaque psoriasis (ICONIC-ASCEND). ClinicalTrials.gov. Identifier: NCT06095115. Updated March 6, 2024. Accessed March 11, 2025. https://clinicaltrials.gov/study/NCT06095115
3. A study of JNJ-77242113 in participants with moderate to severe plaque psoriasis (ICONIC-ADVANCE 1). ClinicalTrials.gov. Identifier: NCT06143878. Updated February 26, 2024. Accessed March 11, 2025. https://clinicaltrials.gov/study/NCT06143878
4. A study of JNJ-77242113 in participants with moderate to severe plaque psoriasis (ICONIC-ADVANCE 2). ClinicalTrials.gov. Identifier: NCT06220604. Updated February 26, 2024. Accessed March 11, 2025. https://clinicaltrials.gov/study/NCT06220604