The Clinical Trials Behind Johnson & Johnson's Icotyde Approval – Trials Spotlight

Icotyde (icotrokinra), an interleukin-23 (IL-23) receptor antagonist, was approved by the U.S. Food and Drug Administration (FDA) in March 2026. Icotyde is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and children who weigh at least 40 kg and who are at least 12 years old and who are candidates for systemic therapy or phototherapy. The clinical trials involved in the ICONIC clinical development program, a set of five Phase 3 clinical trials that we outline below, were pivotal in achieving that approval.

The ICONIC-LEAD trial initiated the program in October 2023, evaluating the effectiveness of JNJ-77242113 (icotrokinra) in participants with moderate to severe plaque psoriasis. ICONIC-TOTAL also launched in October 2023, evaluating the effectiveness of JNJ-77242113 in participants with plaque psoriasis in special areas including the soles of feet, genitals, palms of hands, and the scalp. In February 2024, ICONIC-ADVANCE 1 launched, followed closely by ICONIC-ADVANCE 2 in March. The purpose of the two ICONIC-ADVANCE head-to-head superiority studies was to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib. Finally, the fifth trial in the development program, ICONIC-ASCEND, initiated in April of 2025, and compared the effectiveness of JNJ-7724113 to ustekinumab.

ICONIC– Trials Details

A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis (ICONIC-LEAD)

• Sponsor: Janssen Research & Development
• Description: The purpose of this study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis.
• Intervention(s): JNJ-77242113, placebo
• Primary Outcome Measures: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>= )2-Grade Improvement From Baseline to Week 16; Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16.
• Time Frames: Baseline to week 16; Baseline to week 16.
• Study Details 
• Source

A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/​or Palms of the Hands and the Soles of the Feet) (ICONIC-TOTAL)

• Sponsor: Janssen Research & Development
• Description: The purpose of the study is to see how effective JNJ-77242113 is in participants with plaque psoriasis affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet).
• Interventions: JNJ-77242113, placebo
• Primary Outcome Measures: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2 Grade Improvement From Baseline at Week 16.
• Time Frame: Baseline and week 16.
• Study Details
• Source

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 1)

• Sponsor: Janssen Research & Development
• Description: The purpose of the study is to see how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.
• Interventions: JNJ-77242113, JNJ-77242113 placebo, deucravacitinib, deucravacitinib placebo
• Primary Outcome Measures: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2-Grade Improvement From Baseline to Week 16; JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16.
• Time Frames: Baseline and week 16; Baseline and week 16.
• Study Details
• Source

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)

• Sponsor: Janssen Research & Development
• Description: The purpose of the study is to evaluate how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.
• Interventions: JNJ-77242113, JNJ-77242113 placebo, deucravacitinib, deucravacitinib placebo
• Primary Outcome Measures: JNJ-77242113 and Placebo Group: Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2 Grade Improvement From Baseline at Week 16; JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16.
• Time Frames: Baseline and week 16; Baseline and week 16.
• Study Details
• Source

A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ASCEND)

• Sponsor: Janssen Research & Development
• Description: The main purpose of this study is to assess how well JNJ-77242113 works when compared to placebo and ustekinumab in participants with moderate to severe plaque psoriasis.
• Interventions: JNJ-77242113, JNJ-77242113 placebo, ustekinumab, ustekinumab placebo
• Primary Outcome Measures: JNJ-77242113 and Placebo Group: Percentage of Participants with Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater than or Equal to (>=) 2 Grade Improvement from Baseline at Week 16; JNJ-77242113 and Placebo Group: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 16.
• Time Frames: Week 16; Week 16.
• Study Details
• Source

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