A Phase 3 trial (NCT06220604) involving deucravacitinib as a comparator completed its primary phase on 2024-11-15, with key results posted. The study, titled ICONIC-ADVANCE 2, evaluated JNJ-77242113 for moderate to severe plaque psoriasis. Key results showed that JNJ-77242113 achieved an Investigator's Global Assessment (IGA) score of 0 or 1 and >= 2-grade improvement from baseline in 70.9% of participants at Week 16, compared to 8.6% for the placebo arm.

Background

The trial investigated treatments for moderate to severe plaque psoriasis, a chronic inflammatory skin condition. Deucravacitinib was included as a comparator intervention in this study.

Trial design

This was a Phase 3 trial (NCT06220604) titled "A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)". The study enrolled 731 participants with moderate to severe plaque psoriasis. The trial's purpose was to evaluate the effectiveness of JNJ-77242113 compared to placebo and deucravacitinib. Interventions included JNJ-77242113, JNJ-77242113 matching placebo, deucravacitinib, and deucravacitinib matching placebo. The primary outcomes were not explicitly detailed in the posted data for this primary completion event.

Key results

The trial reported key measurements and analyses for participants receiving JNJ-77242113 200 mg compared to the placebo arm (Arm 1: Placebo Followed by JNJ-77242113 200 mg):

  • At Week 16, 70.9% of participants treated with JNJ-77242113 200 mg achieved an Investigator's Global Assessment (IGA) score of 0 or 1 and >= 2-grade improvement from baseline, compared to 8.6% for the placebo arm. The treatment difference was 62.6% (95.0% CI: 53.3%, 69.5%; p=0.001).
  • At Week 16, 57.5% of participants treated with JNJ-77242113 200 mg achieved Psoriasis Area and Severity Index (PASI) 90 response, compared to 1.2% for the placebo arm. The treatment difference was 56.5% (95.0% CI: 49.0%, 62.4%; p=0.001).
  • At Week 16, 36.9% of participants treated with JNJ-77242113 200 mg achieved an IGA score of 0, compared to 1.2% for the placebo arm. The treatment difference was 35.9% (95.0% CI: 28.8%, 42.0%; p=0.001).
  • At Week 4, 16.3% of participants treated with JNJ-77242113 200 mg achieved PASI 75 response, compared to 3.7% for the placebo arm. The treatment difference was 12.5% (95.0% CI: 5.1%, 18.0%; p=0.005).
  • At Week 16, 77.8% of participants treated with JNJ-77242113 200 mg achieved PASI 75 response, compared to 9.9% for the placebo arm. The treatment difference was 68.0% (95.0% CI: 58.6%, 74.9%; p=0.001).
  • At Week 8, 25.3% of participants treated with JNJ-77242113 200 mg achieved PASI 90 response, compared to 0.0% for the placebo arm. The treatment difference was 25.4% (95.0% CI: 19.7%, 30.4%; p=0.005).

What this means

The posted results indicate that JNJ-77242113 demonstrated significant efficacy in treating moderate to severe plaque psoriasis, achieving high rates of skin clearance as measured by IGA and PASI scores compared to placebo. For instance, the substantial difference in IGA 0/1 response at Week 16 (70.9% vs 8.6%) and PASI 75 response at Week 16 (77.8% vs 9.9%) highlights its potential in this indication. The trial included deucravacitinib as a comparator, though specific outcome measurements for deucravacitinib versus JNJ-77242113 or placebo were not detailed in the provided data.

Source

The trial's primary completion and associated results were posted on 2024-11-15 on ClinicalTrials.gov, an official database of clinical studies. The full details are available on clinicaltrials.gov under the identifier NCT06220604.