New phase 3 data of JNJ-2113 for plaque psoriasis in patients aged 12 years, older

New phase 3 data of JNJ-2113 for plaque psoriasis in patients aged 12 years, older | Image Credit: © SNAB - © SNAB - stock.adobe.com.

Positive, phase 3 data for once-daily JNJ-2113 (icotrokinra) has been announced by Protagonist Therapeutics in collaboration with Johnson & Johnson that demonstrated "significant" skin clearance compared to placebo in adults and adolescents with moderate-to-severe plaque psoriasis, according to a press release from Protagonist.¹

The data comes from the phase 3 investigational trials ICONIC-LEAD (NCT06095115) and ICONIC-TOTAL (NCT06095102), that evaluated JNJ-2113 (formerly PN-235), a potential first-in-class targeted oral peptide designed to block the IL-23 receptor in pateints aged 12 years and older with moderate-to-severe plaque psoriasis.¹

The ICONIC-LEAD trial's inclusion criteria included the diagnosis of plaque psoriasis, with or without psoriatic arthritis, for at least 26 weeks prior to first administration of intervention, a total body surface area greater than or equal to 10% at screening and baseline, total psoriasis area and severity index (PASI) greater than or equal to 12 at screening and baseline, and a total investigator global assessment (IGA) greater than or equal to 3 at screening and baseline, according to study details via ClinicalTrials.gov. Enrollment featured 684 individuals.²

In the ICONIC-LEAD trial, 64.7% of individuals treated with once-daily JNJ-2113 achieved IGA scores of 0/1 (clear or almost clear skin) compared to 8.3% receiving placebo at week 16. Additionally, nearly half (49.6%) of patients who received JNJ-2113 achieved PASI 90 versus 4.4% of patients who received placebo.¹

At week 24, increases in response rates continued, with 74.1% of patients treated with JNJ-2113 achieving IGA scores of 0/1, and 64.9% achieving PASI 90, according to Protagonist.²

In the ICONIC-TOTAL trial comprised of 311 patients, once-daily JNJ-2113 met the primary outcome of IGA of 0/1 at week 16 compared to placebo.^1,3

"These positive phase 3 results confirm the compelling efficacy and safety trends that were observed with the previous Phase 2b FRONTIER-1 and -2 studies, highlighting [JNJ-2113] potential as a best-in-class oral agent providing an ideal combination of significant skin clearance with demonstrated tolerability in a once-daily pill for treating plaque psoriasis," said Dinesh V. Patel, PhD, president, CEO of Protagonist, in a press release. "These results also continue to validate Protagonist's innovative peptide technology platform and its effectiveness in creating highly differentiated new chemical entities to address unmet needs in various disease areas."¹

References:

1. Protagonist Announces Positive Topline Results From Phase 3 ICONIC Studies of Icotrokinra (JNJ-2113) in Plaque Psoriasis, a First-in-Class Investigational Targeted Oral Peptide That Selectively Blocks the IL-23 Receptor. Protagonist Therapeutics. Press release. November 18, 2024. Accessed November 20, 2024. https://www.accesswire.com/944100/protagonist-announces-positive-topline-results-from-phase-3-iconic-studies-of-icotrokinra-jnj-2113-a-first-in-class-investigational-targeted-oral-peptide-that-selectively-blocks-the-il-23-receptor

2. A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis (ICONIC-LEAD). ClinicalTrials.gov. Updated October 24, 2024. Accessed November 20, 2024. https://clinicaltrials.gov/study/NCT06095115#participation-criteria

3. 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). ClinicalTrials.gov. Updated October 15, 2024. Accessed November 20, 2024. https://clinicaltrials.gov/study/NCT06095102