Johnson & Johnson Submits NDA for Icotrokinra in Plaque Psoriasis

Johnson & Johnson announced today the company has submitted a New Drug Application (NDA) to the US FDA for icotrokinra in adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis.¹

The company is seeking approval for its first-in-class, investigational oral peptide that selectively blocks the IL-23 receptor.

Image Credit: © Milan Lipowski - stock.adobe.com

Supporting Data

The NDA submission is backed by positive data from the ICONIC clinical development program, which encompasses the phase 3 ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604),^2-3 ICONIC-LEAD (NCT06095115),⁴ and ICONIC-TOTAL (NCT06095102)⁵ clinical trials.

Among adolescent participants in the ICONIC-LEAD study, icotrokinra demonstrated rapid and substantial skin clearance by week 16, with 84.1% of patients achieving Investigator's Global Assessment (IGA) 0/1 and 70.5% reaching a Psoriasis Area and Severity Index (PASI) score of 90, significantly outperforming placebo. Clinical responses deepened through week 24, with 86.4% achieving IGA 0/1, 88.6% reaching PASI 90, and 63.6% achieving complete clearance (PASI 100).⁴

Topline results from the ICONIC-ADVANCE 1 and 2 trials confirmed that icotrokinra met its co-primary endpoints (IGA 0/1 and PASI 90) at week 16 compared to placebo in patients with moderate to severe plaque psoriasis. The investigational therapy also demonstrated superiority over the oral agent deucravacitinib at both weeks 16 and 24 across all key secondary endpoints.^2-3

ICONIC-TOTAL data highlighted the potential of icotrokinra in treating challenging cases of scalp and genital psoriasis, supporting its versatility across difficult-to-treat disease locations.⁵

Long-term data, including 52-week results from ICONIC-LEAD and ICONIC-TOTAL and findings from a randomized withdrawal analysis assessing durability of response, will be presented at an upcoming medical meeting.

Expert Insights

"The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences," said Liza O’Dowd, MD, vice president, immunodermatology and respiratory disease area lead at Johnson & Johnson Innovative Medicine, in a news release.¹ "Given the breadth and depth of our studies, along with the robust clinical results reported to date, we are confident that icotrokinra has the potential to transform how physicians and patients think about plaque psoriasis care, establishing a new standard in the treatment of this immune-mediated disease."

Robert Bissonnette, MD, presented late-breaking data from the ICONIC-LEAD study at this year's American Academy of Dermatology Annual Meeting. Bissonnette, lead investigator and chairman at Innovaderm Research, Montreal, Canada, shared insights into the promise of the results.

"What was really interesting was that was that the efficacy continued to increase over time," Bissonnette said in an interview with Dermatology Times. "And when you look at the curve, it was still going up."

The rates of near or total clearance achieved with icotrokinra are especially important in adolescents, said Lawrence (Larry) Eichenfield, MD, lead presenter of the ICONIC-LEAD data and chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego.

"Young patients with plaque psoriasis face unique challenges due to the visible and uncomfortable nature of the disease," Eichenfield told Dermatology Times, "making effective treatment options that align with their needs and preferences all the more important."

References

1. Johnson & Johnson seeks first icotrokinra US FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis. News release. Johnson & Johnson. July 21, 2025. Accessed July 21, 2025. https://www.jnj.com/media-center/press-releases/johnson-johnson-seeks-first-icotrokinra-u-s-fda-approval-aiming-to-revolutionize-treatment-paradigm-for-adults-and-adolescents-with-plaque-psoriasis
2. 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 July 21, 2025. https://clinicaltrials.gov/study/NCT06143878
3. 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 July 21, 2025. https://clinicaltrials.gov/study/NCT06220604
4. 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 July 21, 2025. https://clinicaltrials.gov/study/NCT06095115