Johnson & Johnson Presents 52-Week Phase 3 Data for Icotrokinra in Plaque Psoriasis

Johnson & Johnson announced new long-term, 52-week data from the Phase 3 ICONIC-TOTAL study evaluating icotrokinra, a first-in-class investigational targeted oral peptide that precisely blocks the IL-23 receptor, in adults and adolescents (aged 12 years and older) with plaque psoriasis (PsO) affecting high-impact sites.

The data, presented at the 2025 Fall Clinical Dermatology Conference, assessed patients with at least moderate scalp, genital, and/or hand/foot plaque psoriasis (≥1% Body Surface Area affected). Through Week 52, icotrokinra demonstrated durable and high rates of site-specific psoriasis clearance across all difficult-to-treat regions.

Key Efficacy Results Through Week 52

• Scalp psoriasis: 72% achieved ss-IGA 0/1, and 57% achieved ss-IGA 0
• Genital psoriasis: 85% achieved sPGA-G 0/1, and 73% achieved sPGA-G 0
• Hand/foot psoriasis: Clearance (hf-PGA 0/1) increased from 42% at Week 16 to 62% at Week 52

Expert Commentary on Clinical Impact

“Many of the patients in my practice experience significant distress when psoriasis affects sensitive areas such as the scalp, genitals, hands, and feet,” said Edward (Ted) Lain, MD, MBA, Executive Director, Austin Institute for Clinical Research, and study investigator.
“The durable response rates observed in the ICONIC-TOTAL study show that icotrokinra has the potential to be a meaningful new option for effectively managing moderate-to-severe plaque psoriasis long-term in both adults and adolescents.”

Durable Skin Clearance and Safety Profile

Across all patients treated with once-daily icotrokinra, 67% achieved clear or almost clear skin (IGA 0/1) and 44% achieved completely clear skin (IGA 0) at Week 52.
Response rates were consistent among those treated continuously versus those transitioning from placebo at Week 16 (67% vs. 68%, respectively).

Adverse event (AE) and serious AE rates remained stable through Week 52, with no new safety signals identified compared to earlier study data.

Company Perspective on Long-Term Findings

“The new long-term data from ICONIC-TOTAL adds to the robust findings seen across several studies this year, including the recently reported ICONIC-LEAD 52-week data,” said Liza O'Dowd, MD, Vice President, Immunodermatology and Respiratory Disease Areas Lead, Johnson & Johnson Innovative Medicine.

“Psoriasis that affects high-impact skin sites often results in greater physical discomfort for patients. Icotrokinra is being developed with the goal of setting a new standard of treatment — combining the precision of targeted therapy, high levels of skin clearance, and a favorable safety profile with the convenience of a once-daily oral pill.”

Overview of the ICONIC Clinical Development Program

The pivotal Phase 3 ICONIC program for icotrokinra (JNJ-2113) in adults and adolescents (≥12 years) with moderate-to-severe plaque psoriasis began in Q4 2023, following a license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company.

Ongoing and Planned Phase 3 Studies:

• ICONIC-LEAD (NCT06095115): Evaluates efficacy and safety vs. placebo with PASI 90 and IGA 0/1 as co-primary endpoints.
• ICONIC-TOTAL (NCT06095102): Evaluates patients with psoriasis affecting special areas (scalp, genital, hands, and feet).
• ICONIC-ADVANCE 1 & 2: Compare icotrokinra with placebo and deucravacitinib in adults with moderate-to-severe PsO.
• ICONIC-ASCEND: Compares icotrokinra with placebo and ustekinumab in moderate-to-severe PsO.
• ICONIC-PsA 1 & 2: Assess efficacy and safety in active psoriatic arthritis.
• ICONIC-UC and ICONIC-CD: Evaluate icotrokinra in ulcerative colitis and Crohn’s disease, respectively.

About Plaque Psoriasis (PsO)

Plaque psoriasis is a chronic, immune-mediated inflammatory disease affecting approximately 8 million Americans and over 125 million people globally. It leads to the overproduction of skin cells, forming inflamed, scaly plaques that are often itchy or painful.

About 25% of patients experience moderate-to-severe forms of the disease. Psoriasis frequently affects visible or sensitive areas such as the scalp, hands, feet, and genitals — significantly impacting quality of life, mental health, and social interactions.

About Icotrokinra (JNJ-2113)

Icotrokinra is the first targeted oral peptide designed to precisely block the IL-23 receptor, a key driver of inflammation in psoriasis and other autoimmune diseases. It binds to the IL-23 receptor with single-digit picomolar affinity, enabling potent and selective inhibition of IL-23 signaling in human T cells.

The molecule was jointly discovered by Protagonist Therapeutics and Janssen Biotech, under a 2017 collaboration and license agreement. Johnson & Johnson holds exclusive global rights to develop and commercialize icotrokinra and related compounds across multiple indications, including psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease.

Johnson & Johnson’s Broader Mission

Johnson & Johnson’s mission, “Health is everything,” reflects its commitment to advancing healthcare innovation to prevent, treat, and cure complex diseases. The company aims to develop smarter, less invasive, and more personalized treatments, driving progress toward a future where healthcare solutions are accessible and transformative.

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