Icotrokinra shows superiority to deucravacitinib in the first reported head-to-head trials of investigational targeted oral peptide for the treatment of plaque psoriasis

Icotrokinra demonstrated superior skin clearance at Weeks 16 and 24 compared to deucravacitinib and similar adverse event rates to placebo in Phase 3 ICONIC-ADVANCE studies.¹

Icotrokinra also showed sustained skin clearance and similar safety profile, relative to placebo, in both adults and adolescents at Week 52 in Phase 3 ICONIC-LEAD study.²

High Wycombe, UK (19th September, 2025) – Johnson & Johnson today announced new data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies which assessed the superiority of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, compared to placebo and deucravacitinib in patients with moderate-to-severe plaque psoriasis.¹ This data was presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress.¹ Additionally, new long-term 52-week data from the Phase 3 ICONIC-LEAD study investigating icotrokinra in adults and paediatric patients 12 years of age and older (adolescents) with moderate to severe plaque psoriasis were presented as a late-breaking abstract at EADV.²

Icotrokinra met both co-primary endpoints (IGA 0/1 and PASI 90) compared to placebo at Week 16, with similar adverse event rates, and met the secondary endpoint by showing superiority to deucravacitinib at multiple timepoints (Week 16 and Week 24) in adult patients in the ICONIC-ADVANCE 1 and 2 studies (icotrokinra n=311/322, placebo n = 156/82, deucravacitinib n =307/327).^1,a

• Icotrokinra showed superior skin clearance rates vs placebo at Week 16 (IGA 0/1 68/70% vs 11/9%; PASI 90 55/57% vs 4/1%; all p<0.001).¹
• Icotrokinra showed complete skin clearance vs deucravacitinib at Weeks 16 (IGA 0 37/37% vs 16/17%; PASI 100 31/32% vs 11/14%; all adjusted p<0.001) and 24 (2-fold or greater rates than at Week 16, all adjusted p<0.001).¹
• A similar proportion of patients experienced adverse events (AEs) between icotrokinra and placebo groups, with no new safety signals identified.¹ Icotrokinra AE rates were numerically lower vs deucravacitinib through Week 24.¹

“These head-to-head data clearly demonstrate superior complete skin clearance rates for icotrokinra compared to deucravacitinib,” said Linda Stein Gold, M.D., Director of Dermatology Clinical Research at Henry Ford Health and ICONIC-ADVANCE study investigator.b “With significantly higher response rates seen as early as Week 16 and increasing at Week 24,¹ this novel targeted oral peptide treatment has the potential to be an appealing new option for patients with moderate-to-severe plaque psoriasis.”

Icotrokinra demonstrated sustained skin clearance and similar safety profile to placebo through Week 52 with no new safety signals identified in the ICONIC-LEADc drug withdrawal/re-retreatment study.²

• At Week 52, adult icotrokinra PASI 90 responders re-randomised to icotrokinra at Week 24 had superior maintenance of PASI 90 response versus those re-randomised to placebo (84% vs 21%; p<0.001).^2,d
• At Week 52, 86% of adolescents who received icotrokinra for the full 52 weeks and 77% of those switched from placebo to icotrokinra at Week 16 achieved PASI 90 response.²
• ICONIC-LEAD Week 16 primary endpoint data was previously presented at the American Academy of Dermatology 2025 Congress.³
• Safety in ICONIC-LEAD participants with moderate-to-severe plaque psoriasis was consistent with that observed through Week 24.² The safety profile of icotrokinra was shown to be favourable, relative to placebo, as previously demonstrated in the ICONIC-LEAD and ICONIC-TOTAL clinical studies.^2,4

“The long-term data from ICONIC-LEAD continue to demonstrate the potential of icotrokinra to address the need for a novel targeted oral psoriasis treatment,” said Jennifer Soung, M.D., Director of Clinical Research at Southern California Dermatology and ICONIC-LEAD study investigator.^b “With a substantial proportion of adults and adolescents achieving clear or almost clear skin while maintaining a favourable safety profile through 52 weeks,² icotrokinra could be a compelling new therapeutic option that aligns with both patient and provider goals for an oral treatment once approved.”

“We’re excited to see the icotrokinra Phase 3 ICONIC programme continue to deliver robust and clinically meaningful head-to-head and long-term results,” said Liza O’Dowd, MD, Vice President, Immunodermatology Lead, Johnson & Johnson Innovative Medicine.

“Those living with psoriasis face many challenges beyond the physical manifestations,” said Dr Mark Graham, Therapeutic Area Head, Immunology, Johnson & Johnson Innovative Medicine EMEA. “The latest results from our ICONIC clinical development programme demonstrate our commitment to continue driving new treatment options for patients so they can achieve better health outcomes and an improved quality of life.”

Editor’s notes:

a. ICONIC- ADVANCE 1 and 2 are Phase 3 randomised clinical trials (RCTs) evaluating the efficacy and safety of icotrokinra compared with placebo and deucravacitinib in 774 and 731 adult participants with moderate-to-severe plaque Pso with PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints.^1,5,6

b. Drs. Soung and Stein Gold are paid consultants for Johnson & Johnson. They have not been compensated for any media work

c. ICONIC-LEAD is a Phase 3 RCT evaluating the efficacy and safety of icotrokinra compared with placebo in 684 participants (icotrokinra=456; placebo=228) 12 years of age or older with moderate-to-severe plaque Pso, with the higher efficacy bar of PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints. ICONIC-LEAD enrolled 66 adolescent patients 12 years of age and older.^2,4,7

d. The PASI score grades the amount of surface area on each body region that is covered by psoriasis plaques and the severity of plaques for their redness, thickness and scaliness. PASI 90 means a 90% reduction in baseline PASI score.⁸

About the ICONIC Clinical Development Program

The pivotal Phase 3 ICONIC clinical development program of icotrokinra (JNJ-2113) in adult and pediatric patients 12 years of age and older with moderate-to-severe plaque Pso was initiated with two studies in Q4 2023 – ICONIC-LEAD and ICONIC-TOTAL – pursuant to the license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johson company.⁹

ICONIC-LEAD (EudraCT: 2023-505120-59-00, NCT06095115) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo in participants with moderate-to-severe plaque Pso, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary endpoints.^8,10

ICONIC-TOTAL (EudraCT: 2023-505122-34-00, NCT06095102) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo for the treatment of Pso in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint. ^8,10

About Plaque Psoriasis

Plaque psoriasis (Pso) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.¹³ It is estimated that 6.4 million people in Europe and more than 125 million people worldwide live with the disease.^14,15 Nearly one-quarter of all people with plaque Pso have cases that are considered moderate-to-severe.¹⁶ Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones.¹⁷ Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.¹⁷ Living with plaque Pso can be a challenge and impact life beyond a person’s physical health, including emotional health, relationships, and handling the stressors of life. Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.^18,19

About Icotrokinra (JNJ-77242113, JNJ-2113)

Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque Psoriais (Pso), ulcerative colitis (UC) and offers potential in other IL-23-mediated diseases.^20,21 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signaling in human T cells. ^22,23 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.²⁴

Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialise compounds derived from the research conducted pursuant to the agreement against a broad range of indications. ^25,26,27

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Follow us at https://www.linkedin.com/company/jnjinnovativemedicineuk/ .

©Janssen-Cilag Limited, a Johnson & Johnson Company. All rights reserved.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of Icotrokinra. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen-Cilag Limited and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. Janssen-Cilag Limited nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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