New ICOTYDE^® (icotrokinra) data reinforces first-line systemic use in plaque psoriasis with powerful skin clearance and consistent safety profile

Spring House, PA (November 06, 2026) – Johnson & Johnson (NYSE: JNJ) today announced positive data from the Phase 3 ICONIC-ASCEND^a study evaluating ICOTYDE^® (icotrokinra), the first and only targeted oral peptide that precisely blocks the IL-23 receptor¹, in adult and pediatric patients 12 years of age and older with moderate-to-severe plaque psoriasis (PsO) versus placebo and ustekinumab. The study met both co-primary endpoints of Psoriasis Area and Severity Index score (PASI) 90 ^b (55.2% versus 3.6%) and Investigator’s Global Assessment (IGA) 0/1^c (70.4% versus 9.5%) versus placebo, confirming ICOTYDE consistently demonstrates powerful skin clearance and a favorable safety profile in a once-daily pill in moderate-to-severe plaque PsO at Week 16.²

“These results add to the unprecedented body of evidence supporting ICOTYDE as a first-line systemic therapy across a broad range of patients with moderate-to-severe plaque psoriasis,” said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. “In this first head-to-head study of an oral therapy versus an injectable biologic in plaque psoriasis, ICOTYDE delivered consistent skin clearance against a comparator that performed at a level well above what has been seen historically.”

Across all multiplicity-controlled key secondary endpoints, ICOTYDE achieved non-inferiority to ustekinumab at Week 28 with numerically higher response rates in skin clearance (IGA 0, IGA 0/1, PASI 90, PASI 100) in both systemic-naïve and biologic-experienced patients.^{d, e} In a pre-specified sub-group analysis, ICOTYDE also delivered a 17-point improvement in complete skin clearance (PASI 100) versus ustekinumab (48.1% versus 31.2%; nominal p=0.028) at Week 28.²

The safety profile of ICOTYDE was consistent with previous studies, with no new safety signals identified.²

Editor’s notes:

a. ICONIC-ASCEND is a Phase 3 randomized, double-blind, placebo-controlled study, and the first-ever head-to-head study of an oral pill, ICOTYDE, compared to an injectable biologic, ustekinumab, in moderate-to-severe plaque PsO^.3
b. 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 corresponds to an improvement of >=90% in PASI score from baseline and PASI 100 corresponds to an improvement of >=100% in PASI score from baseline.⁴
c. The Investigator’s Global Assessment (IGA) is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, and 4 indicates severe disease. ⁵
d. Participants in ICONIC-ASCEND were enrolled into two prespecified cohorts. Cohort A (24% of participants) were naïve to systemic therapy or those previously exposed to systemic therapy but who discontinued for reasons other than inadequate response, intolerance, or contraindication. Cohort B (76% of participants) comprised systemic therapy–experienced participants with inadequate response, intolerance, or contraindication to one or more systemic therapies.
e. Patients across all key secondary endpoints achieved numerically higher response rates in skin clearance, though statistical superiority was not demonstrated.

About the ICONIC clinical development program
The pivotal Phase 3 ICONIC clinical development program includes four studies of ICOTYDE in patients with moderate-to-severe plaque PsO.

• ICONIC-LEAD (NCT06095115) is a RCT to evaluate the efficacy and safety of ICOTYDE 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.⁶
• ICONIC-TOTAL (NCT06095102) is a RCT to evaluate the efficacy and safety of ICOTYDE 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.⁷
• ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) are RCTs to evaluate the efficacy and safety of ICOTYDE compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.^8,9

Additional studies underway include: ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) in active psoriatic arthritis; ICONIC-ASCEND (NCT06934226) in moderate-to-severe plaque psoriasis; ICONIC-UC (NCT071196748) in moderately to severely active ulcerative colitis; and ICONIC-CD (NCT7196722) in moderately to severely active Crohn’s disease.^{10,11,12,13,14}

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.¹⁵ It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.¹⁶ Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe.¹⁴ 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. 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.¹⁸ 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.¹⁹

About ICOTYDE^® (icotrokinra)

ICOTYDE (icotrokinra) is the first and only targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque PsO.^1,[20],[21] ICOTYDE binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, precise inhibition of IL-23 signaling in human T cells.[22] Clinical significance of these findings is unknown.

ICOTYDE is currently approved in the U.S. for the treatment of moderate-to-severe plaque PsO in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. Patients on ICOTYDE take one pill, once daily upon waking with water on an empty stomach, at least 30 minutes before eating.²³

ICOTYDE is also approved in Europe, Japan and China for the treatment of adults and adolescents with psoriasis.

ICOTYDE 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 ICOTYDE in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.^24,25,26

ICOTYDE is also being studied in active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.^8,9,11,12

ICOTYDE INDICATION AND IMPORTANT SAFETY INFORMATION

WHAT IS ICOTYDE (icotrokinra)?
ICOTYDE 200 mg is a prescription medicine used to treat moderate to severe plaque psoriasis in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg), who may benefit from taking injections or medicines by mouth (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ICOTYDE?

• Infections. Medicines that interact with the immune system, such as ICOTYDE, may lower your ability to fight infections and may increase your risk of infections. Your healthcare provider may check you for infections and tuberculosis (TB) before starting treatment and may treat you for TB before you begin treatment with ICOTYDE if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with ICOTYDE.

Tell your healthcare provider right away if you have any infection or have symptoms of an infection, including:

• fever, sweat, or chills
• cough
• shortness of breath
• blood in your mucus (phlegm)
• muscle aches
• warm, red, or painful skin or sores on your body different from your psoriasis
• weight loss
• diarrhea or stomach pain
• burning when you urinate or urinating more often than normal

Before taking ICOTYDE, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection that does not go away or that keeps coming back.
• have tuberculosis (TB) or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). Avoid receiving live vaccines during treatment with ICOTYDE.
• have kidney problems.
• are pregnant or plan to become pregnant. It is not known if ICOTYDE can harm your unborn baby.
  Pregnancy Safety Study. There is a pregnancy safety study for women who take ICOTYDE during pregnancy. The purpose of this study is to collect information about the health of you and your baby. If you are pregnant or become pregnant during treatment with ICOTYDE, you can report your pregnancy by calling 1-800-526-7736 or visiting www.ICOTYDE.com.
• are breastfeeding or plan to breastfeed. It is not known if ICOTYDE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ICOTYDE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of ICOTYDE?

ICOTYDE may cause serious side effects. See “What is the most important information I should know about ICOTYDE?”
The most common side effects of ICOTYDE include:

• headache
• nausea
• cough
• fungal infection
• tiredness

These are not all the possible side effects of ICOTYDE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

How should I take ICOTYDE?

• Take ICOTYDE exactly as your healthcare provider tells you to take it.
• Take ICOTYDE 1 time a day when you wake up on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food.
• If you have difficulty swallowing tablets, ICOTYDE can be dispersed in water. For more information, please read the Medication Guide.
• If you miss a dose of ICOTYDE, take the dose as soon as you remember and go back to your regular schedule the next day.

Please read the full Prescribing Information, including Medication Guide, for ICOTYDE and discuss any questions that you have with your doctor.

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.
Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.
Janssen Biotech, Inc. is a Johnson & Johnson company.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding ICOTYDE (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 materialize, actual results could vary materially from the expectations and projections of 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 behavior 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 most recent Annual Report on Form 10-K, 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, investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

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¹ Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8.
² Data on file.
³ Clinicaltrials.gov. A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate-to-severe Plaque Psoriasis (ICONIC-ASCEND). Identifier NCT06934226. https://clinicaltrials.gov/study/NCT06934226. Accessed November 2026.
⁴ Thompson Jr, D. How the Psoriasis Area and Severity Index works. Everyday Health. Available at: https://www.everydayhealth.com/psoriasis/living-with/how-the-pasi-index-works. Accessed November 2026.
⁵ Langley RG, Feldman SR, Nyirady J, van de Kerkhof P, Papavassilis C. The 5-point Investigator’s Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2015 Feb;26(1):23-31. doi: 10.3109/09546634.2013.865009. Epub 2013 Dec 20. PMID: 24354461. Accessed November 2026.
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⁷ Clinicaltrials.gov. A study of JNJ-2113 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). Identifier NCT06095102. https://classic.clinicaltrials.gov/ct2/show/NCT06095102. Accessed November 2026.
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¹⁰ Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1). Identifier NCT06878404. https://clinicaltrials.gov/study/NCT06878404. Accessed November 2026.
¹¹ A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2). Identifier NCT06807424. https://clinicaltrials.gov/study/NCT06807424. Accessed November 2026.
¹² Clinicaltrials.gov. A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate-to-severe Plaque Psoriasis (ICONIC-ASCEND). Identifier NCT06934226. https://clinicaltrials.gov/study/NCT06934226. Accessed November 2026.
¹³ Clinicaltrials.gov. A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis (ICONIC-UC). Identifier NCT07196748. https://clinicaltrials.gov/study/NCT07196748. Accessed November 2026.
¹⁴ Clinicaltrials.gov. A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn’s Disease (ICONIC-CD). Identifier NCT07196722. https://clinicaltrials.gov/study/NCT07196722. Accessed November 2026.
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²⁰ Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229.
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²² Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14.
²³ ICOTYDE^® prescribing information.
²⁴ Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-amendment-of-agreement-with-janssen-biotech-for-the-continued-development-and-commercialization-of-il-23-antagonists-301343621.html. Accessed November 2026.
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