ICOTYDE™ (icotrokinra) one-year results confirm lasting skin clearance and favorable safety profile in once‑daily pill for plaque psoriasis

(Moderate)

(Positive)

Rhea-AI Summary

Johnson & Johnson (NYSE: JNJ) reported 52-week Phase 3 results for ICOTYDE (icotrokinra) in moderate-to-severe plaque psoriasis showing sustained skin clearance and a favorable safety profile.

ADVANCE 1 PASI100 rose from 41% to 49%, ADVANCE 2 from 33% to 48%; adolescents reached 57% PASI100 and 61% IGA 0 at Week 52. No new safety signals were identified.

Positive

PASI100 Week 24→52: ADVANCE 1 41%→49%
PASI100 Week 24→52: ADVANCE 2 33%→48%
Adolescent outcomes: 57% PASI100 and 61% IGA 0 at Week 52
86% PASI90 in adolescents at one year, with 92% maintaining from Week 24 to 52
No new safety signals through Week 52 in pooled trials

Negative

None.

Market Context

This announcement highlights robust one‑year Phase 3 data for ICOTYDE, with high complete and near‑c...

Analysis

This announcement highlights robust one‑year Phase 3 data for ICOTYDE, with high complete and near‑complete clearance rates and no new safety signals in adults and adolescents. It builds directly on the recent FDA approval for plaque psoriasis and supports ICOTYDE’s positioning as a once‑daily oral systemic therapy. Investors may watch for longer‑term safety follow‑up, real‑world adoption trends, and how this therapy competes against existing systemic and biologic options in moderate‑to‑severe disease.

Key Figures

PASI 100 Week 52 ADVANCE 1: 49% PASI 100 Week 52 ADVANCE 2: 48% PASI 100 Week 52 switchers: 50% and 43% +5 more

8 metrics

PASI 100 Week 52 ADVANCE 1 49% ICOTYDE patients, PASI 100 from Week 24 (41%) to Week 52

PASI 100 Week 52 ADVANCE 2 48% ICOTYDE patients, PASI 100 from Week 24 (33%) to Week 52

PASI 100 Week 52 switchers 50% and 43% Placebo→ICOTYDE patients in ADVANCE 1 and 2 at Week 52

Adolescent PASI 100 57% ICONIC-LEAD adolescents on ICOTYDE at Week 52

Adolescent IGA 0 61% ICONIC-LEAD adolescents with IGA 0 at Week 52

Adolescent PASI 90 86% ICONIC-LEAD adolescents achieving PASI 90 at one year

Maintain PASI 90 92% Adolescents maintaining PASI 90 from Week 24 to Week 52

ICONIC-LEAD sample size 684 participants Phase 3 ICONIC-LEAD (ICOTYDE=456; placebo=228), ages 12+

Historical Context

5 past events · Latest: Mar 18 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 18	FDA approval	Positive	-0.3%	FDA approval of ICOTYDE for moderate-to-severe plaque psoriasis in adults/adolescents.
Mar 13	Clinical data update	Positive	-0.2%	Phase 1 Erda-iDRS data showing high complete response and durable outcomes in NMIBC.
Mar 12	FDA approval	Positive	-0.4%	U.S. FDA approval of TECNIS PureSee EDOF intraocular lens for cataract surgery.
Mar 05	FDA approval	Positive	-2.3%	FDA approval of TECVAYLI plus DARZALEX FASPRO for earlier-line multiple myeloma.
Mar 03	Regulatory designation	Positive	-0.7%	FDA Fast Track designation for nipocalimab in systemic lupus erythematosus.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive regulatory and clinical milestones have often seen modestly negative next-day price reactions, suggesting a tendency for muted or fading responses to good news.

Recent Company History

Over March 2026, Johnson & Johnson reported multiple positive catalysts: FDA approvals for ICOTYDE, TECNIS PureSee IOL, and TECVAYLI plus DARZALEX FASPRO, along with Fast Track designation for nipocalimab and strong early Erda-iDRS data. Despite these favorable updates, 24-hour price reactions ranged from about -0.21% to -2.31%. Today’s one-year ICOTYDE data extend that narrative by reinforcing durability and safety after the recent approval, fitting into a sequence of advancing immunology and oncology programs.

Key Terms

phase 3 randomized controlled trials, pasi 100, pasi 90, iga, +2 more

6 terms

phase 3 randomized controlled trials medical

"ICONIC-ADVANCE 1 & 2 are Phase 3 randomized controlled trials (RCTs)..."

Phase 3 randomized controlled trials are large, late-stage medical studies that compare a new treatment against a standard treatment or placebo by assigning participants by chance so results aren’t biased. They measure how well the treatment works and how safe it is across diverse populations, acting like a final field test before regulatory approval; for investors the outcomes strongly influence a drug’s commercial prospects, approval likelihood, and company valuation.

pasi 100 medical

"rates of completely clear skin (PASI 100) increased from 41% to 49%..."

PASI 100 is a clinical-trial measure meaning a patient’s psoriasis has cleared completely, showing a 100% improvement on the Psoriasis Area and Severity Index. Think of it like a before-and-after photo where all visible signs of the condition are gone. For investors, PASI 100 signals a therapy’s top-level effectiveness claim, which can drive regulatory approval prospects, market adoption and a product’s commercial value.

pasi 90 medical

"with PASI 90 and IGA score of 0/1 with at least a 2-grade improvement..."

PASI 90 is a clinical measure showing a 90% reduction in the size and severity of a patient’s psoriasis lesions compared with where they started, based on the Psoriasis Area and Severity Index (PASI). For investors, a drug or therapy that achieves PASI 90 signals very strong effectiveness—like shrinking a visible problem to almost nothing—which can boost the chances of regulatory approval, wider doctor use, higher pricing power and larger sales potential.

iga medical

"with PASI 90 and IGA score of 0/1 with at least a 2-grade improvement..."

IgA (immunoglobulin A) is an antibody that acts like a first-line security guard on the body's surfaces—such as the gut, respiratory tract and eyes—helping block infections and clear harmful substances. For investors, IgA matters because it is a target and a biomarker in diagnostics and drug development for infections, autoimmune conditions and some kidney diseases; changes in IgA levels can influence clinical trial outcomes, regulatory decisions and market demand for treatments and tests.

il-23 receptor medical

"ICOTYDE is the first and only targeted oral peptide that precisely blocks the IL-23 receptor."

A protein on the surface of certain immune cells that acts like a lock for the signaling molecule interleukin‑23 (IL‑23); when IL‑23 binds this receptor it turns on inflammation and immune activity. Investors care because drugs that block this receptor can calm harmful inflammation in diseases such as psoriasis and inflammatory bowel disease, so its role directly affects drug development prospects, regulatory success, and market value—think of therapies as keys or blockers that disable a problematic lock.

adverse event medical

"The ICOTYDE adverse event profile through Week 52 was consistent..."

An adverse event is any unwanted or harmful medical occurrence experienced by a person during a clinical trial or after using a product, whether or not it is caused by the treatment. Investors watch these reports because they can signal safety problems that delay approvals, trigger additional testing, reduce sales, or harm a company’s reputation — similar to how a series of car breakdowns can cut value and future sales for an automaker.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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03/28/2026 - 10:00 AM

Johnson & Johnson presents new data showing high rates of complete skin clearance achieved at Week 24 and Week 52 in ICONIC-ADVANCE 1 and 2 studies

Nearly 60% of adolescents treated with ICOTYDE achieved completely clear skin at Week 52 in the ICONIC-LEAD study

SPRING HOUSE, Pa., March 28, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new long-term 52-week data from the Phase 3 ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies, which assessed the efficacy and safety of ICOTYDE™ (icotrokinra) in the treatment of patients with moderate-to-severe plaque psoriasis (PsO). ICOTYDE is the first and only targeted oral peptide that precisely blocks the IL-23 receptor.¹ These data are being presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting.

ICOTYDE achieved high levels of complete skin clearance up to Week 52 with no new safety signals²^,a

In the ICOTYDE treatment arms, rates of completely clear skin (PASI 100) increased from 41% to 49% and 33% to 48% from Week 24 to Week 52 in ADVANCE 1 and 2, respectively.^a,b
Patients who switched from placebo to ICOTYDE at Week 16 achieved similar rates of complete skin clearance by Week 52 (50% and 43% in ADVANCE 1 and 2, respectively) as those who were treated with ICOTYDE for the full 52 weeks.
The ICOTYDE adverse event profile through Week 52 was consistent with that observed through Weeks 16 and 24, and no new safety signal was identified through Week 52. ICOTYDE overall adverse event and infection rates were lower than deucravacitinib through Week 24.

"Introducing a once‑daily targeted oral peptide for treating moderate‑to‑severe plaque psoriasis offers patients an option with a unique combination of benefits and a favorable safety profile," said Linda Stein Gold, M.D., Director of Dermatology Clinical Research at Henry Ford Health and ICONIC‑ADVANCE study investigator.^c"The results from one‑year studies show encouraging outcomes for patients as they navigate this chronic condition."

ICOTYDE demonstrated sustained skin clearance and a favorable safety profile in adolescents through Week 52 with no new safety signals identified in the ICONIC-LEAD study³^,d

Nearly 60% of adolescents treated with ICOTYDE achieved completely clear skin (57% PASI 100, 61% IGA 0) at Week 52.
In adolescents enrolled in ICONIC-LEAD, 86% achieved PASI 90 response at one year, with 92% maintaining that response from Week 24 to Week 52.
No increase in AE incidence was observed over one year of treatment.
Additional Week 52 data from ICONIC-LEAD was previously presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress.

"For the first time, patients 12 and older have access to a novel therapy capable of delivering sustained skin clearance and a favorable safety profile in a once-daily pill," said Jennifer Soung, M.D., Director of Clinical Research at Southern California Dermatology and ICONIC‑LEAD study investigator.^c "ICOTYDE is a transformative advance in plaque psoriasis treatment and expands what's possible for this age group."

"The ICOTYDE one year data showcase what's possible when targeted science meets real-world patient needs," said Liza O'Dowd, M.D., Vice President, Immunodermatology and Respiratory Disease Areas Lead, Johnson & Johnson. "Across age groups, high‑impact disease sites, and in head‑to‑head trials, the results point to a new first-line systemic therapy that can move the needle on treatment gaps in plaque psoriasis."

Editor's notes:

a. ICONIC-ADVANCE 1 & 2 are Phase 3 randomized controlled trials (RCTs) evaluating the efficacy and safety of ICOTYDE compared with placebo and deucravacitinib in 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.
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 100 corresponds to an improvement of >=100% in PASI score from baseline.⁴c. Drs. Soung and Stein Gold are paid consultants for Johnson & Johnson. They have not been compensated for any media work.
d. ICONIC-LEAD is a Phase 3 RCT evaluating the efficacy and safety of ICOTYDE compared with placebo in 684 participants (ICOTYDE=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.

About the ICONIC Clinical Development Program
The pivotal Phase 3 ICONIC clinical development program includes five Phase 3 studies of ICOTYDE in patients 12 and older 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.⁵
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.⁶
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.⁷^,⁸
ICONIC-ASCEND (NCT06934226) is a RCT to evaluate the efficacy and safety of ICOTYDE compared with placebo and ustekinumab in participants with moderate-to-severe plaque.⁹

Additional studies underway in other disease areas include: ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) in active psoriatic arthritis; 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

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.¹⁴ It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.¹⁵ 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.¹⁶ 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.¹⁷ 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.¹⁴^,¹⁸

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.^1,¹⁹^,²⁰ 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.²¹ Clinical significance of these findings is unknown.

ICOTYDE is currently approved in the U.S. for the treatment of adults, and pediatric patients 12 years of age and older who weigh at least 40 kg, with moderate-to-severe plaque PsO who are candidates for systemic therapy or phototherapy. Patients on ICOTYDE take one pill, once a day with water upon waking, 30 minutes prior to eating food.²²

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.²³^,²⁴^,²⁵

ICOTYDE is also being studied in active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease^.¹⁰^,¹¹^,¹²^,13

ICOTYDE™ INDICATION AND IMPORTANT SAFETY INFORMATION

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

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	• fungal infection
• nausea	• tiredness
• cough

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.

cp-564097v2

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 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.

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 Stein Gold L. et al. Durability of response with icotrokinra, a targeted oral peptide, in adults with moderate-to-severe plaque psoriasis: One-year results from the Phase 3, placebo- and active comparator-controlled ICONIC-ADVANCE 1 & ICONIC ADVANCE 2 trials. 73228
³ Soung J. et al. Durability of icotrokinra (targeted oral peptide) effects in adolescents with moderate-to-severe plaque psoriasis: One-year results from the ICONIC-LEAD study. 73600
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 March 2025.
⁵ Clinicaltrials.gov. A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. https://classic.clinicaltrials.gov/ct2/show/NCT06095115. Accessed May 2025.
⁶ 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 May 2025.
⁷ Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate-to-severe Plaque Psoriasis. Identifier NCT06143878. https://clinicaltrials.gov/study/NCT06143878?term=jnj-77242113&rank=10. Accessed May 2025.
⁸ Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate-to-severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604. https://clinicaltrials.gov/study/NCT06220604. Accessed May 2025.
⁹ 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 January 2026.
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 January 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 January 2026.
¹² 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 January 2026.
¹³ 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 January 2026.
¹⁴ National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed May 2025.
¹⁵ National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed May 2025.
¹⁶ National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/plaque/.Accessed April 2025.
¹⁷ National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed June 2025.
¹⁸ National Psoriasis Foundation. High Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed Sep June 2025.
¹⁹ 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.
²⁰ Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.
²¹ 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.
²² ICOTYDE™ prescribing information.
²³ 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 May 2025.
²⁴ Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: https://www.prnewswire.com/news-releases/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral-interleukin-23-receptor-antagonist-jnj-2113-301823039.html. Accessed May 2025.
²⁵ Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-topline-results-for-phase-2b-frontier-1-clinical-trial-of-oral-il-23-receptor-antagonist-jnj-2113-pn-235-in-psoriasis-301764181.html. Accessed May 2025.

Media contact:	Investor contact:
Meg Farina	Jessica Margevich
mfarina@its.jnj.com	investor-relations@its.jnj.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/icotyde-icotrokinra-one-year-results-confirm-lasting-skin-clearance-and-favorable-safety-profile-in-oncedaily-pill-for-plaque-psoriasis-302727762.html

SOURCE Johnson & Johnson

FAQ

What 52-week efficacy did ICOTYDE (JNJ) show in ADVANCE 1 and 2 trials?

ICOTYDE demonstrated increased complete clearance by Week 52 versus Week 24, with ADVANCE 1 rising 41% to 49% and ADVANCE 2 33% to 48%. According to the company, these gains reflect sustained PASI100 responses through one year in Phase 3 studies.

How did adolescents respond to ICOTYDE at Week 52 in ICONIC-LEAD (JNJ)?

Adolescents achieved high sustained clearance: 57% PASI100 and 61% IGA 0 at Week 52. According to the company, 86% reached PASI90 and 92% of those maintained response from Week 24 to Week 52 in the adolescent subgroup.

Were any new safety signals reported for ICOTYDE through Week 52 (JNJ)?

No new safety signals were reported through Week 52 across ICONIC trials. According to the company, adverse event rates through one year remained consistent with earlier timepoints and raised no new safety concerns.

How did placebo-switch patients perform after switching to ICOTYDE in ADVANCE 1 and 2 (JNJ)?

Placebo-to-ICOTYDE switchers reached similar Week 52 clearance rates as continuous ICOTYDE patients, with ~50% and 43% PASI100 in ADVANCE 1 and 2 respectively. According to the company, delayed starters caught up by one year.

What is ICOTYDE's mechanism and administration in the ICONIC Phase 3 program (JNJ)?

ICOTYDE is a once-daily oral peptide that selectively blocks the IL-23 receptor. According to the company, the pill formulation delivers targeted IL-23R inhibition for moderate-to-severe plaque psoriasis in Phase 3 trials.