Johnson & Johnson ICOTYDE (icotrokinra) has posted new two-year results from the Phase 3 ICONIC-LEAD study in adults and adolescents with moderate-to-severe plaque psoriasis. Announced from Spring House, Pa., on October 9, 2026, the data were presented at Fall Clinical Dermatology (FCD) 2026 and cover patients aged 12 years and older.
Johnson & Johnson (NYSE: JNJ) describes ICOTYDE as the first and only targeted oral peptide that precisely blocks the IL-23 receptor. At Week 112, the company reported consistently high skin clearance and patient-reported symptom improvement, with no new safety signals identified. The company frames long-term durability as central to treatment choice in a chronic, lifelong disease.
Mark Lebwohl, M.D., of the Icahn School of Medicine at Mount Sinai and an ICONIC-LEAD investigator, said durable results are essential in therapy selection. He called the drug a “practice-changing” oral option for adult and adolescent patients. The release discloses that Dr. Lebwohl is a paid consultant for Johnson & Johnson but was not compensated for media work. David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head at Johnson & Johnson, said long-term management is key.
What the Johnson & Johnson ICOTYDE Two-Year Skin Clearance Data Show
The Johnson & Johnson ICOTYDE dataset shows that ≥72% of treated patients achieved a Psoriasis Area and Severity Index (PASI) score of 90 at Week 112. At least 70% reached clear or almost clear skin, measured as an Investigator’s Global Assessment (IGA) score of 0/1, from Week 64 through Week 112. PASI grades the body surface covered by plaques and their redness, thickness and scaliness. IGA is a five-point scale from 0 (clear) to 4 (severe).
Complete clearance was also sustained. From Week 64 through Week 112, ≥44% of ICOTYDE-treated patients achieved PASI 100 and ≥46% achieved IGA 0, meaning clear skin. Clinically meaningful itch improvement was sustained in 78% of patients from Week 64 to Week 112. The release does not give Week 112 placebo-comparison figures or separate adolescent-subgroup response rates. Those figures are Not disclosed.
The release also reports on withdrawal and retreatment. Among PASI 90 responders withdrawn from ICOTYDE at Week 24, 85% regained a PASI 90 response within 24 weeks of retreatment. The release does not state how many patients were withdrawn or the exact retreatment sample size, so those numbers are Not disclosed.
Johnson & Johnson ICOTYDE ICONIC-LEAD Study Design and Safety Profile
ICONIC-LEAD is a Phase 3 randomized controlled trial that tests Johnson & Johnson ICOTYDE against placebo in 684 participants aged 12 or older, with 456 on ICOTYDE and 228 on placebo. The co-primary endpoints are PASI 90 and an IGA score of 0/1 with at least a 2-grade improvement, which the company calls a higher efficacy bar. The trial enrolled 66 adolescents, and withdrawal and retreatment responses were captured at Week 24.
On safety, the company states that findings through Week 112 were consistent with the established profile of ICOTYDE and that no new safety signals were identified. The most common side effects listed in the important safety information are headache, nausea, cough, fungal infection and tiredness. Specific incidence rates and discontinuation rates for the two-year period are Not disclosed in the release.
The important safety information for Johnson & Johnson ICOTYDE notes that medicines which interact with the immune system may lower the ability to fight infections. Providers may check for infections and tuberculosis (TB) before treatment, and patients should avoid live vaccines during treatment. Patients should also tell their provider about kidney problems, pregnancy or breastfeeding. A pregnancy safety study is open to women who take the drug while pregnant.
Johnson & Johnson ICOTYDE Mechanism, Dosing and Global Approvals
ICOTYDE is designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque psoriasis. According to the release, it binds the receptor with single-digit picomolar affinity and showed potent, precise inhibition of IL-23 signaling in human T cells. The company adds that the clinical significance of these findings is unknown.
Johnson & Johnson ICOTYDE is approved in the U.S. for moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. The dose is one 200 mg pill once daily on waking, taken with water on an empty stomach at least 30 minutes before eating. The product is also approved in Europe, Japan and China for adults and adolescents with psoriasis.
The drug was jointly discovered and is being developed under a 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. It also holds the rights to commercialize compounds derived from the research against a broad range of indications. Financial terms are Not disclosed in this release.
Johnson & Johnson ICOTYDE ICONIC Program and the Plaque Psoriasis Burden
The pivotal ICONIC program for Johnson & Johnson ICOTYDE includes four psoriasis studies. ICONIC-LEAD (NCT06095115) compares the drug with placebo. ICONIC-TOTAL (NCT06095102) targets special areas such as the scalp, genitals, hands and feet. ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) compare ICOTYDE with both placebo and deucravacitinib in adults.
Further studies are underway in other conditions. ICONIC-PsA 1 and ICONIC-PsA 2 cover active psoriatic arthritis, and ICONIC-ASCEND covers moderate-to-severe plaque psoriasis. ICONIC-UC covers ulcerative colitis, and ICONIC-CD covers Crohn’s disease. The release gives no results or timelines for these studies, so those details are Not disclosed.
Plaque psoriasis is a chronic immune-mediated disease that causes inflamed, scaly plaques that may be itchy or painful. The National Psoriasis Foundation estimates that 8 million Americans and more than 125 million people worldwide live with the disease. Nearly one-quarter of cases are moderate-to-severe. Johnson & Johnson ICOTYDE remains subject to the forward-looking risks the company describes, including clinical, regulatory, manufacturing, competitive and commercial uncertainty.
Structured Data Tables
Table 1: ICOTYDE ICONIC-LEAD Efficacy Outcomes
| Endpoint | Result | Timepoint |
|---|---|---|
| PASI 90 | ≥72% of ICOTYDE-treated patients | Week 112 |
| IGA 0/1 (clear or almost clear) | ≥70% | Week 64 through Week 112 |
| PASI 100 | ≥44% | Week 64 through Week 112 |
| IGA 0 (clear) | ≥46% | Week 64 through Week 112 |
| Itch improvement (clinically meaningful) | 78% of patients | Week 64 to Week 112 |
| PASI 90 regained after retreatment | 85% of PASI 90 responders withdrawn at Week 24 | Within 24 weeks of retreatment |
| Placebo comparison at Week 112 | Not disclosed | Not disclosed |
Table 2: ICONIC-LEAD Study Design
| Parameter | Detail |
|---|---|
| Phase | Phase 3, randomized controlled trial |
| NCT identifier | NCT06095115 |
| Population | Ages 12+, moderate-to-severe plaque psoriasis |
| Total participants | 684 |
| ICOTYDE arm | 456 |
| Placebo arm | 228 |
| Adolescents enrolled | 66 |
| Co-primary endpoints | PASI 90; IGA 0/1 with at least 2-grade improvement |
| Data presented at | Fall Clinical Dermatology 2026 |
Table 3: ICONIC Clinical Development Program
| Study | NCT Number | Indication / Comparator |
|---|---|---|
| ICONIC-LEAD | NCT06095115 | Plaque psoriasis vs placebo |
| ICONIC-TOTAL | NCT06095102 | Plaque psoriasis in special areas (scalp, genital, hands and feet) vs placebo |
| ICONIC-ADVANCE 1 | NCT06143878 | Plaque psoriasis vs placebo and deucravacitinib |
| ICONIC-ADVANCE 2 | NCT06220604 | Plaque psoriasis vs placebo and deucravacitinib |
| ICONIC-PsA 1 | NCT06878404 | Active psoriatic arthritis |
| ICONIC-PsA 2 | NCT06807424 | Active psoriatic arthritis |
| ICONIC-ASCEND | NCT06934226 | Moderate-to-severe plaque psoriasis |
| ICONIC-UC | NCT07196748 | Ulcerative colitis |
| ICONIC-CD | NCT07196722 | Crohn’s disease |
Table 4: ICOTYDE Product and Regulatory Snapshot
| Attribute | Detail |
|---|---|
| Brand / generic name | ICOTYDE® (icotrokinra) |
| Developer / sponsor | Johnson & Johnson (Janssen Biotech, Inc.) |
| Collaboration partner | Protagonist |
| Mechanism | Targeted oral peptide that blocks the IL-23 receptor |
| Dose and administration | 200 mg, one pill daily on waking, with water on an empty stomach, 30 minutes before eating |
| U.S. indication | Moderate-to-severe plaque psoriasis, ages 12+ and ≥40 kg, systemic therapy or phototherapy candidates |
| Other approvals | Europe, Japan, China |
| Common side effects | Headache, nausea, cough, fungal infection, tiredness |
| Pricing and launch details | Not disclosed |
