Johnson & Johnson reports 52-week Phase 3 ICOTYDE data showing sustained efficacy and safety in plaque psoriasis, reinforcing its recent FDA approval.
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
Johnson & Johnson has reported new 52-week results from its Phase 3 ICONIC clinical program evaluating ICOTYDE™ (icotrokinra) in patients with moderate-to-severe plaque psoriasis. The data, presented at the American Academy of Dermatology Annual Meeting 2026, demonstrate sustained efficacy and a consistent safety profile through one year of treatment.
The update follows the company’s March 2026 announcement of U.S. FDA approval for ICOTYDE as a first-line systemic therapy for adults and adolescents with plaque psoriasis. The newly presented findings extend those earlier results by providing long-term evidence on durability of response and safety.
Liza O’Dowd, Vice President, Immuno-dermatology and Respiratory Disease Areas Lead, Johnson & Johnson. highlighted that the one-year data demonstrate ICOTYDE’s potential to deliver meaningful, real-world benefits, supporting its role as a new first-line systemic option that can address unmet treatment needs in plaque psoriasis.
Across the Phase 3 ICONIC-ADVANCE 1 and 2 trials (NCT06143878; NCT06220604), ICOTYDE continued to improve skin clearance rates over time. The proportion of patients achieving complete skin clearance (PASI 100) increased from 41% to 49% in ADVANCE 1 and from 33% to 48% in ADVANCE 2 between Week 24 and Week 52.
Patients who initially received placebo and switched to ICOTYDE at Week 16 achieved comparable outcomes by one year, with PASI 100 rates of 50% and 43% in ADVANCE 1 and 2, respectively. These findings suggest that delayed initiation of treatment can still lead to meaningful clinical benefit.
The safety profile of ICOTYDE remained stable through 52 weeks, with no new safety signals identified. Adverse event rates were consistent with earlier readouts at Weeks 16 and 24.
Notably, overall adverse event and infection rates were reported to be lower than those observed with deucravacitinib through Week 24, supporting a favorable tolerability profile.
In the ICONIC-LEAD study, which included adolescent patients aged 12 years and older, ICOTYDE demonstrated robust and sustained efficacy.
At Week 52, 57% of adolescents achieved complete skin clearance (PASI 100), while 61% reached an Investigator’s Global Assessment (IGA) score of 0. In addition, 86% of patients achieved a PASI 90 response, reflecting a high level of skin improvement.
Among responders, 92% maintained PASI 90 response from Week 24 through Week 52, indicating durable disease control.
No increase in adverse event incidence was observed over one year in this population.
ICOTYDE is the first targeted oral peptide designed to selectively block the IL-23 receptor, a key driver of inflammatory pathways in plaque psoriasis. By directly inhibiting IL-23 signaling, the therapy offers a novel oral alternative to biologics and small molecules.
With once-daily dosing and sustained efficacy across both adult and adolescent populations, ICOTYDE is positioned as a potential first-line systemic option for patients requiring more than topical or phototherapy-based treatment.
Investigators highlighted the clinical relevance of long-term disease control in a chronic condition like psoriasis, noting that sustained skin clearance and consistent safety are critical for improving patient outcomes and quality of life.
In addition to plaque psoriasis, ICOTYDE is currently being evaluated in other immune-mediated conditions, including psoriatic arthritis, ulcerative colitis, and Crohn’s disease.
The 52-week data strengthen the clinical profile of ICOTYDE beyond its initial approval, supporting its potential role in addressing unmet needs in systemic psoriasis treatment.
Reference
ICOTYDE™ (icotrokinra) one-year results confirm lasting skin clearance and favorable safety profile in once‑daily pill for plaque psoriasis, 28 March 2026, ICOTYDE™ (icotrokinra) one-year results confirm lasting skin clearance and favorable safety profile in once‑daily pill for plaque psoriasis
A Study of JNJ-77242113 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis, ClinicalTrials.gov ID NCT06143878, https://clinicaltrials.gov/study/NCT06143878
A Study of JNJ-77242113 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2), ClinicalTrials.gov ID NCT06220604, https://clinicaltrials.gov/study/NCT06220604
About the Writer
Vennela Reddy, B.Pharm is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.