Johnson & Johnson’s Icotrokinra Succeeds Across Multiple Trials in Moderate-to-Severe Plaque Psoriasis, Ulcerative Colitis
Icotrokinra met all primary endpoints in the studies, demonstrating significant skin clearance and clinical remission.
Johnson & Johnson has shared positive results from multiple clinical trials of icotrokinra in moderate-to-severe plaque psoriasis (PsO) and ulcerative colitis (UC). Icotrokinra, an investigational, targeted oral peptide, demonstrated significant skin clearance in the Phase III ICONIC-LEAD and ICONIC-ADVANCE trials, as well as clinical remission in the Phase IIb ANTHEM-UC study.1,2
In the ICONIC-LEAD study, icotrokinra significantly outperformed placebo with 65% of patients achieving an Investigator’s Global Assessment (IGA) score of 0/1 (clear or almost clear skin) and 50% achieving a Psoriasis Area and Severity Index (PASI) 90 response at week 16. Nearly half of patients treated with icotrokinra achieved completely clear skin at week 24.
In a press release, Robert Bissonnette, MD, chairman at Innovaderm Research, Montreal, Canada and ICONIC-LEAD study investigator said, “People living with moderate-to-severe plaque psoriasis are seeking options that balance efficacy, safety and ease of use. These study results are promising, and show the potential for treatment with icotrokinra to offer patients the unique combination of complete skin clearance and a favorable safety profile in a once daily pill.”
Icotrokinra also showed promise in the Phase III ICONIC-ADVANCE 1&2 studies, meeting the co-primary endpoints of IGA 0/1 and PASI 90 versus placebo at week 16, as well as all key secondary endpoints at weeks 16 and 24.
“The robust results seen to date underscore the potential for icotrokinra to shift treatment expectations in moderate-to-severe plaque psoriasis,” Liza O’Dowd, vice president, immunodermatology disease area lead, Johnson & Johnson Innovative Medicine, said in the press release. “As part of our ongoing commitment to pioneer innovations for patients, we are proud to advance this first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, which shows promise as a potential first-line systemic therapy for the treatment of plaque psoriasis.”
In the Phase IIb ANTHEM-UC study evaluating icotrokinra for the treatment of UC, patients treated with the highest dose of icotrokinra achieved a response rate of 63.5% at week 12 versus just 27% for the placebo group. Additionally, 30.2% of patients treated with icotrokinra demonstrated clinical remission at week 12.
In another press release, Esi Lamousé-Smith, MD, PhD, vice president, gastroenterology disease area lead, immunology, Johnson & Johnson said, “These impressive findings show the potential of icotrokinra to transform the treatment paradigm for people living with ulcerative colitis by offering a distinctive combination of therapeutic benefit, tolerability, and convenience with a once-daily oral treatment. With over a quarter century of innovation in inflammatory bowel disease, coupled with our deep expertise in the IL-23 pathway, we are excited about these results and the groundbreaking potential of icotrokinra in the treatment of immune-mediated diseases.”
References
1. Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis. News release. Johnson & Johnson. March 8, 2025. Accessed March 12, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-potential-to-set-a-new-standard-of-treatment-in-plaque-psoriasis
2. Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients. News release. Johnson & Johnson. March 10, 2025. Accessed March 12, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-meets-primary-endpoint-of-clinical-response-in-ulcerative-colitis-study-and-shows-potential-to-transform-the-treatment-paradigm-for-patients
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
