Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis

March 10, 2025 – Biotechnology, Clinical Trials, Drug Discovery, Other, PharmaceuticalIcotrokinra, Johnson & Johnson, Johnson & Johnson Innovative Medicine, clinical trials, plaque psoriasis

  • Combination of complete skin clearance data and favourable safety profile in a once daily pill could shift treatment paradigm
  • Nearly half of patients with moderate-to-severe plaque psoriasis (Pso) treated with investigational icotrokinra achieved completely clear skin (IGA 0) at Week 24 in ICONIC-LEAD
  • Topline results from Phase 3 ICONIC-ADVANCE 1&2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque Pso
  • These results pave the way to initiate the first-ever head-to-head study seeking to demonstrate the superiority of a pill versus injectable biologic in moderate-to-severe plaque Pso.

10 March 2025 — Beerse, Belgium — Johnson & Johnson today announced new icotrokinra (JNJ-2113) data from its comprehensive Phase 3 clinical programme and the start of the first head-to-head study in plaque psoriasis (Pso) seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab. Icotrokinra is a first of its kind investigational targeted oral peptide that selectively blocks the IL-23 receptor and is being studied in adults and adolescents 12 years of age and older with moderate-to-severe plaque Pso.

Data from the Phase 3 ICONIC-LEADa study, presented as a late-breaking abstract at the 2025 American
Academy of Dermatology (AAD) Annual Meeting, show once daily icotrokinra demonstrated significant
complete skin clearance data and a favourable safety profile in adults and adolescents 12 years of age
and older with moderate-to-severe plaque Pso.

In the ICONIC-LEAD study, nearly two-thirds (65%) of 684 patients treated with once daily icotrokinra
achieved an Investigator’s Global Assessment (IGA)b score of 0/1 (clear or almost clear skin) and 50%
achieved a Psoriasis Area and Severity Index (PASI)c 90 response, compared to 8% and 4% receiving
placebo, respectively (P<0.001 for both endpoints) at Week 16. Continued skin clearance improvement
was reported at Week 24 with 74% of patients treated with icotrokinra achieving IGA 0/1 and 65%
achieving PASI 90. At Week 24, nearly half of patients treated with icotrokinra achieved completely clear
skin – 46% reached IGA 0 and 40% reached PASI 100. Similar proportions of patients experienced
adverse events (AEs) between icotrokinra (49%) and placebo groups (49%) through Week 16. The
safety profile is still being established, but through Week 24 of treatment with icotrokinra no safety signal emerged.

Results from a subgroup analysis of the ICONIC-LEAD study evaluating icotrokinra in the adolescent
population will be presented at a forthcoming medical meeting.

“People living with moderate-to-severe plaque psoriasis are seeking options that balance efficacy, safety
and ease of use,” said Robert Bissonnette, M.D., Chairman at Innovaderm Research, Montreal, Canada
and ICONIC-LEAD study investigator.d “These study results are promising and show icotrokinra offering
patients the potential combination of complete skin clearance and a favourable safety profile in a once
daily pill.”

Additionally, topline results show that the Phase 3 ICONIC-ADVANCE 1&2e studies met their co-primary
endpoints of IGA 0/1 and PASI90 versus placebo at Week 16. Icotrokinra also met all key secondary
endpoints at Week 16 that measured superiority to deucravacitinib in patients with moderate-to-severe
plaque Pso.2,3,4,5 Based on the positive outcomes of the ADVANCE studies, Johnson & Johnson is
initiating the Phase 3 ICONIC-ASCENDf study, the first head-to-head study seeking to demonstrate the
superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab representing an
important step forward in psoriasis research.

“The robust results seen to date underscore the potential for icotrokinra to shift treatment expectations in moderate-to-severe plaque psoriasis,” said Liza O’Dowd, Vice President, Immunodermatology Disease
Area Lead, Johnson & Johnson Innovative Medicine. “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.”

“Psoriasis is a debilitating condition that presents many challenges, having a significant impact on quality of life, including emotional wellbeing,” said Mark Graham, Senior Director, Therapeutic Area Lead, Immunology, Johnson & Johnson Innovative Medicine EMEA. “The IL-23 pathway allows us to build on our decades-long heritage in psoriasis and evolve patient care by unlocking a new and potentially
differentiated treatment option for patients living with the condition.”

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 www.jnj.com/EMEA.

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