Once-daily oral icotrokinra (Icotyde) outperformed placebo and was noninferior to ustekinumab in adults and adolescents with moderate to severe plaque psoriasis in the phase 3 ICONIC-ASCEND study, according to topline results Johnson & Johnson announced in November 2026.¹
Icotrokinra is a targeted oral peptide that blocks the interleukin-23 (IL-23) receptor. In the US, it is already approved for moderate to severe plaque psoriasis in patients aged 12 years and older weighing at least 40 kg who are eligible for systemic therapy or phototherapy. It is also approved in Europe, Japan, and China.¹ ICONIC-ASCEND is the first head-to-head comparison of an oral agent with an injectable biologic in plaque psoriasis.¹
What Did ICONIC-ASCEND Show for Icotrokinra Versus Placebo?
ICONIC-ASCEND (NCT06934226) is a randomized, double-blind, placebo-controlled phase 3 trial comparing icotrokinra with placebo and ustekinumab in patients aged 12 years and older.² Participants were enrolled into 2 prespecified cohorts. About 24% had never received systemic therapy, or had stopped a prior systemic agent for reasons other than efficacy, tolerability, or contraindication. The other 76% had an inadequate response, intolerance, or contraindication to at least 1 systemic therapy.¹
Both co-primary endpoints were met at week 16. A 90% or greater improvement in the Psoriasis Area and Severity Index (PASI 90) was reached by 55.2% of patients taking icotrokinra versus 3.6% of placebo recipients. An Investigator’s Global Assessment score of clear or almost clear (IGA 0/1) was achieved by 70.4% and 9.5%, respectively.¹
How Did Icotrokinra Compare with Ustekinumab?
At week 28, icotrokinra was noninferior to ustekinumab across all multiplicity-controlled key secondary endpoints. According to Johnson & Johnson, IGA 0, IGA 0/1, PASI 90, and PASI 100 response rates were numerically higher with icotrokinra in both systemic-naive and biologic-experienced patients, although statistical superiority was not shown.¹
In a prespecified analysis of systemic-naive patients, 48.1% of those taking icotrokinra achieved complete skin clearance (PASI 100) at week 28, compared with 31.2% of those receiving ustekinumab (nominal P = .028). The company also noted the ustekinumab arm performed above historical levels.¹
The safety profile of icotrokinra was consistent with earlier studies, and no new safety signals emerged. The announcement did not include full patient numbers or detailed adverse event data.¹
Icotrokinra is also being studied in psoriatic arthritis in the ICONIC-PsA 1 and ICONIC-PsA 2 trials, and in ulcerative colitis and Crohn’s disease.¹
Editor's Note: This summary has been edited for grammar and clarity using artificial intelligence tools.
References
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). NCT06934226. Accessed November 13, 2026. https://clinicaltrials.gov/study/NCT06934226.
