RESULTS IN HIGH-IMPACT AREAS
See the data from the ICONIC-TOTAL trial
ICONIC-LEAD (N=684): A phase 3, multicenter, randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of ICOTYDE 200 mg orally once daily in adult and adolescent patients 12 years and older and weighing at least 40 kg with moderate to severe plaque psoriasis defined as IGA ≥3, PASI ≥12, and BSA ≥10%. Patients randomized to placebo crossed over to ICOTYDE at Week 16. Adults with a treatment response entered randomized withdrawal and retreatment from Week 24 to Week 52. Patients received open-label ICOTYDE from Week 52 to Week 156. Safety will be assessed through Week 160.1,2
View trialICONIC-LEAD co-primary endpoints at Week 16 in adults and adolescents aged ≥12 years with plaque PsO*:
IGA 0/1: ICOTYDE 65% (295/456) vs placebo 8% (19/228); PASI 90: ICOTYDE 50% (226/456) vs placebo 4% (10/228); P<0.001 (NRI)1,2
In the subgroup of patients aged 12 to 17 years at Week 16 (NRI)1
Completely clear skin at Week 243,4
75%
IGA 0 (NRI)
(33/44)
64%
PASI 100 (NRI)
(28/44)
Endpoints were assessed as part of prespecified sensitivity analyses. Data were not multiplicity controlled. Therefore, statistical significance has not been established.
*BSA ≥10%, IGA ≥3, and PASI ≥12.
OTHER SECONDARY ENDPOINTS (NRI)1
Results in patients aged ≥12 years at Week 521
Hypothetical patient.
82%
(n=36/44)
achieved IGA 0/1
86%
(n=38/44)
achieved PASI 90
95%
(n=42/44)
achieved PASI 75
Week 52 data were not multiplicity controlled. Therefore, statistical significance has not been established.
BSA, body surface area; IGA, Investigator's Global Assessment; NRI, nonresponder imputation; PASI, Psoriasis Area and Severity Index; PsO, psoriasis.
References: 1. ICOTYDE [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Bissonnette R, Soung J, Hebert AA, et al. Oral icotrokinra for plaque psoriasis in adults and adolescents. N Engl J Med. 2025;393(18):1784-1795. doi:10.1056/NEJMoa2504187
3. Data on file. Janssen Biotech, Inc. 4. Eichenfield L, Galimberti R, Hebert A, et al. Icotrokinra, a novel targeted oral peptide (IL-23R-inhibitor), in adolescents with moderate-to-severe plaque psoriasis: results of subgroup analyses from a phase 3, randomized, double-blind, placebo-controlled study (ICONIC-LEAD). Presented at: World Congress of Pediatric Dermatology; April 8-11, 2025; Buenos Aires, Argentina.