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icotrokinra

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Icotrokinra – Overview of ICONIC-ASCEND Clinical Trial

Last Updated: 11/21/2025

SUMMARY

  • Icotrokinra (JNJ-77242113) is a targeted oral peptide that selectively binds the interleukin-23 (IL-23) receptor and inhibits IL-23 pathway signaling.1 
  • Icotrokinra is being studied in five plaque psoriasis (PsO) phase 3 clinical trials (ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, ICONIC-ADVANCE 2, ICONIC-ASCEND).2-6
  • ICONIC-ASCEND is an ongoing, phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled and ustekinumab active comparator-controlled study (NCT06934226) evaluating the efficacy and safety of oral icotrokinra once daily (QD) in patients ≥12 years of age with moderate to severe plaque PsO.6

CLINICAL DATA

ICONIC-ASCEND

A phase 3, multicenter, randomized, double-blind, PBO-controlled and ustekinumab active comparator-controlled study is currently evaluating the efficacy and safety of icotrokinra QD in adult and adolescent patients aged ≥12 years of age with moderate to severe plaque PsO.6

Study Design/Methods


Select Inclusion/Exclusion Criteria in the ICONIC-ASCEND Study6
Select Inclusion Criteria
Select Exclusion Criteria
  • Age ≥12 years with a diagnosis of plaque PsO (with or without psoriatic arthritis) who were candidates for phototherapy or systemic therapy
  • Total BSA ≥10%, PASI ≥12, and IGA ≥3 at screening and baseline
  • Nonplaque form of PsO (eg, erythrodermic, guttate, or pustular)
  • Drug-induced PsO
  • Any major surgery within 8 weeks before screening or transplanted organ (with exception of a corneal transplant >12 weeks prior to the study).
Abbreviations: BSA, body surface area; IGA, investigator’s global assessment; PASI, Psoriasis Area and Severity Index; PsO, psoriasis.
  • Adult and adolescent patients were randomized in a 4:1:4 ratio to receive oral icotrokinra QD, PBO (with PBO crossover to icotrokinra at week 16), or subcutaneous ustekinumab at weeks 0, 4, and 16 (with ustekinumab crossover to icotrokinra at week 28). All participants will receive ustekinumab and icotrokinra matching placebos as needed to maintain blinding. See Figure: ICONIC-ASCEND Study Design.6

ICONIC-ASCEND Study Design6

Abbreviations: DBL, database lock; ICO, icotrokinra; PBO, placebo; QD, once daily; R, randomization; SC, subcutaneous; UST, ustekinumab.


ICONIC-ASCEND Key Clinical Trial Outcome Measures6
Primary Endpoints
Time Frame
Icotrokinra versus PBO
   Percentage of patients who achieved an IGA score of cleared (0) or minimal (1)
   and ≥2-grade improvement from baseline
Week 16
   Percentage of patients who achieved PASI 90 response
Week 16
Key Secondary Endpoints
Icotrokinra versus PBO
   Percentage of patients who achieved IGA score of cleared (0)
Week 16
   Percentage of patients who achieved PASI 75 response
Week 16
   Percentage of patients who achieved PASI 100 response
Week 16
   Percentage of patients who achieved PSSD Symptom of 0
Week 16
   Percentage of patients with ≥4-point improvement from baseline in PSSD Itch score
Week 16
Icotrokinra versus ustekinumab
   Percentage of patients who achieved PASI 100 response
Week 28
   Percentage of patients who achieved IGA score of cleared (0)
Week 28
   Percentage of patients who achieved PASI 90 response
Week 28
   Percentage of patients with ≥4-point improvement from baseline in PSSD itch score
Week 28
Abbreviations: IGA, Investigator’s Global Assessment; PASI, Psoriasis Area and Severity Index; PBO, placebo; PSSD, Psoriasis Symptoms and Signs Diary.
Note: Additional details regarding study outcome definitions can be found on clinicaltrials.gov.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 21 November 2025.

 

References

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1 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.  
2 Janssen Research & Development, LLC. A study of JNJ-77242113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/​or palms of the hands and the soles of the feet) (ICONIC-TOTAL). ln: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 October 10]. Available from: https://clinicaltrials.gov/study/NCT06095102 NLM Identifier: NCT06095102.  
3 Janssen Research & Development, LLC. A study of JNJ-77242113 for the treatment of participants with moderate to severe plaque psoriasis. ln: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 October 10]. Available from: https://clinicaltrials.gov/study/NCT06143878 NLM Identifier: NCT06143878.  
4 Janssen Research & Development, LLC. A study of JNJ-77242113 in adolescent and adult participants with moderate to severe plaque psoriasis (ICONIC-LEAD). ln: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 October 10]. Available from: https://clinicaltrials.gov/study/NCT06095115 NLM Identifier: NCT06095115.  
5 Janssen Research & Development, LLC. A study of JNJ-77242113 for the treatment of participants with moderate to severe plaque psoriasis (ICONIC-ADVANCE 2). ln: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 October 10]. Available from: https://clinicaltrials.gov/study/NCT06220604 NLM Identifier: NCT06220604.  
6 Janssen Research & Development, LLC. 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). ln: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 October 10]. Available from: https://clinicaltrials.gov/study/NCT06934226 NLM Identifier: NCT06934226.