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icotrokinra

Medical Information

Icotrokinra - Treatment of Psoriatic Arthritis - ICONIC-PsA Program

Last Updated: 08/01/2025

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 2 psoriatic arthritis (PsA) phase 3 clinical trials: ICONIC-PsA 1 and ICONIC-PsA 2. Results are not currently available.²^-⁴
ICONIC-PsA 1 and ICONIC-PsA 2 are ongoing, phase 3, multicenter, randomized, double-blind, placebo-controlled studies evaluating the safety and efficacy of icotrokinra in biologic-naïve and biologic-experienced adult patients with active PsA, respectively.²^-⁴
The design of the ICONIC-PsA phase 3 clinical trial program was informed and supported by exploratory assessments from FRONTIER-1 study.²
- FRONTIER-1 is a completed phase 2b multicenter, randomized, placebo-controlled study assessing the safety and efficacy of icotrokinra in adult patients with moderate to severe plaque psoriasis (PsO).⁵

CLINICAL STUDIES

Phase 3 Studies – ICONIC-PsA 1 and ICONIC-PsA 2

Merola et al (2025)² designed two phase 3, multicenter, randomized, double-blind, placebo-controlled studies to evaluate the safety and efficacy of icotrokinra in adult patients with active PsA (ICONIC-PsA 1, N=540; ICONIC-PsA 2, N=750), respectively. Results are not currently available.

Study Design/Methods

ICONIC-PsA 1 is evaluating icotrokinra vs. placebo (PBO) in biologic-naïve adult patients (≥18 years of age) with active PsA.²^,³
Select inclusion and exclusion criteria for ICONIC-PsA 1 are described in Table:
Select Inclusion/Exclusion Criteria for ICONIC-PsA 1.²^,³

Select Inclusion/Exclusion Criteria for ICONIC-PsA 1²^,³

Inclusion Criteria	Exclusion Criteria
Active PsA ≥3 months Met CASPAR at screening ≥3 TJC and SJC CRP ≥0.1 mg/dL ≥1 PsA subtype: distal interphalangeal joint involvement, polyarticular arthritis (without rheumatoid nodules), arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis Active plaque PsO with ≥1 psoriatic plaque ≥2 cm in diameter or psoriatic nail changes	Previous treatment with biologic DMARDs for PsA or PsO Diagnosis of other inflammatory diseases (eg, RA, SLE, or Lyme disease)
Abbreviations: CASPAR, ClASsification criteria for Psoriatic ARthritis; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; PsA, psoriatic arthritis; PsO, psoriasis; RA, rheumatoid arthritis; SJC, swollen joint count; SLE, systemic lupus erythematosus; TJC, tender joint count

ICONIC-PsA 2 is evaluating icotrokinra vs. PBO in adult biologic-experienced adult patients (≥18 years of age) with active PsA.²^,⁴
Select inclusion and exclusion criteria for ICONIC-PsA 2 are described in Table:
Select Inclusion/Exclusion Criteria for ICONIC-PsA 2 ²^,⁴

Select Inclusion/Exclusion Criteria for ICONIC-PsA 2²^,⁴

Inclusion Criteria	Exclusion Criteria
Patient must have previously received treatment with 1 biologic agent for PsA or PsO, with the reason for discontinuation documented Active PsA ≥3 months Met CASPAR at screening ≥3 TJC and SJC CRP ≥0.1 mg/dL ≥1 PsA subtype: distal interphalangeal joint involvement, polyarticular arthritis (without rheumatoid nodules), arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis Active plaque PsO with ≥1 psoriatic plaque ≥2 cm in diameter or psoriatic nail changes	Diagnosis of other inflammatory diseases (eg, RA, SLE, or Lyme disease)
Abbreviations: CASPAR, ClASsification criteria for Psoriatic ARthritis; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; PsA, psoriatic arthritis; PsO, psoriasis; RA, rheumatoid arthritis; SJC, swollen joint count; SLE, systemic lupus erythematosus; TJC, tender joint count

Inclusion Criteria

Exclusion Criteria

Patient must have previously received treatment with 1 biologic agent for PsA or PsO, with the reason for discontinuation documented
Active PsA ≥3 months
Met CASPAR at screening
≥3 TJC and SJC
CRP ≥0.1 mg/dL
≥1 PsA subtype: distal interphalangeal joint involvement, polyarticular arthritis (without rheumatoid nodules), arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Active plaque PsO with ≥1 psoriatic plaque
≥2 cm in diameter or psoriatic nail changes

Diagnosis of other inflammatory diseases (eg, RA, SLE, or Lyme disease)

Abbreviations: CASPAR, ClASsification criteria for Psoriatic ARthritis; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; PsA, psoriatic arthritis; PsO, psoriasis; RA, rheumatoid arthritis; SJC, swollen joint count; SLE, systemic lupus erythematosus; TJC, tender joint count

The primary, secondary, and safety outcome measures are described in Table:
Primary, Secondary, and Safety Endpoints for ICONIC-PsA 1 and ICONIC-PsA 2 ²^-⁴

Primary, Secondary, and Safety Endpoints for ICONIC-PsA 1 and ICONIC-PsA 2²^-⁴

Primary Endpoint
Proportion of patients who achieve an ACR 20 response at week 16
Secondary Endpoints
At week 16, proportion of patients achieving: ACR 50/70 responses PASI 75/90/100 responses (with baseline BSA ≥3% and IGA score of ≥2 at baseline) IGA 0/1 response (with ≥2 grade improvement from baseline) Resolution of enthesitis Resolution of dactylitis MDA At week 16, change from baseline in: HAQ-DI score SF-36 PCS score Enthesitis score (LEI) Dactylitis score (DSS) FACIT-Fatigue score
Safety
AEs Clinical laboratory tests Vital signs
Abbreviations: ACR 20/50/70, ≥20%/50%/70% improvement in American College of Rheumatology response criteria; AE, adverse events; BSA, body surface area; DSS, Dactylitis Severity Score; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire-Disability Index; IGA, Investigator’s Global Assessment; LEI, Leeds Enthesitis Index; MDA, minimal disease activity; PASI 75/90/100, ≥75%/90%/100% improvement in Psoriasis Area and Severity Index; SF-36 PCS, 36-Item Short Form Survey physical component summary

The study designs are summarized in Figure: ICONIC Study Designs ²

A screenshot of a graph

AI-generated content may be incorrect. ICONIC-PsA Program Study Designs²

Abbreviations: ACR20, ≥20% improvement in American College of Rheumatology response criteria; CASPAR, ClASsification criteria for Psoriatic ARthritis; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drugs; ICO, icotrokinra; PBO, placebo; PE, primary endpoint; PO, oral; PsA, psoriatic arthritis; QD, once daily; R, randomization; SJC, swollen joint count; TJC, tender joint count
^aN=540 was estimated to have ≥90% power to detect a significant statistical difference between ICO and PBO.

A chart with text and numbers

AI-generated content may be incorrect.

Abbreviations: ACR20, ≥20% improvement in American College of Rheumatology response criteria; CASPAR, ClASsification criteria for Psoriatic ARthritis; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drugs; ICO, icotrokinra; PBO, placebo; PE, primary endpoint; PO, oral; PsA, psoriatic arthritis; QD, once daily; R, randomization; SJC, swollen joint count; TJC, tender joint count
^aN=750 was estimated to have ≥90% power to detect a significant statistical difference between ICO and PBO.
^bPatients must have been previously treated with 1 biologic for PsA or PsO and the reason for discontinuation must be documented.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 24 July 2025.

References

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1	Gooderham M, Lain E, Bissonnette R, et al. Phase 3 results from an innovative trial design of treating plaque psoriasis involving difficult-to-treat, high-impact sites with icotrokinra, a targeted oral peptide that selectively inhibits the IL-23-receptor. Poster presented at: SID Annual Meeting; May 7-10, 2025; San Diego, CA.
2	Merola JF, Mease PJ, Coates LC, et al. Icotrokinra, a first-in-class, targeted oral peptide, in participants with psoriatic disease: exploratory assessments from a phase 2 psoriasis study informing a phase 3 clinical program in psoriatic arthritis. Poster presented at: European Alliance of Associations for Rheumatology (EULAR); June 11-14, 2025; Barcelona, Spain.
3	Janssen Research & Development, LLC. A study to evaluate the efficacy and safety of JNJ-77242113 (Icotrokinra) in biologic-naïve participants with active psoriatic arthritis (ICONIC-PsA 1). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 July 22]. Available from: https://clinicaltrials.gov/study/NCT06878404 NLM Identifier: NCT06878404.
4	Janssen Research & Development, LLC. A study to evaluate the efficacy and safety of icotrokinra (JNJ-77242113) in biologic-experienced participants with active psoriatic arthritis (ICONIC-PsA 2). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 July 20]. Available from: https://clinicaltrials.gov/study/NCT06807424 NLM Identifier: NCT06807424.
5	Janssen Research & Development, LLC. A study of JNJ-77242113 in participants with moderate-to-severe plaque psoriasis (FRONTIER 1). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 May 25]. Available from: https://www.clinicaltrials.gov/study/NCT05223868 NLM Identifier: NCT05223868.

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