ICOTYDE™

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ICOTYDE™ (icotrokinra)

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ICOTYDE - Treatment of Psoriatic Arthritis - ICONIC-PsA Program

Last Updated: 07/31/2026

SUMMARY

The company cannot recommend any practices, procedures, or usage of ICOTYDE that deviate from the approved labeling.
ICOTYDE is being studied in 2 psoriatic arthritis (PsA) phase 3 clinical trials: ICONIC-PsA 1 and ICONIC-PsA 2. Results are not currently available.¹^-³
ICONIC-PsA 1 and ICONIC-PsA 2 are ongoing, phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled studies evaluating the safety and efficacy of ICOTYDE in adults with active PsA.¹^-³
- ICONIC-PsA 1 is evaluating ICOTYDE in biologic-naïve patients.
- ICONIC-PsA 2 is evaluating ICOTYDE in both biologic-experienced and biologic-naïve patients.
The design of the ICONIC-PsA phase 3 clinical trial program was informed and supported by exploratory assessments from FRONTIER-1 study.¹
- FRONTIER-1 is a completed phase 2b multicenter, randomized, PBO-controlled study assessing the safety and efficacy of ICOTYDE in adult patients with moderate to severe plaque psoriasis (PsO).⁴

CLINICAL STUDIES

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

Merola et al (2025)¹ designed two phase 3, multicenter, randomized, double-blind, PBO-controlled studies to evaluate the safety and efficacy of ICOTYDE 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 ICOTYDE vs PBO in biologic-naïve adult patients (≥18 years of age) with active PsA.¹^,²
Selected inclusion and exclusion criteria for ICONIC-PsA 1 are described in Table: Selected Inclusion/Exclusion Criteria for ICONIC-PsA 1.¹^,²

Selected Inclusion/Exclusion Criteria for ICONIC-PsA 1¹^,²

Inclusion Criteria	Exclusion Criteria
Active PsA ≥3 months Met CASPAR at screening ≥3 TJC and SJC CRP ≥0.1 mg/dL ≥1 PsA subtype^a 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 ^aPsA subtypes include distal interphalangeal joint involvement, polyarticular arthritis (without rheumatoid nodules), arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.

Inclusion Criteria

Exclusion Criteria

Active PsA ≥3 months
Met CASPAR at screening
≥3 TJC and SJC
CRP ≥0.1 mg/dL
≥1 PsA subtype^a
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
^aPsA subtypes include distal interphalangeal joint involvement, polyarticular arthritis (without rheumatoid nodules), arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.

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

Selected Inclusion/Exclusion Criteria for ICONIC-PsA 2¹^,³

Inclusion Criteria	Exclusion Criteria
Active PsA despite current or previous use of ≥1 of the following: Non-biologic DMARD Apremilast therapy Biologic agent (limited to only 1) Active PsA ≥3 months Met CASPAR at screening ≥3 TJC and SJC CRP ≥0.1 mg/dL ≥1 PsA subtype^a 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 ^aPsA subtypes include distal interphalangeal joint involvement, polyarticular arthritis (without rheumatoid nodules), arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.

Inclusion Criteria

Exclusion Criteria

Active PsA despite current or previous use of ≥1 of the following:
- Non-biologic DMARD
- Apremilast therapy
- Biologic agent (limited to only 1)
Active PsA ≥3 months
Met CASPAR at screening
≥3 TJC and SJC
CRP ≥0.1 mg/dL
≥1 PsA subtype^a
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)

The primary, secondary, and safety outcome measures are described in Table: Primary, Secondary, and Safety Endpoints for ICONIC-PsA 1 and ICONIC-PsA 2 ¹^-³

Primary, Secondary, and Safety Endpoints for ICONIC-PsA 1 and ICONIC-PsA 2¹^-³

Primary Endpoint
Proportion of patients who achieved an ACR20 response at week 16
Secondary Endpoints
At week 16, proportion of patients achieving: ACR50/70 responses PASI 75/90/100 responses (among patients with baseline: BSA ≥3% and IGA score of ≥2) IGA 0/1 response with ≥2 grade improvement (among patients with baseline: BSA ≥3% and IGA score of ≥2) 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: ACR20/50/70, ≥20%/50%/70% improvement in American College of Rheumatology response criteria; AE, adverse event; 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 ¹

ICONIC-PsA Program Study Designs¹

Abbreviations: ACR20, ≥20% improvement in American College of Rheumatology response criteria; ICO, ICOTYDE; PBO, placebo; PE, primary endpoint; PO, oral; PsA, psoriatic arthritis; QD, once daily; R, randomization
^aN=540 was estimated to have ≥90% power to detect a significant statistical difference between ICO and PBO.

Abbreviations: ACR20, ≥20% improvement in American College of Rheumatology response criteria; ICO, ICOTYDE; PBO, placebo; PE, primary endpoint; PO, oral; PsA, psoriatic arthritis; QD, once daily; R, randomization
^aN=750 was estimated to have ≥90% power to detect a significant statistical difference between ICO and PBO.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 22 July 2026.

References

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1	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.
2	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 2026 June 05]. Available from: https://clinicaltrials.gov/study/NCT06878404 NLM Identifier: NCT06878404.
3	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 2026 July 06]. Available from: https://clinicaltrials.gov/study/NCT06807424 NLM Identifier: NCT06807424.
4	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 2026 February 13]. Available from: https://www.clinicaltrials.gov/study/NCT05223868 NLM Identifier: NCT05223868.

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