Skip to content
DataLookout
Start free
Menu

ICONIC-PsA 2NCT06807424

A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis

StatusActive, Not Recruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 27 versions: 22 with changes below, 5 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Enrollment target: estimated 750 to confirmed 813
    • Site details revised at 236 of 236 sites
  2. Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 14 of 14 entries
    • Site details revised at 4 of 236 sites
  3. Trial sites expanded: 233 → 236 locationsv25
  4. Trial sites expanded: 224 → 233 locationsv24
  5. Trial sites expanded: 216 → 224 locationsv23
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 214 to 216v22
  2. Eligibility criteria revised
    • Site details revised at 1 of 214 sites
    • Study title expanded, about 2 words
    v21
  3. Study sites revised (214)v20
  4. Study sites revised (214)v19
  5. Study sites revised (214)v18
  6. Study sites: 213 to 214v17
  7. Study sites: 207 to 213v14
  8. Study sites: 200 to 207v13
  9. Study sites: 195 to 200v12
  10. Primary endpoint revised
    • Study sites: 189 to 195
    • Eligibility criteria expanded, about 6 words
    v11
  11. Study sites: 175 to 189v10
  12. Study sites: 141 to 175v8
  13. Study sites: 76 to 141v7
  14. Study sites: 38 to 76v6
  15. Study sites: 34 to 38v5
  16. Study sites: 4 to 34v4
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16
Timeframe: Week 16

Secondary (14)

Proportion of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than Equal to (>=) 3 Percent (%) and With Baseline IGA Score of >=2
Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2
Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2
Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And >=2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2
Proportion of Participants who Achieved an ACR 50 Response at Week 16
Show 9 moreShow less
Proportion of Participants who Achieved an ACR 70 Response at Week 16
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16
Changes From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline
Change From Baseline in Enthesitis Score at Week 16 in Participants With Enthesitis at Baseline
Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline
Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline
Proportion of Participants who Achieved Minimal Disease Activity (MDA) at Week 16
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16

Arms and interventions

Group I: Icotrokinra Dose 1Experimental

Participants will receive icotrokinra Dose 1. Participants who have not discontinued will be eligible to enter a long term extension (LTE) and will continue to receive icotrokinra Dose 1.

Group II: Icotrokinra Dose 2Experimental

Participants will receive icotrokinra Dose 2. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 2.

Group III: PlaceboPlacebo comparator

Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra Dose 1 or Dose 2 at Week 16. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 1 or Dose 2.

Drugs: Icotrokinra, Placebo

Sites

236 sites in 24 countries

China 25, United States 25, Poland 19, Japan 16, Hungary 15, Italy 11, Spain 11, United Kingdom 11, Czechia 10, Germany 10, India 9, Bulgaria 8, Canada 7, Romania 7, Argentina 6, Brazil 6, Denmark 6, Malaysia 6, Mexico 6, Turkey (Türkiye) 6, Australia 5, Thailand 5, Taiwan 4, Hong Kong 2