Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06878404 | A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis | PHASE3 | ACTIVE NOT_RECRUITING | 552 | — | — | Feb 21, 2025 | Feb 4, 2028 | Jun 5, 2026 | 155 | United States, Argentina +14 |
| NCT06807424 | A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis | PHASE3 | RECRUITING | 750 | — | — | Jan 9, 2025 | Oct 18, 2028 | Jun 5, 2026 | 216 | United States, Argentina +21 |
The ACR 20 responders are participants with an improvement of greater than or equal to (\>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein).
The ACR 20 responders are participants with an improvement of greater than or equal to (\>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity \[arthritis, VAS\] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein).
| Arm | Type | Description |
|---|---|---|
| Group I: Icotrokinra Dose 1 | EXPERIMENTAL | Participants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1. |
| Group II: Icotrokinra Dose 2 | EXPERIMENTAL | Participants will receive icotrokinra dose 2. Participants who continue into a LTE will continue to receive icotrokinra dose 2. |
| Group III: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2. |
| Group IV: Active Reference Comparator | ACTIVE_COMPARATOR | Participants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2. |
| Name | Type | Description |
|---|---|---|
| Icotrokinra | DRUG | Icotrokinra will be administered. |
| Placebo | DRUG | Placebo will be administered. |
| Active reference comparator | DRUG | Active reference drug will be administered. |
Inclusion Criteria: * Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) at screening * Have active PsA as defined by: (a) At least 3 swollen joints and at least ...