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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05437263 | A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis | PHASE3 | ACTIVE NOT_RECRUITING | 241 | — | — | Oct 31, 2022 | Jul 1, 2026 | Sep 29, 2025 | 109 | United States, Argentina +20 |
| NCT06433999 | A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis | PHASE2 | COMPLETED | 5 | — | — | Aug 28, 2024 | Feb 28, 2025 | May 20, 2025 | 1 | United States |
TIS is a composite endpoint based on improvement in the 6 Disease Activity Core Set Measure (CSM) scores and ranges from 0 to 100 (2016 American College of Rheumatology \[ACR\] Myositis Response Criteria/European League Against Rheumatism \[EULAR\]) where a higher score indicates more improvement
| Arm | Type | Description |
|---|---|---|
| Brepocitinib Dose Level 1 PO QD | EXPERIMENTAL | - |
| Brepocitinib Dose Level 2 PO QD | EXPERIMENTAL | - |
| Placebo PO QD | PLACEBO_COMPARATOR | - |
| Brepocitinib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Brepocitinib | DRUG | Oral Brepocitinib |
| Placebo | DRUG | Oral Placebo |
Inclusion Criteria: * A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies * Adult subjects (18-75 years old) * Active muscle and skin disease at screening and baseline * Prior therapy OR current therapy with corticosteroids, hydr...