Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Brepocitinib · 6 trials · 10 indications
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
Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs, laboratory evaluation for hematology, blood chemistry, and urinalysis; vital signs; electrocardiograms (ECGs); and physical examinations. The investigator will determine whether the change is clinically meaningful.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Brepocitinib Dose Level 1 PO QD | EXPERIMENTAL | - |
| Brepocitinib Dose Level 2 PO QD | EXPERIMENTAL | - |
| Placebo PO QD | PLACEBO_COMPARATOR | - |
| Brepocitinib Dose Level 1 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Brepocitinib Dose Level 2 | EXPERIMENTAL | - |
| Brepocitinib | EXPERIMENTAL | - |
| Brepocitinib Dose Level 1 by mouth (PO) once daily (QD) | EXPERIMENTAL | - |
| Brepocitinib Dose Level 2 by mouth (PO) once daily (QD) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Brepocitinib PO QD | DRUG | Brepocitinib PO QD |
| Placebo PO QD | DRUG | Placebo PO QD |
| Brepocitinib | DRUG | Oral Brepocitinib |
| Placebo | DRUG | Oral Placebo |
| Oral Brepocitinib | DRUG | Oral |
| Oral Placebo | DRUG | Drug: Oral Placebo |
Inclusion Criteria: * Adult subjects (18-75 years old) * Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis) * Active uveitic disease in at least 1 eye * Weight \> 40 kg with a body mass index ≤ 40 kg/m2 Exclusion Criteria: Has confirmed or suspected curre...