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Also known as Brepocitinib PO QD, Oral Brepocitinib
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 | - |
| Part 1: Brepocitinib Dose Level 1 | EXPERIMENTAL | Oral Brepocitinib |
| Part 1: Brepocitinib Dose Level 2 | EXPERIMENTAL | Oral Brepocitinib |
| Part 1: Placebo | PLACEBO_COMPARATOR | - |
| Part 2: Brepocitinib Dose Level 1 | EXPERIMENTAL | Oral Brepocitinib |
| Part 2: Placebo | PLACEBO_COMPARATOR | - |
| 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 | 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...
Brepocitinib is an investigational oral small molecule being studied for dermatomyositis, lichen planopilaris, posterior uveitis, cutaneous sarcoidosis, and non-infectious intermediate uveitis. It is in clinical development for these immunology indications, with active trials in dermatomyositis, uveitis, and cutaneous sarcoidosis.
Brepocitinib targets TYK2 and JAK1, acting as an inhibitor of these kinases. By inhibiting TYK2 and JAK1, it is designed to modulate signaling pathways involved in inflammatory and autoimmune conditions.
Brepocitinib is being developed by Roivant Sciences Ltd., a biopharmaceutical company traded under the ticker ROIV. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple immunology indications.
Brepocitinib is in Phase 2 and Phase 3 clinical development. It has received FDA Breakthrough Therapy designation and Priority Review designation, though it remains investigational and is not yet approved. Active trials include Phase 3 studies in dermatomyositis and uveitis.
Brepocitinib is being studied in several trials, including NCT05437263 for dermatomyositis (Phase 3, active), NCT06431373 for non-infectious non-anterior uveitis (Phase 3, active), NCT06433999 for skin-predominant dermatomyositis (Phase 2, completed), and NCT06978725 for cutaneous sarcoidosis (Phase 2, recruiting).
Yes, Brepocitinib is also known as Brepocitinib PO QD and Oral Brepocitinib. These names refer to the same drug, which is administered orally once daily in clinical trials.