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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 oral small molecule drug developed by Roivant Sciences Ltd. (ticker ROIV) for immunology indications. It is being studied in cutaneous sarcoidosis, dermatomyositis, lichen planopilaris, and non-infectious intermediate and posterior uveitis. Brepocitinib is investigational and remains in clinical development.
Brepocitinib targets TYK2 and JAK1, two kinases involved in inflammatory signaling. It is classified as an inhibitor of these targets. By inhibiting TYK2 and JAK1, brepocitinib is designed to reduce immune pathway activity relevant to immune-mediated skin and eye conditions.
Brepocitinib is developed by Roivant Sciences Ltd., which trades under the ticker ROIV. Roivant is the sponsor of the clinical program studying brepocitinib across several immunology indications, including lichen planopilaris, cutaneous sarcoidosis, dermatomyositis, and uveitis.
Brepocitinib is in Phase 2 and Phase 3 clinical development. A Phase 2/3 study in lichen planopilaris and a Phase 2 study in cutaneous sarcoidosis are recruiting, and a Phase 3 study in non-infectious, non-anterior uveitis is active but not recruiting. Brepocitinib is investigational and has received a Breakthrough Therapy designation.
Brepocitinib is being studied in NCT07532603, a Phase 2/3 trial in adults with lichen planopilaris, and NCT06978725, a Phase 2 trial in adults with cutaneous sarcoidosis, both recruiting. NCT06431373 is a Phase 3 trial in active, non-infectious, non-anterior uveitis that is active but not recruiting. NCT06433999, a completed Phase 2 dermatomyositis study, has also been conducted.
Yes. Brepocitinib, Brepocitinib PO QD, and Oral Brepocitinib refer to the same investigational drug. The alternative names describe the once-daily oral formulation of brepocitinib being developed by Roivant Sciences Ltd. for immunology indications including lichen planopilaris, cutaneous sarcoidosis, dermatomyositis, and uveitis.