Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Brivekimig · 2 trials · 2 indications
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count.
Mixed meal tolerance test MMTT stimulated C-peptide concentration is to be calculated from area under the concentration-time curve (AUC)
| Arm | Type | Description |
|---|---|---|
| Brivekimig dose regimen A | EXPERIMENTAL | Participants will receive Brivekimig dose regimen A. |
| Brivekimig dose regimen B | EXPERIMENTAL | Participants will receive Brivekimig dose regimen B. |
| Brivekimig dose regimen C | EXPERIMENTAL | Participants will receive Brivekimig dose regimen C. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive Brivekimig matching placebo. |
| Brivekimig | EXPERIMENTAL | Participants will receive subcutaneous injection of brivekimig. |
| Name | Type | Description |
|---|---|---|
| Brivekimig | DRUG | * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection |
| Placebo | DRUG | * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection |
Inclusion Criteria: * Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to Baseline * Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), ...