Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
brodalumab · 3 trials · 2 indications
ACR20 is used as a measurement of the proportion of subjects who are reaching a 20% improvement of tender an swollen joint counts. The higher percent of subjects reaching a higher improvement percentage shows greater success.
Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection
Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection
Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on Day 30
Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on day 30
Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2
| Arm | Type | Description |
|---|---|---|
| 210 mg brodalumab | EXPERIMENTAL | Administered via subcutaneous injections. |
| 140 mg brodalumab | EXPERIMENTAL | Administered via subcutaneous injection. |
| Placebo | PLACEBO_COMPARATOR | Administered via subcutaneous injection until week 24. |
| Brodalumab (single 1.5mL pre-filled syringe) | EXPERIMENTAL | A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection |
| Brodalumab (2 pre-filled syringes [1.0mL + 0.5mL]) | EXPERIMENTAL | A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections |
| Brodalumab 140mg SC | EXPERIMENTAL | open label, all subjects receive brodulamab |
| Midazolam (MDZ) 2mg oral, Brodalumab 210mg SC | EXPERIMENTAL | MDZ 2mg oral (Day 1 and Day 9), Brodalumab 210mg SC (Day 2) |
| Name | Type | Description |
|---|---|---|
| 210 mg brodalumab | DRUG | 210 mg brodalumab administered via subcutaneous injection. |
| 140 mg brodalumab | DRUG | 140 mg brodalumab administered via subcutaneous injection. |
| Placebo | DRUG | Placebo administered via subcutaneous injection until week 24. |
| Brodalumab | DRUG | Brodalumab is a large molecule for the treatment of inflammatory diseases |
Inclusion Criteria: Subjects has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal interphalangeal joints). Subjects must have at least 1 psoriatic skin lesion. Exclusion Criteria: • -Subjec...