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...
Brodalumab is an investigational drug being studied for the treatment of psoriasis and psoriatic arthritis. It is in clinical development for these dermatological conditions, with completed trials in both indications. The drug is not approved and remains under investigation.
Brodalumab is being developed by Bausch Health Companies Inc. (NYSE: BHC). The company is conducting clinical trials to evaluate the drug's safety and efficacy in psoriasis and psoriatic arthritis.
Brodalumab is in Phase 1 clinical development. While some completed trials were Phase 1 and Phase 3, the current development stage is Phase 1. It is an investigational drug and has not been approved by regulatory authorities.
Brodalumab has completed three clinical trials: NCT01937260, a Phase 1 drug-drug interaction study in psoriasis; NCT02024646, a Phase 3 efficacy and safety study in psoriatic arthritis; and NCT02173392, a Phase 1 bioequivalence study in psoriasis. All trials are completed.
Brodalumab is a distinct investigational drug being developed by Bausch Health. It is not the same as other approved psoriasis treatments, as it is still in clinical development and has not been approved for any indication.