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 being developed by Bausch Health Companies Inc. (BHC) and is currently in Phase 1 clinical development for these indications.
Brodalumab is a small molecule that targets the interleukin-17 receptor. By binding to this receptor, it is designed to block the activity of interleukin-17, a cytokine involved in the inflammatory response that contributes to psoriasis and psoriatic arthritis.
Brodalumab is being developed by Bausch Health Companies Inc., a company traded on the stock exchange under the ticker symbol BHC. The drug is currently in clinical trials for psoriasis and psoriatic arthritis.
Brodalumab is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for psoriasis and psoriatic arthritis, but the drug remains in early-stage development.
Brodalumab has been studied in several clinical trials. One trial, NCT01937260, was a Phase 1 drug-drug interaction study in psoriasis subjects. Another, NCT02024646, was a Phase 3 study in psoriatic arthritis. A third, NCT02173392, was a Phase 1 bioequivalence study in psoriasis. All trials have been completed.
Brodalumab is also known by other names, including Siliq and Kyntheum. These alternative names may be used in different contexts or regions, but they refer to the same drug being developed by Bausch Health Companies Inc.