Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication SILIQ ® (brodalumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. FDA label
Also known as AMG 827
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...
Top 11 of 12 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 4 | PHASE3 | Zasocitinib |
| Johnson & Johnson | JNJ | 9 | PHASE3 | Guselkumab, Ustekinumab, Icotrokinra, JNJ-88545223 |
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Risankizumab, Adalimumab, Lutikizumab |
| Bristol-Myers Squibb Company | BMY | 4 | PHASE3 | Deucravacitinib |
| MoonLake Immunotherapeutics Class A | MLTX | 3 | PHASE3 | Sonelokimab |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Ixekizumab, Tirzepatide |
| Amgen Inc. | AMGN | 2 | PHASE3 | Apremilast |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE1 | Secukinumab |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Pfizer Inc. | PFE | 2 | - | tofacitinib |
Brodalumab is a monoclonal antibody developed for psoriasis and psoriatic arthritis, both immune-mediated inflammatory conditions. It is being studied in adults 18 years and older. The clinical program includes a Phase 3 trial in psoriatic arthritis and Phase 1 studies in psoriasis, including bioequivalence and drug-drug interaction evaluations.
Brodalumab targets IL17RA, the interleukin-17 receptor A. It acts as an antagonist at this receptor, blocking signaling through the IL-17 pathway, which is involved in the inflammatory processes underlying psoriasis and psoriatic arthritis.
Brodalumab is being developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company is responsible for the clinical development program in psoriasis and psoriatic arthritis.
Brodalumab is in Phase 1 development according to the current pipeline status. It is an investigational monoclonal antibody and has not been approved by the FDA for the indications described. The program includes completed Phase 1 and Phase 3 trials.
Brodalumab has been studied in completed trials including NCT02173392, a Phase 1 bioequivalence study in psoriasis; NCT02024646, a Phase 3 trial in psoriatic arthritis; and NCT01937260, a Phase 1 drug-drug interaction and pharmacodynamic study in psoriasis. No trials are currently active.