Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alefacept · 5 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Course A1 | EXPERIMENTAL | - |
| Course A2 | PLACEBO_COMPARATOR | - |
| Course B | EXPERIMENTAL | Open label extension |
| 1 | EXPERIMENTAL | Dose regimen 1 |
| 2 | EXPERIMENTAL | Dose regimen 2 |
| Name | Type | Description |
|---|---|---|
| alefacept | DRUG | Intramuscular (IM) |
| placebo | DRUG | Intramuscular (IM) |
| Methotrexate | DRUG | Oral |
Inclusion Criteria: * Diagnosis of Chronic Plaque Psoriasis involving ≥ 10% body surface area * Treatment history for Psoriasis in which 3 or more conventional anti-psoriatic therapies are inappropriate or ineffective * CD4+ T lymphocyte counts at or above the lower limit of normal Exclusion Crite...
Alefacept is being developed for chronic plaque psoriasis, psoriasis, and psoriatic arthritis. It is an investigational therapy studied in adults with moderate to severe forms of these dermatologic and joint conditions. Clinical trials have evaluated its use in patients for whom conventional treatment is ineffective or inappropriate, as well as in patients weighing between 100 kg and 150 kg.
Alefacept targets CD2 and acts as an inhibitor. By binding to CD2, it interferes with the activation and proliferation of T cells, which are involved in the inflammatory process underlying psoriasis and psoriatic arthritis. This targeted approach is designed to modulate the immune response rather than broadly suppress it.
Alefacept is being developed by Biogen Inc., which trades under the ticker symbol BIIB. The company has sponsored Phase 3 and Phase 2 clinical trials of the drug in chronic plaque psoriasis and psoriatic arthritis across multiple countries including the United States, Canada, and several European nations.
Alefacept is in Phase 3 clinical development. It has been evaluated in three completed Phase 3 trials and one completed Phase 2 trial. The Phase 3 program includes studies in chronic plaque psoriasis, while the Phase 2 study examined psoriatic arthritis. All trials have been completed, and no active trials are currently listed.
Alefacept has been studied in four completed clinical trials. These include NCT00692172, an open-label Phase 3 safety study of multiple courses in chronic plaque psoriasis; NCT00674063, a Phase 3 dosing study in patients weighing 100 kg to 150 kg; NCT00673556, a Phase 3 efficacy and safety study in patients for whom conventional treatment is ineffective or inappropriate; and NCT00659412, a Phase 2 placebo-controlled study in psoriatic arthritis.
Alefacept is an investigational drug and has not been approved by the FDA for the indications described. It remains in clinical development, with all reported trials completed. The development program includes Phase 3 studies in chronic plaque psoriasis and a Phase 2 study in psoriatic arthritis, but no regulatory approval has been granted for these uses.