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Also known as Amevive, ASP0485
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 studied for chronic plaque psoriasis, psoriasis, and psoriatic arthritis. It is a dermatology therapy developed by Biogen Inc. for patients with these inflammatory skin and joint conditions. Clinical development has focused on moderate to severe chronic plaque psoriasis and on psoriatic arthritis.
Alefacept targets CD2 and acts as an inhibitor of this target. CD2 is a cell surface receptor involved in T cell activation. By binding CD2, alefacept is designed to interfere with the T cell driven immune responses that contribute to psoriasis and psoriatic arthritis.
Alefacept is developed by Biogen Inc., which trades under the ticker BIIB. Biogen has sponsored the clinical trial program evaluating alefacept in chronic plaque psoriasis and psoriatic arthritis, including Phase 3 studies in psoriasis and a Phase 2 study in psoriatic arthritis.
Alefacept has been evaluated in Phase 3 clinical development for chronic plaque psoriasis and in Phase 2 for psoriatic arthritis. The Phase 3 program includes three completed studies, and the Phase 2 psoriatic arthritis study is also completed. No active trials are currently listed.
Alefacept has been studied in four completed trials: NCT00692172, an open-label Phase 3 safety study of multiple intramuscular courses in chronic plaque psoriasis; NCT00674063, a Phase 3 dosing study in patients weighing 100 kg to 150 kg; NCT00673556, a Phase 3 study in patients for whom conventional treatment was ineffective or inappropriate; and NCT00659412, a Phase 2 placebo-controlled psoriatic arthritis study.