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Alefacept

Phase 3

Chronic Plaque Psoriasis | Small molecule | Dermatology |Biogen Inc.|Last Updated: Aug 23, 2023

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment673

FDA Designations

No designations recorded

Clinical trial landscape

Alefacept · 5 trials · 3 indications

Phase 3 4Phase 2 1
NCT00673556A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or InappropriateChronic Plaque Psoriasis
COMPLETED195 Analytics
NCT00674063A Study to Assess the Efficacy and Safety of Two Dosing Regimens of Alefacept in Subjects Weighing Between 100kg and 150kg With Moderate to Severe Chronic Plaque PsoriasisChronic Plaque Psoriasis
COMPLETED78 Analytics
NCT00692172Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque PsoriasisPsoriasis
COMPLETED175 Analytics
NCT00233662Safety and Tolerability of Repeat Courses of IM AlefaceptChronic Plaque Psoriasis
COMPLETED400 Analytics
PHASE3COMPLETED
A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
Chronic Plaque Psoriasis
NCT00673556195
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PHASE3COMPLETED
A Study to Assess the Efficacy and Safety of Two Dosing Regimens of Alefacept in Subjects Weighing Between 100kg and 150kg With Moderate to Severe Chronic Plaque Psoriasis
Chronic Plaque Psoriasis
NCT0067406378
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PHASE3COMPLETED
Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis
Psoriasis
NCT00692172175
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PHASE3COMPLETED
Safety and Tolerability of Repeat Courses of IM Alefacept
Chronic Plaque Psoriasis
NCT00233662400
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Study Endpoints

Primary Endpoints

Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50
14 Weeks
Proportion of subjects receiving a Psoriasis Area and Severity Index (PASI) score of ≥75 compared to baseline
1 Week post treatment
Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring
Throughout treatment course
Incidence of infections, malignancies, serious adverse events, adverse events leading to discontinuation of study drug, dose withholding (due to infection or decreased T cells), and changes in lymphocyte counts over time.
Proportion of patients achieving a score in the assessment system of the American College of Rheumatology Core Set Measurements of ACR 20, ACR 50 and ACR 70
12 Weeks and at any time

Secondary Endpoints

Proportion of patients achieving a PASI score of ≥ 50 any time during study
Throughout study
Proportion of patients achieving a PASI score of ≥ 75
14 Weeks
Proportion of subjects in each dosing regimen receiving a PASI score of ≥75 compared to baseline
1 Week post treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Course A1EXPERIMENTAL -
Course A2PLACEBO_COMPARATOR -
Course BEXPERIMENTALOpen label extension
1EXPERIMENTALDose regimen 1
2EXPERIMENTALDose regimen 2

Interventions

NameTypeDescription
alefaceptDRUGIntramuscular (IM)
placeboDRUGIntramuscular (IM)
MethotrexateDRUGOral
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites34

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...

Countries:United StatesAustriaBelgiumCanadaGermanyDenmarkFranceNetherlandsSpainUnited KingdomSwitzerlandPolandRussia
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Frequently asked questions about Alefacept

What is Alefacept used for?

Alefacept is an investigational small molecule being developed for chronic plaque psoriasis, psoriasis, and psoriatic arthritis. It has been studied in Phase 3 clinical trials for chronic plaque psoriasis and in Phase 2 for psoriatic arthritis. The drug is not approved and remains in clinical development.

Who makes Alefacept?

Alefacept is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker BIIB. Biogen has sponsored multiple clinical trials evaluating the drug for dermatological conditions including chronic plaque psoriasis and psoriatic arthritis.

What phase is Alefacept in?

Alefacept is in Phase 3 clinical development. It has completed Phase 3 trials for chronic plaque psoriasis and a Phase 2 trial for psoriatic arthritis. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Alefacept in?

Alefacept has been studied in several completed trials, including NCT00233662, a Phase 3 safety and tolerability study in chronic plaque psoriasis with 400 participants, and NCT00659412, a Phase 2 placebo-controlled study in psoriatic arthritis with 185 participants. Other Phase 3 trials include NCT00673556 and NCT00674063.

Is Alefacept the same as other psoriasis treatments?

Alefacept is a distinct investigational small molecule developed by Biogen Inc. for chronic plaque psoriasis and psoriatic arthritis. It is not the same as other marketed psoriasis drugs, and no alternative names have been reported for this compound.