Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects

Astellas

Status and phase: Completed; Phase 4

Conditions: Plaque Psoriasis

Treatments: Procedure: Narrow Band UVB Phototherapy; Drug: alefacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00658606

AME-001

Details and patient eligibility

About

Assess the efficacy and safety of alefacept with nbUVB compared to alefacept alone in chronic plaque psoriasis subjects. Combination therapy may improve the clinical response to psoriatic subjects as both modalities have an effect on T cells

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has given written informed consent
• Subject has a diagnosis of moderate to severe chronic plaque psoriasis involving >=10% with a Psoriasis Area and Severity Index (PASI) score >=10 at Baseline
• Subject has CD4+ T lymphocyte (CD4) count at or above the lower limit of normal
• Male and female subjects must use an adequate means of contraception from screening to end of study.

Exclusion criteria

• Subject who received alefacept in the past

• Subject who has shown no improvement following an adequate course of nbUVB in the past

• Subject who has been treated in the past with either therapy or cyclosporine

• Subject with any active cancer, including skin cancer at Baseline

• Subject with erythrodermic, pustular or predominantly guttate psoriasis

• Subject who has used treatment for psoriasis prior to Baseline as follows:

  • Topical treatment within 14 days
  • Oral treatment within 28 days
  • Broad band UVB (bbUVB) or nbUVB treatment within 56 days
  • Biological treatment within 84 days

• Serious local infection or serious systemic infection within the 3 months prior to the first dose of study drug

• Subject with a history of drug or alcohol abuse within the past 2 years

• Subject that is known to be infected with the AIDS virus

• Subject with any other skin disease or other disease that might interfere with psoriasis status assessments

• Female subject who is nursing, pregnant or planning to become pregnant while in this study

• Subject who is currently enrolled in any other investigational drug or device study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Alefacept alone

Active Comparator group

Description:

15 mg alefacept intramuscularly (IM) once weekly for 12 weeks

Treatment:

Drug: alefacept

Alefacept + nbUVB

Experimental group

Description:

15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks

Treatment:

Procedure: Narrow Band UVB Phototherapy