Phase 4
Completed N=98
Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects
Source: ClinicalTrials.gov NCT00658606 ↗Enrolled (actual)
98
Serious AEs
2.0%
Results posted
Apr 2011
Primary outcomePrimary: Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16 — 22.4; 44.9 Percentage of Subjects — p=0.032
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16 |
22.4; 44.9 | 0.032 sig |
| SECONDARY Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study |
26.5; 36.7 | 0.037 sig |
| SECONDARY Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16 |
21.9; 20.0; 13.9; 6.6; -8.0; -13.4 | 0.001 sig |
| SECONDARY Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study |
21.9; 20.0; 14.4; 8.2; -7.5; -11.9 | 0.382 |
| SECONDARY Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16 |
22.5; 42.9; 77.6; 57.1 | 0.052 |
| SECONDARY Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study |
34.7; 59.2; 65.3; 40.8 | 0.026 sig |
| SECONDARY Percentage of Subjects Who Achieve PASI 90 at Week 16 |
8.2; 20.4; 91.8; 79.6 | 0.147 |
| SECONDARY Time to Relapse |
98.0; 119.0 | 0.566 |
| SECONDARY Time for 50% Decrease in PASI |
84.0; 56.0 | 0.001 sig |
| SECONDARY Time for a 75% Decrease in PASI |
99.5; 84.0 | 0.007 sig |
| SECONDARY Change in Dermatology Life Quality Index (DLQI) |
11.0; 9.1; 8.2; 5.6; -2.7; -3.5 | 0.539 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00658606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.