Phase 3
N=30
Study of the Drug Efalizumab (Raptiva), for Adult Patients With Moderate to Severe Plaque Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00115076 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants With Clinical Improvement of Target Lesions — 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Efalizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rockefeller University
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Improvement of Target Lesions |
18 | — |
| SECONDARY Assessment of Overall Clinical Response as Measured by Psoriasis Area and Severity Index (PASI) |
34.58; 12.94 | — |
Summary
Our laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is to study the action and the effects of Efalizumab, on psoriasis. This medication has been studied extensively and has been found to be effective and safe in the treatment of psoriasis. The eligible patient will have 10% of his/her body surface area involved with psoriasis vulgaris.
Eligibility Criteria
Inclusion Criteria
Signed informed consent
- Plaque psoriasis covering >10% of total BSA
- Diagnosis of plaque psoriasis for at least 6 months
- PASI score >=12 (see Appendix A) or Linear PASI score of >= 8.0 at screening (see Appendix B)
- In the opinion of the investigator, candidate for systemic therapy for psoriasis:
- Who has not been previously treated (naive to systemic treatment) OR
- Who has had prior treatment with systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil (MMF), thioguanine, hydroxyurea, sirolimus, azathioprine, 6-MP, etanercept)
- Body weight of 3 times the upper limits of normal (ULN)
- Diagnosis of hepatic cirrhosis, regardless of cause or severity
- WBC count 14,000/μL
- Serum creatinine >2 times the ULN
- Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
- Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Subjects with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled
- History of substance abuse within the last 5 years
- Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug Note: Certain medications and vaccines may not be used for specified periods of time prior to enrollment or at any time during the treatment period.
Data sourced from ClinicalTrials.gov (NCT00115076). 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.