At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 89 enrolled

Drug / intervention

efalizumab +1 moredrug

Likely dose

efalizumab 0.7 mg/kgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00669214

NCT00669214Phase 4Completed

Compare CT.gov

A Phase IV Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of 1.0 mg/kg Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp

Genentech, Inc.·interventional·Posted Apr 30, 2008·Updated Jun 6, 2017

In Brief

A Phase 4 clinical trial evaluating efalizumab and placebo for Psoriasis. Completed, enrolled 89 participants.

Detailed Summary

This was a Phase IV randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of subcutaneous efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis with involvement of the scalp who had no previous exposure to efalizumab. The study consisted of a screening period, a double-blind treatment period, an open-label treatment period, and an observation/follow-up period. The study enrolled 100 patients. 11 patients were excluded from all analyses because of data issues.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPsoriasis

Countries--

Collaborators--

Timeline

Phase 4CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2008

First PostedApr 2008

Primary CompletionJan 2009

TodayJul 2026

First PostedApr 30, 2008

Enrollment StartFeb 1, 2008

Primary CompletionJan 1, 2009

TodayJul 2, 2026

Enrollment to primary: 11 monthsPosted 18.2 years ago

Interventions

efalizumabdrug

All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).

placebodrug

All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).