CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 31 enrolled
Drug / intervention
Efalizumabdrug
Likely dose
1.0 mg/kg subcutaneously weekly for 24 dosesAI-extracted
Key inclusion· 6
  • ✓Plaque psoriasis covering >10% of body surface area
  • ✓PASI score ≥12 or Linear PASI ≥8.0 at screening
  • ✓Diagnosis of plaque psoriasis for at least 6 months
  • ✓Candidate for systemic therapy (treatment-naive or prior systemic therapy)
Key exclusion· 11
  • ✕Guttate, erythrodermic, or pustular psoriasis as sole or predominant form
  • ✕History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies or Fc-containing fusion proteins
  • ✕Efalizumab treatment within the last 12 months
  • ✕Active, uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection

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

Search/NCT00115076
NCT00115076Phase 3Completed
CompareCT.gov

A Phase IIIB Study to Evaluate the Mechanism of Action of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy

Rockefeller University·interventional·Posted Jun 21, 2005·Updated Feb 8, 2021

In Brief

A Phase 3 clinical trial evaluating Efalizumab for Psoriasis. Completed, enrolled 31 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 21, 2005
Enrollment StartAug 4, 2003
Primary CompletionMay 18, 2009
Study CompletionApr 6, 2011
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 21.0 years ago

Interventions

Efalizumabdrug

24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection