CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 621 enrolled
Drug / intervention
BIIB019 (Daclizumab High Yield Process) +1 morebiological
Likely dose
Not stated in 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/NCT00390221
NCT00390221Phase 2Completed
CompareCT.gov

Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis

Biogen·interventional·Posted Oct 19, 2006·Updated Jul 11, 2016

In Brief

A Phase 2 clinical trial evaluating BIIB019 (Daclizumab High Yield Process) and Placebo for Relapsing-Remitting Multiple Sclerosis. Completed, enrolled 621 participants across 56 sites in 8 countries.

Detailed Summary

The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing-Remitting Multiple Sclerosis
CountriesCzechia, Germany, Hungary, India, Poland, Russia, Ukraine, United Kingdom
CollaboratorsAbbVie

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 19, 2006
Enrollment StartFeb 1, 2008
Primary CompletionMay 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.7 years ago

Interventions

BIIB019 (Daclizumab High Yield Process)biological

SC injection

Placebodrug

Placebo SC injection