Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis

Phase 2 Completed 270 enrolled PDL BioPharma, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This research study is being conducted in the U.S. and Europe to evaluate the safety and efficacy of daclizumab for the treatment of multiple sclerosis (MS).

Timeline

Start: 2005-04
Primary completion: —
Completion: 2006-10

Outcome

Mixed primary results

paper the interferon beta and placebo group compared with 1.32 in the interferon beta and high-dose daclizumab group (difference 72%, 95% CI 34% to 88%; p=0.004) PMID 20163990 ↗

paper the interferon beta and low-dose daclizumab group (25%, -76% to 68%; p=0.51) PMID 20163990 ↗

Publications

Wynn D, Kaufman M, Montalban X, Vollmer T, Simon J, Elkins J, O'Neill G, Neyer L, Sheridan J, Wang C, Fong A, Rose JW; CHOICE investigators. Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta. Lancet Neurol. 2010 Apr;9(4):381-90. doi: 10.1016/S1474-4422(10)70033-8. Epub 2010 Feb 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daclizumab	Monoclonal antibody	1 mg/kg	Subcutaneous
Subject	Daclizumab	Monoclonal antibody	2 mg/kg	Subcutaneous