Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00870740
• Date of registration: 26/03/2009
• Prospective Registration: No
• Primary sponsor: Biogen
• Public title: Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis SELECTION
• Scientific title: A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT)
• Date of first enrolment: February 2009
• Target sample size: 517
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00870740
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Czech Republic, Germany, Hungary, India, Poland, Russian Federation, Ukraine, United Kingdom

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Participated in Study 205MS201 (NCT00390221) for at least 52 weeks and was compliant
with the 205MS201 protocol in the opinion of the Investigator.

Key Exclusion Criteria:

- Subjects with any significant change in their medical status from 205MS201 that would
preclude administration of DAC HYP, as determined by the Investigator

- Any subject who has permanently discontinued study treatment in Study 205MS201 except
subjects who were unblinded during evaluation of an adverse event (AE) and found to be
on placebo

- Planned ongoing treatment with any approved or experimental treatment for MS except
for the protocol-allowed use of concomitant interferon-beta

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing-Remitting Multiple Sclerosis

Intervention(s)

Biological: BIIB019 (Daclizumab High Yield Process)

Drug: Placebo

Primary Outcome(s)

Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline [Time Frame: Up to 72 weeks]

Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities [Time Frame: Up to 72 Weeks]

Number of Participants With Abnormalities in Blood Chemistry Laboratory Data [Time Frame: Up to 72 Weeks]

Number of Participants With Abnormalities in Vital Signs [Time Frame: Up to Week 72]

Number of Participants With Treatment-emergent Adverse Events (AEs) [Time Frame: Up to 72 weeks]

Secondary Outcome(s)

Mean Number of New Gadolinium-enhancing Lesions [Time Frame: Week 20, Week 52]

Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions [Time Frame: Baseline, Week 52]

Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions [Time Frame: Baseline, Week 52]

Rate of Percentage Change From Baseline in Mean Total Brain Volume [Time Frame: Baseline, Week 52]

Mean Number of New or Newly-enlarging T2 Hyperintense Lesions [Time Frame: Baseline, Week 20, Week 52]

Adjusted Annualized Relapse Rate [Time Frame: Up to 72 weeks]

Estimated Proportion of Participants With a Relapse [Time Frame: Up to 72 weeks]

Mean Volume of New T1 Hypointense Lesions [Time Frame: Baseline, Week 20, Week 52]

Secondary ID(s)

205-MS-202

EUDRA CT No.: 2008-005559-46

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AbbVie

Results

• Results available: Yes
• Date Posted: 30/08/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00870740