Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301

Phase 1

• Conditions: Relapsing-remitting Multiple Sclerosis; MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-003176-39-IE
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-11
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Must be a subject currently participating in Study 205MS301 who has completed either the Week 144 Visit or the End of Study Visit (Week 96) or subject currently participating in study 205MS203 or study 205MS302.
3. Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Medical History
1. Any subject who permanently discontinued study treatment in Study 205MS301, Study 205Ms203, or Study 205MS302 prior to the end of the study treatment period, or had an Early Termination visit in those studies or any subject who has completed all the safety follow-up visits after week 144 of Study 205MS303 per the original protocol.
Note: Subjects for whom dosing was temporarily suspended in Study 205MS301, Study 205MS203, or Study 205MS302 are not excluded from participation in this extension study if the criteria for resuming DAC HYP treatment under the parent study protocol have been met at the time of enrollment into Study 205MS303.
2. Any significant change in the subject’s medical history that would preclude administration of DAC HYP, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject’s participation in Study 205MS301, Study 205MS203, or Study 205MS302. The Investigator must re review the subject’s medical fitness for participation and consider any factors that would preclude treatment in Study 205MS303, including:
• History of any significant cardiac, endocrine, hematological, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological (other than MS), and/or other major disease (e.g., malignancy) that would preclude administration of DAC HYP.
• Clinically significant laboratory abnormalities (hematology and blood chemistry) from the most recently available test in parent study, as determined by the Investigator. Laboratory findings mandating discontinuation of study treatment as defined in parent study protocol are exclusionary.
3. Other medical reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment.
Treatment History
4. Treatment with any prohibited concomitant medication during the parent study.
Note: Subjects who start an approved, open-label IFN ß preparation after completion of dosing in Study 205MS301 are not excluded, but IFN ß treatment must be discontinued before the first dose of DAC HYP in Study 205MS303 is given.
Miscellaneous
5. Female subjects who are currently pregnant or breastfeeding, or considering becoming pregnant while in the study.
6. History of drug or alcohol abuse (as defined by the Investigator) at any time after the start of Study 205MS303 or any of the parent studies.
7. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to assess the safety and tolerability of long-term treatment with DAC HYP monotherapy in subjects who completed Study 205MS301, Study 205MS203, or Study 205MS302.;Secondary Objective: Secondary objectives of this study are as follows:<br>•To assess the long-term immunogenicity of DAC HYP administered by PFS <br>•To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and patient-reported impact of MS, following long-term treatment with DAC HYP<br>•To assess the safety, tolerability, and efficacy of switching to DAC HYP in subjects previously on long-term treatment with interferon ß 1a in Study 205MS301<br>•To evaluate PD parameters that may be associated with treatment response<br>;Primary end point(s): Incidence of AEs and SAEs;Timepoint(s) of evaluation of this end point: As necessary