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Long-term Extension Study to Evaluate the Safety and Efficacy of Daclizumab High Yield Process

Phase 2/3
Completed
Conditions
Relapsing-Remitting Multiple Sclerosis (RRMS)
Registration Number
CTRI/2012/05/002705
Lead Sponsor
Biogen Idec
Brief Summary

All subjects will receive one DAC HYP 150 mg SC injection every 4 weeks.  xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

After the first 12 weeks in this study, subjects will have the option of administering DAC HYP at home.  Subjects who are not able to administer their own dose or prefer not to administer their own dose of DAC HYP will be given the option to choose another individual to administer their treatment or to have their treatment administered by staff at the study site.

A protocol-defined futility analysis in the 205MS201 study did not find evidence of futility at the proposed dose of DAC HYP, which was originally selected based on the findings of the completed Phase 2 DAC-1012 study.  Additionally, the ongoing safety review of the 205MS201 and 205MS202 studies supports continued dosing and initiation of home dosing for subjects who have previously tolerated DAC HYP dosing in the clinic.  Prior to self-administration of DAC HYP as an SC injection in this study, subjects will have received DAC HYP for a minimum of 15 months and a maximum of 27 months comprising their treatment in the 205MS201 and 205MS202 studies plus the first 3 months of observed therapy in the current study.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
450
Inclusion Criteria
  • 1.Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use PHI in accordance with national and local subject privacy regulations.
  • 2.Must be a subject from Study 205MS202 who completed at least 52 weeks and must have been compliant with the 205MS202 protocol in the opinion of the Investigator.
  • 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.
Exclusion Criteria
  • 1.Subjects with any significant change in their medical status from the previous study 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 the 205MS201 or 205MS202 studies.
  • The Investigator must re review the subject’s medical fitness for participation and must consider any diseases that would preclude treatment.
  • 2.Any subject who has permanently discontinued study treatment in Study 205MS202 due to an AE.
  • 3.Current enrollment in any investigational drug study other than Study 205MS202.
  • 4.Ongoing treatment with any approved or experimental disease-modifying treatment for MS.
  • 5.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
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary objective of this study is to assess the safety of extended treatment with DAC HYP monotherapy in subjects with RRMS144 weeks
Secondary Outcome Measures
NameTimeMethod
The secondary objectives of this study are to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing MS relapse, slowing disability progression, and reducing new MS lesion formation in this study population.•Immunogenicity

Trial Locations

Locations (5)

Brain Care

🇮🇳

Jaipur, RAJASTHAN, India

Nizams Institute of Medical Sciences

🇮🇳

Hyderabad, ANDHRA PRADESH, India

Seth G S Medical College and KEM Hospital

🇮🇳

(Suburban), MAHARASHTRA, India

Sri Aurobindo Seva Kendra

🇮🇳

Kolkata, WEST BENGAL, India

St Johns Medical College Hospital

🇮🇳

Bangalore, KARNATAKA, India

Brain Care
🇮🇳Jaipur, RAJASTHAN, India
Dr Rajaram Agrawal
Principal investigator
91-9829063895
drrajaram195@rediffmail.com

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