Long-term extension study to evaluate safety and efficacy of DAC HYP
Research type
Research Study
Full title
A Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301
IRAS ID
128025
Contact name
Benjamin Turner
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2012-003176-39
Clinicaltrials.gov Identifier
Research summary
Patients with multiple sclerosis (MS) frequently have inadequate treatment options. Approved first-line therapies often fail to stop disease progression while more effective alternatives may be delayed or withheld due to safety considerations.
Daclizumab High Yield Process (DAC HYP) is a monoclonal antibody (meaning that it can bind to specialised molecules on certain cells). DAC HYP binds to a molecule called CD25 on the surface of activated immune cells and reduces the number of them in the body.
The primary hypothesis for using DAC HYP to treat MS is to selectively inhibit activated T cells.
DAC HYP is an investigational drug being developed by Biogen Idec Inc. and Abbott Biotherapeutics Corp. and has been tested in humans previously and was found to be generally safe and well tolerated.
This study will provide participants who complete Phase 3 Study 205MS301 with the opportunity to receive open-label DAC HYP monotherapy. This study will allow evaluation of long-term safety, efficacy, and immunogenicity of DAC HYP in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS).
Since Study 205MS301 is still ongoing, the identity of the product that participants received in Study 205MS301 cannot be disclosed.
Around 1800 patients with RRMS will be enrolled in this study at approximately 260 sites worldwide and be treated with DAC HYP injections. Approximately 60 participants will be recruited in the UK.
Treatment with DAC HYP will last up to approximately 3 years. All participants will receive one subcutaneous injection of DAC HYP each month. Participants will visit the clinic 15 times during the 3 year treatment period. Four additional post-treatment visits with safety lab testing will be required after the last dose of study treatment.
Procedures include medical history, physical examination, vital signs, blood and urine sample collection, questionnaires, completion of dosing diary and brain MRI.REC name
London - Fulham Research Ethics Committee
REC reference
13/LO/0671
Date of REC Opinion
31 Jul 2013
REC opinion
Further Information Favourable Opinion