Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis (SELECTED)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01051349
First received: January 15, 2010
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield Process (DAC HYP) (BIIB019) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS) relapse, slowing disability progression, and reducing new MS lesion formation in this study population.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Biological: BIIB019 (Daclizumab HYP)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Adverse Events (AEs), Serious AEs (SAEs) and discontinuation of DAC HYP due to AEs, and withdrawals due to AEs. [ Time Frame: 288 weeks ] [ Designated as safety issue: Yes ]
  • Autoinjector Substudy: Daclizumab area-under-the-curve over the dosing interval (AUC0-Τ) after substudy Dose 4 [ Time Frame: Pre-dose and up to 28 days post-dose at the fourth substudy injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Annual change in total number of new or newly enlarging T2 hyperintense lesions [ Time Frame: From Baseline through 288 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.

  • Annual change in volume of new or newly enlarging T2 hyperintense lesions) [ Time Frame: From Baseline through 288 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.

  • Annual change in total number of Gadolinium-enhancing lesions [ Time Frame: From Baseline through 288 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.

  • Annual change in number of T1 hypointense lesions [ Time Frame: From Baseline through 288 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.

  • Annual change in volume of new gadolinium-enhancing lesions. [ Time Frame: From Baseline through 288 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.

  • Annual change in volume of T1 hypointense lesions [ Time Frame: From Baseline through 288 weeks ] [ Designated as safety issue: No ]
    Evaluated by magnetic resonance imaging (MRI) by a central reader.

  • Total brain volume [ Time Frame: From Baseline through 288 weeks ] [ Designated as safety issue: No ]
    To assess brain atrophy, total brain volume will be measured by magnetic resonance imaging (MRI) and analyzed by a central reader.

  • Number of participants with antibodies to DAC HYP. [ Time Frame: 288 weeks ] [ Designated as safety issue: Yes ]
  • Annualized Relapse Rate (ARR) [ Time Frame: 288 weeks ] [ Designated as safety issue: Yes ]
    Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The ARR will be calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.

  • Number of participants with sustained disability progression [ Time Frame: 288 weeks ] [ Designated as safety issue: No ]
    Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 12 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.

  • Autoinjector Substudy: Observed maximum concentration (Cmax) of daclizumab [ Time Frame: Pre-dose and up to 28 days post-dose at the first and fourth substudy injections ] [ Designated as safety issue: No ]
  • Autoinjector Substudy: Time to reach maximum concentration (Tmax) of daclizumab [ Time Frame: Pre-dose and up to 28 days post-dose at the first and fourth substudy injections ] [ Designated as safety issue: No ]
  • Autoinjector Substudy: Observed minimum concentration (Cmin) of daclizumab [ Time Frame: Pre-dose at the first and fourth substudy injections ] [ Designated as safety issue: No ]
  • Autoinjector Substudy: Injector site pain [ Time Frame: 10 minutes, 30 minutes, one hour and eight hours after the first and fourth substudy injections ] [ Designated as safety issue: No ]
    Reported by the participant on a visual analog scale (VAS)

  • Autoinjector Substudy: Clinician injection site assessment [ Time Frame: After the first and fourth substudy injections ] [ Designated as safety issue: No ]

Enrollment: 410
Study Start Date: March 2010
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: BIIB019 (Daclizumab HYP)
    Daclizumab High Yield Process 150 mg subcutaneous injection every 4 weeks for up to 6 years
    Other Names:
    • DAC HYP
    • (Daclizumab High Yield Process)
Detailed Description:

This study will provide participants who complete Study 205MS202 (NCT00870740) with the option to receive continued open-label Daclizumab High Yield Process (DAC HYP) monotherapy and to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Approximately 60 to 100 participants will be enrolled into an optional open-label, 16-week autoinjector substudy at a selected subset of sites which will run concurrently during the main study, and will evaluate the systemic exposure and local tolerability of subcutaneous administration of DAC HYP by autoinjector. The 2013-2014 trivalent influenza vaccine will be offered to all eligible participants as an optional substudy to assess the effect of DAC-HYP treatment on the immune response to vaccination,

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Study Eligibility:

Key Inclusion Criteria:

  • 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.
  • Subjects who have completed 52 weeks in Study 205MS202 (NCT00870740) and were compliant with the 205MS202 protocol in the opinion of the Investigator.
  • 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.

Key Exclusion Criteria:

  • Subjects with any significant change in their medical status from the previous study that would prelude administration of Daclizumab High Yield Process (DAC HYP) as determined by the Investigator 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.
  • Any subject who has permanently discontinued study treatment in Study 205MS202 due to an adverse event.
  • Current enrollment in any investigational drug study other than Study 205MS202.
  • Ongoing treatment with any approved or experimental disease-modifying treatment for multiple sclerosis.
  • For subjects currently taking valproic acid, carbamazepine, lamotrigine, or phenytoin:

    • Subjects treated with any of these agents for fewer than 6 months prior to study entry are excluded from study participation unless they discontinue the agent(s) prior to study entry.
    • Subjects treated with 2 or more of these agents for more than 6 months prior to study entry are excluded from study participation unless they reduce to ≤1 agent prior to study entry.
    • Subjects who have had dose escalations of one of these agents within the 6 months prior to study entry are excluded from study participation unless they revert to a previous dose that had been used for at least 6 months prior to study entry or unless they discontinue the agent prior to study entry
  • Subjects who are currently receiving treatment with isoniazid, propylthiouracil, or nimesulide at the time of study entry and are not able to discontinue the agent or change to an alternative medication allowed by the protocol.

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

Autoinjector substudy Eligibility:

Key Inclusion Criteria:

As above and

  • Ability to understand the purpose and risks of the substudy and provide signed and dated informed consent.
  • Must have received at least 6 consecutive monthly doses of 150 mg DAC HYP in Study 205MS203. Note: Subjects are allowed to receive both vialed material and PFS material prior to randomization.
  • Must have a Body Mass Index within the range 18 to 32 kg/m2, inclusive.

Key Exclusion Criteria:

As above and Subjects will be excluded from enrollment into the autoinjector substudy if any of the following exclusion criteria exist at the time of randomization into the substudy:

  • Any clinically significant adverse event, in the opinion of the Investigator, that is ongoing at the time of randomization.
  • Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) greater than the upper limit of normal (>ULN). Testing must have been performed within 30 days prior to randomization.
  • Unwillingness or inability to comply with the requirements of the substudy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051349

  Show 67 Study Locations
Sponsors and Collaborators
Biogen Idec
AbbVie
Investigators
Study Director: Medical Director Biogen Idec
  More Information

Additional Information:
No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01051349     History of Changes
Other Study ID Numbers: 205-MS-203
Study First Received: January 15, 2010
Last Updated: September 25, 2014
Health Authority: Ukraine: State Expert Centre of the Ministry of Health of Ukraine
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
India: Drugs Controller General of India
Germany: Paul-Ehrlich-Institut
Russia: Ministry of Health of the Russian Federation

Keywords provided by Biogen Idec:
MS
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Daclizumab
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014