Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301

• Register: EUCTR
• Last refreshed on: 7 January 2019
• Main ID: EUCTR2012-003176-39-PL
• Date of registration: 04/03/2013
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec Research Limited
• Public title: Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301
• Scientific 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 - EXTEND
• Date of first enrolment: 17/04/2013
• Target sample size: 1600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003176-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Brazil, Canada, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Mexico, Moldova, Republic of, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States

Contacts

• Name: EXTEND Clinical Trials Team
• Affiliation: Biogen Idec Research Limited

• Name: EXTEND Clinical Trials Team
• Affiliation: Biogen Idec Research Limited

Key inclusion & exclusion criteria

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, Study205MS203, 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 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) as determined by the Investigator. Laboratory findings mandating discontinuation of study treatment as defined in parent study 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 Study 205MS301.
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Relapsing-remitting Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: DACLIZUMAB HYP
Product Code: BIIB019
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Daclizumab
Current Sponsor code: BIIB019
Other descriptive name: Daclizumab HYP (DAC HYP)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

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.

Timepoint(s) of evaluation of this end point: As necessary

Primary end point(s): Incidence of AEs and SAEs

Secondary Objective: Secondary objectives of this study are as follows:
• To assess the long-term immunogenicity of DAC HYP administered by PFS
• 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
• 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
• To evaluate PD parameters that may be associated with treatment response

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Throughout the course of the study

Secondary end point(s): • Relapse outcomes: annualized relapse rate (ARR), and proportion of subjects who relapse
• Sustained disability progression defined by at least a 1.0 point increase on the Expanded Disability Status Scale (EDSS) score from a baseline EDSS =1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS <1.0 that is sustained for 24 weeks
• Magnetic Resonance Imaging (MRI) outcomes: total number and volume of new or newly enlarging T2 hyperintense lesions, Gd-enhancing lesions, T1 hypointense lesions, and brain volume change on brain MRI
• Change in Multiple Sclerosis Functional Composite (MSFC) score
• Change in EDSS score
• Change in Symbol Digit Modalities Test (SDMT) score
• Change in 3 Second Paced Auditory Serial Addition Test (PASAT 3)
score
• Proportion of subjects who are free from disease activity.
• Change in Multiple Sclerosis Impact Scale-29 (MSIS-29) physical and psychological scores
• Change in quality of life as assessed by the European Quality of Life, 5 dimensions (EQ-5D) and European Quality of Life, visual analog scale (EQ VAS)
• Change in direct HRU (hospitalizations, emergency room visits, and unscheduled neurologist visits)
• Change in treatment satisfaction as assessed by the subject
• Change in subject productivity as assessed by the HRPQ
• Change in clinical laboratory assessments (hematology and blood chemistry)
• Local tolerability as assessed by subject-reported injection site pain (VAS) and clinician injection site assessments
• Incidence of anti-DAC binding antibodies (ADAbs) to DAC-HYP over time
• Incidence of anti-DAC HYP neutralizing antibodies (NAbs) to DAC HYP over time

Secondary ID(s)

2012-003176-39-DE

205MS303

Source(s) of Monetary Support

Biogen Idec Research Limited