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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)

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

BIIB019 (Daclizumab)

trivalent seasonal influenza vaccine

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring MS, Multiple Sclerosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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 (NCT00390221) or 205MS202 (NCT00870740) 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 (NCT00870740) due to an adverse event.
Current enrollment in any investigational drug study other than Study 205MS202 (NCT00870740).
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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIIB019

Arm Description

Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 288.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab

Secondary Outcome Measures

Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline

New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader.

Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline

New or newly enlarging T2 hyperintense lesions evaluated by MRI and analyzed by a central reader.

Number of Participants With Total Number of New Gadolinium-enhancing Lesions

New Gadolinium-enhancing lesions was evaluated by MRI and analyzed by a central reader.

Annual Change in Number of T1 Hypointense Lesions

Annual Change in Volume of New Gadolinium-Enhancing Lesions

Annual Change in Volume of T1 Hypointense Lesions

Volume of T1 hypointense lesions was evaluated by MRI and analyzed by a central reader.

Percent Change in Total Brain Volume

To assess brain atrophy, total brain volume was be measured by MRI and analyzed by a central reader.

Number of Participants With Antibodies to DAC HYP

Annualized Relapse Rate (ARR)

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 was 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. Adjusted ARR was reported.

Number of Participants With Sustained Disability Progression for 12 Weeks

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.

Number of Participants With Sustained Disability Progression for 24 Weeks

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 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. 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.

Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab

Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4

Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4

Participant-Reported Pain Visual Analog Scale (VAS) Score

The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end ("0 [no pain]" on the left and "100 [very painful]" on the right). The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain.

Summary of Injection Site Assessment Performed by Clinician

Injection site assessment was performed by clinician and are defined as erythema (redness) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; pigmentation changes (skin discoloration other than redness) rated on a 3 point scale from 0-2, where 0=none, 1=hypopigmentation and 2=hyperpigmentation; induration (swelling) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; tenderness to pressure rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; and local temperature changes of injection sites rated on a 3 point scale where 0=normal, 1=warm and 1=hot. Only those score categories for which there was at least 1 participant are reported. Here, Injection=Inj, post-dose=PD

Full Information

NCT ID

NCT01051349

First Posted

January 15, 2010

Last Updated

April 11, 2018

Sponsor

Biogen

Collaborators

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT01051349

Brief Title

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

Acronym

SELECTED

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

March 31, 2010 (Actual)

Primary Completion Date

August 25, 2016 (Actual)

Study Completion Date

August 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

Collaborators

AbbVie

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing-Remitting Multiple Sclerosis

Keywords

MS, Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

410 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIIB019

Arm Type

Experimental

Arm Description

Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 288.

Intervention Type

Biological

Intervention Name(s)

BIIB019 (Daclizumab)

Other Intervention Name(s)

Daclizumab High Yield Process, DAC HYP

Intervention Description

Administered as specified in the treatment arm.

Intervention Type

Biological

Intervention Name(s)

trivalent seasonal influenza vaccine

Intervention Description

All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs

Description

Time Frame

Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)

Title

Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab

Time Frame

Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose

Secondary Outcome Measure Information:

Title

Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline

Description

New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader.

Time Frame