Phase 2
N=410
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
Relapsing-Remitting Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01051349 ↗Enrolled (actual)
410
Serious AEs
36.1%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs — 358; 148; 91; 90 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BIIB019 (Daclizumab) (Biological); trivalent seasonal influenza vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs |
358; 148; 91; 90 | — |
| PRIMARY Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab |
610.5; 666.8 | — |
| SECONDARY Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline |
255; 39; 27; 12; 5; 6 | — |
| SECONDARY Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline |
-340.8; -237.7; 38.2; -251.2; -269.7; 31.9 | — |
| SECONDARY Number of Participants With Total Number of New Gadolinium-enhancing Lesions |
22; 3; 6; 11; 14; 7 | — |
| SECONDARY Annual Change in Number of T1 Hypointense Lesions |
— | — |
| SECONDARY Annual Change in Volume of New Gadolinium-Enhancing Lesions |
— | — |
| SECONDARY Annual Change in Volume of T1 Hypointense Lesions |
-183.5; -160.6; -142.4; -115.2; -140.8; -148.4 | — |
| SECONDARY Percent Change in Total Brain Volume |
-0.4; -0.4; -0.2; -0.5; -0.2; 0.1 | — |
| SECONDARY Number of Participants With Antibodies to DAC HYP |
43 | — |
| SECONDARY Annualized Relapse Rate (ARR) |
0.124 | — |
| SECONDARY Number of Participants With Sustained Disability Progression for 12 Weeks |
22; 17; 13; 7; 2 | — |
| SECONDARY Number of Participants With Sustained Disability Progression for 24 Weeks |
19; 18; 11; 7; 3 | — |
| SECONDARY Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab |
31.8; 33.6 | — |
| SECONDARY Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4 |
5.0; 6.0 | — |
| SECONDARY Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4 |
13.8; 15.7 | — |
| SECONDARY Participant-Reported Pain Visual Analog Scale (VAS) Score |
12.7; 14.5; 0.1; 0.4; 0.1; 0.3 | — |
| SECONDARY Summary of Injection Site Assessment Performed by Clinician |
29; 29; 1; 1; 30; 29 | — |
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.
Eligibility 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 (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.
Data sourced from ClinicalTrials.gov (NCT01051349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.