Phase 2
Completed N=517
Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis
Source: ClinicalTrials.gov NCT00870740 ↗Enrolled (actual)
517
Serious AEs
16.3%
Results posted
Aug 2016
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (AEs) — 61; 57; 70; 57 participants
Summary
The primary objective of the study was to assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation included the following major components:
* An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in Study 201.
* An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP.
* An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP after a 6-month washout period.
* An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during Study 201.
The secondary objective is to assess the durability of the effect of DAC HYP on multiple sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (AEs) |
61; 57; 70; 57; 61; 62 | — |
| PRIMARY Number of Participants With Abnormalities in Vital Signs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities |
0; 3; 3; 4; 3; 2 | — |
| PRIMARY Number of Participants With Abnormalities in Blood Chemistry Laboratory Data |
65; 62; 61; 62; 60; 55 | — |
| PRIMARY Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline |
7; 21; 3; 162; 150; 167 | — |
| SECONDARY Adjusted Annualized Relapse Rate |
0.179; 0.302; 0.165 | — |
| SECONDARY Estimated Proportion of Participants With a Relapse |
0.186; 0.166; 0.249; 0.160; 0.235; 0.111 | — |
| SECONDARY Mean Number of New Gadolinium-enhancing Lesions |
0.3; 1.1; 0.2; 0.2; 0.2; 0.2 | — |
| SECONDARY Mean Number of New or Newly-enlarging T2 Hyperintense Lesions |
46.0; 41.1; 39.8; 1.1; 2.6; 0.5 | — |
| SECONDARY Mean Volume of New T1 Hypointense Lesions |
232.13; 228.90; 126.50; 94.20; 52.26; 44.92 | — |
| SECONDARY Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions |
-7.75; -8.44; -0.78; -4.90; -5.40; -8.98 | — |
| SECONDARY Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions |
-3.99; -7.15; -5.51; -13.89; -6.72; -16.59 | — |
| SECONDARY Rate of Percentage Change From Baseline in Mean Total Brain Volume |
-0.772; -0.930; -0.622; -0.528; -0.505; -0.452 | — |
Eligibility Criteria
Key Inclusion Criteria
- Participated in Study 205MS201 (NCT00390221) for at least 52 weeks and was compliant with the 205MS201 protocol in the opinion of the Investigator.
Key Exclusion Criteria
- Subjects with any significant change in their medical status from 205MS201 that would preclude administration of DAC HYP, as determined by the Investigator
- Any subject who has permanently discontinued study treatment in Study 205MS201 except subjects who were unblinded during evaluation of an adverse event (AE) and found to be on placebo
- Planned ongoing treatment with any approved or experimental treatment for MS except for the protocol-allowed use of concomitant interferon-beta
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00870740). 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. Informational only — not medical advice.