Trials / Completed
CompletedNCT02028884
Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 85 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 12 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment in participants with NMO and NMOSD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Satralizumab | Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W). |
| DRUG | Placebo | Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W). |
| DRUG | Baseline Treatment | As specified in the protocol, one of the following drugs at a stable dose is required as monotherapy for baseline treatment during the double-blind period: azathioprine (AZA); mycophenolate mofetil (MMF); or oral corticosteroids (CS). For participants aged 12 to 17 years at the time of informed consent, baseline treatment with AZA or MMF in combination with oral CS is also permitted. Change or termination of baseline treatment is only permitted during the open-label extension period. |
Timeline
- Start date
- 2014-02-20
- Primary completion
- 2018-06-06
- Completion
- 2021-12-23
- First posted
- 2014-01-07
- Last updated
- 2023-04-18
- Results posted
- 2020-12-31
Locations
40 sites across 11 countries: United States, France, Germany, Hungary, Italy, Japan, Poland, Spain, Taiwan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02028884. Inclusion in this directory is not an endorsement.