Evaluation of IMU-838 in Relapsing MS (Sample Size: 1121)
A study has been designed to assess the efficacy, safety, and tolerability of the drug IMU-838 compared to a placebo in patients with relapsing multiple sclerosis. The study is randomized and controlled, involving 1121 participants.
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Why it matters
This research could provide insights into how IMU-838 may perform in managing relapses in multiple sclerosis, contributing to treatment options. However, as results are not available yet, we cannot draw conclusions about its effectiveness or safety.
What this does not prove
No results are posted, and the planned study design and endpoints are not findings, limiting our current understanding of the study's implications.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 1121 · Actual
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Yes
- Research areas
- Not classified
Original sources
Supporting passages (9)
study design"studyType": "INTERVENTIONAL"
sample size"count": 1121
sample size basis"type": "ACTUAL"
randomized"allocation": "RANDOMIZED"
controlled"studyType": "INTERVENTIONAL"
regulatory approval"isFdaRegulatedDrug": true
primary endpoint"measure": "To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse"
findings"detailedDescription": "This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU-838 in adult patients with RMS.
limitationsPlanned enrolment and endpoints are not findings.
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