AI CuratorAI-generated
Research summary · AI summary · not yet reviewedSubjects not reportedPhase 3Trial registry
Efficacy Evaluation of IMU-838 Tablets in Patients with Relapsing Multiple Sclerosis
A Phase 3 interventional study plans to enroll 1100 patients to assess the efficacy, safety, and tolerability of IMU-838 tablets compared to a matched placebo over 72 weeks, focusing on time to first relapse.
- Tags
- #MSResearch
- Most relevant to
- —
- Source
- Read original source
This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
This study aims to gather significant data on a potential new treatment for relapsing multiple sclerosis, which could impact future therapeutic strategies and patient outcomes.
What this does not prove
No results have been posted yet, and the planned endpoints do not indicate actual findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 1100 · basis not reported
- Randomised
- Yes
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (10)
study phasePHASE3
sample size1100
study designINTERVENTIONAL
randomizedRANDOMIZED
interventionDrug: IMU-838 tablets
comparatorDrug: Placebo matching IMU-838 tablets
primary endpointTo evaluate efficacy of IMU-838 versus placebo based on time to first relapse
follow up72 weeks
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.\n\nThe study will consist of the following periods:\n\nScreening Period: Approximately 28 days Main Treatment Period: 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years"
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.