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NCT05201638 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
A Phase 3 study of Multiple Sclerosis (Relapsing Remitting), sponsored by Immunic.
- Active
- Registry status
- Phase 3
- Development phase
- 1,100
- Enrollment target
- 20
- Study locations
NCT05201638: Active Phase 3 study of Multiple Sclerosis (Relapsing Remitting), sponsored by Immunic.
NCT05201638 is a Phase 3 study of Multiple Sclerosis (Relapsing Remitting) that is active but no longer recruiting, run by Immunic. The registered enrollment target is 1,100 participants, above the 525-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (110% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05201638, a Phase 3 study of Multiple Sclerosis (Relapsing Remitting), is active but no longer recruiting, sponsored by Immunic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,100 participants
- Enrollment target
- 20
- Study locations
Study Summary
Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-2)
Primary Outcome
Survival analysis of time to first relapse, occurred after the start of study treatment administration and before the end of the double-blind period, censored at a maximum of 72 weeks.
Conditions Studied
Interventions
- DRUG IMU-838 tablets
- DRUG Placebo matching IMU-838 tablets
Study Locations (20)
Other
- Heratsi Hospital Complex 1 - Yerevan
- Saint Gregory the Illuminator Medical Center - Yerevan
- Erebouni Medical Center - Yerevan
- UCC of Rep of Srpska - Banja Luka
- Cantonal Hospital Bihac Dr. Irfan Ljubijankic - Bihać
- University Clinical Center of Sarajevo - Sarajevo
- University Clinical Center Sarajevo - Sarajevo
- University Clinical Center Tuzla - Tuzla
- Astra Clinic - Tallinn
- University Hospital Muenster, Institute Translational Neurology dept. Neurology - Münster
- Post-Graduation Institute of Medical Education and Research (PGIMER) - Chandigarh
- Fortis Memorial Research Institute - Gurugramam
- Polakulath Narayanan Renai Medicity MSSH - Kochi
- Dr Ram Manohar Lohia Institute of Medical Sciences - Lucknow
- All India Institute of Medical Sciences - New Delhi
- GB Pant Institute of Postgraduate Medical Education and Research - New Delhi
- SRI Guru Ram Das Institute of Medical Sciences and Research - Punjābi Bāgh
- DKS PGI - Raipur
Florida
- Neuro of Central Florida - Altamonte Springs
- Healthcare Innovations - Coral Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,100 participants |
| Start Date | 2022-01-12 |
| Est. Completion | 2033-10 |
| Phase | Phase 3 |
What the registry record for NCT05201638 still lists
NCT05201638 is an interventional study that assigns participants to a tested intervention. Its 1,100 participants enrollment target places it among the larger protocols in the corpus, above the 525-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (110% higher).
The record links to 1 condition, with Multiple Sclerosis (Relapsing Remitting) appearing as the primary indexed condition, and to 2 interventions - of which IMU-838 tablets is the first listed.
NCT05201638 names 20 study sites across 2 states, led by Other, Florida.
Frequently Asked Questions
What is clinical trial NCT05201638 about?
NCT05201638 is a clinical study titled "Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis". Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-2)
What is the current status of trial NCT05201638?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,100 participants. The study started on 2022-01-12. Estimated completion is 2033-10.
What conditions does trial NCT05201638 study?
This clinical trial studies the following conditions: Multiple Sclerosis (Relapsing Remitting).
What interventions are being tested in trial NCT05201638?
The interventions under investigation include: IMU-838 tablets (DRUG), Placebo matching IMU-838 tablets (DRUG).
Who is sponsoring clinical trial NCT05201638?
This trial is sponsored by Immunic, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05201638 being conducted?
This trial has 20 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis (Relapsing Remitting)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05201638's enrollment target sits among peer trials
1,100 2nd of 29 the highest of 29 other Multiple Sclerosis (Relapsing Remitting) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis (Relapsing Remitting) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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