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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 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.
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)
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05201638
The ClinicalTrials.gov registry entry for NCT05201638 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,100 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 525-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (110% higher). The listed sponsor is Immunic, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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