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NCT03341962 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Dose-finding IMU-838 for Ulcerative Colitis
A Phase 2 study, sponsored by Immunic.
- Terminated
- Registry status
- Phase 2
- Development phase
- 263
- Enrollment target
NCT03341962: Clinical Trial Phase 2 study, sponsored by Immunic.
NCT03341962 is a Phase 2 study that was terminated before completion, run by Immunic. The registered enrollment target is 263 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03341962, a Phase 2 study, was terminated before completion, sponsored by Immunic.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 263 participants
- Enrollment target
Study Summary
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy with an option for open-label treatment extension in moderate-to-severe ulcerative colitis (CALDOSE-1).
Primary Outcome
Composite endpoint: Proportion of patients with both, symptomatic remission (Mayo rectal bleeding subscore = 0, and Mayo stool frequency subscore of 0 or 1) and endoscopic healing (Modified Mayo endoscopy subscore of 0 or 1) at Week 10. All patients who were randomized to 30 mg/day and 45 mg/day were used for the assessment of the primary efficacy endpoint
Interventions
- DRUG Placebo
- DRUG IMU-838
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 263 participants |
| Start Date | 2018-03-15 |
| Est. Completion | 2022-11-16 |
| Phase | Phase 2 |
Why NCT03341962 stopped before completion
NCT03341962 is an interventional study that assigns participants to a tested intervention. The registered 263 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03341962 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03341962 about?
NCT03341962 is a clinical study titled "Phase 2 Dose-finding IMU-838 for Ulcerative Colitis". This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy with an option for open-label treatment extension in moderate-to-severe ulcerative colitis (CALDOSE-1).
What is the current status of trial NCT03341962?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 263 participants. The study started on 2018-03-15. Estimated completion is 2022-11-16.
What interventions are being tested in trial NCT03341962?
The interventions under investigation include: Placebo (DRUG), IMU-838 (DRUG).
Who is sponsoring clinical trial NCT03341962?
This trial is sponsored by Immunic, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03341962's enrollment target sits among peer trials
263 210th of 2000 higher than 1,791 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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