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NCT03850509 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Oral OPS-2071 in Participants With Crohn's Disease Showing Symptoms of Active Inflammation
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT03850509: Clinical Trial Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03850509 is a Phase 2 study that was terminated before completion, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03850509, a Phase 2 study, was terminated before completion, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effects and safety of OPS-2071 (150, 300, or 600 mg twice a day \[BID\]) versus placebo, as add-on therapy in participants with Crohn's disease who show symptoms of active inflammation despite being on ongoing treatment.
Primary Outcome
Clinical remission was defined as CDAI score \<150 at Week 12. The CDAI evaluated severity of signs and symptoms of Chron's Disease. Some components of the CDAI were reported by the investigator (physical examination for the presence of an abdominal mass and extraintestinal complications, laboratory results for hematocrit levels, and weight) while other components were determined with data collected in a participant diary (number of liquid or soft stools, number of antidiarrheal medications, abd
Interventions
- DRUG Placebo
- DRUG OPS-2071
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2020-02-25 |
| Est. Completion | 2020-05-22 |
| Phase | Phase 2 |
Why NCT03850509 stopped before completion
NCT03850509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03850509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03850509 about?
NCT03850509 is a clinical study titled "Efficacy and Safety of Oral OPS-2071 in Participants With Crohn's Disease Showing Symptoms of Active Inflammation". The purpose of this study is to evaluate the effects and safety of OPS-2071 (150, 300, or 600 mg twice a day \[BID\]) versus placebo, as add-on therapy in participants with Crohn's disease who show symptoms of active inflammation despite being on ongoing treatment.
What is the current status of trial NCT03850509?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2020-02-25. Estimated completion is 2020-05-22.
What interventions are being tested in trial NCT03850509?
The interventions under investigation include: Placebo (DRUG), OPS-2071 (DRUG).
Who is sponsoring clinical trial NCT03850509?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03850509's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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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