Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
Public ClinicalTrials.gov record NCT03861143. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
Study identification
- NCT ID
- NCT03861143
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 198 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 14, 2019 (Actual)
- Primary completion
- Dec 10, 2020 (Actual)
- Completion
- Jun 17, 2021 (Actual)
- Last update posted
- Jun 29, 2023
2019 – 2021
United States locations
- U.S. sites
- 9
- U.S. states
- 4
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Axis Clinical Trials | Los Angeles | California | 90036 | — |
| Ventura Clinical Trials | Ventura | California | 93003 | — |
| Clinical Research of California | Walnut Creek | California | 94598 | — |
| Medycal Research Inc. | Brooksville | Florida | 34613 | — |
| Invesclinic.U.S,LLC.FL | Fort Lauderdale | Florida | 33308 | — |
| I.H.S Health LLC | Kissimmee | Florida | 34741 | — |
| Smart Medical Research | Richmond Hill | New York | 11102 | — |
| Invesclinic.U.S,LLC. | McAllen | Texas | 78503 | — |
| Texas Gastroenterology Associates | Spring | Texas | 77386 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03861143, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 29, 2023 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03861143 live on ClinicalTrials.gov.