Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
Completed · Phase 2 · Has a placebo group
Conditions studied: Ulcerative Colitis
In brief
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.
Key facts
- Study ID
- NCT03861143
- Run by
- NImmune Biopharma
- People needed
- 198
- Starts
- 2019-08-14
- Expected to finish
- 2021-06-17
- Last updated by the study team
- 2023-06-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Axis Clinical Trials — Los Angeles, California, United States
- Ventura Clinical Trials — Ventura, California, United States
- Clinical Research of California — Walnut Creek, California, United States
- Medycal Research Inc. — Brooksville, Florida, United States
- Invesclinic.U.S,LLC.FL — Fort Lauderdale, Florida, United States
- I.H.S Health LLC — Kissimmee, Florida, United States
- Smart Medical Research — Richmond Hill, New York, United States
- Invesclinic.U.S,LLC. — McAllen, Texas, United States
- Texas Gastroenterology Associates — Spring, Texas, United States
- Polyclinic and Daily hospital "Dr Al Tawil" — Sarajevo, Federation BiH, Bosnia and Herzegovina
- Cantonal Hospital Zenica, Gastroenterology — Zenica, Bosnia and Herzegovina
- Polyclinic Duvnjak — Zagreb, Croatia
- RIVERM E D Sp. zo.o. — Poznan, Greater Poland Voivodeship, Poland
- Centrum Badan Klinicznych PI-House Sp. z o.o. — Gdansk, Pomeranian Voivodeship, Poland
- Municipal Non-profit Enterprise "City Outpatient Clinic No 9 of Kharkiv City Council, Surgery department, Kharkiv — Kharkiv, Ukraine
- Multidisciplinary Medical Center of Odesa National Medical University, First Surgery Department ,Odesa National Medical University , Chair of General and Military Surgeon — Odesa, Ukraine
Full record on ClinicalTrials.gov
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