Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
NCT ID: NCT03861143
Last Updated: 2023-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
198 participants
INTERVENTIONAL
2019-08-14
2021-06-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BT-11 low-dose (440 mg)
Oral, once daily tablet
BT-11 (440 mg)
Oral, once daily tablet
BT-11 high-dose (880 mg)
Oral, once daily tablet
BT-11 (880 mg)
Oral, once daily tablet
Placebo
Oral, once daily tablet
Placebo
Oral, once daily tablet
Interventions
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BT-11 (440 mg)
Oral, once daily tablet
BT-11 (880 mg)
Oral, once daily tablet
Placebo
Oral, once daily tablet
Eligibility Criteria
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Inclusion Criteria
2. . Diagnosis of UC for at least 3 months prior to screening.
3. . UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES 2 (confirmed by central reader).
4. . Able to participate fully in all aspects of this clinical trial.
5. . Written informed consent must be obtained and documented.
Exclusion Criteria
2. . Modified Truelove and Witts criteria (2: 6 bloody stools per day and one or more of the following: pulse \> 90 bpm, temperature \> 37.8°C, hemoglobin \< 10.5 g/dl, or hs-CRP \> 30 mg/I).
3. . Disease activity limited to distal 15 cm (proctitis).
4. . Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine \[6-MP\]) within 25 days prior to randomization.
5. . Unable to attend study visits or comply with procedures.
6. . Concurrent participation in any other interventional study.
7. . Prior enrollment in the current study and had received study treatment.
18 Years
65 Years
ALL
No
Sponsors
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NImmune Biopharma
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BT-11-201
Identifier Type: -
Identifier Source: org_study_id
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