Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03800420|
Recruitment Status : Terminated (to carry out the rest of the study with new CRO and modified protocol as a multi-regional study.)
First Posted : January 11, 2019
Last Update Posted : July 30, 2021
This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis.
This study consists of three cohorts with 16-week treatment period per cohort that will be conducted sequentially.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: BBT-401-1S Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis|
|Actual Study Start Date :||April 22, 2019|
|Actual Primary Completion Date :||May 18, 2020|
|Actual Study Completion Date :||July 31, 2020|
BBT-401-1S, Oral capsule, QD
Total 16 week treatment period: BBT-401-1S, QD for the first 12 weeks and then placebo, QD for the last 4 weeks
Placebo Comparator: Placebo
Placebo, Oral capsule, QD
Total 16 week treatment period: Placebo, QD for the first 8 weeks and then BBT-401-1S, QD for the last 8 weeks
- Change from Baseline in Total Mayo Score [ Time Frame: Week 8 ]
Total Mayo Score (0-12): Sum of stool frequency (0-3), rectal bleeding (0-3), endoscopic findings (0-3), physician's global assessment (0-3).
Lower values represent a better outcome.
- Change from Baseline in Partial Mayo Score [ Time Frame: Week 8 ]
Partial Mayo Score (0-9): Sum of stool frequency (0-3), rectal bleeding (0-3), physician's global assessment (0-3).
Lower values represent a better outcome.
- Change from Baseline in Histologic Assessment of Endoscopic Biopsy [ Time Frame: Week 8 ]Biopsy samples will be assessed in Geboes score (0-6). Lower values represent a better outcome.
- Change from Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8) [ Time Frame: Week 8 ]Lower values represent a better outcome.
- Number and Severity of TEAEs [ Time Frame: up to 8 weeks after the last dose ]Assess the efficacy and safety of multiple oral doses of BBT-401- 1S in patients with active UC
- Plasma Concentration of BBT- 401-1S [ Time Frame: Day 1, Week 4, Week 8 ]Assess the plasma concentration of multiple oral doses of BBT-401-1S in patients with active UC
- Change from Baseline in Concentration of Serum CRP [ Time Frame: Week 8 ]Evaluate the effects of BBT-401-1S on biomarkers
- Change from Baseline in Concentration of Fecal Calprotectin [ Time Frame: Week 8 ]Evaluate the effects of BBT-401-1S on biomarkers
- Change from Baseline in Concentration of Fecal Lactoferrin [ Time Frame: Week 8 ]Evaluate the effects of BBT-401-1S on biomarkers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800420
|United States, California|
|Sacramento, California, United States, 95821|
|Ventura, California, United States, 93003|
|United States, Florida|
|Boca Raton, Florida, United States, 33487|
|Pembroke Pines, Florida, United States, 33029|
|United States, Maryland|
|Rockville, Maryland, United States, 20850|
|United States, Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, North Carolina|
|Monroe, North Carolina, United States, 28112|
|United States, Tennessee|
|Chattanooga, Tennessee, United States, 37421|
|United States, Texas|
|Austin, Texas, United States, 78705|
|McAllen, Texas, United States, 78503|
|United States, Washington|
|Seattle, Washington, United States, 98195|