Trial Outcomes & Findings for Efficacy and Safety of Oral BT-11 in Ulcerative Colitis (NCT NCT03861143)
NCT ID: NCT03861143
Last Updated: 2023-06-29
Results Overview
Clinical remission rate at Week 12, defined using the 3-component modified Mayo Score as a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and an endoscopic subscore of 0 or 1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
198 participants
Primary outcome timeframe
Week 12
Results posted on
2023-06-29
Participant Flow
Participant milestones
| Measure |
BT-11 Low-dose (440 mg)
Oral, once daily tablet
|
BT-11 High-dose (880 mg)
Oral, once daily tablet
|
Placebo
Oral, once daily tablet
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
66
|
|
Overall Study
COMPLETED
|
62
|
59
|
58
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
BT-11 Low-dose (440 mg)
n=66 Participants
Oral, once daily tablet
|
BT-11 High-dose (880 mg)
n=66 Participants
Oral, once daily tablet
|
Placebo
n=66 Participants
Oral, once daily tablet
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.1 years
STANDARD_DEVIATION 14.9 • n=93 Participants
|
43.3 years
STANDARD_DEVIATION 14.9 • n=4 Participants
|
43.3 years
STANDARD_DEVIATION 14.5 • n=27 Participants
|
43.2 years
STANDARD_DEVIATION 14.7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
93 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
105 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
194 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: ITT
Clinical remission rate at Week 12, defined using the 3-component modified Mayo Score as a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and an endoscopic subscore of 0 or 1.
Outcome measures
| Measure |
BT-11 Low-dose (440 mg)
n=66 Participants
Oral, once daily tablet
|
BT-11 High-dose (880 mg)
n=66 Participants
Oral, once daily tablet
|
Placebo
n=66 Participants
Oral, once daily tablet
|
|---|---|---|---|
|
Clinical Remission
|
30.3 percentage of participants
|
31.8 percentage of participants
|
22.7 percentage of participants
|
Adverse Events
BT-11 Low-dose (440 mg)
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
BT-11 High-dose (880 mg)
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BT-11 Low-dose (440 mg)
n=66 participants at risk
Oral, once daily tablet
|
BT-11 High-dose (880 mg)
n=66 participants at risk
Oral, once daily tablet
|
Placebo
n=66 participants at risk
Oral, once daily tablet
|
|---|---|---|---|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.00%
0/66 • 15 months
|
1.5%
1/66 • 15 months
|
1.5%
1/66 • 15 months
|
|
Gastrointestinal disorders
Proctitis
|
1.5%
1/66 • 15 months
|
0.00%
0/66 • 15 months
|
0.00%
0/66 • 15 months
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/66 • 15 months
|
1.5%
1/66 • 15 months
|
0.00%
0/66 • 15 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/66 • 15 months
|
0.00%
0/66 • 15 months
|
1.5%
1/66 • 15 months
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/66 • 15 months
|
0.00%
0/66 • 15 months
|
1.5%
1/66 • 15 months
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
1.5%
1/66 • 15 months
|
0.00%
0/66 • 15 months
|
0.00%
0/66 • 15 months
|
|
Investigations
Coronavirus Test Positive
|
0.00%
0/66 • 15 months
|
1.5%
1/66 • 15 months
|
0.00%
0/66 • 15 months
|
Other adverse events
| Measure |
BT-11 Low-dose (440 mg)
n=66 participants at risk
Oral, once daily tablet
|
BT-11 High-dose (880 mg)
n=66 participants at risk
Oral, once daily tablet
|
Placebo
n=66 participants at risk
Oral, once daily tablet
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
2/66 • 15 months
|
7.6%
5/66 • 15 months
|
0.00%
0/66 • 15 months
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
15.2%
10/66 • 15 months
|
12.1%
8/66 • 15 months
|
9.1%
6/66 • 15 months
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
3/66 • 15 months
|
0.00%
0/66 • 15 months
|
1.5%
1/66 • 15 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/66 • 15 months
|
4.5%
3/66 • 15 months
|
0.00%
0/66 • 15 months
|
|
Infections and infestations
Corona Virus Infection
|
1.5%
1/66 • 15 months
|
1.5%
1/66 • 15 months
|
6.1%
4/66 • 15 months
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
1.5%
1/66 • 15 months
|
4.5%
3/66 • 15 months
|
0.00%
0/66 • 15 months
|
|
Nervous system disorders
Headache
|
0.00%
0/66 • 15 months
|
1.5%
1/66 • 15 months
|
4.5%
3/66 • 15 months
|
|
General disorders
Other
|
9.1%
6/66 • 15 months
|
12.1%
8/66 • 15 months
|
19.7%
13/66 • 15 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place