Trial Outcomes & Findings for Efficacy and Safety of BBT-401-1S in Ulcerative Colitis (NCT NCT03800420)
NCT ID: NCT03800420
Last Updated: 2022-03-21
Results Overview
The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 12 points. The Total Mayo score consists of 4 subscores( Stool frequency, Rectal bleeding, Findings of endoscopy, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Week 8
Results posted on
2022-03-21
Participant Flow
Participant milestones
| Measure |
BBT-401-1S
BBT-401-1S, Oral capsule, QD
BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.
|
Placebo
Placebo, Oral capsule, QD
Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
4
|
|
Overall Study
COMPLETED
|
10
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
BBT-401-1S
n=12 Participants
BBT-401-1S, Oral capsule, QD
BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.
|
Placebo
n=4 Participants
Placebo, Oral capsule, QD
Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Mixed (White/Black)
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: No data was collected for this outcome measure due to early termination of study.
The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 12 points. The Total Mayo score consists of 4 subscores( Stool frequency, Rectal bleeding, Findings of endoscopy, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 8Population: No data was collected for this outcome measure due to early termination of study.
The Partial Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 9 points. The Partial Mayo score consists of 3 subscores( Stool frequency, Rectal bleeding, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 8Population: No data was collected for this outcome measure due to early termination of study.
Histological assessment of endoscopic biopsy is an appropriate method for evaluating mucosal healing (Carbonnel et al, 1994).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 8Population: No data was collected for this outcome measure due to early termination of study.
The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is the first validated index for the assessment of overall endoscopic activity. The model incorporates the vascular pattern score(0-2), the presence of bleeding score(0-3) and the presence of erosions and ulcers score (0-3). Higher score of the sum of these subscore indicates more severe disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 8 weeks after the last doseTreatment Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug.
Outcome measures
| Measure |
BBT-401-1S First and Then Placebo
n=12 Participants
Total 16 weeks
First 12 weeks, BBT-401-1S, Oral capsule, QD. Followed by 4 weeks Placebo, Oral capsule, QD.
|
Placebo First and Then BBT-401-1S
n=4 Participants
Total 16 weeks First Placebo, 8 weeks Oral capsule, QD Followed by 8 weeks BBT-401-1S, Oral capsule, QD
|
|---|---|---|
|
Number and Severity of TEAEs
Abdominal pain
|
1 Number of events
|
0 Number of events
|
|
Number and Severity of TEAEs
Gastrointestinal tract mucosal pigmentation
|
1 Number of events
|
0 Number of events
|
|
Number and Severity of TEAEs
Haemorrhoids
|
1 Number of events
|
0 Number of events
|
|
Number and Severity of TEAEs
Melaena
|
1 Number of events
|
0 Number of events
|
|
Number and Severity of TEAEs
Nasopharyngitis
|
1 Number of events
|
0 Number of events
|
|
Number and Severity of TEAEs
Onychomycosis
|
1 Number of events
|
0 Number of events
|
|
Number and Severity of TEAEs
Condition aggravated
|
1 Number of events
|
0 Number of events
|
SECONDARY outcome
Timeframe: Day 1, Week 4, Week 8Population: All samples were below LLOQ and therefore plasma concentrations could not be calculated, (Plasma PK samples of one active patient were not collected.)
Analysis of Plasma Pharmacokinetics for BBT- 401 -1S
Outcome measures
| Measure |
BBT-401-1S First and Then Placebo
n=11 Participants
Total 16 weeks
First 12 weeks, BBT-401-1S, Oral capsule, QD. Followed by 4 weeks Placebo, Oral capsule, QD.
|
Placebo First and Then BBT-401-1S
n=4 Participants
Total 16 weeks First Placebo, 8 weeks Oral capsule, QD Followed by 8 weeks BBT-401-1S, Oral capsule, QD
|
|---|---|---|
|
Plasma Concentration of BBT- 401-1S
|
NA ng/ml
Samples were below the LLOQ
|
NA ng/ml
Samples were below the LLOQ
|
SECONDARY outcome
Timeframe: Week 8Population: No data was collected for this outcome measure due to early termination of study.
Widely used serum indicator of inflammation in Ulcerative Colitis(UC).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 8Population: No data was collected for this outcome measure due to early termination of study.
Reliable surrogate marker for disease activity in Ulcerative Colitis (UC).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 8Population: No data was collected for this outcome measure due to early termination of study.
A stool (fecal) test that is used to detect inflammation in the intestines.
Outcome measures
Outcome data not reported
Adverse Events
BBT-401-1S
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BBT-401-1S
n=12 participants at risk
BBT-401-1S, Oral capsule, QD
BBT-401-1S first and then Placebo: Total 16 week treatment period: Subject takes BBT-401-1S and Placebo. If the subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.
|
Placebo
n=4 participants at risk
Placebo, Oral capsule, QD
Placebo first and then BBT-401-1S: Total 16 week treatment period: Subject take BBT-401-1S and Placebo. If the subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
16.7%
2/12 • Number of events 2 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
0.00%
0/4 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
0.00%
0/4 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • Number of events 1 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
0.00%
0/4 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
|
Gastrointestinal disorders
Gastrointestinal tract mucosal pigmentation
|
8.3%
1/12 • Number of events 1 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
0.00%
0/4 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • Number of events 1 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
0.00%
0/4 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
|
Gastrointestinal disorders
Melaena
|
8.3%
1/12 • Number of events 1 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
0.00%
0/4 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
2/12 • Number of events 2 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
25.0%
1/4 • Number of events 1 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
|
Infections and infestations
Onychomycosis
|
8.3%
1/12 • Number of events 1 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
0.00%
0/4 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
|
General disorders
Condition aggravated
|
8.3%
1/12 • Number of events 1 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
0.00%
0/4 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
|
Investigations
Faecal calprotectin increased
|
8.3%
1/12 • Number of events 1 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
0.00%
0/4 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
|
Investigations
Stool analysis abnormal
|
8.3%
1/12 • Number of events 1 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
0.00%
0/4 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
0.00%
0/4 • 1 year
TEAEs by MedDRA SOC and PT in study BBT401-UC-US02 . Note 1: A Treatment-Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug. Note 2: Subjects with one or more adverse events within a level of MedDRA term is counted only once in that level; and percentages are based on the group totals in the column headers.
|
Additional Information
Clinical Trials_inquiries
Clinical Trials_inquiries
Phone: +82-31-8092-3280
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution and Investigator shall not publish the results of this study without the prior written consent of sponsor. As used herein, the term "publish" shall include oral presentations, written abstracts, written manuscripts, etc.
- Publication restrictions are in place
Restriction type: OTHER