A Phase 2 interventional study of BBT-401-1S first and then Placebo and Placebo first and then BBT-401-1S in Ulcerative Colitis, sponsored by Bridge Biotherapeutics, Inc.. Terminated at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-21.
Sponsored by Bridge Biotherapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 16 is below the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Bridge Biotherapeutics, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
BBT-401-1S, Oral capsule, QD
Drug: BBT-401-1S first and then Placebo
Placebo, Oral capsule, QD
Drug: Placebo first and then BBT-401-1S
Total 16 week treatment period: The subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.
Total 16 week treatment period: The subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.
Change From Baseline in Total Mayo Score
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.
Time frame: Week 8
Change From Baseline in Partial Mayo Score
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.
Time frame: Week 8
Change From Baseline in Histologic Assessment of Endoscopic Biopsy
Histological assessment of endoscopic biopsy is an appropriate method for evaluating mucosal healing (Carbonnel et al, 1994).
Time frame: Week 8
Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8)
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.
Time frame: Week 8
Number and Severity of TEAEs
Treatment Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug.
Time frame: up to 8 weeks after the last dose
Plasma Concentration of BBT- 401-1S
Analysis of Plasma Pharmacokinetics for BBT- 401 -1S
Time frame: Day 1, Week 4, Week 8
Change From Baseline in Concentration of Serum CRP
Widely used serum indicator of inflammation in Ulcerative Colitis(UC).
Time frame: Week 8
Change From Baseline in Concentration of Fecal Calprotectin
Reliable surrogate marker for disease activity in Ulcerative Colitis (UC).
Time frame: Week 8
Change From Baseline in Concentration of Fecal Lactoferrin
A stool (fecal) test that is used to detect inflammation in the intestines.
Time frame: Week 8
| Milestone | BBT-401-1S | Placebo |
|---|---|---|
| Started | 12 | 4 |
| Completed | 10 | 3 |
| Not completed | 2 | 1 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Histological assessment of endoscopic biopsy is an appropriate method for evaluating mucosal healing (Carbonnel et al, 1994).
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Treatment Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug.
| Number of events | BBT-401-1S | Placebo |
|---|---|---|
| Abdominal pain | 1 | 0 |
| Gastrointestinal tract mucosal pigmentation | 1 | 0 |
| Haemorrhoids | 1 | 0 |
| Melaena | 1 | 0 |
| Nasopharyngitis | 1 | 0 |
| Onychomycosis | 1 | 0 |
| Condition aggravated | 1 | 0 |
Analysis of Plasma Pharmacokinetics for BBT- 401 -1S
| ng/ml | BBT-401-1S | Placebo |
|---|---|---|
| Plasma Concentration of BBT- 401-1S | NA (NA to NA) | NA (NA to NA) |
Widely used serum indicator of inflammation in Ulcerative Colitis(UC).
No measurements were reported for this outcome.
Reliable surrogate marker for disease activity in Ulcerative Colitis (UC).
No measurements were reported for this outcome.
A stool (fecal) test that is used to detect inflammation in the intestines.
No measurements were reported for this outcome.
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BBT-401-1S | 0/12 (0%) | 0/12 (0%) | 8/12 (66.7%) |
| Placebo | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| Event | BBT-401-1S | Placebo |
|---|---|---|
| NasopharyngitisInfections and infestations | 2/12 | 1/4 |
| Colitis ulcerativeGastrointestinal disorders | 2/12 | 0/4 |
| Abdominal painGastrointestinal disorders | 1/12 | 0/4 |
| FlatulenceGastrointestinal disorders | 1/12 | 0/4 |
| Gastrointestinal tract mucosal pigmentationGastrointestinal disorders | 1/12 | 0/4 |
| HaemorrhoidsGastrointestinal disorders | 1/12 | 0/4 |
| MelaenaGastrointestinal disorders | 1/12 | 0/4 |
| OnychomycosisInfections and infestations | 1/12 | 0/4 |
| Condition aggravatedGeneral disorders | 1/12 | 0/4 |
| Faecal calprotectin increasedInvestigations | 1/12 | 0/4 |
subjects who were randomized
| Age, Categorical(Participants) | BBT-401-1S | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 4 | 15 |
| >=65 years | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | BBT-401-1S | Placebo | Total |
|---|---|---|---|
| Female | 4 | 1 | 5 |
| Male | 8 | 3 | 11 |
| Race/Ethnicity, Customized(Participants) | BBT-401-1S | Placebo | Total |
|---|---|---|---|
| Race — White | 11 | 4 | 15 |
| Race — Mixed (White/Black) | 1 | 0 | 1 |
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This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Bridge Biotherapeutics, Inc.