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BBT-401-1S (800mg) for Ulcerative Colitis

Phase 2
Waitlist Available
Research Sponsored by Bridge Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 57
Awards & highlights

Study Summary

This study is evaluating whether a new drug can help people with ulcerative colitis.

Eligible Conditions
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 57
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57
Secondary outcome measures
Change From Baseline to Day 57 in Total Mayo Score
Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score at Day 57
Percentage of Participants Who Achieved an Endoscopic Remission at Day 57

Side effects data

From 2022 Phase 2 trial • 38 Patients • NCT04596293
8%
Bartholin's cyst removal
8%
Abscess drainage
8%
Pyrexia
8%
Nasopharyngitis
8%
Anaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo/Induction Phase
BBT-401-1S 800mg/Induction Phase
BBT-401-1S 1600mg/Induction Phase
Placebo/Extension Phase
BBT-401-1S 800mg/ Extension Phase
BBT-401-1S 1600mg/ Extension Phase

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: BBT-401-1S (800mg)Experimental Treatment1 Intervention
Induction Phase: BBT-401 800mg for 8 weeks Extension Phase: After 8 weeks, Participants who achieved clinical remission in the induction phase will continue the same treatment for 8 weeks Participants who did not achieve clinical remission in the induction phase will receive BBT-401 1600mg for 8 weeks
Group II: BBT-401-1S (1,600mg)Experimental Treatment1 Intervention
Induction Phase: BBT-401 1600mg for 8 weeks Extension Phase: After 8 weeks, Participants will continue the same treatment for 8 weeks
Group III: PlaceboPlacebo Group1 Intervention
Induction Phase: Placebo for 8 weeks Extension Phase: After 8 weeks, Participants who achieved clinical remission in the induction phase will continue the same treatment for 8 weeks Participants who did not achieve clinical remission in the induction phase will receive BBT-401 800mg for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BBT-401-1S or Placebo
2021
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

CovanceIndustry Sponsor
119 Previous Clinical Trials
12,778 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
2 Patients Enrolled for Ulcerative Colitis
Bridge Biotherapeutics, Inc.Lead Sponsor
9 Previous Clinical Trials
515 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
98 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis
2021. "Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04596293.
~10 spots leftby Apr 2025
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