A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension Phase
Overview
- Phase
- Phase 2
- Intervention
- BBT-401-1S or Placebo
- Conditions
- Ulcerative Colitis
- Sponsor
- Bridge Biotherapeutics, Inc.
- Enrollment
- 38
- Locations
- 29
- Primary Endpoint
- Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, of any race, ≥18 and ≤60 years of age.
- •Have been diagnosed with active UC for ≥3 months prior to Day 1, as determined by clinical and endoscopic evidence and documented in a histopathology evaluation.
- •Have a total Mayo score ≥6, an endoscopic subscore ≥2, rectal bleeding subscore ≥1, and a stool frequency subscore ≥1, regardless of standard of care history.
- •Able to comprehend and willing to voluntarily sign an ICF and to abide by the study restrictions.
Exclusion Criteria
- •Have received:
- •intravenous corticosteroids, rectally administered corticosteroids, or rectally administered 5-aminosalicylic acid within 3 weeks, or
- •Janus kinase (JAK) inhibitors within 2 weeks, or
- •cyclosporine, mycophenolate, tacrolimus, or methotrexate within 5 weeks, or
- •anti-TNF-α biologics within 9 weeks, or
- •any other biologics (including ustekinumab and vedolizumab) for the treatment of UC within 12 weeks.
- •Have received orally administered azathioprine or 6-mercaptopurine that has been stable for \<8 weeks.
- •Have received orally administered 5-aminosalicylic acid, sulphasalazine, or low-dose corticosteroids (prednisolone ≤20 mg/day or equivalent) that have been stable for \<5 weeks.
- •Have received any other concomitant medications for UC that have been stable (ie, have not started dosing with a new drug or had a change to their dosing regimen) for \<7 days or 5 half-lives, whichever is longer.
- •Have Crohn's disease, indeterminate colitis, ischaemic colitis, fulminant colitis, toxic megacolon, chronic (as determined by the investigator) pancolitis, confined proctitis (distal, ≤15 cm), or symptomatic intestinal stenosis.
Arms & Interventions
BBT-401-1S (800mg)
* 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
Intervention: BBT-401-1S or Placebo
BBT-401-1S (1,600mg)
* Induction Phase: BBT-401 1600mg for 8 weeks * Extension Phase: After 8 weeks, Participants will continue the same treatment for 8 weeks
Intervention: BBT-401-1S or Placebo
Placebo
* 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
Intervention: BBT-401-1S or Placebo
Outcomes
Primary Outcomes
Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57
Time Frame: Day 57
Clinical Response was defined as a Total Mayo Score, as measured by a reduction of ≥ 3 points and ≥ 30% improvement from baseline of Total Mayo Score, which included a decrease in rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore ≤ 1
Secondary Outcomes
- Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score at Day 57(Day 57)
- Percentage of Participants Who Achieved an Endoscopic Remission at Day 57(Day 57)
- Change From Baseline to Day 57 in Total Mayo Score(Baseline, Day 57)