NCT03800420

Efficacy and Safety of BBT-401-1S in Ulcerative Colitis

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Bridge Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	BBT-401-1S first and then Placebo	Total 16 week treatment period: The subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.
DRUG	Placebo first and then BBT-401-1S	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.

Timeline

• Start date: 2019-04-22
• Primary completion: 2020-05-18
• Completion: 2020-07-31
• First posted: 2019-01-11
• Last updated: 2022-03-21
• Results posted: 2022-03-21

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study