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

NCT03800420 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-03-21

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • KCRN Research, LLC

    collaborator INDUSTRY

  • Bridge Biotherapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2020-05-18
Completion
2020-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03800420 on ClinicalTrials.gov