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

Bridge Biotherapeutics, Inc.11 sites in 1 country16 target enrollmentApril 22, 2019

ConditionsUlcerative Colitis

InterventionsBBT-401-1S first and then Placebo Placebo first and then BBT-401-1S

DrugsBBT-401-1S first and then Placebo Placebo first and then BBT-401-1S

Overview

Phase: Phase 2
Intervention: BBT-401-1S first and then Placebo
Conditions: Ulcerative Colitis
Sponsor: Bridge Biotherapeutics, Inc.
Enrollment: 16
Locations: 11
Primary Endpoint: Change From Baseline in Total Mayo Score
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 22, 2019

End Date

July 31, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bridge Biotherapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provision of signed and dated informed consent form (ICF)
•Stated willingness to comply with all study procedures and availability for the duration of the study
•Male or female, aged \>=18 years
•Diagnosed with active UC for at least 3 months prior to screening
•Total Mayo score \>=5 and Endoscopic sub-score \>=1
•Stable dosing regimens of oral drugs (if currently administered) as follows: 5-ASA or sulfasalazine at a stable dose for at least 4 weeks, purine analogues (azathioprine, mercaptopurine, thiopurines) or methotrexate at a stable dose for at least 12 weeks, and low-dose oral corticosteroid (up to 20 mg prednisone/day or equivalent) for at least 4 weeks prior to the first dose of study treatment. Doses of oral drugs must remain stable until the end of study treatment (with possible exception for tapering steroid dose after 8 weeks)
•For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the last dose
•For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 3 months after the last dose

Exclusion Criteria

•Use of anti-TNF-a biologics or any other biologics for treatment of UC within 60 days prior to randomization.
•Any rectal therapy for treatment of UC or intravenous corticosteroids within 2 weeks prior to randomization.
•Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
•Previous extensive colonic resection (subtotal or total colectomy)
•Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
•Evidence of or treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to randomization
•Active infection with the HIV or Hepatitis B or C viruses
•Clinically significant active extra-intestinal infection (e.g., pneumonia, pyelonephritis)
•Clinically significant abnormal vital signs, physical examination or 12-lead electrocardiogram (ECG) at screening or baseline
•Clinically significant abnormal results of liver function tests (ALT/AST, bilirubin and alkaline phosphatase) \> 2X the upper limit of normal (ULN) at screening

Arms & Interventions

BBT-401-1S

BBT-401-1S, Oral capsule, QD

Intervention: BBT-401-1S first and then Placebo

Placebo

Placebo, Oral capsule, QD

Intervention: Placebo first and then BBT-401-1S

Outcomes

Primary Outcomes

Change From Baseline in Total Mayo Score

Time Frame: Week 8

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.

Secondary Outcomes

Change From Baseline in Partial Mayo Score(Week 8)
Change From Baseline in Histologic Assessment of Endoscopic Biopsy(Week 8)
Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8)(Week 8)
Number and Severity of TEAEs(up to 8 weeks after the last dose)
Plasma Concentration of BBT- 401-1S(Day 1, Week 4, Week 8)
Change From Baseline in Concentration of Serum CRP(Week 8)
Change From Baseline in Concentration of Fecal Calprotectin(Week 8)
Change From Baseline in Concentration of Fecal Lactoferrin(Week 8)