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

• ClinicalTrials.gov Identifier: NCT03800420
• Recruitment Status: Terminated
• First Posted: January 11, 2019
• Last Update Posted: October 19, 2020
• Sponsor: Bridge Biotherapeutics, Inc.
• Collaborator: KCRN Research, LLC
• Information provided by (Responsible Party): Bridge Biotherapeutics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ulcerative Colitis	Drug: Active group; Drug: Placebo group	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: April 22, 2019
• Actual Primary Completion Date: May 18, 2020
• Actual Study Completion Date: July 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: BBT-401-1S; BBT-401-1S, Oral capsule, QD	Drug: Active group; BBT-401-1S 12 weeks + Placebo 4 weeks
Placebo Comparator: Placebo; Placebo, Oral capsule, QD	Drug: Placebo group; Placebo 8 weeks + BBT-401-1S 8 weeks

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline in Total Mayo Score [ Time Frame: Week 8 ]

   Total Mayo Score (0-12): Sum of stool frequency (0-3), rectal bleeding (0-3), endoscopic findings (0-3), physician's global assessment (0-3).

   Lower values represent a better outcome.

Secondary Outcome Measures :

1. Change from Baseline in Partial Mayo Score [ Time Frame: Week 8 ]

   Partial Mayo Score (0-9): Sum of stool frequency (0-3), rectal bleeding (0-3), physician's global assessment (0-3).

   Lower values represent a better outcome.

2. Change from Baseline in Histologic Assessment of Endoscopic Biopsy [ Time Frame: Week 8 ]
   Biopsy samples will be assessed in Geboes score (0-6). Lower values represent a better outcome.
3. Change from Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8) [ Time Frame: Week 8 ]
   Lower values represent a better outcome.
4. Number and Severity of TEAEs [ Time Frame: up to 8 weeks after the last dose ]
   Assess the efficacy and safety of multiple oral doses of BBT-401- 1S in patients with active UC
5. Plasma Concentration of BBT- 401-1S [ Time Frame: Day 1, Week 4, Week 8 ]
   Assess the plasma concentration of multiple oral doses of BBT-401-1S in patients with active UC
6. Change from Baseline in Concentration of Serum CRP [ Time Frame: Week 8 ]
   Evaluate the effects of BBT-401-1S on biomarkers
7. Change from Baseline in Concentration of Fecal Calprotectin [ Time Frame: Week 8 ]
   Evaluate the effects of BBT-401-1S on biomarkers
8. Change from Baseline in Concentration of Fecal Lactoferrin [ Time Frame: Week 8 ]
   Evaluate the effects of BBT-401-1S on biomarkers

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
• Other clinically significant abnormal laboratory results at screening in the investigator's opinion
• History of any clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study
• Pregnancy or lactation
• Treatment with another investigational drug or other intervention within 30 days prior to screening

Contacts and Locations

Locations

United States, California

Site 03

Sacramento, California, United States, 95821

Site 01

Ventura, California, United States, 93003

United States, Florida

Site 11

Boca Raton, Florida, United States, 33487

Site 12

Pembroke Pines, Florida, United States, 33029

United States, Maryland

Site 04

Rockville, Maryland, United States, 20850

United States, Michigan

Site 10

Ann Arbor, Michigan, United States, 48109

United States, North Carolina

Site 02

Monroe, North Carolina, United States, 28112

United States, Tennessee

Site 08

Chattanooga, Tennessee, United States, 37421

United States, Texas

Site 05

Austin, Texas, United States, 78705

Site 13

McAllen, Texas, United States, 78503

United States, Washington

Site 09

Seattle, Washington, United States, 98195

Sponsors and Collaborators

Bridge Biotherapeutics, Inc.

KCRN Research, LLC

Investigators

• Study Director: Jeong-Hyun Ryou, M.D., Ph.D.; Bridge Biotherapeutics, Inc.

More Information

• Responsible Party: Bridge Biotherapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03800420
• Other Study ID Numbers: BBT401-UC-US02
• First Posted: January 11, 2019
• Last Update Posted: October 19, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bridge Biotherapeutics, Inc.:

Pellino-1

Additional relevant MeSH terms:

Colitis; Colitis, Ulcerative; Ulcer; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Inflammatory Bowel Diseases