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

NCT03800420 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: BBT401-UC-US02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 11

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.

Conditions

Ulcerative Colitis

Keywords

Pellino-1

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total Mayo Score

  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.

  Week 8

Secondary Outcomes (8)

• 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

Study Arms (2)

BBT-401-1S

EXPERIMENTAL

BBT-401-1S, Oral capsule, QD

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

Placebo

PLACEBO COMPARATOR

Placebo, Oral capsule, QD

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

Interventions

BBT-401-1S first and then Placebo DRUG

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

BBT-401-1S

Placebo first and then BBT-401-1S DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bridge Biotherapeutics, Inc.: lead
• KCRN Research, LLC: collaborator

Study Sites (11)

Site 03

Sacramento, California, 95821, United States

Location

Site 01

Ventura, California, 93003, United States

Location

Site 11

Boca Raton, Florida, 33487, United States

Location

Site 12

Pembroke Pines, Florida, 33029, United States

Location

Site 04

Rockville, Maryland, 20850, United States

Location

Site 10

Ann Arbor, Michigan, 48109, United States

Location

Site 02

Monroe, North Carolina, 28112, United States

Location

Site 08

Chattanooga, Tennessee, 37421, United States

Location

Site 05

Austin, Texas, 78705, United States

Location

Site 13

McAllen, Texas, 78503, United States

Location

Site 09

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Clinical Trials_inquiries
• Organization: Clinical Trials_inquiries

clinicaltrials.gov_inquiries@bridgebiorx.com

+82-31-8092-3280

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 11, 2019
• Study Start: April 22, 2019
• Primary Completion: May 18, 2020
• Study Completion: July 31, 2020
• Last Updated: March 21, 2022
• Results First Posted: March 21, 2022

Record last verified: 2022-02

Locations

US (11)