Status:
TERMINATED
Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
Lead Sponsor:
Bridge Biotherapeutics, Inc.
Collaborating Sponsors:
KCRN Research, LLC
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03800420
Start Date
April 22 2019
End Date
July 31 2020
Last Update
March 21 2022
Active Locations (11)
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1
Site 03
Sacramento, California, United States, 95821
2
Site 01
Ventura, California, United States, 93003
3
Site 11
Boca Raton, Florida, United States, 33487
4
Site 12
Pembroke Pines, Florida, United States, 33029