Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: BBT-401-1S first and then Placebo; Placebo first and then BBT-401-1S
Intervention description: Total 16 week treatment period: The subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pellino-1

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.
    

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

          -  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