efficacy and safety of bbt-401-1s in ulcerative colitis

Conditions: Ulcerative Colitis

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

Keywords: pellino-1