Phase 2
Completed N=198
Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
Source: ClinicalTrials.gov NCT03861143 ↗Enrolled (actual)
198
Serious AEs
4.0%
Results posted
Nov 2022
Primary outcomePrimary: Clinical Remission — 30.3; 31.8; 22.7 percentage of participants
Summary
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Remission |
30.3; 31.8; 22.7 | — |
Eligibility Criteria
Key Inclusion Criteria
- . Male and female subjects aged 18 to 75 years, inclusive.
- . Diagnosis of UC for at least 3 months prior to screening.
- . UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES 2 (confirmed by central reader).
- . Able to participate fully in all aspects of this clinical trial.
- . Written informed consent must be obtained and documented.
Key Exclusion Criteria
- . A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with CD.
- . Modified Truelove and Witts criteria (2: 6 bloody stools per day and one or more of the following: pulse > 90 bpm, temperature > 37.8°C, hemoglobin 30 mg/I).
- . Disease activity limited to distal 15 cm (proctitis).
- . Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine [6-MP]) within 25 days prior to randomization.
- . Unable to attend study visits or comply with procedures.
- . Concurrent participation in any other interventional study.
- . Prior enrollment in the current study and had received study treatment.
Data sourced from ClinicalTrials.gov (NCT03861143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.