Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

Study Overview
=================
Brief 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.

Official Title
-----------------
A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: BT-11 (440 mg)
* Drug: BT-11 (880 mg)
* Drug: Placebo


Participation Criteria
=================
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 < 10.5 g/dl, or hs-CRP > 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BT-11 low-dose (440 mg)<br>Oral, once daily tablet | Drug: BT-11 (440 mg)<br>* Oral, once daily tablet<br>|
| Experimental: BT-11 high-dose (880 mg)<br>Oral, once daily tablet | Drug: BT-11 (880 mg)<br>* Oral, once daily tablet<br>|
| Placebo Comparator: Placebo<br>Oral, once daily tablet | Drug: Placebo<br>* Oral, once daily tablet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission | Clinical remission rate at Week 12, defined using the 3-component modified Mayo Score as a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and an endoscopic subscore of 0 or 1. | Week 12 |