Ulcerative Colitis
Conditions
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.
Interventions
DRUGBT-11 (440 mg)
Oral, once daily tablet
DRUGBT-11 (880 mg)
Oral, once daily tablet
DRUGPlacebo
Oral, once daily tablet
Sponsors
NImmune Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. . Male and female subjects aged 18 to 75 years, inclusive. 2. . Diagnosis of UC for at least 3 months prior to screening. 3. . UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES 2 (confirmed by central reader). 4. . Able to participate fully in all aspects of this clinical trial. 5. . Written informed consent must be obtained and documented. Key
Exclusion criteria
1. . A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with CD. 2. . 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). 3. . Disease activity limited to distal 15 cm (proctitis). 4. . Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine \[6-MP\]) within 25 days prior to randomization. 5. . Unable to attend study visits or comply with procedures. 6. . Concurrent participation in any other interventional study. 7. . Prior enrollment in the current study and had received study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Remission | Week 12 | 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. |
Countries
Bosnia and Herzegovina, Croatia, Poland, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BT-11 Low-dose (440 mg) Oral, once daily tablet | 66 |
| BT-11 High-dose (880 mg) Oral, once daily tablet | 66 |
| Placebo Oral, once daily tablet | 66 |
| Total | 198 |
Baseline characteristics
| Characteristic | BT-11 Low-dose (440 mg) | BT-11 High-dose (880 mg) | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 43.1 years STANDARD_DEVIATION 14.9 | 43.3 years STANDARD_DEVIATION 14.9 | 43.3 years STANDARD_DEVIATION 14.5 | 43.2 years STANDARD_DEVIATION 14.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 65 Participants | 65 Participants | 64 Participants | 194 Participants |
| Sex: Female, Male Female | 40 Participants | 22 Participants | 31 Participants | 93 Participants |
| Sex: Female, Male Male | 26 Participants | 44 Participants | 35 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 66 | 0 / 66 |
| other Total, other adverse events | 23 / 66 | 29 / 66 | 27 / 66 |
| serious Total, serious adverse events | 2 / 66 | 3 / 66 | 3 / 66 |
Outcome results
Primary
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.
Time frame: Week 12
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BT-11 Low-dose (440 mg) | Clinical Remission | 30.3 percentage of participants |
| BT-11 High-dose (880 mg) | Clinical Remission | 31.8 percentage of participants |
| Placebo | Clinical Remission | 22.7 percentage of participants |