Crohn's Disease
Conditions
Brief summary
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.
Interventions
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 induction study. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 induction compared to placebo in subjects with moderate to severe CD. Approximately 100 sites will participate from Europe and the USA. A total of 150 subjects with moderate to severe CD (CDAI Score 220-450 and a Simplified Endoscopic Index of Severity of Crohn's Disease (SES-CD) SCORED ≥ 6 (≥ 4 for isolated ileitis) will be randomized in a 1:1 ratio to receive BT-11 1,000 mg or placebo. Each of the treatment arms will comprise 75 subjects. The randomization will be stratified by prior exposure to biologic therapy for CD (yes/no) and corticosteroid use at baseline (yes/no). The study consists of a 28-day screening period, a 12-week induction phase, and a 2-week post-treatment safety follow-up period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months; 2. Moderately to severely active CD as defined by: a CDAI score of 220 450, and an SES-CD scored ≥ 6 ( ≥ 4 for isolated ileitis) (centrally read); Key
Exclusion criteria
1. Ulcerative colitis; 2. Known current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Remission Rate | 12 weeks | Clinical remission defined by CDAI score \<150. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BT-11 880 mg Oral once daily tablet
BT-11 880 mg: Oral once daily tablet | 12 |
| Placebo Oral once daily tablet
Placebo: Oral once daily tablet | 11 |
| Total | 23 |
Baseline characteristics
| Characteristic | BT-11 880 mg | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 11 Participants | 23 Participants |
| Age, Continuous | 37.1 years STANDARD_DEVIATION 9.7 | 39.9 years STANDARD_DEVIATION 13.7 | 38.4 years STANDARD_DEVIATION 11.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 11 |
| other Total, other adverse events | 7 / 12 | 7 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 |
Outcome results
Primary
Clinical Remission Rate
Clinical remission defined by CDAI score \<150.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BT-11 880 mg | Clinical Remission Rate | 3 Participants |
| Placebo | Clinical Remission Rate | 1 Participants |