NCT03870334TerminatedPhase 2
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
NImmune Biopharma1 site in 1 country27 target enrollmentStarted: May 5, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Clinical Remission Rate
Study Overview
Brief Summary
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects aged 18 to 75 years with a diagnosis of CD for at least 3 months;
- •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:
- •Ulcerative colitis;
- •Known current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.
Exclusion Criteria
- Not provided
Arms & Interventions
BT-11 880 mg
Experimental
Oral once daily tablet
Intervention: BT-11 880 mg (Drug)
Placebo
Placebo Comparator
Oral once daily tablet
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Clinical Remission Rate
Time Frame: 12 weeks
Clinical remission defined by CDAI score \<150.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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