Status:
TERMINATED
Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
Lead Sponsor:
NImmune Biopharma
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.
Eligibility Criteria
Inclusion
- Key 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
Key Trial Info
Start Date :
May 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03870334
Start Date
May 5 2021
End Date
August 26 2022
Last Update
December 4 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Study Center
Tampa, Florida, United States, 33592