Study Stopped
Decision by Landos Biopharma (not related to safety or efficacy)
Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease
A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This is a phase 2, randomized, double-blind, multicenter study to assess the therapeutic efficacy, safety, and mechanisms of omilancor (BT-11) in patients with moderate to severe Crohn's Disease (CD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2021
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2021
CompletedFirst Posted
Study publicly available on registry
September 27, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedJune 7, 2023
June 1, 2023
3 months
August 16, 2021
June 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Biomarkers of reponse
12 weeks
Study Arms (2)
BT-11 880 mg
EXPERIMENTALOral once daily tablet
Standard of care
ACTIVE COMPARATORBiologic
Interventions
Eligibility Criteria
You may qualify if:
- Male and female subjects age 18 to 75 years, inclusive.
- Diagnosis of CD for at least 6 weeks prior to screening
- Moderate to severely active CD as defined by all of the following:
- CDAI score of 220-450
- PRO-2 stool frequency (SF) ≥ 4 and/or abdominal pain (AP) ≥ 2
- SES-CD ≥ 6 ( ≥4 for isolated ileitis) scored by a blinded central reader
You may not qualify if:
- Participant has ulcerative colitis
- Participant is at imminent risk of ileo-colectomy
- Prior enrolment in the current study and had received study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2021
First Posted
September 27, 2021
Study Start
November 1, 2021
Primary Completion
February 1, 2022
Study Completion
February 1, 2022
Last Updated
June 7, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share