Trial Outcomes & Findings for Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease (NCT NCT03870334)

NCT ID: NCT03870334

Last Updated: 2023-12-04

Results Overview

Clinical remission defined by CDAI score \<150.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2023-12-04

Participant Flow

Participant milestones

Measure	BT-11 880 mg Oral once daily tablet BT-11 880 mg: Oral once daily tablet	Placebo Oral once daily tablet Placebo: Oral once daily tablet
Overall Study STARTED	12	11
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease

Baseline characteristics by cohort

Measure	BT-11 880 mg n=12 Participants Oral once daily tablet BT-11 880 mg: Oral once daily tablet	Placebo n=11 Participants Oral once daily tablet Placebo: Oral once daily tablet	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.1 years STANDARD_DEVIATION 9.7 • n=5 Participants	39.9 years STANDARD_DEVIATION 13.7 • n=7 Participants	38.4 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Clinical remission defined by CDAI score <150.

Outcome measures

Measure	BT-11 880 mg n=12 Participants Oral once daily tablet BT-11 880 mg: Oral once daily tablet	Placebo n=11 Participants Oral once daily tablet Placebo: Oral once daily tablet
Clinical Remission Rate	3 Participants	1 Participants

Adverse Events

BT-11 880 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	BT-11 880 mg n=12 participants at risk Oral once daily tablet BT-11 880 mg: Oral once daily tablet	Placebo n=11 participants at risk Oral once daily tablet Placebo: Oral once daily tablet
Infections and infestations Infections and Infestations	8.3% 1/12 • 30 weeks	27.3% 3/11 • 30 weeks
General disorders Other	50.0% 6/12 • 30 weeks	36.4% 4/11 • 30 weeks

Additional Information

Project Management

NImmune

Phone: (540) 944-4545

Email: pm@nimmun.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER