Trial Outcomes & Findings for A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease (NCT NCT01442363)
NCT ID: NCT01442363
Last Updated: 2023-11-13
Results Overview
Percent of responders during Week 12. Response is defined as ≥30% decrease in mean NRS score for perianal pain (for the 7 treatment days immediately preceding the Week 12 visit) compared to the screening period.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-11-13
Participant Flow
Participant milestones
| Measure |
BLI-1300 (High Dose)
Investigational Product (20%) Ointment
|
BLI-1300 (Low Dose)
Investigational Product (10%) Ointment
|
Placebo
Placebo Ointment
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
0
|
|
Overall Study
COMPLETED
|
2
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease
Baseline characteristics by cohort
| Measure |
BLI-1300 (High Dose)
n=2 Participants
Investigational Product (20%) Ointment
|
BLI-1300 (Low Dose)
n=2 Participants
Investigational Product (10%) Ointment
|
Placebo
Placebo Ointment
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The study was discontinued and no patients were enrolled in the placebo arm.
Percent of responders during Week 12. Response is defined as ≥30% decrease in mean NRS score for perianal pain (for the 7 treatment days immediately preceding the Week 12 visit) compared to the screening period.
Outcome measures
| Measure |
BLI-1300 (High Dose)
n=2 Participants
Investigational Product (20%) Ointment
|
BLI-1300 (Low Dose)
n=2 Participants
Investigational Product (10%) Ointment
|
Placebo
Placebo Ointment
|
|---|---|---|---|
|
Percentage of Perianal Pain Responders
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
BLI-1300 (High Dose)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BLI-1300 (Low Dose)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BLI-1300 (High Dose)
n=2 participants at risk
Investigational Product (20%) Ointment
|
BLI-1300 (Low Dose)
n=2 participants at risk
Investigational Product (10%) Ointment
|
Placebo
Placebo Ointment
|
|---|---|---|---|
|
Gastrointestinal disorders
rectal throbbing
|
0.00%
0/2 • 12 weeks
The study was discontinued and no patients were enrolled in the placebo arm.
|
50.0%
1/2 • 12 weeks
The study was discontinued and no patients were enrolled in the placebo arm.
|
—
0/0 • 12 weeks
The study was discontinued and no patients were enrolled in the placebo arm.
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/2 • 12 weeks
The study was discontinued and no patients were enrolled in the placebo arm.
|
50.0%
1/2 • 12 weeks
The study was discontinued and no patients were enrolled in the placebo arm.
|
—
0/0 • 12 weeks
The study was discontinued and no patients were enrolled in the placebo arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sole disclosure restriction which sponsor imposes on the PI is a sixty (60) day limited restriction in order to the protect potentially proprietary information which may be patentable.
- Publication restrictions are in place
Restriction type: OTHER