Perianal Crohn's Disease
Conditions
Keywords
Crohn's disease, perianal, inflammatory bowel disease, fistula
Brief summary
This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is designed to determine the effects of BLI-1300 ointment on perianal pain associated with active Perianal Crohn's Disease (PCD).
Interventions
DRUGBLI-1300 low dose
topical ointment
DRUGBLI-1300 high dose
topical ointment
DRUGplacebo
topical ointment
Sponsors
Braintree Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All subjects must give written informed consent. * Male or female subjects, 18 years of age. * Confirmed diagnosis of Crohn's Disease. * Subject must have a 3 month documented history of perianal Crohn's Disease (PCD) and with clinical evidence of active PCD. * Subject must have a Crohn's Disease Activity Index (CDAI) total score of ≤ 350 at Visit 2. * Subjects must have a qualifying perianal pain score at Visits 1 and 2.
Exclusion criteria
* Women of childbearing potential who are not using adequate contraception. * Women who are pregnant or breastfeeding. * Subjects on unstable regimens of Crohn's therapy (e.g. tumor necrosis factor (TNF) inhibitors, immunosuppressants, steroids). * Subjects taking strong analgesics that could interfere with pain measurements. Subjects with a perianal abscess requiring incision and drainage. * Subjects with anal stenosis. * Subjects with fistulae outside the immediate perianal area. * Subjects who have had abdominal surgery for Crohn's disease within the past 12 weeks. * Subjects who have had significant anorectal surgery for Crohns disease within the past 8 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Perianal Pain Responders | 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BLI-1300 (High Dose) Investigational Product (20%) Ointment | 2 |
| BLI-1300 (Low Dose) Investigational Product (10%) Ointment | 2 |
| Placebo Placebo Ointment | 0 |
| Total | 4 |
Baseline characteristics
| Characteristic | BLI-1300 (High Dose) | BLI-1300 (Low Dose) | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 0 Participants | 4 Participants |
| Region of Enrollment United States | 2 Participants | 2 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 0 |
| other Total, other adverse events | 0 / 2 | 1 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 0 |
Outcome results
Primary
Percentage of Perianal Pain Responders
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.
Time frame: 12 weeks
Population: The study was discontinued and no patients were enrolled in the placebo arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BLI-1300 (High Dose) | Percentage of Perianal Pain Responders | 0 Participants |
| BLI-1300 (Low Dose) | Percentage of Perianal Pain Responders | 0 Participants |
| Placebo | Percentage of Perianal Pain Responders | 0 Participants |