Ulcerative Colitis
Conditions
Brief summary
This is an open label, single-arm, proof of mechanism study to explore the efficacy and safety of rectally administered BBT-401-1S in subjects with ulcerative colitis.
Interventions
DRUGBBT-401-1S
BBT-401-1S, 8 weeks, once a day
Sponsors
Covance
Bridge Biotherapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, of any race, ≥18 and ≤60 years of age on Day 1. * Have been diagnosed with active distal UC for ≥3 months prior to Day 1, as determined by clinical and endoscopic evidence and documented in a histopathology evaluation. * Have UC that is restricted to between the descending colon and the rectum (ie, left sided distal colitis), with demarcation of the lesion confirmed by endoscopy. * Have a total Mayo score ≥6, an endoscopic subscore ≥2, rectal bleeding subscore ≥1, and a stool frequency subscore ≥1.
Exclusion criteria
* Have used any biologics or Janus kinase (JAK) inhibitors including, but not limited to, anti TNF α biologics or tofacitinib for the treatment of UC. * Have used any purine analogues (azathioprine, mercaptopurine, or thiopurines) or immunosuppressants (methotrexate or cyclosporine) for the treatment of UC within 12 weeks or have any history of nonresponse to these medications. * Have used any rectal therapy for the treatment of UC with exception of rectal suppository of 5-aminosalicylic acid, or any intravenous corticosteroids within 2 weeks prior to Day 1. * Have received oral and/or rectal suppository 5-aminosalicylic acid, oral sulphasalazine, or low-dose oral corticosteroids that have been stable for \<4 weeks. Doses of the drugs must remain stable until the last dose of study drug. * Have received any other concomitant medications for UC that have been stable (ie, have not started dosing with a new drug or had a change to their dosing regimen) for \<7 days or 5 half lives, whichever is longer, prior to Day 1. * Have Crohn's disease, indeterminate colitis, ischaemic colitis, fulminant colitis, toxic megacolon, chronic pancolitis, or symptomatic intestinal stenosis. * Have a history of extensive colonic resection (subtotal or total colectomy) or are anticipated to require surgical intervention for UC. * Have an ileostomy or colostomy. * Have evidence of treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to Day 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic remission rate | Day 57 | measured by a Mayo endoscopic subscore of 0 or 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic response rate | Day 57 | defined by a ≥2-point reduction from baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission rate | Day 57 | measured by a total Mayo score of ≤2 points, with no individual subscore exceeding 1 point |
| Clinical response rate | Day 57 | measured by a reduction of ≥3 points and ≥30% improvement from baseline of total Mayo score, which includes a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore ≤1 |
| Inflammatory Bowel Disease Questionnaire total score | Day 57 | measured by change from baseline. Scores for each question range between 1 and 7, reflecting poor to good health-related quality-of-life, for a range of possible total scores from 32 to 224. |
Countries
New Zealand
Outcome results
None listed