Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

An Open Label, Proof of Mechanism Study to Explore the Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04478825
• Other study ID #: BBT401-UC-004
• Status: Terminated
• Phase: Phase 1
• Start date: June 1, 2021
• Est. completion date: August 24, 2021

Study information

• Verified date: September 2021
• Source: Bridge Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 24, 2021
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 a 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• BBT-401-1S
BBT-401-1S, 8 weeks, once a day

Locations

Country	Name	City	State
New Zealand	P3 Research	Tauranga
New Zealand	P3 Research	Wellington

Sponsors (2)

Lead Sponsor	Collaborator
Bridge Biotherapeutics, Inc.	Covance

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical remission rate	measured by a total Mayo score of =2 points, with no individual subscore exceeding 1 point	Day 57
Other	Clinical response rate	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	Day 57
Other	Inflammatory Bowel Disease Questionnaire total score	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.	Day 57
Primary	Endoscopic remission rate	measured by a Mayo endoscopic subscore of 0 or 1	Day 57
Secondary	Endoscopic response rate	defined by a =2-point reduction from baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score	Day 57