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

Ulcerative Colitis Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04596293
• Other study ID #: BBT401-UC-005
• Status: Completed
• Phase: Phase 2
• Start date: June 11, 2021
• Est. completion date: July 12, 2022

Study information

• Verified date: August 2023
• Source: Bridge Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 12, 2022
• Est. primary completion date: May 17, 2022
• 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.
• Have been diagnosed with active UC for =3 months prior to Day 1, as determined by clinical and endoscopic evidence and documented in a histopathology evaluation.
• Have a total Mayo score =6, an endoscopic subscore =2, rectal bleeding subscore =1, and a stool frequency subscore =1, regardless of standard of care history.
• Able to comprehend and willing to voluntarily sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

• Have received:

1. intravenous corticosteroids, rectally administered corticosteroids, or rectally administered 5-aminosalicylic acid within 3 weeks, or

2. Janus kinase (JAK) inhibitors within 2 weeks, or

3. cyclosporine, mycophenolate, tacrolimus, or methotrexate within 5 weeks, or

4. anti-TNF-a biologics within 9 weeks, or

5. any other biologics (including ustekinumab and vedolizumab) for the treatment of UC within 12 weeks.

• Have received orally administered azathioprine or 6-mercaptopurine that has been stable for <8 weeks.
• Have received orally administered 5-aminosalicylic acid, sulphasalazine, or low-dose corticosteroids (prednisolone =20 mg/day or equivalent) that have been stable for <5 weeks.
• 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.
• Have Crohn's disease, indeterminate colitis, ischaemic colitis, fulminant colitis, toxic megacolon, chronic (as determined by the investigator) pancolitis, confined proctitis (distal, =15 cm), 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, colostomy, or known fixed symptomatic stenosis of the intestine.
• Have a positive test for Clostridium difficile, or 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 or Placebo
Administered by 200mg capsules of BBT-401-1S or placebo

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan	Gyeonggido
Korea, Republic of	Kyungpook National University Chilgok Hospital	Bugok	Daegu
Korea, Republic of	Yeungnam University Hospital	Daegu	Gwang'yeogsi
Korea, Republic of	Inje University Haeundae Paik Hospital	Haeundae	Busan Gwang'yeogsi
Korea, Republic of	Inje University, Seoul Paik Hospital	Junggu	Seoul
Korea, Republic of	The Catholic university of Korea, Seoul St Mary's Hospital	Seocho	Seoul Teugbyeolsi
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gang'weondo
Poland	Centrum Medyczne Pratia Bydgoszcz	Bydgoszcz	Kujawsko-pomorskie,
Poland	VITA LONGA Sp. z o.o.	Katowice	Slaskie
Poland	Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego	Lódz	Lódzkie
Poland	Centrum Medyczne Melita Medical	Wroclaw	Wroclaw
Ukraine	Municipal Non-Profit Enterprise City Clinical Hospital No. 2 named after prof. O.O. Shalimov of the	Kharkiv	Kharkivs'ka Oblast
Ukraine	Municipal Non-Profit Enterprise Kherson City Clinical Hospital named after E.E.Karabelesha of Kherso	Kherson	Khersons'ka Oblast
Ukraine	Communal Non-profit enterprise Kyiv City Clinical Hospital No. 18, of the executive body of the Kyiv	Kyiv	Kyïv
Ukraine	Medical Centre of the Limited Liability Company Medical Clinic Blagomed, Treatment and Diagnostic Di	Kyiv	Kyïv
Ukraine	Municipal Non-Profit Enterprise of the Kyiv Regional Council Kyiv Regional Hospital, Therapeutics De	Kyiv
Ukraine	Municipal Enterprise Volyn Regional Clinical Hospital of the Volyn Regional Council, Department of S	Luts'k	Vinnyts'ka Oblast
Ukraine	Medical Center RCLIN Ukraine of the Limited Liability Company Cardiocom	Obukhiv	Kyïv
Ukraine	Medical Center of LLC Oxford Medical-Vinnytsia	Vinnytsia	Vinnyts'ka Oblast
Ukraine	Communal Non-profit enterprise Vinnytsya city clinical hospital 1 gastroenterology department	Vinnytsya	Vinnyts'ka Oblast
United States	Javara Research	Charlotte	North Carolina
United States	Saini Surinder S MD	Fountain Valley	California
United States	Intercity Gastroentertology	Fresh Meadows	New York
United States	Gastro Care Institute	Lancaster	California
United States	Premier Gastroenterology	Little Rock	Arkansas
United States	Premier Gastroenterology	Little Rock	Arkansas
United States	Inves Clinic	McAllen	Texas
United States	Discovery Clinical Trials - AACT	Pflugerville	Texas
United States	Velocity Clinical Research	Riverton	Utah
United States	West Jordan	West Jordan	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Bridge Biotherapeutics, Inc.	Covance

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57	Clinical Response was defined as a Total Mayo Score, as measured by a reduction of = 3 points and = 30% improvement from baseline of Total Mayo Score, which included a decrease in rectal bleeding subscore of = 1 point or an absolute rectal bleeding subscore = 1	Day 57
Secondary	Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score at Day 57	Clinical Remission was defined as a Total Mayo score, as measured by a total Mayo score of = 2 points, with no individual subscore exceeding 1 point. Change from baseline to Day 57 in Total Mayo Score. The Total Mayo Score is consisted of 4 subscores (stool frequency, rectal bleeding, findings on endoscopy, physician's global assessment), each graded from 0 to 3 with higher scores indicating more severe disease	Day 57
Secondary	Percentage of Participants Who Achieved an Endoscopic Remission at Day 57	Endoscopic Remission was defined as a Mayo endoscopic subscore of 0 or 1. Change from baseline to Day 57 in Total Mayo Score. The Total Mayo Score is consisted of 4 subscores (stool frequency, rectal bleeding, findings on endoscopy, physician's global assessment), each graded from 0 to 3 with higher scores indicating more severe disease	Day 57
Secondary	Change From Baseline to Day 57 in Total Mayo Score	Change from Baseline to Day 57 in Total Mayo Score. Change from baseline to Day 57 in Total Mayo Score. The Total Mayo Score, ranged from 0 to 12, are sum of 4 subscores. Subscores are stool frequency, rectal bleeding, findings on endoscopy, and physician's global assessment, each graded from 0 to 3 with higher scores indicating more severe disease.	Baseline, Day 57