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

Completed · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT04596293

Run by

Bridge Biotherapeutics, Inc.

People needed

38

Starts

2021-06-11

Expected to finish

2022-07-12

Last updated by the study team

2023-09-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Have received:
• intravenous corticosteroids, rectally administered corticosteroids, or rectally administered 5-aminosalicylic acid within 3 weeks, or
• Janus kinase (JAK) inhibitors within 2 weeks, or
• cyclosporine, mycophenolate, tacrolimus, or methotrexate within 5 weeks, or
• anti-TNF-α biologics within 9 weeks, or
• 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.

Where it is running

• Premier Gastroenterology — Little Rock, Arkansas, United States
• Premier Gastroenterology — Little Rock, Arkansas, United States
• Saini Surinder S MD — Fountain Valley, California, United States
• Gastro Care Institute — Lancaster, California, United States
• Intercity Gastroentertology — Fresh Meadows, New York, United States
• Javara Research — Charlotte, North Carolina, 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, United States
• Centrum Medyczne Pratia Bydgoszcz — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
• VITA LONGA Sp. z o.o. — Katowice, Silesian Voivodeship, Poland
• Centrum Medyczne Melita Medical — Wroclaw, Wroclaw, Poland
• Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego — Lodz, Łódź Voivodeship, Poland
• Inje University Haeundae Paik Hospital — Haeundae, Busan Gwang'yeogsi, South Korea
• Kyungpook National University Chilgok Hospital — Bugok, Daegu, South Korea
• Wonju Severance Christian Hospital — Wŏnju, Gang'weondo, South Korea
• Yeungnam University Hospital — Daegu, Gwang'yeogsi, South Korea
• Korea University Ansan Hospital — Ansan, Gyeonggido, South Korea
• Inje University, Seoul Paik Hospital — Junggu, Seoul, South Korea
• The Catholic university of Korea, Seoul St Mary's Hospital — Seocho, Seoul Teugbyeolsi, South Korea
• Municipal Non-Profit Enterprise City Clinical Hospital No. 2 named after prof. O.O. Shalimov of the — Kharkiv, Kharkiv Oblast, Ukraine
• Municipal Non-Profit Enterprise Kherson City Clinical Hospital named after E.E.Karabelesha of Kherso — Kherson, Kherson Oblast, Ukraine
• Medical Centre of the Limited Liability Company Medical Clinic Blagomed, Treatment and Diagnostic Di — Kyiv, Kyïv, Ukraine
• Communal Non-profit enterprise Kyiv City Clinical Hospital No. 18, of the executive body of the Kyiv — Kyiv, Kyïv, Ukraine

Full record on ClinicalTrials.gov

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