Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis
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| ClinicalTrials.gov Identifier: NCT04596293 |
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Recruitment Status :
Recruiting
First Posted : October 22, 2020
Last Update Posted : December 8, 2021
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Sponsor:
Bridge Biotherapeutics, Inc.
Collaborator:
Covance
Information provided by (Responsible Party):
Bridge Biotherapeutics, Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ulcerative Colitis | Drug: BBT-401-1S Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 36 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | June 11, 2021 |
| Estimated Primary Completion Date : | February 28, 2022 |
| Estimated Study Completion Date : | April 30, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
| Arm | Intervention/treatment |
|---|---|
| Experimental: BBT-401-1S (800mg) |
Drug: BBT-401-1S
BBT-401-1S 8 weeks + Extension phase 8 weeks |
| Experimental: BBT-401-1S (1,600mg) |
Drug: BBT-401-1S
BBT-401-1S 8 weeks + Extension phase 8 weeks |
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo 8 weeks + Extension phase 8 weeks |
Primary Outcome Measures :
- Clinical response rate [ Time Frame: Week 8 ]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
Secondary Outcome Measures :
- Clinical remission rate [ Time Frame: Week 8 ]Measured by a total Mayo score of ≤2 points, with no individual subscore exceeding 1 point
- Endoscopic remission rate [ Time Frame: Week 8 ]Measured by a Mayo endoscopic subscore of 0 or 1
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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:
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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. Doses of oral drugs must remain stable until the last dose of study drug.
- 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. Doses of oral 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.
- 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.
- Have active infection with the human immunodeficiency virus or hepatitis B or C viruses.
- Have clinically significant active extraintestinal infection (eg, pneumonia, pyelonephritis).
- Have, in the opinion of the investigator, clinically significant abnormal vital signs, physical examination findings, or 12-lead electrocardiograms (ECGs) at screening or Day 1.
- Have a history of any disease or condition (including mental and emotional conditions) that, in the opinion of the investigator (or designee), would affect participation in this study.
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Have clinically significant abnormal liver function tests, including:
- estimated glomerular filtration rate ≤50 mL/min/1.73m2
- alanine aminotransferase or aspartate aminotransferase >2 × the upper limit of normal (ULN)
- direct bilirubin >1.5 ULN.
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Have other clinically significant abnormal clinical laboratory results that, in the opinion of the investigator, preclude participation in the study, including:
- platelet count <100,000/μL
- haemoglobin <8.5 g/dL
- neutrophils <1500/μL
- lymphocytes <500/mm3
- absolute white blood cells count <3000/μL.
- Have participated in a clinical study involving administration of an investigational drug in the past 30 days prior to Day 1.
- Have previously participated in any study of BBT-401-1S.
- In the opinion of the investigator (or designee) or the sponsor, should not participate in this study.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596293
Contacts
| Contact: Bridge Biotherapeutics, Inc. | +82-31-8092-3280 | clinicaltrials.gov_inquiries@Bridgebiorx.com |
Locations
Show 33 study locations
Sponsors and Collaborators
Bridge Biotherapeutics, Inc.
Covance
| Responsible Party: | Bridge Biotherapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT04596293 |
| Other Study ID Numbers: |
BBT401-UC-005 |
| First Posted: | October 22, 2020 Key Record Dates |
| Last Update Posted: | December 8, 2021 |
| Last Verified: | December 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |