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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04596293
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : December 8, 2021
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Bridge Biotherapeutics, Inc.

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

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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


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 :
  1. 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 :
  1. Clinical remission rate [ Time Frame: Week 8 ]
    Measured by a total Mayo score of ≤2 points, with no individual subscore exceeding 1 point

  2. 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.


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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:

  • 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-α 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. 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.
  • Have clinically significant abnormal liver function tests, including:

    1. estimated glomerular filtration rate ≤50 mL/min/1.73m2
    2. alanine aminotransferase or aspartate aminotransferase >2 × the upper limit of normal (ULN)
    3. direct bilirubin >1.5 ULN.
  • Have other clinically significant abnormal clinical laboratory results that, in the opinion of the investigator, preclude participation in the study, including:

    1. platelet count <100,000/μL
    2. haemoglobin <8.5 g/dL
    3. neutrophils <1500/μL
    4. lymphocytes <500/mm3
    5. 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
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Contact: Bridge Biotherapeutics, Inc. +82-31-8092-3280 clinicaltrials.gov_inquiries@Bridgebiorx.com

Locations
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Sponsors and Collaborators
Bridge Biotherapeutics, Inc.
Covance
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases