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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.

Tracking Information
First Submitted Date  ICMJE October 15, 2020
First Posted Date  ICMJE October 22, 2020
Last Update Posted Date December 8, 2021
Actual Study Start Date  ICMJE June 11, 2021
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: BBT-401-1S
    BBT-401-1S 8 weeks + Extension phase 8 weeks
  • Drug: Placebo
    Placebo 8 weeks + Extension phase 8 weeks
Study Arms  ICMJE
  • Experimental: BBT-401-1S (800mg)
    Intervention: Drug: BBT-401-1S
  • Experimental: BBT-401-1S (1,600mg)
    Intervention: Drug: BBT-401-1S
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 20, 2020)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bridge Biotherapeutics, Inc. +82-31-8092-3280 clinicaltrials.gov_inquiries@Bridgebiorx.com
Listed Location Countries  ICMJE Korea, Republic of,   New Zealand,   Poland,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04596293
Other Study ID Numbers  ICMJE BBT401-UC-005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bridge Biotherapeutics, Inc.
Study Sponsor  ICMJE Bridge Biotherapeutics, Inc.
Collaborators  ICMJE Covance
Investigators  ICMJE Not Provided
PRS Account Bridge Biotherapeutics, Inc.
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP