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

August 16, 2023 updated by: Bridge Biotherapeutics, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Busan Gwang'yeogsi
      • Haeundae, Busan Gwang'yeogsi, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
    • Daegu
      • Bugok, Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
    • Gang'weondo
      • Wŏnju, Gang'weondo, Korea, Republic of, 26426
        • Wonju Severance Christian Hospital
    • Gwang'yeogsi
      • Daegu, Gwang'yeogsi, Korea, Republic of, 42415
        • Yeungnam University Hospital
    • Gyeonggido
      • Ansan, Gyeonggido, Korea, Republic of, 15355
        • Korea University Ansan Hospital
    • Seoul
      • Junggu, Seoul, Korea, Republic of, 04551
        • Inje University, Seoul Paik Hospital
    • Seoul Teugbyeolsi
      • Seocho, Seoul Teugbyeolsi, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St Mary's Hospital
  • Poland
    • Kujawsko-pomorskie,
      • Bydgoszcz, Kujawsko-pomorskie,, Poland, 85-796
        • Centrum medyczne Pratia Bydgoszcz
    • Wroclaw
      • Wrocław, Wroclaw, Poland, 50-449
        • Centrum Medyczne Melita Medical
    • Łódzkie
      • Łódź, Łódzkie, Poland, 90-153
        • Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego
    • Śląskie
      • Katowice, Śląskie, Poland, 40-748
        • Vita Longa Sp. z o.o.
  • Ukraine
      • Kyiv, Ukraine, 04078
        • Municipal Non-Profit Enterprise of the Kyiv Regional Council Kyiv Regional Hospital, Therapeutics De
    • Kharkivs'ka Oblast
      • Kharkiv, Kharkivs'ka Oblast, Ukraine, 61037
        • Municipal Non-Profit Enterprise City Clinical Hospital No. 2 named after prof. O.O. Shalimov of the
    • Khersons'ka Oblast
      • Kherson, Khersons'ka Oblast, Ukraine, 73003
        • Municipal Non-Profit Enterprise Kherson City Clinical Hospital named after E.E.Karabelesha of Kherso
    • Kyïv
      • Kyiv, Kyïv, Ukraine, 01023
        • Medical Centre of the Limited Liability Company Medical Clinic Blagomed, Treatment and Diagnostic Di
      • Kyiv, Kyïv, Ukraine, 01030
        • Communal Non-profit enterprise Kyiv City Clinical Hospital No. 18, of the executive body of the Kyiv
      • Obukhiv, Kyïv, Ukraine, 08711
        • Medical Center RCLIN Ukraine of the Limited Liability Company Cardiocom
    • Vinnyts'ka Oblast
      • Luts'k, Vinnyts'ka Oblast, Ukraine, 43005
        • Municipal Enterprise Volyn Regional Clinical Hospital of the Volyn Regional Council, Department of S
      • Vinnytsia, Vinnyts'ka Oblast, Ukraine, 21018
        • Medical Center of LLC Oxford Medical-Vinnytsia
      • Vinnytsya, Vinnyts'ka Oblast, Ukraine, 21018
        • Communal Non-profit enterprise Vinnytsya city clinical hospital 1 gastroenterology department
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Premier Gastroenterology
      • Little Rock, Arkansas, United States, 72211
        • Premier Gastroenterology
    • California
      • Fountain Valley, California, United States, 92708
        • Saini Surinder S MD
      • Lancaster, California, United States, 93534
        • Gastro Care Institute
    • New York
      • Fresh Meadows, New York, United States, 11366
        • Intercity Gastroentertology
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Javara Research
    • Texas
      • McAllen, Texas, United States, 78503
        • Inves Clinic
      • Pflugerville, Texas, United States, 78660
        • Discovery Clinical Trials - AACT
    • Utah
      • Riverton, Utah, United States, 84065
        • Velocity Clinical Research
      • West Jordan, Utah, United States, 84088
        • West Jordan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BBT-401-1S (800mg)
  • Induction Phase: BBT-401 800mg for 8 weeks

  • Extension Phase: After 8 weeks,

    • Participants who achieved clinical remission in the induction phase will continue the same treatment for 8 weeks
    • Participants who did not achieve clinical remission in the induction phase will receive BBT-401 1600mg for 8 weeks
Drug: BBT-401-1S or Placebo
Administered by 200mg capsules of BBT-401-1S or placebo
Experimental: BBT-401-1S (1,600mg)
  • Induction Phase: BBT-401 1600mg for 8 weeks
  • Extension Phase: After 8 weeks, Participants will continue the same treatment for 8 weeks
Drug: BBT-401-1S or Placebo
Administered by 200mg capsules of BBT-401-1S or placebo
Placebo Comparator: Placebo
  • Induction Phase: Placebo for 8 weeks

  • Extension Phase: After 8 weeks,

    • Participants who achieved clinical remission in the induction phase will continue the same treatment for 8 weeks
    • Participants who did not achieve clinical remission in the induction phase will receive BBT-401 800mg for 8 weeks
Drug: BBT-401-1S or Placebo
Administered by 200mg capsules of BBT-401-1S or placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score at Day 57
Time Frame: 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
Percentage of Participants Who Achieved an Endoscopic Remission at Day 57
Time Frame: 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
Change From Baseline to Day 57 in Total Mayo Score
Time Frame: Baseline, Day 57
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bridge Biotherapeutics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Covance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BBT401-UC-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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