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

A Phase 2 study of Ulcerative Colitis, run by Bridge Biotherapeutics, Inc. at 30 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Ulcerative Colitis
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: 30 sitesin 4 countries
Study dates: 11 Jun 2021to 12 Jul 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

30 sites in 4 countries.

Country

City, postcode or hospital

30 sites in 4 countries

United States10 sites

Javara Research
Charlotte, North Carolina, 28210
Saini Surinder S MD
Fountain Valley, California, 92708
Intercity Gastroentertology
Fresh Meadows, New York, 11366
Gastro Care Institute
Lancaster, California, 93534
Premier Gastroenterology
Little Rock, Arkansas, 72211
Premier Gastroenterology
Little Rock, Arkansas, 72212
Inves Clinic
McAllen, Texas, 78503
Discovery Clinical Trials - AACT
Pflugerville, Texas, 78660
Velocity Clinical Research
Riverton, Utah, 84065
West Jordan
West Jordan, Utah, 84088

Other trials in United States

Ukraine9 sites

Municipal Non-Profit Enterprise City Clinical Hospital No. 2 named after prof. O.O. Shalimov of the
Kharkiv, Kharkiv Oblast, 61037
Municipal Non-Profit Enterprise Kherson City Clinical Hospital named after E.E.Karabelesha of Kherso
Kherson, Kherson Oblast, 73003
Medical Centre of the Limited Liability Company Medical Clinic Blagomed, Treatment and Diagnostic Di
Kyiv, Kyïv, 01023
Communal Non-profit enterprise Kyiv City Clinical Hospital No. 18, of the executive body of the Kyiv
Kyiv, Kyïv, 01030
Municipal Non-Profit Enterprise of the Kyiv Regional Council Kyiv Regional Hospital, Therapeutics De
Kyiv, 04078
Municipal Enterprise Volyn Regional Clinical Hospital of the Volyn Regional Council, Department of S
Luts'k, Vinnytsia Oblast, 43005
Medical Center RCLIN Ukraine of the Limited Liability Company Cardiocom
Obukhiv, Kyïv, 08711
Communal Non-profit enterprise Vinnytsya city clinical hospital 1 gastroenterology department
Vinnytsia, Vinnytsia Oblast, 21018
Medical Center of LLC Oxford Medical-Vinnytsia
Vinnytsia, Vinnytsia Oblast, 21018

Other trials in Ukraine

South Korea7 sites

Korea University Ansan Hospital
Ansan, Gyeonggido, 15355
Kyungpook National University Chilgok Hospital
Bugok, Daegu, 41404
Yeungnam University Hospital
Daegu, Gwang'yeogsi, 42415
Inje University Haeundae Paik Hospital
Haeundae, Busan Gwang'yeogsi, 48108
Inje University, Seoul Paik Hospital
Junggu, Seoul, 04551
The Catholic university of Korea, Seoul St Mary's Hospital
Seocho, Seoul Teugbyeolsi, 06591
Wonju Severance Christian Hospital
Wŏnju, Gang'weondo, 26426

Other trials in South Korea

Poland4 sites

Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
VITA LONGA Sp. z o.o.
Katowice, Silesian Voivodeship, 40-748
Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego
Lodz, Łódź Voivodeship, 90-153
Centrum Medyczne Melita Medical
Wroclaw, Wroclaw, 50-449

Other trials in Poland

About this study

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

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.

Conditions: Ulcerative Colitis
Being tested: BBT-401-1S or Placebo
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BBT-401-1S or PlaceboDrug
Administered by 200mg capsules of BBT-401-1S or placebo

Study groups in NCT04596293
Study group	Role	What they receive
BBT-401-1S (800mg)	Experimental	* 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 Receives: Drug: BBT-401-1S or Placebo
BBT-401-1S (1,600mg)	Experimental	* Induction Phase: BBT-401 1600mg for 8 weeks * Extension Phase: After 8 weeks, Participants will continue the same treatment for 8 weeks Receives: Drug: BBT-401-1S or Placebo
Placebo	Placebo comparator	* 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 Receives: Drug: BBT-401-1S or Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at 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
Measured: Day 57

Secondary outcomes (3)

Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score at 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
Measured: Day 57
Percentage of Participants Who Achieved an Endoscopic Remission at 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
Measured: Day 57
Change From Baseline to Day 57 in Total Mayo Score
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.
Measured: Baseline, Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 202112 Jul 2022

First posted22 Oct 2020
Study start11 Jun 2021
Primary completion17 May 2022
Study completion12 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04596293
Sponsor's protocol ID: BBT401-UC-005
Status last verified: Aug 2023
First submitted: 15 Oct 2020
Last updated: 7 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04596293
Acronym / sponsor ID: BBT401-UC-005
Conditions: Ulcerative Colitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Bridge Biotherapeutics, Inc.Industry (pharma, biotech, devices)
Collaborators: Covance
Study start: 11 Jun 2021 (actual)
Primary completion: 17 May 2022 (actual)
Study completion: 12 Jul 2022 (actual)
First posted: 22 Oct 2020 (actual)
Results: Posted 7 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
BBT-401-1S (800mg)	Experimental	Drug: BBT-401-1S or Placebo* 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
BBT-401-1S (1,600mg)	Experimental	Drug: BBT-401-1S or Placebo* Induction Phase: BBT-401 1600mg for 8 weeks * Extension Phase: After 8 weeks, Participants will continue the same treatment for 8 weeks
Placebo	Placebo comparator	Drug: BBT-401-1S or 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

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (13 listed)

Have received:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BBT-401-1S or PlaceboAdministered by 200mg capsules of BBT-401-1S or placebo	Drug	BBT-401-1S (1,600mg), BBT-401-1S (800mg), Placebo

Primary outcome

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

3 secondary outcomes

Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score at Day 57
Time frame: Day 57
Percentage of Participants Who Achieved an Endoscopic Remission at Day 57
Time frame: Day 57
Change From Baseline to Day 57 in Total Mayo Score
Time frame: Baseline, Day 57

Results and safety

Results posted to the registry on 7 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	11	11
BBT-401-1S (800mg)	11	11
BBT-401-1S (1,600mg)	11	10

Primary outcome: Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57

Time frame: Day 57. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Placebo n = 11	BBT-401-1S (800mg) n = 11	BBT-401-1S (1,600mg) n = 11
Value	63.6 (30.8 to 89.1)	54.5 (23.4 to 83.3)	54.5 (23.4 to 83.3)

Placebo vs BBT-401-1S (800mg): p = 1.0000, Fisher Exact
BBT-401-1S (800mg) vs BBT-401-1S (1,600mg): p = 1.0000, Fisher Exact

Population analysed: The intent-to-treat (ITT) population included all subjects who receive at least 1 dose of study drug, and who have a partial Mayo score recorded on Day 1 and at least 1 post-baseline Mayo score recorded. Subjects are categorized in the treatment group to which they are randomized.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From ICF consent up to 16 weeks for those who had completed the study or discontinued early. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo/Induction Phase	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
BBT-401-1S 800mg/Induction Phase	1 of 12 (8.3%)	3 of 12 (25%)	0 of 12
BBT-401-1S 1600mg/Induction Phase	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Placebo/Extension Phase	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
BBT-401-1S 800mg/ Extension Phase	0 of 8 (0%)	2 of 8 (25%)	0 of 8
BBT-401-1S 1600mg/ Extension Phase	0 of 17 (0%)	4 of 17 (23.5%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

30 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Ulcerative Colitis, run by Bridge Biotherapeutics, Inc. at 30 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Ukraine, South Korea, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57 (time frame: Day 57). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04596293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.