Ulcerative ColitisPhase 2NCT03800420
Efficacy and Safety of BBT-401-1S in Ulcerative Colitis
A Phase 2 study of Ulcerative Colitis, run by Bridge Biotherapeutics, Inc. at 11 sites in United States.
Trial summary
This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis. This study consists of three cohorts with 16-week treatment period per cohort that will be conducted sequentially. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 16 participants
- Where
- 11 sitesUnited States
- Study dates
- 22 Apr 2019to 31 Jul 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged >=18 years
- Diagnosed with active UC for at least 3 months prior to screening
- Total Mayo score >=5 and Endoscopic sub-score >=1
- Stable dosing regimens of oral drugs (if currently administered) as follows: 5-ASA or sulfasalazine at a stable dose for at least 4 weeks, purine analogues (azathioprine, mercaptopurine, thiopurines) or methotrexate at a stable dose for at least 12 weeks, and low-dose oral corticosteroid (up to 20 mg prednisone/day or equivalent) for at least 4 weeks prior to the first dose of study treatment. Doses of oral drugs must remain stable until the end of study treatment (with possible exception for tapering steroid dose after 8 weeks)
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the last dose
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 3 months after the last dose
Who cannot join
- Use of anti-TNF-a biologics or any other biologics for treatment of UC within 60 days prior to randomization.
- Any rectal therapy for treatment of UC or intravenous corticosteroids within 2 weeks prior to randomization.
- Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
- Previous extensive colonic resection (subtotal or total colectomy)
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- Evidence of or treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to randomization
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- Active infection with the HIV or Hepatitis B or C viruses
- Clinically significant active extra-intestinal infection (e.g., pneumonia, pyelonephritis)
- Clinically significant abnormal vital signs, physical examination or 12-lead electrocardiogram (ECG) at screening or baseline
- Clinically significant abnormal results of liver function tests (ALT/AST, bilirubin and alkaline phosphatase) > 2X the upper limit of normal (ULN) at screening
- Other clinically significant abnormal laboratory results at screening in the investigator's opinion
- History of any clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study
- Pregnancy or lactation
- Treatment with another investigational drug or other intervention within 30 days prior to screening
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Site 10
Ann Arbor, Michigan, 48109
Site 05
Austin, Texas, 78705
Site 11
Boca Raton, Florida, 33487
Site 08
Chattanooga, Tennessee, 37421
Site 13
McAllen, Texas, 78503
Site 02
Monroe, North Carolina, 28112
Site 12
Pembroke Pines, Florida, 33029
Site 04
Rockville, Maryland, 20850
Site 03
Sacramento, California, 95821
Site 09
Seattle, Washington, 98195
Site 01
Ventura, California, 93003
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis
This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis.
This study consists of three cohorts with 16-week treatment period per cohort that will be conducted sequentially.
- Conditions
- Ulcerative Colitis
- Being tested
- BBT-401-1S first and then Placebo, Placebo first and then BBT-401-1S
- Keywords
- Pellino-1
- 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 first and then PlaceboDrug
Total 16 week treatment period: The subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks.
Placebo first and then BBT-401-1SDrug
Total 16 week treatment period: The subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BBT-401-1S | Experimental | BBT-401-1S, Oral capsule, QD Receives: Drug: BBT-401-1S first and then Placebo |
| Placebo | Placebo comparator | Placebo, Oral capsule, QD Receives: Drug: Placebo first and then BBT-401-1S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Mayo Score
The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 12 points. The Total Mayo score consists of 4 subscores( Stool frequency, Rectal bleeding, Findings of endoscopy, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.
Measured: Week 8
Secondary outcomes (8)
Change From Baseline in Partial Mayo Score
The Partial Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 9 points. The Partial Mayo score consists of 3 subscores( Stool frequency, Rectal bleeding, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.
Measured: Week 8
Change From Baseline in Histologic Assessment of Endoscopic Biopsy
Histological assessment of endoscopic biopsy is an appropriate method for evaluating mucosal healing (Carbonnel et al, 1994).
Measured: Week 8
Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8)
The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is the first validated index for the assessment of overall endoscopic activity. The model incorporates the vascular pattern score(0-2), the presence of bleeding score(0-3) and the presence of erosions and ulcers score (0-3). Higher score of the sum of these subscore indicates more severe disease.
Measured: Week 8
Number and Severity of TEAEs
Treatment Emergent Adverse Event (TEAE) is defined as an adverse event that occurs or worsens on or after the first dose of study drug.
Measured: up to 8 weeks after the last dose
Plasma Concentration of BBT- 401-1S
Analysis of Plasma Pharmacokinetics for BBT- 401 -1S
Measured: Day 1, Week 4, Week 8
Change From Baseline in Concentration of Serum CRP
Widely used serum indicator of inflammation in Ulcerative Colitis(UC).
Measured: Week 8
Change From Baseline in Concentration of Fecal Calprotectin
Reliable surrogate marker for disease activity in Ulcerative Colitis (UC).
Measured: Week 8
Change From Baseline in Concentration of Fecal Lactoferrin
A stool (fecal) test that is used to detect inflammation in the intestines.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start22 Apr 2019
- Primary completion18 May 2020
- Study completion31 Jul 2020
Why it stopped: to carry out the rest of the study with new CRO and modified protocol as a multi-regional study.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bridge Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800420
- Sponsor's protocol ID
- BBT401-UC-US02
- Status last verified
- Feb 2022
- First submitted
- 7 Jan 2019
- Last updated
- 21 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03800420
- Acronym / sponsor ID
- BBT401-UC-US02
- Conditions
- Ulcerative Colitis
- Keywords
- Pellino-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: to carry out the rest of the study with new CRO and modified protocol as a multi-regional study.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Bridge Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Posted 21 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is randomized, placebo-controlled, dose-escalation, multicenter, Phase 2 study to evaluate the efficacy and safety of BBT-401-1S in patients with active ulcerative colitis.
This study consists of three cohorts with 16-week treatment period per cohort that will be conducted sequentially.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BBT-401-1S | Experimental | Drug: BBT-401-1S first and then PlaceboBBT-401-1S, Oral capsule, QD |
| Placebo | Placebo comparator | Drug: Placebo first and then BBT-401-1SPlacebo, Oral capsule, QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged >=18 years
- Diagnosed with active UC for at least 3 months prior to screening
- Total Mayo score >=5 and Endoscopic sub-score >=1
Key exclusion criteria (14 listed)
- Use of anti-TNF-a biologics or any other biologics for treatment of UC within 60 days prior to randomization.
- Any rectal therapy for treatment of UC or intravenous corticosteroids within 2 weeks prior to randomization.
- Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
- Previous extensive colonic resection (subtotal or total colectomy)
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
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 first and then PlaceboTotal 16 week treatment period: The subject takes BBT-401-1S, QD for the first 12 weeks, then placebo for the last 4 weeks. | Drug | BBT-401-1S |
| Placebo first and then BBT-401-1STotal 16 week treatment period: The subject takes the placebo, QD for the first 8 weeks, then BBT-401-1S for the last 8 weeks. | Drug | Placebo |
Primary outcome
Change From Baseline in Total Mayo Score
Time frame: Week 8
The Total Mayo score is an instrument designed to measure disease activity of ulcerative colitis, with scores ranging from 0 to 12 points. The Total Mayo score consists of 4 subscores( Stool frequency, Rectal bleeding, Findings of endoscopy, Physician global assessment), each graded from 0 to 3 with higher scores indicating more severe disease.
8 secondary outcomes
Change From Baseline in Partial Mayo Score
Time frame: Week 8
Change From Baseline in Histologic Assessment of Endoscopic Biopsy
Time frame: Week 8
Change From Baseline in Ulcerative Colitis Endoscopic Index of Severity (0-8)
Time frame: Week 8
Number and Severity of TEAEs
Time frame: up to 8 weeks after the last dose
Plasma Concentration of BBT- 401-1S
Time frame: Day 1, Week 4, Week 8
Change From Baseline in Concentration of Serum CRP
Time frame: Week 8
Change From Baseline in Concentration of Fecal Calprotectin
Time frame: Week 8
Change From Baseline in Concentration of Fecal Lactoferrin
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- 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.
11 sites in 1 country: 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 11 sites in United States.
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 8 inclusion and 14 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: stopped early, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 21 Mar 2022). 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?
Change From Baseline in Total Mayo Score (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2022.