Ulcerative ColitisPhase 1NCT04478825
Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis
A Phase 1 study testing BBT-401-1S in people with Ulcerative Colitis, run by Bridge Biotherapeutics, Inc. at 2 sites in New Zealand.
Trial summary
This is an open label, single-arm, proof of mechanism study to explore the efficacy and safety of rectally 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
- What is being tested?
- BBT-401-1S
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 1 Jun 2021to 24 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 on Day 1.
- Have been diagnosed with active distal UC for ≥3 months prior to Day 1, as determined by clinical and endoscopic evidence and documented in a histopathology evaluation.
- Have UC that is restricted to between the descending colon and the rectum (ie, left sided distal colitis), with demarcation of the lesion confirmed by endoscopy.
- Have a total Mayo score ≥6, an endoscopic subscore ≥2, rectal bleeding subscore ≥1, and a stool frequency subscore ≥1.
Who cannot join
- Have used any biologics or Janus kinase (JAK) inhibitors including, but not limited to, anti TNF α biologics or tofacitinib for the treatment of UC.
- Have used any purine analogues (azathioprine, mercaptopurine, or thiopurines) or immunosuppressants (methotrexate or cyclosporine) for the treatment of UC within 12 weeks or have any history of nonresponse to these medications.
- Have used any rectal therapy for the treatment of UC with exception of rectal suppository of 5-aminosalicylic acid, or any intravenous corticosteroids within 2 weeks prior to Day 1.
- Have received oral and/or rectal suppository 5-aminosalicylic acid, oral sulphasalazine, or low-dose oral corticosteroids that have been stable for <4 weeks. Doses of the 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, prior to Day 1.
- Have Crohn's disease, indeterminate colitis, ischaemic colitis, fulminant colitis, toxic megacolon, chronic pancolitis, or symptomatic intestinal stenosis.
Show all 9Show fewer
- Have a history of extensive colonic resection (subtotal or total colectomy) or are anticipated to require surgical intervention for UC.
- Have an ileostomy or colostomy.
- 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
2 sites in 1 country.
About this study
Official title: An Open Label, Proof of Mechanism Study to Explore the Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis
This is an open label, single-arm, proof of mechanism study to explore the efficacy and safety of rectally administered BBT-401-1S in subjects with ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- BBT-401-1S
- 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-401-1SDrug
BBT-401-1S, 8 weeks, once a day
| Study group | Role | What they receive |
|---|---|---|
| BBT-401-1S | Experimental | BBT-401-1S, rectal administration Receives: Drug: BBT-401-1S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic remission rate
measured by a Mayo endoscopic subscore of 0 or 1
Measured: Day 57
Secondary outcomes (1)
Endoscopic response rate
defined by a ≥2-point reduction from baseline in Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Jun 2021
- Primary completion4 Aug 2021
- Study completion24 Aug 2021
Why it stopped: Internal Company Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bridge Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478825
- Sponsor's protocol ID
- BBT401-UC-004
- Status last verified
- Sep 2021
- First submitted
- 16 Jul 2020
- Last updated
- 1 Oct 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Proof of Mechanism Study to Explore the Efficacy and Safety of Rectally Administered BBT-401-1S in Subjects With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04478825
- Acronym / sponsor ID
- BBT401-UC-004
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal Company Decision
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Bridge Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, single-arm, proof of mechanism study to explore the efficacy and safety of rectally administered BBT-401-1S in subjects with ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BBT-401-1S | Experimental | Drug: BBT-401-1SBBT-401-1S, rectal administration |
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 on Day 1.
- Have been diagnosed with active distal UC for ≥3 months prior to Day 1, as determined by clinical and endoscopic evidence and documented in a histopathology evaluation.
- Have UC that is restricted to between the descending colon and the rectum (ie, left sided distal colitis), with demarcation of the lesion confirmed by endoscopy.
- Have a total Mayo score ≥6, an endoscopic subscore ≥2, rectal bleeding subscore ≥1, and a stool frequency subscore ≥1.
Key exclusion criteria (9 listed)
- Have used any biologics or Janus kinase (JAK) inhibitors including, but not limited to, anti TNF α biologics or tofacitinib for the treatment of UC.
- Have used any purine analogues (azathioprine, mercaptopurine, or thiopurines) or immunosuppressants (methotrexate or cyclosporine) for the treatment of UC within 12 weeks or have any history of nonresponse to these medications.
- Have used any rectal therapy for the treatment of UC with exception of rectal suppository of 5-aminosalicylic acid, or any intravenous corticosteroids within 2 weeks prior to Day 1.
- Have received oral and/or rectal suppository 5-aminosalicylic acid, oral sulphasalazine, or low-dose oral corticosteroids that have been stable for <4 weeks. Doses of the 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, prior to Day 1.
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-401-1SBBT-401-1S, 8 weeks, once a day | Drug | BBT-401-1S |
Primary outcome
Endoscopic remission rate
Time frame: Day 57
measured by a Mayo endoscopic subscore of 0 or 1
1 secondary outcome
Endoscopic response rate
Time frame: Day 57
Results and safety
The study was stopped early (reason given: Internal Company Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BBT-401-1S in people with Ulcerative Colitis, run by Bridge Biotherapeutics, Inc. at 2 sites in New Zealand.
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 9 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 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Internal Company Decision). Results are not available in the source record.
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?
Endoscopic remission rate (time frame: Day 57). 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 1 Oct 2021.