Ulcerative ColitisPhase 2NCT03861143
Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
A Phase 2 study testing BT-11 (440 mg) and BT-11 (880 mg) in people with Ulcerative Colitis, run by NImmune Biopharma at 16 sites in 5 countries.
Trial summary
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- BT-11 (440 mg) and BT-11 (880 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 14 Aug 2019to 17 Jun 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Male and female subjects aged 18 to 75 years, inclusive.
- . Diagnosis of UC for at least 3 months prior to screening.
- . UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES 2 (confirmed by central reader).
- . Able to participate fully in all aspects of this clinical trial.
- . Written informed consent must be obtained and documented.
Who cannot join
- . A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with CD.
- . Modified Truelove and Witts criteria (2: 6 bloody stools per day and one or more of the following: pulse > 90 bpm, temperature > 37.8°C, hemoglobin < 10.5 g/dl, or hs-CRP > 30 mg/I).
- . Disease activity limited to distal 15 cm (proctitis).
- . Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine [6-MP]) within 25 days prior to randomization.
- . Unable to attend study visits or comply with procedures.
- . Concurrent participation in any other interventional study.
- . Prior enrollment in the current study and had received study treatment.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
United States9 sites
Medycal Research Inc.
Brooksville, Florida, 34613
Invesclinic.U.S,LLC.FL
Fort Lauderdale, Florida, 33308
I.H.S Health LLC
Kissimmee, Florida, 34741
Axis Clinical Trials
Los Angeles, California, 90036
Invesclinic.U.S,LLC.
McAllen, Texas, 78503
Smart Medical Research
Richmond Hill, New York, 11102
Texas Gastroenterology Associates
Spring, Texas, 77386
Ventura Clinical Trials
Ventura, California, 93003
Clinical Research of California
Walnut Creek, California, 94598
Bosnia and Herzegovina2 sites
Polyclinic and Daily hospital "Dr Al Tawil"
Sarajevo, Federation BiH, 71000
Cantonal Hospital Zenica, Gastroenterology
Zenica, 72000
Poland2 sites
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80546
RIVERM E D Sp. zo.o.
Poznan, Greater Poland Voivodeship, 61441
Ukraine2 sites
Municipal Non-profit Enterprise "City Outpatient Clinic No 9 of Kharkiv City Council, Surgery department, Kharkiv
Kharkiv, 61172
Multidisciplinary Medical Center of Odesa National Medical University, First Surgery Department ,Odesa National Medical University , Chair of General and Military Surgeon
Odesa, 65082
About this study
Official title: A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
- Conditions
- Ulcerative Colitis
- Being tested
- BT-11 (440 mg), BT-11 (880 mg), 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.
BT-11 (440 mg)Drug
Oral, once daily tablet
BT-11 (880 mg)Drug
Oral, once daily tablet
PlaceboDrug
Oral, once daily tablet
| Study group | Role | What they receive |
|---|---|---|
| BT-11 low-dose (440 mg) | Experimental | Oral, once daily tablet Receives: Drug: BT-11 (440 mg) |
| BT-11 high-dose (880 mg) | Experimental | Oral, once daily tablet Receives: Drug: BT-11 (880 mg) |
| Placebo | Placebo comparator | Oral, once daily tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission
Clinical remission rate at Week 12, defined using the 3-component modified Mayo Score as a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and an endoscopic subscore of 0 or 1.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start14 Aug 2019
- Primary completion10 Dec 2020
- Study completion17 Jun 2021
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
- Model description
- This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- NImmune Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861143
- Sponsor's protocol ID
- BT-11-201
- Status last verified
- Jun 2023
- First submitted
- 27 Feb 2019
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03861143
- Acronym / sponsor ID
- BT-11-201
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- NImmune BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Posted 3 Nov 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 a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
| Arm | Type | Receives |
|---|---|---|
| BT-11 low-dose (440 mg) | Experimental | Drug: BT-11 (440 mg)Oral, once daily tablet |
| BT-11 high-dose (880 mg) | Experimental | Drug: BT-11 (880 mg)Oral, once daily tablet |
| Placebo | Placebo comparator | Drug: PlaceboOral, once daily tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- . Male and female subjects aged 18 to 75 years, inclusive.
- . Diagnosis of UC for at least 3 months prior to screening.
- . UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES 2 (confirmed by central reader).
- . Able to participate fully in all aspects of this clinical trial.
- . Written informed consent must be obtained and documented.
Key exclusion criteria (7 listed)
- . A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with CD.
- . Modified Truelove and Witts criteria (2: 6 bloody stools per day and one or more of the following: pulse > 90 bpm, temperature > 37.8°C, hemoglobin < 10.5 g/dl, or hs-CRP > 30 mg/I).
- . Disease activity limited to distal 15 cm (proctitis).
- . Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine [6-MP]) within 25 days prior to randomization.
- . Unable to attend study visits or comply with procedures.
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 |
|---|---|---|
| BT-11 (440 mg)Oral, once daily tablet | Drug | BT-11 low-dose (440 mg) |
| BT-11 (880 mg)Oral, once daily tablet | Drug | BT-11 high-dose (880 mg) |
| PlaceboOral, once daily tablet | Drug | Placebo |
Primary outcome
Clinical Remission
Time frame: Week 12
Clinical remission rate at Week 12, defined using the 3-component modified Mayo Score as a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and an endoscopic subscore of 0 or 1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BT-11 (440 mg) and BT-11 (880 mg) in people with Ulcerative Colitis, run by NImmune Biopharma at 16 sites in 5 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 5 inclusion and 7 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Bosnia and Herzegovina, Poland, Ukraine, Croatia. 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 3 Nov 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?
Clinical Remission (time frame: Week 12). 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 29 Jun 2023.