Ulcerative ColitisPhase 2NCT02426372
Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis
A Phase 2 study testing QBECO SSI in people with Ulcerative Colitis, run by Qu Biologics Inc. at 3 sites in Canada.
Trial summary
The purpose of this open-label, dose-ranging, exploratory study is to evaluate the safety, tolerability, compliance, mechanism of action and efficacy of QBECO site specific immunomodulation for the induction of clinical response and remission in subjects with moderate to severe ulcerative colitis Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- QBECO SSI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2015to Dec 2016
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects who have reached age of majority
- Willing to learn and able to self-administer study drug
- Diagnosis of UC established at least 6 months before screening visit, by clinical and endoscopic evidence.
- Currently experiencing moderate to severe active UC defined as a Mayo score of 6-12 (inclusive) at Screening.
- Endoscopic evidence of active mucosal disease, as assessed by flexible sigmoidoscopy, with an Endoscopic Finding Sub-score of ≥2 at Screening.
- Rectal Bleeding Sub-score of ≥1 at Screening.
- Physician's Global Assessment Sub-score of ≥2 at Screening.
- Male/female subjects who agree to practice effective methods of contraception
Who cannot join
- History of colonic or rectal surgery other than hemorrhoid surgery or appendectomy
- Currently receiving total parenteral nutrition
- Disease limited to ulcerative proctitis
- Diagnosed with Crohn's disease, indeterminate colitis, microscopic colitis or, ischemic or infectious colitis
- Known or suspected hypersensitivity to any component of the product
- Known human immunodeficiency virus (HIV) infection or other immunosuppressive disorder
Show all 9Show fewer
- Concurrently participating in another study or receiving other experimental or investigational therapies within past 3 months
- Females who are currently pregnant or lactating
- Any history of malignancy. Exceptions may apply for cervical cancer and some forms of skin cancer
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Alberta
Edmonton, Alberta
McMaster University
Hamilton, Ontario
GI Research Institute
Vancouver, British Columbia
About this study
Official title: An Open Label, Dose Ranging, Exploratory Study to Evaluate the Safety, Tolerability, Compliance, Mechanism of Action and Efficacy of QBECO Site Specific Immunomodulation for the Induction of Clinical Response and Remission in Subjects With Moderate to Severe Ulcerative Colitis
The purpose of this open-label, dose-ranging, exploratory study is to evaluate the safety, tolerability, compliance, mechanism of action and efficacy of QBECO site specific immunomodulation for the induction of clinical response and remission in subjects with moderate to severe ulcerative colitis
- Conditions
- Ulcerative Colitis
- Being tested
- QBECO SSI
- Keywords
- Ulcerative Colitis, Inflammatory Bowel Disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QBECO SSIBiological
QBECO Site Specific Immunomodulators
| Study group | Role | What they receive |
|---|---|---|
| QBECO SSI 0.02 mL | Experimental | 0.02 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks. Receives: Biological: QBECO SSI |
| QBECO SSI 0.05 mL | Experimental | 0.05 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks. Receives: Biological: QBECO SSI |
| QBECO SSI 0.1 mL | Experimental | 0.1 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks. Receives: Biological: QBECO SSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent AEs and clinically significant changes or abnormalities from physical examinations, vital signs and laboratory results (composite)
Measured: Day 1 to Week 56
Proportion of subjects in clinical remission
Mayo score ≤ 2 points, with no individual subscore >1
Measured: Week 52
Secondary outcomes (3)
Proportion of subjects in clinical remission
Mayo score ≤ 2 points, with no individual subscore >1
Measured: Week 16
Proportion of subjects with a clinical response
A decrease of the Mayo score from screening of at least 3 points and at least 30%, AND either a decrease from the pre-treatment screening sub-score for rectal bleeding of at least 1 point, OR rectal bleeding sub-score of 0 or 1
Measured: Week 16
Proportion of subjects with a clinical response
A decrease of the Mayo score from screening of at least 3 points and at least 30%, AND either a decrease from the pre-treatment screening sub-score for rectal bleeding of at least 1 point, OR rectal bleeding sub-score of 0 or 1
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qu Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Qu Biologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426372
- Sponsor's protocol ID
- QBECO-UC-01
- Status last verified
- Aug 2017
- First submitted
- 21 Apr 2015
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Dose Ranging, Exploratory Study to Evaluate the Safety, Tolerability, Compliance, Mechanism of Action and Efficacy of QBECO Site Specific Immunomodulation for the Induction of Clinical Response and Remission in Subjects With Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02426372
- Acronym / sponsor ID
- QBECO-UC-01
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Inflammatory Bowel Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Qu Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Apr 2015 (estimated)
- 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.
The purpose of this open-label, dose-ranging, exploratory study is to evaluate the safety, tolerability, compliance, mechanism of action and efficacy of QBECO site specific immunomodulation for the induction of clinical response and remission in subjects with moderate to severe ulcerative colitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QBECO SSI 0.02 mL | Experimental | Biological: QBECO SSI0.02 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks. |
| QBECO SSI 0.05 mL | Experimental | Biological: QBECO SSI0.05 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks. |
| QBECO SSI 0.1 mL | Experimental | Biological: QBECO SSI0.1 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects who have reached age of majority
- Willing to learn and able to self-administer study drug
- Diagnosis of UC established at least 6 months before screening visit, by clinical and endoscopic evidence.
- Currently experiencing moderate to severe active UC defined as a Mayo score of 6-12 (inclusive) at Screening.
- Endoscopic evidence of active mucosal disease, as assessed by flexible sigmoidoscopy, with an Endoscopic Finding Sub-score of ≥2 at Screening.
Key exclusion criteria (9 listed)
- History of colonic or rectal surgery other than hemorrhoid surgery or appendectomy
- Currently receiving total parenteral nutrition
- Disease limited to ulcerative proctitis
- Diagnosed with Crohn's disease, indeterminate colitis, microscopic colitis or, ischemic or infectious colitis
- Known or suspected hypersensitivity to any component of the product
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 |
|---|---|---|
| QBECO SSIQBECO Site Specific Immunomodulators | Biological | QBECO SSI 0.02 mL, QBECO SSI 0.05 mL, QBECO SSI 0.1 mL |
Primary outcome
Incidence of treatment emergent AEs and clinically significant changes or abnormalities from physical examinations, vital signs and laboratory results (composite)
Time frame: Day 1 to Week 56
Proportion of subjects in clinical remission
Time frame: Week 52
Mayo score ≤ 2 points, with no individual subscore >1
3 secondary outcomes
Proportion of subjects in clinical remission
Time frame: Week 16
Proportion of subjects with a clinical response
Time frame: Week 16
Proportion of subjects with a clinical response
Time frame: Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
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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.
Study Director study director
Qu Biologics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QBECO SSI in people with Ulcerative Colitis, run by Qu Biologics Inc. at 3 sites in Canada.
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 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: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment emergent AEs and clinically significant changes or abnormalities from physical examinations, vital signs and laboratory results (composite) (time frame: Day 1 to Week 56). The study lists 2 primary outcomes in all. 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 24 Aug 2017.