Crohn's DiseasePhase 1/2NCT01809275
Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's Disease
A Phase 1/2 study testing QBECO in people with Crohn's Disease and Inflammatory Bowel Disease, run by Qu Biologics Inc. at 4 sites in Canada.
Trial summary
The purpose of this study is to evaluate the safety profile and to obtain an indication as to the therapeutic effect of QBECO induction treatment on clinical improvement in moderate to severe Crohn's Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Inflammatory Bowel Disease
- What is being tested?
- QBECO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 4 sitesCanada
- Study dates
- Mar 2013to Jul 2016
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An adult, age 18 and above
- Diagnosed with Crohn's disease AT LEAST six (6) months prior to screening
- Crohn's disease diagnosis was verified by one of these procedures: 1) Colonoscopy 2) Capsule endoscopy 3) Computed Tomography (CT) scan 4) Magnetic Resonance Imaging (MRI) 5) Ultrasound
- Active Crohn's disease at the time of screening
- Female participants: Agree to practice two effective methods of contraception, at the same time, from the time of signing the informed consent form, during the entire study treatment and for two (2) months after taking the last dose of study treatment.
- Male participants: Agree to practice effective barrier contraception during the entire study treatment period and for two (2) months after taking the last dose of study treatment.
Who cannot join
- Currently pregnant or breastfeeding
- Have known or suspected hypersensitivity to any component of the product
- Had more than three (3) small bowel resections or diagnosis of short bowel syndrome
- Currently anticipate undergoing any major surgical intervention for Crohn's disease during the next six (6) months
- Previously been treated with any Qu Biologics' Site Specific Immunomodulators (SSIs) for any disease
- Diagnosed with chronic (i.e., long term) hepatitis B or C infection
Show all 10Show fewer
- Diagnosed with congenital (i.e., existing at or before birth) or acquired immunodeficiency (i.e., lack of body defense system). For example, human immunodeficiency virus (HIV) infection, organ transplantation (i.e., specifically received an organ from a donor), etc.
- Daily use of narcotic drugs containing opiates (such as morphine, codeine, etc.) for pain control
- Have a current or recent history (within the past 12 months) of alcohol dependence or illicit drug use, with the exception of medicinal marijuana prescribed by a physician
- Have a history of cancer within the last five (5) years. Exceptions may apply for cervical cancer and some forms of skin cancer
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
University of Alberta Zeidler Ledcor Centre
Edmonton, Alberta, T6G 2X8
GI Research Institute
Vancouver, British Columbia, V6Z 2K5
Toronto Digestive Disease Associates
Vaughan, Ontario, L4L 4Y7
About this study
Official title: A Phase 1/2 Randomized, Placebo-Controlled, Double-Blind Study of the Induction of Clinical Response and Remission by QBECO in Subjects With Moderate to Severe Crohn's Disease
The purpose of this study is to evaluate the safety profile and to obtain an indication as to the therapeutic effect of QBECO induction treatment on clinical improvement in moderate to severe Crohn's Disease.
- Conditions
- Crohn's Disease, Inflammatory Bowel Disease
- Being tested
- QBECO, Placebo
- Keywords
- Crohn's Disease, Inflammatory Bowel Disease, CDAI
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QBECODrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| QBECO | Experimental | Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks Receives: Drug: QBECO |
| Placebo | Placebo comparator | Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Assessing adverse events, concomitant therapies, clinical chemistry, hematology, urinalysis chemistry
Measured: 8 weeks
Clinical improvement
Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline
Measured: 8 weeks
Secondary outcomes (4)
Clinical remission
Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline
Measured: 8 weeks
Clinical response
Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline
Measured: 8 weeks
Intestinal inflammation
Assessing the change in fecal calprotectin from baseline
Measured: 8 weeks
Systemic inflammation
Assessing the change in C-reactive protein (CRP) from baseline
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qu Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M D, Study director, Qu Biologics Inc.M D, Principal investigator, GI Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809275
- Sponsor's protocol ID
- QBECO-01
- Status last verified
- Aug 2016
- First submitted
- 8 Mar 2013
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sutcliffe S, Kalyan S, Pankovich J, Chen JMH, Gluck R, Thompson D, Bosiljcic M, Bazett M, Fedorak RN, Panaccione R, Axler J, Marshall JK, Mullins DW, Kabakchiev B, McGovern DPB, Jang J, Coldman A, Vandermeirsch G, Bressler B, Gunn H. Novel Microbial-Based Immunotherapy Approach for Crohn's Disease. Front Med (Lausanne). 2019 Jul 19;6:170. doi: 10.3389/fmed.2019.00170. eCollection 2019.
PubMed 31380382
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Randomized, Placebo-Controlled, Double-Blind Study of the Induction of Clinical Response and Remission by QBECO in Subjects With Moderate to Severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT01809275
- Acronym / sponsor ID
- QBECO-01
- Conditions
- Crohn's Disease, Inflammatory Bowel Disease
- Keywords
- Crohn's Disease, Inflammatory Bowel Disease, CDAI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Qu Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 Mar 2013 (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 study is to evaluate the safety profile and to obtain an indication as to the therapeutic effect of QBECO induction treatment on clinical improvement in moderate to severe Crohn's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QBECO | Experimental | Drug: QBECOIndividualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks |
| Placebo | Placebo comparator | Drug: PlaceboIndividualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- An adult, age 18 and above
- Diagnosed with Crohn's disease AT LEAST six (6) months prior to screening
- Crohn's disease diagnosis was verified by one of these procedures: 1) Colonoscopy 2) Capsule endoscopy 3) Computed Tomography (CT) scan 4) Magnetic Resonance Imaging (MRI) 5) Ultrasound
- Active Crohn's disease at the time of screening
- Female participants: Agree to practice two effective methods of contraception, at the same time, from the time of signing the informed consent form, during the entire study treatment and for two (2) months after taking the last dose of study treatment.
Key exclusion criteria (10 listed)
- Currently pregnant or breastfeeding
- Have known or suspected hypersensitivity to any component of the product
- Had more than three (3) small bowel resections or diagnosis of short bowel syndrome
- Currently anticipate undergoing any major surgical intervention for Crohn's disease during the next six (6) months
- Previously been treated with any Qu Biologics' Site Specific Immunomodulators (SSIs) for any disease
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 | Drug | QBECO |
| Placebo | Drug | Placebo |
Primary outcome
Safety
Time frame: 8 weeks
Assessing adverse events, concomitant therapies, clinical chemistry, hematology, urinalysis chemistry
Clinical improvement
Time frame: 8 weeks
Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline
4 secondary outcomes
Clinical remission
Time frame: 8 weeks
Clinical response
Time frame: 8 weeks
Intestinal inflammation
Time frame: 8 weeks
Systemic inflammation
Time frame: 8 weeks
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 23 Aug 2016.
- Derived from this study: PubMed 31380382Sutcliffe S, Kalyan S, Pankovich J, Chen JMH, Gluck R, Thompson D, Bosiljcic M, Bazett M, Fedorak RN, Panaccione R, Axler J, Marshall JK, Mullins DW, Kabakchiev B, McGovern DPB, Jang J, Coldman A, Vandermeirsch G, Bressler B, Gunn H. Novel Microbial-Based Immunotherapy Approach for Crohn's Disease. Front Med (Lausanne). 2019 Jul 19;6:170. doi: 10.3389/fmed.2019.00170. eCollection 2019.
- Informational website for this trialLink provided by the sponsor.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
M D study director
Qu Biologics Inc.
M D principal investigator
GI Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QBECO in people with Crohn's Disease and Inflammatory Bowel Disease, run by Qu Biologics Inc. at 4 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 6 inclusion and 10 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 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 combined 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.
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?
Safety (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT01809275, which also lists 1 linked publication.
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 23 Aug 2016.