Crohn DiseasePhase 2NCT03472690
QBECO SSI for Clinical and Endoscopic Remission in Moderate to Severe Crohn's Disease
A Phase 2 study testing QBECO-SSI in people with Crohn Disease, run by Qu Biologics Inc. at 3 sites in Canada.
Trial summary
The QBECO-CD-02 trial in subjects with moderate to severe Crohn's disease (CD) is intended to build on past experience with QBECO SSI and further establish the safety and efficacy of QBECO SSI for the induction of clinical and/or endoscopic response and remission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- QBECO-SSI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 3 sitesCanada
- Study dates
- 25 Jun 2018to 25 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have an established diagnosis of ileal, ileocolonic or colonic CD of at least 3 months duration prior to planned initial dose as determined by endoscopic imaging.
- Participants with a recorded Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥7 at screening. Subjects with ileitis only will require SES-CD score ≥4.
- Participants with:
- a minimum total abdominal pain score above 21 for 7 consecutive days during the screening period, as rated on an 11-point numeric rating scale, OR
- a minimum total number of liquid/very soft stools above 10, (Type 6 or 7 as rated by the BSFS), for 7 consecutive days during the screening period.
- Participants may be receiving a therapeutic dose of the following medications:
Show all 17Show fewer
- Oral 5-ASA compounds provided that the dose has been stable for the 2 weeks immediately before screening visit.
- Oral corticosteroid therapy (prednisone at a stable dose ≤ 30 mg/day, budesonide at a stable dose ≤ 9 mg/day, or equivalent steroid) provided that the dose has been stable for the 2 weeks before screening visit.
- Probiotics provided that the dose has been stable for the 2 weeks immediately before screening visit.
- Anti-diarrheal medications (e.g., loperamide, diphenoxylate with atropine) for control of chronic diarrhoea.
- Azathioprine or 6-MP provided that the dose has been stable for the 8 weeks immediately before screening visit.
- Methotrexate provided that the dose has been stable for the 8 weeks immediately before screening visit.
- Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole) provided that the dose has been stable for at least 2 weeks before screening visit.
- All men must agree to use contraception during the treatment period and for at least 2 months after the last dose of study medication and refrain from donating sperm during this period.
- Women will be eligible to participate if they are not pregnant , not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR ii. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 2 months after the last dose of study medication.
- Capable of giving signed informed consent as described in Section 11.1.3 - Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Consent to genetic sample collection is not mandatory for inclusion.
Who cannot join
- Medical Conditions
- Evidence of abdominal abscess during screening.
- Extensive colonic resection or subtotal or total colectomy.
- Diagnosis of short bowel syndrome.
- Have received tube feeding, defined formula diets, or parenteral alimentation within 21 days before screening visit.
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
Show all 46Show fewer
- Evidence of or treatment for C. difficile infection or other intestinal pathogen within 28 days before screening visit.
- Currently require or are anticipated to require major surgical intervention for CD (e.g., bowel resection) during the first 26 weeks of the study.
- History or evidence of adenomatous colonic polyps that have not been removed.
- Chronic hepatitis B or C infection.
- Any identified congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, human immunodeficiency virus infection, organ transplantation).
- Any live vaccinations within 30 days before screening visit except for the influenza vaccine.
- Women who are lactating or have a positive urine pregnancy test during the Screening period.
- Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, haematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the Investigator, would confound the study results or compromise subject safety.
- Any surgical procedure requiring general (e.g., endotracheal) anaesthesia within 30 days before screening visit or is planning to undergo major surgery during the first 26 weeks of the study.
- A current or recent colorectal histopathology report that shows positive dysplasia within the past 3 years from final screening visit.
- Any history of malignancy, except for the following: (a) adequately-treated non-metastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year before screening visit; and (c) history of cervical carcinoma that has been adequately treated and that has not recurred for at least 3 years before screening visit. Subjects with remote history of malignancy (e.g., > 5 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with Qu Biologics' sponsor on a case-by-case basis before enrolment.
- Prior Concomitant therapy
- Within 30 days before screening visit, have received any of the following for the treatment of underlying disease:
- Non-biologic therapies (e.g., cyclosporine, thalidomide) other than those specifically listed above
- A non-biologic investigational therapy
- An approved non-biologic therapy in an investigational protocol
- Within 60 days before screening visit, have received any of the following:
- Infliximab
- Adalimumab
- Certolizumab pegol
- Any other investigational or approved biological agent, other than local administration for non-IBD conditions (e.g., intra-ocular injections)
- Use of topical (rectal) treatment with 5-ASA or corticosteroid enema/suppositories within 2 weeks before screening visit.
- Diagnostic assessments
- Any of the following laboratory abnormalities during the Screening period:
- Haemoglobin level < 9 g/dL (90 g/L)
- White blood cell (WBC) count < 3 x 103/µL (3 x 109/L)
- Lymphocyte count < 0.5 x 103/µL (0.5 x 109/L)
- Platelet count < 100 x 103/µL (100 x 109/L) or > 1200 x 103/µL (1200 x 109/L)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x the upper limit of normal (ULN)
- Alkaline Phosphatase > 3 x ULN
- Serum creatinine > 2 x ULN
- Albumin < 2.0 g/dL (< 20 g/L)
- Prior/Concurrent Clinical Study Experience
- Previous exposure to QBECO SSI or any other Qu Biologics' SSI.
- Other Exclusions
- Known or suspected hypersensitivity to any component of the study treatment (i.e., killed whole cell bacterial vaccines).
- Daily use of narcotic drugs containing opiates (such as morphine, codeine, etc.) for pain control.
- A current or recent diagnosis (within the past 12 months) of alcohol dependence or illicit drug use, with the exception of medicinal marijuana prescribed by a physician.
- Active psychiatric problems that, in the Investigator's opinion, may interfere with compliance with the study procedures.
- Unable to attend all the study visits or comply with study procedures.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
McMaster University Medical Centre
Hamilton, Ontario, L8S 4K1
Fraser Clinical Trials
New Westminster, British Columbia, V3L3W4
G.I. Research Institute
Vancouver, British Columbia, V6Z 2K5
About this study
Official title: A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects With Moderate to Severe Crohn's Disease
The QBECO-CD-02 trial in subjects with moderate to severe Crohn's disease (CD) is intended to build on past experience with QBECO SSI and further establish the safety and efficacy of QBECO SSI for the induction of clinical and/or endoscopic response and remission.
The study will be conducted in three stages; a Lead-in, Main Induction and Main Maintenance .The first 20 patients will be enrolled in the Lead-in study, at approximately 5 study centers in Canada. Subsequent patients will be enrolled in the Main study, which aims to enroll 150 patients. The Lead-in component will be an open-label study to evaluate endoscopic healing endpoints. The Main Induction study will be randomized and placebo-controlled. Participants meeting response criteria following the Main Induction study will be eligible to continue into the Main Maintenance study, remaining on their initially randomized treatment. Participants not meeting response criteria will complete their follow-up and study involvement at the end of the Main Induction.
Read the detailed description
The QBECO-CD-02 trial in subjects with moderate to severe Crohn's disease (CD) is intended to build on past experience with QBECO SSI and further establish the safety and efficacy of QBECO SSI for the induction of clinical and/or endoscopic response and remission.
- Overall Design:
Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe Crohn's disease to establish the safety and efficacy of QBECO SSI for the induction and maintenance of clinical and/or endoscopic response and remission. The study will be conducted in three stages; a Lead-in, Main Induction and Main Maintenance . The first 20 patients will be enrolled in the Lead-in study, at selected study centers. Subsequent patients will be enrolled in the Main study. The Lead-in component will be an open-label study to evaluate endoscopic healing endpoints. The Main Induction study will be randomized and placebo-controlled. Participants meeting response criteria following the Main Induction study will be eligible to continue into the Main Maintenance study, remaining on their initially randomized treatment. Participants not meeting response criteria will complete their follow-up and study involvement at the end of the Main Induction.
Primary Endpoints will be evaluated at various times throughout each stage of the study. In the Lead-In study, primary endpoints will be measured at Week 16 and 26 for determination of the induction duration and again at Week 52 as initial data on maintenance. In the Main Induction, the primary endpoints will be assessed when the last subject completes the induction period, either Week 16 or Week 26 depending on the finding of the Lead-In. In the Main Maintenance, the primary endpoints will be measured at Week 52. Safety Assessments will be carried out throughout the study and at the Week 56 visits for all subjects completing the study.
The study will be run at approximately 50 study centers in Canada, the United States of America and Eastern Europe.
ii. Number of Participants:
20 participants will be enrolled in the Lead-In study. No Lead-In study participants will be enrolled in the Main Induction or Maintenance component of the study.
150 participants will be randomized to the Main Induction study, resulting in an estimated total of 70 subjects proceeding to the Main Maintenance component of the study.
iii. Intervention Groups and Duration:
Approximately 170 adult subjects (N=170) with moderate to severe CD, 20 patients in the Lead-In study and 150 patients in the Main study, stratified by prior anti-TNFα inhibitor/ biologic therapy use. Patients will be randomized 2:1, active drug:placebo, and will receive 52 weeks of QBECO SSI treatment or placebo.
iv. Objectives and Endpoints:
Lead-In:
- Primary
- To determine whether Week 26 provides superior endoscopic healing outcomes compared to Week 16
- To evaluate the incidence of adverse events (safety \& tolerability) as measured by frequency and severity of adverse events.
- Secondary
- To determine the effect of QBECO SSI on endoscopic remission at the end of 52 weeks of treatment
- To determine the effect of QBECO SSI on clinical remission, as measured by abdominal pain and soft-stool frequency, at the end of the induction period
Main:
- Induction:
- Primary
- To determine the effect of QBECO SSI on clinical remission, as measured by abdominal pain and soft-stool frequency, at the end of the induction period
- To determine the effect of QBECO SSI on endoscopic remission at the end of the induction period
- To evaluate the incidence of adverse events (safety and tolerability) as measured by frequency and severity of adverse events.
- Secondary
- To determine the effect of QBECO SSI on abdominal pain score at the end of the induction period (i.e., change from baseline)
- To determine the effect of QBECO SSI on soft-stool score at the end of the induction period (i.e., change from baseline)
- To determine the effect of QBECO SSI on endoscopic response at the end of the induction period
- To determine the effect of QBECO SSI on Simple Endoscopic Score for Crohn's Disease (SES-CD) scores at the end of the induction period as defined by SES-CD reduction by ≥25% and ≥75% and change from baseline
- To determine the effect of QBECO SSI on histological activity at the end of induction period as defined by 25%, 50% and 75% reduction in global colonic Global Histologic Disease Activity Score (GHAS) and Robarts Histological Index (RHI)
- To determine the effect of QBECO SSI on simultaneous clinical and endoscopic remission at the end of the induction period
- Maintenance:
- Primary
- To determine the effect of QBECO SSI on clinical remission, as measured by abdominal pain and soft-stool frequency, at the end of the maintenance period
- To determine the effect of QBECO SSI on endoscopic remission at the end of the maintenance period
- To determine the safety and tolerability of QBECO SSI treatment, as measured by safety laboratory assessments, vital signs, frequency and severity of adverse events and physical examinations.
- Secondary
- To determine the effect of QBECO SSI on clinical remission and endoscopic remission among subjects who were in clinical or endoscopic remission at the end of induction.
- To determine the effect of QBECO SSI on abdominal pain score at the end of maintenance period (i.e., change from baseline)
- To determine the effect of QBECO SSI on soft-stool score at the end of maintenance period (i.e., change from baseline)To determine the effect of QBECO SSI on endoscopic response at the end of the maintenance period
- To determine the effect of QBECO SSI on SES-CD scores at the end of the maintenance period as defined by SES-CD reduction by ≥25% and ≥75% and change from BL
- To determine the effect of QBECO SSI on histological activity of CD patients at the end of the maintenance period as defined by 25%, 50% and 75% reduction in global colonic GHAS and RHI
- To determine the effect of QBECO SSI on simultaneous clinical and endoscopic remission at the end of the maintenance period
- Conditions
- Crohn Disease
- Being tested
- QBECO-SSI, Placebo
- Keywords
- Inflammatory Bowel Disease 1
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QBECO-SSIBiological
Subcutaneous injection
PlaceboOther
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | 0.1 mL, self-administered subcutaneous injection, every second day Receives: Biological: QBECO-SSI |
| Placebo | Placebo comparator | 0.1 mL, self-administered subcutaneous injection, every second day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead-In: Selection of Induction Point
To determine whether Week 26 provides superior endoscopic healing outcomes compared to Week 16
Measured: week 26
Main: Clinical Remission at Induction
To determine the effect of QBECO SSI on clinical remission, as measured by abdominal pain and soft-stool frequency, at the end of the induction period
Measured: week 16 or 26
Main: Endoscopic Remission (SES-CD score of 0-2) at Induction
To determine the effect of QBECO SSI on endoscopic remission at the end of the induction period
Measured: week 16 or 26
Main: Clinical Remission
To determine the effect of QBECO SSI on clinical remission, as measured by abdominal pain and soft-stool frequency, at the end of the maintenance period
Measured: week 52
Main: Endoscopic Remission (SES-CD score of 0-2)
To determine the effect of QBECO SSI on endoscopic remission at the end of the maintenance period
Measured: week 52
Incidence of Adverse events (Safety Evaluation)
To evaluate the incidence of adverse events (safety and tolerability) as measured by frequency and severity of adverse events.
Measured: week 56
Secondary outcomes (11)
Lead-in: Endoscopic remission (SES-CD score of 0-2)
To determine the effect of QBECO SSI on endoscopic remission at the end of 52 weeks of treatment
Measured: week 52
Main: Endoscopic Remission (SES-CD score of 0-2) Subpopulation
To determine the effect of QBECO SSI on endoscopic remission among subjects who were in clinical or endoscopic remission at the end of induction.
Measured: week 52
Main: Clinical Remission Subpopulation
To determine the effect of QBECO SSI on clinical remission among subjects who were in clinical or endoscopic remission at the end of induction.
Measured: week 52
Main: Abdominal Pain (11-point numerical rating scale (from 0 (no pain) to 10 (maximum pain)))
To determine the effect of QBECO SSI on abdominal pain score at the end of maintenance period (i.e., change from baseline)
Measured: week 52
Main: Soft-stool Score
To determine the effect of QBECO SSI on soft-stool score at the end of maintenance period (i.e., change from baseline)
Measured: week 52
Main: Abdominal Pain (11-point numerical rating scale (from 0 (no pain) to 10 (maximum pain))) at Induction
To determine the effect of QBECO SSI on abdominal pain score at the end of the induction period (i.e., change from baseline)
Measured: week 16 or 26
Main: Soft-stool score at Induction
To determine the effect of QBECO SSI on soft-stool score at the end of the induction period (i.e., change from baseline)
Measured: week 16 or 26
Main: SES-CD Scores
To determine the effect of QBECO SSI on SES-CD scores at the end of the maintenance period as defined by SES-CD reduction by ≥25% and ≥75% and change from baseline
Measured: week 52
Main: Histological Activity
To determine the effect of QBECO SSI on histological activity of CD patients at the end of the maintenance period as defined by 25%, 50% and 75% reduction in global colonic Global Histologic Disease Activity Score (GHAS) and Robarts Histological Index (RHI)
Measured: week 52
Main: SES-CD Scores at Induction
To determine the effect of QBECO SSI on SES-CD scores at the end of the induction period as defined by SES-CD reduction by ≥25% and ≥75% and change from baseline
Measured: week 16 or 26
Main: Histological Activity at Induction
To determine the effect of QBECO SSI on histological activity of CD patients at the end of the induction period as defined by 25%, 50% and 75% reduction in global colonic Global Histologic Disease Activity Score (GHAS) and Robarts Histological Index (RHI)
Measured: week 16 or 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start25 Jun 2018
- Primary completion20 Dec 2020
- Study completion25 Feb 2021
Why it stopped: Corporate Decision to terminate study after Lead-In portion of the study completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qu Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472690
- Sponsor's protocol ID
- QBECO-CD-02
- Status last verified
- May 2021
- First submitted
- 8 Mar 2018
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects With Moderate to Severe Crohn's Disease
- ClinicalTrials.gov ID
- NCT03472690
- Acronym / sponsor ID
- QBECO-CD-02
- Conditions
- Crohn Disease
- Keywords
- Inflammatory Bowel Disease 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Corporate Decision to terminate study after Lead-In portion of the study completed.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Qu Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 21 Mar 2018 (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.
The QBECO-CD-02 trial in subjects with moderate to severe Crohn's disease (CD) is intended to build on past experience with QBECO SSI and further establish the safety and efficacy of QBECO SSI for the induction of clinical and/or endoscopic response and remission.
The study will be conducted in three stages; a Lead-in, Main Induction and Main Maintenance .The first 20 patients will be enrolled in the Lead-in study, at approximately 5 study centers in Canada. Subsequent patients will be enrolled in the Main study, which aims to enroll 150 patients. The Lead-in component will be an open-label study to evaluate endoscopic healing endpoints. The Main Induction study will be randomized and placebo-controlled. Participants meeting response criteria following the Main Induction study will be eligible to continue into the Main Maintenance study, remaining on their initially randomized treatment. Participants not meeting response criteria will complete their follow-up and study involvement at the end of the Main Induction.
Detailed description
The QBECO-CD-02 trial in subjects with moderate to severe Crohn's disease (CD) is intended to build on past experience with QBECO SSI and further establish the safety and efficacy of QBECO SSI for the induction of clinical and/or endoscopic response and remission.
- Overall Design:
Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe Crohn's disease to establish the safety and efficacy of QBECO SSI for the induction and maintenance of clinical and/or endoscopic response and remission. The study will be conducted in three stages; a Lead-in, Main Induction and Main Maintenance . The first 20 patients will be enrolled in the Lead-in study, at selected study centers. Subsequent patients will be enrolled in the Main study. The Lead-in component will be an open-label study to evaluate endoscopic healing endpoints. The Main Induction study will be randomized and placebo-controlled. Participants meeting response criteria following the Main Induction study will be eligible to continue into the Main Maintenance study, remaining on their initially randomized treatment. Participants not meeting response criteria will complete their follow-up and study involvement at the end of the Main Induction.
Primary Endpoints will be evaluated at various times throughout each stage of the study. In the Lead-In study, primary endpoints will be measured at Week 16 and 26 for determination of the induction duration and again at Week 52 as initial data on maintenance. In the Main Induction, the primary endpoints will be assessed when the last subject completes the induction period, either Week 16 or Week 26 depending on the finding of the Lead-In. In the Main Maintenance, the primary endpoints will be measured at Week 52. Safety Assessments will be carried out throughout the study and at the Week 56 visits for all subjects completing the study.
The study will be run at approximately 50 study centers in Canada, the United States of America and Eastern Europe.
ii. Number of Participants:
20 participants will be enrolled in the Lead-In study. No Lead-In study participants will be enrolled in the Main Induction or Maintenance component of the study.
150 participants will be randomized to the Main Induction study, resulting in an estimated total of 70 subjects proceeding to the Main Maintenance component of the study.
iii. Intervention Groups and Duration:
Approximately 170 adult subjects (N=170) with moderate to severe CD, 20 patients in the Lead-In study and 150 patients in the Main study, stratified by prior anti-TNFα inhibitor/ biologic therapy use. Patients will be randomized 2:1, active drug:placebo, and will receive 52 weeks of QBECO SSI treatment or placebo.
iv. Objectives and Endpoints:
Lead-In:
- Primary
- To determine whether Week 26 provides superior endoscopic healing outcomes compared to Week 16
- To evaluate the incidence of adverse events (safety \& tolerability) as measured by frequency and severity of adverse events.
- Secondary
- To determine the effect of QBECO SSI on endoscopic remission at the end of 52 weeks of treatment
- To determine the effect of QBECO SSI on clinical remission, as measured by abdominal pain and soft-stool frequency, at the end of the induction period
Main:
- Induction:
- Primary
- To determine the effect of QBECO SSI on clinical remission, as measured by abdominal pain and soft-stool frequency, at the end of the induction period
- To determine the effect of QBECO SSI on endoscopic remission at the end of the induction period
- To evaluate the incidence of adverse events (safety and tolerability) as measured by frequency and severity of adverse events.
- Secondary
- To determine the effect of QBECO SSI on abdominal pain score at the end of the induction period (i.e., change from baseline)
- To determine the effect of QBECO SSI on soft-stool score at the end of the induction period (i.e., change from baseline)
- To determine the effect of QBECO SSI on endoscopic response at the end of the induction period
- To determine the effect of QBECO SSI on Simple Endoscopic Score for Crohn's Disease (SES-CD) scores at the end of the induction period as defined by SES-CD reduction by ≥25% and ≥75% and change from baseline
- To determine the effect of QBECO SSI on histological activity at the end of induction period as defined by 25%, 50% and 75% reduction in global colonic Global Histologic Disease Activity Score (GHAS) and Robarts Histological Index (RHI)
- To determine the effect of QBECO SSI on simultaneous clinical and endoscopic remission at the end of the induction period
- Maintenance:
- Primary
- To determine the effect of QBECO SSI on clinical remission, as measured by abdominal pain and soft-stool frequency, at the end of the maintenance period
- To determine the effect of QBECO SSI on endoscopic remission at the end of the maintenance period
- To determine the safety and tolerability of QBECO SSI treatment, as measured by safety laboratory assessments, vital signs, frequency and severity of adverse events and physical examinations.
- Secondary
- To determine the effect of QBECO SSI on clinical remission and endoscopic remission among subjects who were in clinical or endoscopic remission at the end of induction.
- To determine the effect of QBECO SSI on abdominal pain score at the end of maintenance period (i.e., change from baseline)
- To determine the effect of QBECO SSI on soft-stool score at the end of maintenance period (i.e., change from baseline)To determine the effect of QBECO SSI on endoscopic response at the end of the maintenance period
- To determine the effect of QBECO SSI on SES-CD scores at the end of the maintenance period as defined by SES-CD reduction by ≥25% and ≥75% and change from BL
- To determine the effect of QBECO SSI on histological activity of CD patients at the end of the maintenance period as defined by 25%, 50% and 75% reduction in global colonic GHAS and RHI
- To determine the effect of QBECO SSI on simultaneous clinical and endoscopic remission at the end of the maintenance period
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 |
|---|---|---|
| Active | Experimental | Biological: QBECO-SSI0.1 mL, self-administered subcutaneous injection, every second day |
| Placebo | Placebo comparator | Other: Placebo0.1 mL, self-administered subcutaneous injection, every second day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participants who have an established diagnosis of ileal, ileocolonic or colonic CD of at least 3 months duration prior to planned initial dose as determined by endoscopic imaging.
- Participants with a recorded Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥7 at screening. Subjects with ileitis only will require SES-CD score ≥4.
- Participants with:
- Participants may be receiving a therapeutic dose of the following medications:
- All men must agree to use contraception during the treatment period and for at least 2 months after the last dose of study medication and refrain from donating sperm during this period.
Key exclusion criteria (46 listed)
- Medical Conditions
- Prior Concomitant therapy
- Diagnostic assessments
- Prior/Concurrent Clinical Study Experience
- Other Exclusions
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-SSISubcutaneous injection | Biological | Active |
| PlaceboSubcutaneous injection | Other | Placebo |
Primary outcome
Lead-In: Selection of Induction Point
Time frame: week 26
To determine whether Week 26 provides superior endoscopic healing outcomes compared to Week 16
Main: Clinical Remission at Induction
Time frame: week 16 or 26
To determine the effect of QBECO SSI on clinical remission, as measured by abdominal pain and soft-stool frequency, at the end of the induction period
Main: Endoscopic Remission (SES-CD score of 0-2) at Induction
Time frame: week 16 or 26
To determine the effect of QBECO SSI on endoscopic remission at the end of the induction period
Main: Clinical Remission
Time frame: week 52
To determine the effect of QBECO SSI on clinical remission, as measured by abdominal pain and soft-stool frequency, at the end of the maintenance period
Main: Endoscopic Remission (SES-CD score of 0-2)
Time frame: week 52
To determine the effect of QBECO SSI on endoscopic remission at the end of the maintenance period
Incidence of Adverse events (Safety Evaluation)
Time frame: week 56
To evaluate the incidence of adverse events (safety and tolerability) as measured by frequency and severity of adverse events.
11 secondary outcomes
Lead-in: Endoscopic remission (SES-CD score of 0-2)
Time frame: week 52
Main: Endoscopic Remission (SES-CD score of 0-2) Subpopulation
Time frame: week 52
Main: Clinical Remission Subpopulation
Time frame: week 52
Main: Abdominal Pain (11-point numerical rating scale (from 0 (no pain) to 10 (maximum pain)))
Time frame: week 52
Main: Soft-stool Score
Time frame: week 52
Main: Abdominal Pain (11-point numerical rating scale (from 0 (no pain) to 10 (maximum pain))) at Induction
Time frame: week 16 or 26
Main: Soft-stool score at Induction
Time frame: week 16 or 26
Main: SES-CD Scores
Time frame: week 52
Main: Histological Activity
Time frame: week 52
Main: SES-CD Scores at Induction
Time frame: week 16 or 26
Main: Histological Activity at Induction
Time frame: week 16 or 26
Results and safety
The study was stopped early (reason given: Corporate Decision to terminate study after Lead-In portion of the study completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- 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.
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 Crohn Disease, 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 17 inclusion and 46 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 18 May 2021. 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. 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?
The study was stopped early (reason given: Corporate Decision to terminate study after Lead-In portion of the study completed.). 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?
Lead-In: Selection of Induction Point (time frame: week 26). The study lists 6 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 18 May 2021.