Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's Disease
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
1 other identifier
interventional
68
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2013
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 8, 2013
CompletedFirst Posted
Study publicly available on registry
March 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 23, 2016
August 1, 2016
2.9 years
March 8, 2013
August 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety
Assessing adverse events, concomitant therapies, clinical chemistry, hematology, urinalysis chemistry
8 weeks
Clinical improvement
Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline
8 weeks
Secondary Outcomes (4)
Clinical remission
8 weeks
Clinical response
8 weeks
Intestinal inflammation
8 weeks
Systemic inflammation
8 weeks
Study Arms (2)
QBECO
EXPERIMENTALIndividualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks
Placebo
PLACEBO COMPARATORIndividualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
University of Alberta Zeidler Ledcor Centre
Edmonton, Alberta, T6G 2X8, Canada
GI Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
Toronto Digestive Disease Associates
Vaughan, Ontario, L4L 4Y7, Canada
Related Publications (1)
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.
PMID: 31380382DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
M D
Qu Biologics Inc.
- PRINCIPAL INVESTIGATOR
M D
GI Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2013
First Posted
March 12, 2013
Study Start
March 1, 2013
Primary Completion
February 1, 2016
Study Completion
July 1, 2016
Last Updated
August 23, 2016
Record last verified: 2016-08