Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Crohn's Disease, Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: QBECO
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QBECO<br>Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks | Drug: QBECO<br> <br> |
| Placebo Comparator: Placebo<br>Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission | Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline | 8 weeks | 
| Clinical response | Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline | 8 weeks | 
| Intestinal inflammation | Assessing the change in fecal calprotectin from baseline | 8 weeks | 
| Systemic inflammation | Assessing the change in C-reactive protein (CRP) from baseline | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, Inflammatory Bowel Disease, CDAI