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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-07-31

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.

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Detailed Description

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Conditions

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Crohn's Disease Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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QBECO

Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks

Group Type EXPERIMENTAL

QBECO

Intervention Type DRUG

Placebo

Individualized maintenance dose ranging from 0.01 - 0.2 mL, administered subcutaneously, every other day for a maximum of 16 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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QBECO

Intervention Type DRUG

Placebo

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No