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

Qu Biologics Inc.4 sites in 1 country68 target enrollmentMarch 2013

ConditionsCrohn's Disease Inflammatory Bowel Disease

InterventionsQBECO Placebo

DrugsQBECO Placebo

Overview

Phase: Phase 1
Intervention: QBECO
Conditions: Crohn's Disease
Sponsor: Qu Biologics Inc.
Enrollment: 68
Locations: 4
Primary Endpoint: Clinical improvement
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

July 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Qu Biologics Inc.

Responsible Party

Sponsor

Eligibility Criteria

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