Trial | NCT01809275  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    qbeco ...

  • Study Participants

    68
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.
Study Started
Mar 31
2013
Primary Completion
Feb 29
2016
Study Completion
Jul 31
2016
Last Update
Aug 23
2016
Estimate

Drug QBECO

Drug Placebo

QBECO Experimental

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

Placebo Placebo Comparator

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

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
No Results Posted