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

Primary Purpose

Crohn's Disease, Inflammatory Bowel Disease

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

QBECO

Placebo

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Inflammatory Bowel Disease, CDAI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Calgary
University of Alberta Zeidler Ledcor Centre
GI Research Institute
Toronto Digestive Disease Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

QBECO

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Safety

Assessing adverse events, concomitant therapies, clinical chemistry, hematology, urinalysis chemistry

Clinical improvement

Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline

Secondary Outcome Measures

Clinical remission

Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline

Clinical response

Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline

Intestinal inflammation

Assessing the change in fecal calprotectin from baseline

Systemic inflammation

Assessing the change in C-reactive protein (CRP) from baseline

Full Information

NCT ID

NCT01809275

First Posted

March 8, 2013

Last Updated

August 19, 2016

Sponsor

Qu Biologics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01809275

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qu Biologics Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease, Inflammatory Bowel Disease

Keywords

Crohn's Disease, Inflammatory Bowel Disease, CDAI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QBECO

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

QBECO

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Safety

Description

Assessing adverse events, concomitant therapies, clinical chemistry, hematology, urinalysis chemistry

Time Frame

8 weeks

Title

Clinical improvement

Description

Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Clinical remission

Description

Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline

Time Frame

8 weeks

Title

Clinical response

Description

Assessing the change in Crohn's Disease Activity Index (CDAI) from baseline

Time Frame

8 weeks

Title

Intestinal inflammation

Description

Assessing the change in fecal calprotectin from baseline

Time Frame

8 weeks

Title

Systemic inflammation

Description

Assessing the change in C-reactive protein (CRP) from baseline

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

M D

Organizational Affiliation

Qu Biologics Inc.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

M D

Organizational Affiliation

GI Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

University of Alberta Zeidler Ledcor Centre

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2X8

Country

Canada

Facility Name

GI Research Institute

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2K5

Country

Canada

Facility Name

Toronto Digestive Disease Associates

City

Vaughan

State/Province

Ontario

ZIP/Postal Code

L4L 4Y7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

31380382

Citation

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.

Results Reference

derived

Links:

URL

http://www.quibd.com

Description

Informational website for this trial

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

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