Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426372
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Qu Biologics Inc.

Tracking Information
First Submitted Date  ICMJE April 21, 2015
First Posted Date  ICMJE April 24, 2015
Last Update Posted Date August 24, 2017
Study Start Date  ICMJE July 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Incidence of treatment emergent AEs and clinically significant changes or abnormalities from physical examinations, vital signs and laboratory results (composite) [ Time Frame: Day 1 to Week 56 ]
  • Proportion of subjects in clinical remission [ Time Frame: Week 52 ]
    Mayo score ≤ 2 points, with no individual subscore >1
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2015)
  • Incidence of treatment emergent AEs and clinically significant changes or abnormalities from physical examinations, vital signs and laboratory results (composite) [ Time Frame: Day 1 to Week 44 ]
  • Proportion of subjects in clinical remission [ Time Frame: Week 40 ]
    Mayo score ≤ 2 points, with no individual subscore >1
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Proportion of subjects in clinical remission [ Time Frame: Week 16 ]
    Mayo score ≤ 2 points, with no individual subscore >1
  • Proportion of subjects with a clinical response [ Time Frame: Week 16 ]
    A decrease of the Mayo score from screening of at least 3 points and at least 30%, AND either a decrease from the pre-treatment screening sub-score for rectal bleeding of at least 1 point, OR rectal bleeding sub-score of 0 or 1
  • Proportion of subjects with a clinical response [ Time Frame: Week 52 ]
    A decrease of the Mayo score from screening of at least 3 points and at least 30%, AND either a decrease from the pre-treatment screening sub-score for rectal bleeding of at least 1 point, OR rectal bleeding sub-score of 0 or 1
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2015)
  • Proportion of subjects in clinical remission [ Time Frame: Week 8 ]
    Mayo score ≤ 2 points, with no individual subscore >1
  • Proportion of subjects with a clinical response [ Time Frame: Week 8 ]
    A decrease of the Mayo score from screening of at least 3 points and at least 30%, AND either a decrease from the pre-treatment screening sub-score for rectal bleeding of at least 1 point, OR rectal bleeding sub-score of 0 or 1
  • Proportion of subjects with a clinical response [ Time Frame: Week 40 ]
    A decrease of the Mayo score from screening of at least 3 points and at least 30%, AND either a decrease from the pre-treatment screening sub-score for rectal bleeding of at least 1 point, OR rectal bleeding sub-score of 0 or 1
Current Other Pre-specified Outcome Measures
 (submitted: November 16, 2015)
Exploratory variables are presence or absence of single nucleotide polymorphisms; changes in immunological biomarkers in blood and colonic tissue; and changes in GI microbiome. (composite) [ Time Frame: up to Week 52 ]
Original Other Pre-specified Outcome Measures
 (submitted: April 23, 2015)
Exploratory variables are presence or absence of single nucleotide polymorphisms; changes in immunological biomarkers in blood and colonic tissue; and changes in GI microbiome. (composite) [ Time Frame: up to Week 40 ]
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis
Official Title  ICMJE An Open Label, Dose Ranging, Exploratory Study to Evaluate the Safety, Tolerability, Compliance, Mechanism of Action and Efficacy of QBECO Site Specific Immunomodulation for the Induction of Clinical Response and Remission in Subjects With Moderate to Severe Ulcerative Colitis
Brief Summary The purpose of this open-label, dose-ranging, exploratory study is to evaluate the safety, tolerability, compliance, mechanism of action and efficacy of QBECO site specific immunomodulation for the induction of clinical response and remission in subjects with moderate to severe ulcerative colitis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Biological: QBECO SSI
QBECO Site Specific Immunomodulators
Study Arms  ICMJE
  • Experimental: QBECO SSI 0.02 mL
    0.02 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks.
    Intervention: Biological: QBECO SSI
  • Experimental: QBECO SSI 0.05 mL
    0.05 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks.
    Intervention: Biological: QBECO SSI
  • Experimental: QBECO SSI 0.1 mL
    0.1 mL administered subcutaneously, every other day for 16 weeks. After completion of the initial 16-week fixed dose treatment period, subjects deemed to be responders will be randomized to one of three maintenance dosing schedules (every second day, weekly, no treatment) for an additional 36 weeks.
    Intervention: Biological: QBECO SSI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 27, 2016)
11
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2015)
15
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects who have reached age of majority
  • Willing to learn and able to self-administer study drug
  • Diagnosis of UC established at least 6 months before screening visit, by clinical and endoscopic evidence.
  • Currently experiencing moderate to severe active UC defined as a Mayo score of 6-12 (inclusive) at Screening.
  • Endoscopic evidence of active mucosal disease, as assessed by flexible sigmoidoscopy, with an Endoscopic Finding Sub-score of ≥2 at Screening.
  • Rectal Bleeding Sub-score of ≥1 at Screening.
  • Physician's Global Assessment Sub-score of ≥2 at Screening.
  • Male/female subjects who agree to practice effective methods of contraception

Exclusion Criteria:

  • History of colonic or rectal surgery other than hemorrhoid surgery or appendectomy
  • Currently receiving total parenteral nutrition
  • Disease limited to ulcerative proctitis
  • Diagnosed with Crohn's disease, indeterminate colitis, microscopic colitis or, ischemic or infectious colitis
  • Known or suspected hypersensitivity to any component of the product
  • Known human immunodeficiency virus (HIV) infection or other immunosuppressive disorder
  • Concurrently participating in another study or receiving other experimental or investigational therapies within past 3 months
  • Females who are currently pregnant or lactating
  • Any history of malignancy. Exceptions may apply for cervical cancer and some forms of skin cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02426372
Other Study ID Numbers  ICMJE QBECO-UC-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qu Biologics Inc.
Study Sponsor  ICMJE Qu Biologics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Qu Biologics
PRS Account Qu Biologics Inc.
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP