Overview

This trial is active, not recruiting.

Condition ulcerative colitis
Treatment qbeco ssi
Phase phase 2
Sponsor Qu Biologics Inc.
Start date July 2015
End date July 2017
Trial size 40 participants
Trial identifier NCT02426372, QBECO-UC-01

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
qbeco ssi
QBECO Site Specific Immunomodulators
(Experimental)
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.
qbeco ssi
QBECO Site Specific Immunomodulators
(Experimental)
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.
qbeco ssi
QBECO Site Specific Immunomodulators

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Proportion of subjects in clinical remission
time frame: Week 16
Proportion of subjects with a clinical response
time frame: Week 16
Proportion of subjects with a clinical response
time frame: Week 52

Eligibility Criteria

Male or female participants at least 19 years old.

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 - Any known allergy or hypersensitivity to killed whole-cell bacterial vaccines or phenol - 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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Qu Biologics Inc..