QBECO SSI for Clinical and Endoscopic Remission in Moderate to Severe Crohn's Disease

NCT03472690 | Terminated Phase 2 DMC

• 1 other identifier: QBECO-CD-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

The QBECO-CD-02 trial in subjects with moderate to severe Crohn's disease (CD) is intended to build on past experience with QBECO SSI and further establish the safety and efficacy of QBECO SSI for the induction of clinical and/or endoscopic response and remission. The study will be conducted in three stages; a Lead-in, Main Induction and Main Maintenance .The first 20 patients will be enrolled in the Lead-in study, at approximately 5 study centers in Canada. Subsequent patients will be enrolled in the Main study, which aims to enroll 150 patients. The Lead-in component will be an open-label study to evaluate endoscopic healing endpoints. The Main Induction study will be randomized and placebo-controlled. Participants meeting response criteria following the Main Induction study will be eligible to continue into the Main Maintenance study, remaining on their initially randomized treatment. Participants not meeting response criteria will complete their follow-up and study involvement at the end of the Main Induction.

Conditions

Crohn Disease

Keywords

Inflammatory Bowel Disease 1

Outcome Measures

Primary Outcomes (6)

• Lead-In: Selection of Induction Point

  To determine whether Week 26 provides superior endoscopic healing outcomes compared to Week 16

  week 26

• Main: Clinical Remission at Induction

  To determine the effect of QBECO SSI on clinical remission, as measured by abdominal pain and soft-stool frequency, at the end of the induction period

  week 16 or 26

• Main: Endoscopic Remission (SES-CD score of 0-2) at Induction

  To determine the effect of QBECO SSI on endoscopic remission at the end of the induction period

  week 16 or 26

• Main: Clinical Remission

  To determine the effect of QBECO SSI on clinical remission, as measured by abdominal pain and soft-stool frequency, at the end of the maintenance period

  week 52

• Main: Endoscopic Remission (SES-CD score of 0-2)

  To determine the effect of QBECO SSI on endoscopic remission at the end of the maintenance period

  week 52

• Incidence of Adverse events (Safety Evaluation)

  To evaluate the incidence of adverse events (safety and tolerability) as measured by frequency and severity of adverse events.

  week 56

Secondary Outcomes (11)

• Lead-in: Endoscopic remission (SES-CD score of 0-2)

  week 52

• Main: Endoscopic Remission (SES-CD score of 0-2) Subpopulation

  week 52

• Main: Clinical Remission Subpopulation

  week 52

• Main: Abdominal Pain (11-point numerical rating scale (from 0 (no pain) to 10 (maximum pain)))

  week 52

• Main: Soft-stool Score

  week 52

Study Arms (2)

Active

EXPERIMENTAL

0.1 mL, self-administered subcutaneous injection, every second day

Biological: QBECO-SSI

Placebo

PLACEBO COMPARATOR

0.1 mL, self-administered subcutaneous injection, every second day

Other: Placebo

Interventions

QBECO-SSI BIOLOGICAL

Subcutaneous injection

Active

Placebo OTHER

Subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have an established diagnosis of ileal, ileocolonic or colonic CD of at least 3 months duration prior to planned initial dose as determined by endoscopic imaging.
• Participants with a recorded Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥7 at screening. Subjects with ileitis only will require SES-CD score ≥4.
• Participants with:
• a minimum total abdominal pain score above 21 for 7 consecutive days during the screening period, as rated on an 11-point numeric rating scale, OR
• a minimum total number of liquid/very soft stools above 10, (Type 6 or 7 as rated by the BSFS), for 7 consecutive days during the screening period.
• Participants may be receiving a therapeutic dose of the following medications:
• Oral 5-ASA compounds provided that the dose has been stable for the 2 weeks immediately before screening visit.
• Oral corticosteroid therapy (prednisone at a stable dose ≤ 30 mg/day, budesonide at a stable dose ≤ 9 mg/day, or equivalent steroid) provided that the dose has been stable for the 2 weeks before screening visit.
• Probiotics provided that the dose has been stable for the 2 weeks immediately before screening visit.
• Anti-diarrheal medications (e.g., loperamide, diphenoxylate with atropine) for control of chronic diarrhoea.
• Azathioprine or 6-MP provided that the dose has been stable for the 8 weeks immediately before screening visit.
• Methotrexate provided that the dose has been stable for the 8 weeks immediately before screening visit.
• Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole) provided that the dose has been stable for at least 2 weeks before screening visit.
• All men must agree to use contraception during the treatment period and for at least 2 months after the last dose of study medication and refrain from donating sperm during this period.
• Women will be eligible to participate if they are not pregnant , not breastfeeding, and at least one of the following conditions applies:

You may not qualify if:

• Medical Conditions
• Evidence of abdominal abscess during screening.
• Extensive colonic resection or subtotal or total colectomy.
• Diagnosis of short bowel syndrome.
• Have received tube feeding, defined formula diets, or parenteral alimentation within 21 days before screening visit.
• Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
• Evidence of or treatment for C. difficile infection or other intestinal pathogen within 28 days before screening visit.
• Currently require or are anticipated to require major surgical intervention for CD (e.g., bowel resection) during the first 26 weeks of the study.
• History or evidence of adenomatous colonic polyps that have not been removed.
• Chronic hepatitis B or C infection.
• Any identified congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, human immunodeficiency virus infection, organ transplantation).
• Any live vaccinations within 30 days before screening visit except for the influenza vaccine.
• Women who are lactating or have a positive urine pregnancy test during the Screening period.
• Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, haematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the Investigator, would confound the study results or compromise subject safety.
• Any surgical procedure requiring general (e.g., endotracheal) anaesthesia within 30 days before screening visit or is planning to undergo major surgery during the first 26 weeks of the study.

Sponsors & Collaborators

• Qu Biologics Inc.: lead

Study Sites (3)

Fraser Clinical Trials

New Westminster, British Columbia, V3L3W4, Canada

Location

G.I. Research Institute

Vancouver, British Columbia, V6Z 2K5, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Stage one is Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 21, 2018
• Study Start: June 25, 2018
• Primary Completion: December 20, 2020
• Study Completion: February 25, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)