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Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects (Ri-CoDIFy 3)

Primary Purpose

Clostridioides Difficile Infection

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ridinilazole
Vancomycin
Sponsored by
Summit Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridioides Difficile Infection focused on measuring Clostridioides difficile infection (CDI), ridinilazole, Adolescents, vancomycin, C. Diff, Clostridium difficile, Diarrhea, Infection, Pediatric

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is aged 12 to <18 years.
  • Has signs and symptoms of CDI including diarrhea such that in the Investigator's opinion CDI antimicrobial therapy is required, and the subject has tested positive for toxin A and/or B of C. difficile in the stool. Diarrhea is defined as ≥ 3 unformed bowel movements (UBMs) based on types 5, 6, 7 on the Bristol Stool Chart and diarrhea information is within 24 hours prior to randomization.

Exclusion Criteria:

  • Has had more than the equivalent of 48 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization.
  • Has received ridinilazole or an investigational vaccine against C. difficile any time in the past, anti-toxic antibodies including bezlotoxumab within the past 6 months, or any other investigational medicinal product for treatment of CDI or fecal microbiota replacement therapy within the past 3 months.
  • Has a clinically relevant positive stool test for pathogens other than C. difficile, within 48 hours of randomization.
  • Has life-threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, toxic megacolon, or ileus.
  • Has had major GI surgery (e.g. significant bowel resection or pancreatectomy but not including appendectomy or cholecystectomy) within past 3 months or has the presence of a colostomy or ileostomy or has the likely requirement of an ostomy during the study.
  • Is receiving treatment that generally is associated with severe diarrhea, intractable vomiting, severe nausea, or inability to swallow that cannot be managed with antiemetics or antidiarrheals and that limits the ability to take oral medications. Cancer treatment that does not comprise ability to take study medication or cause severe diarrhea is allowed.

Sites / Locations

  • University of California, Los Angeles (UCLA) David Geffen School of Medicine
  • Children's Hospital Orange County
  • Continental Clinical Research
  • Dynamic Medical Research LLC
  • D&H National Research Centers
  • HMD Research
  • Children's Center for Digestive Health
  • Snake River Research
  • Ann and Robert H Lurie Children's Hospital of Chicago
  • University of Chicago - Comer Children's Hospital
  • Indiana University Health - Riley Hospital for Children
  • Boston Children's Hospital
  • Children's Hospital of Michigan
  • Icahn School of Medicine at Mount Sinai
  • DiGiovanna Institute for Medical Education and Research
  • Stony Brook University Medical Center
  • Cincinnati Children's Hospital Medical Center
  • University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ridinilazole

Vancomycin

Arm Description

Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.

Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days.

Outcomes

Primary Outcome Measures

Incidence and Severity of Treatment-emergant Adverse Events
Safety was assessed using CTCAE v4.

Secondary Outcome Measures

Full Information

First Posted
March 9, 2021
Last Updated
July 28, 2023
Sponsor
Summit Therapeutics
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT04802837
Brief Title
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
Acronym
Ri-CoDIFy 3
Official Title
A Randomized, Double Blind, Active Controlled Study to Evaluate the Safety and Tolerability of Ridinilazole Compared With Vancomycin and to Assess the Pharmacokinetics of Ridinilazole in Adolescent Subjects (Aged 12 to <18 Years) With Clostridioides Difficile Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
SMT19969-C006 study was terminated in alignment with corporate decision to pursue further development of drug candidate with a partner.
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
September 17, 2021 (Actual)
Study Completion Date
September 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Summit Therapeutics
Collaborators
Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridioides Difficile Infection
Keywords
Clostridioides difficile infection (CDI), ridinilazole, Adolescents, vancomycin, C. Diff, Clostridium difficile, Diarrhea, Infection, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ridinilazole
Arm Type
Experimental
Arm Description
Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.
Arm Title
Vancomycin
Arm Type
Active Comparator
Arm Description
Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days.
Intervention Type
Drug
Intervention Name(s)
Ridinilazole
Intervention Description
Ridinilazole 200mg dosed BID for 10 days.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
Vancomycin 125mg dosed QID for 10 days.
Primary Outcome Measure Information:
Title
Incidence and Severity of Treatment-emergant Adverse Events
Description
Safety was assessed using CTCAE v4.
Time Frame
Until study completion (Day 100)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is aged 12 to <18 years. Has signs and symptoms of CDI including diarrhea such that in the Investigator's opinion CDI antimicrobial therapy is required, and the subject has tested positive for toxin A and/or B of C. difficile in the stool. Diarrhea is defined as ≥ 3 unformed bowel movements (UBMs) based on types 5, 6, 7 on the Bristol Stool Chart and diarrhea information is within 24 hours prior to randomization. Exclusion Criteria: Has had more than the equivalent of 48 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization. Has received ridinilazole or an investigational vaccine against C. difficile any time in the past, anti-toxic antibodies including bezlotoxumab within the past 6 months, or any other investigational medicinal product for treatment of CDI or fecal microbiota replacement therapy within the past 3 months. Has a clinically relevant positive stool test for pathogens other than C. difficile, within 48 hours of randomization. Has life-threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, toxic megacolon, or ileus. Has had major GI surgery (e.g. significant bowel resection or pancreatectomy but not including appendectomy or cholecystectomy) within past 3 months or has the presence of a colostomy or ileostomy or has the likely requirement of an ostomy during the study. Is receiving treatment that generally is associated with severe diarrhea, intractable vomiting, severe nausea, or inability to swallow that cannot be managed with antiemetics or antidiarrheals and that limits the ability to take oral medications. Cancer treatment that does not comprise ability to take study medication or cause severe diarrhea is allowed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Styles, MD
Organizational Affiliation
Summit Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of California, Los Angeles (UCLA) David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Children's Hospital Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Continental Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Dynamic Medical Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
D&H National Research Centers
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
HMD Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Children's Center for Digestive Health
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Snake River Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Ann and Robert H Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago - Comer Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University Health - Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
DiGiovanna Institute for Medical Education and Research
City
New York
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

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