- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04891965
A Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)
A Randomized, Placebo-Controlled, Double-Blind, Phase 1 Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent CDI (primary [meaning the first occurrence they have had] or recurrent infection) who have completed a standard of care course of CDI antibiotics (vancomycin, fidaxomicin, or metronidazole administered for 10 to 21 days) and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily doses of ART24 or placebo. Subjects will be followed for 6 months after the last dose of study drug.
Subjects will receive study drug in the following 2 sequential cohorts:
- Cohort A: ART24 or placebo once daily for 7 days (8 subjects)
- Cohort B: ART24 or placebo once daily for 28 days (28 subjects)
In each cohort, subjects will be randomized in a ratio of 3 [active]:1 [placebo]. Subjects who are randomized to active treatment in both cohorts will receive ART24 (5×10^9 colony-forming units [CFU]) daily.
Initiation of Cohort B will only occur once the Data Review Committee (DRC) has evaluated blinded safety data (through Week 2) from Cohort A and recommends that the study proceed to the next cohort.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Foothills Medical Centre
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Quebec
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Chicoutimi, Quebec, Canada, G7H 7Y8
- Intermed groupe santé
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California
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Palm Springs, California, United States, 92262
- Palmtree Clinical Research
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Florida
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Clearwater, Florida, United States, 33765
- Gastro Florida
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Doral, Florida, United States, 33166
- Doral Medical Research
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Louisiana
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Shreveport, Louisiana, United States, 71105
- Louisiana Research Center
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Montana
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Butte, Montana, United States, 59701
- Mercury Street Medical Group
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Massapequa, New York, United States, 11758
- DiGiovanna Institute
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New York, New York, United States, 10021
- Weill Cornell Medicine
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New York, New York, United States, 10016
- NYU Grossman School of Medicine
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Pennsylvania
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Uniontown, Pennsylvania, United States, 15401
- Frontier Clinical Research, LLC
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Utah
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Riverton, Utah, United States, 84065
- Advanced Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Have successfully completed a full course of a standard of care CDI antibiotic for a qualifying CDI episode (primary or recurrent) within 3 to 7 days of randomization
Qualifying CDI episode must meet all of the following (3) criteria
- Positive stool C. difficile toxin (NAAT, EIA, CCTA, or equivalent test) as documented by study site AND
- History of ≥3 unformed stools (Bristol scores of 5, 6, or 7) within 24 hours
- Received standard of care antibiotic treatment for CDI diagnosis
- Prior to the first dose of study drug, completion of standard of care antibiotic therapy with oral vancomycin, metronidazole, or fidaxomicin for CDI with a treatment duration of 10 to 21 days
- Clinical cure assessed at Day 1 visit (randomization) defined as ≤2 unformed stools per day for at least 2 consecutive days and maintained through Day 1 without the need for further antibiotic therapy
- Able to begin treatment with study drug within 3 to 7 days following completion (i.e., last dose) of the CDI antibiotic course for the qualifying CDI episode
Exclusion Criteria:
- Body mass index ≥40.0 kg/m2
- Life expectancy of ≤12 months
- Inpatient (in hospital or skilled nursing facility) at the time of randomization
- Current (i.e., qualifying) CDI episode required admission to an Intensive Care Unit
- Pregnant, breastfeeding, or seeking pregnancy while on study
- Have, as determined by the Investigator, a history or clinical/laboratory manifestations of significant neurological, renal, hepatic, hematologic, cardiac, pulmonary, metabolic, endocrine, psychiatric, GI disorders other than CDI (including infectious, ischemic, or immunological diseases), human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) infection, or other condition that could interfere with the evaluation of safety or efficacy, or put the subject at risk of harm from study participation
- Have an active malignancy of any type or history of a malignancy within past 5 years, except for treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Have an acute febrile illness (fever >38°C [100.4°F]) at Day 1
- Drug, alcohol, or substance dependence within the last 2 years
Any of the following laboratory results at Screening:
- White blood cell count ≥15,000 cells/mm3
- Absolute neutrophil count <1000/mm3
- Liver function test result (e.g., aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), or total bilirubin) of ≥3 times the upper limit of normal
- Serum albumin <3 g/dL
- Serum creatinine >1.8 mg/dL and oliguric
- Use of systemic antibiotic therapy for conditions other than CDI within 7 days of randomization or expectation to require antibiotic therapy for conditions other than CDI for 12 weeks following the first dose of study drug for Cohort A or 16 weeks following the first dose of study drug for Cohort B, including subtherapeutic doses of oral antibiotics (e.g., for rosacea)
Have a known immunodeficiency disorder, including but not limited to:
- An immunodeficiency disease
- Receiving, or plans to receive, treatment with systemic corticosteroids equivalent to >10 mg prednisone per day
- Receiving, or plans to receive, myelosuppressive chemotherapy
- Previous fecal transplant or live biotherapeutic product within 1 year of randomization
- Treatment with bezlotoxumab (Zinplava™) for the qualifying CDI episode
- Diagnosis of inflammatory bowel disease (including but not limited to: Crohn's disease, ulcerative colitis, microscopic colitis)
- Active irritable bowel syndrome [those with diarrhea predominant or alternating constipation and diarrhea] (in past 6 months based on Rome IV criteria and subject deemed not suitable for study by Investigator's judgment)
- Celiac disease not well controlled on gluten-free diet
- Active gastroparesis, toxic megacolon, pseudomembranous colitis, colostomy, intestinal resection (except appendectomy), ileus or short gut syndrome
- History of chronic diarrhea apart from prior CDI
- Intra-abdominal surgery, including laparoscopic procedures, within 8 weeks of Screening (appendectomy and cholecystectomy excluded)
- History of difficulty swallowing food or liquids
- Taking antidiarrheal agents (e.g., loperamide) or laxatives (e.g., senna) on a regular basis
- Use of non-dietary probiotic supplements within 7 days of Day 1 or plan to use non-dietary probiotic supplements while on study through Week 12 in Cohort A and Week 16 in Cohort B
- Known to have consumed fermented or other foods that may contain B. amyloliquefaciens (such as miso, soybean paste, or fermented rice- or locust bean-derived products) within 7 days prior to Day 1, or plan to consume them prior to Week 12 for Cohort A and prior to Week 16 for Cohort B
- Participation in a clinical trial of an investigational drug or medical device within 30 days or 5 half-lives, whichever is longer, prior to the Screening visit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ART24 (Cohort A)
In Cohort A, subjects will receive ART24 or placebo daily for 7 days
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Each ART24 capsule will contain lyophilized ART24 and inactive excipients.
ART24 will be supplied in a dose strength of 5×10^9 CFU/capsule.
Subjects will receive 1 capsule daily.
Other Names:
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Placebo Comparator: Placebo (Cohort A)
In Cohort A, subjects will receive ART24 or placebo daily for 7 days
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Each placebo capsule is identical in appearance, weight, and packaging to ART24 capsules, but will contain only the inactive excipients.
Subjects will receive 1 capsule daily.
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Experimental: ART24 (Cohort B)
In Cohort B, subjects will receive ART24 or placebo daily for 28 days
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Each ART24 capsule will contain lyophilized ART24 and inactive excipients.
ART24 will be supplied in a dose strength of 5×10^9 CFU/capsule.
Subjects will receive 1 capsule daily.
Other Names:
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Placebo Comparator: Placebo (Cohort B)
In Cohort B, subjects will receive ART24 or placebo daily for 28 days
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Each placebo capsule is identical in appearance, weight, and packaging to ART24 capsules, but will contain only the inactive excipients.
Subjects will receive 1 capsule daily.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the safety and tolerability of ART24 based on the percentage of subjects experiencing treatment-emergent adverse events (TEAEs).
Time Frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
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The percentage of subjects experiencing a TEAE will be summarized using the MedDRA system organ class and preferred term.
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Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
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Assess the safety and tolerability of ART24 based on the number of subjects observed with a change from baseline in clinical laboratory tests, vital signs, physical examination.
Time Frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
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The number of subjects with a change from baseline from normal to abnormal in clinical laboratory test results, vital signs, physical examination will be summarized.
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Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence of CDI
Time Frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
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Defined as ≥3 unformed stools (Bristol Scores of 5, 6, or 7) within 24 hours, AND positive stool testing for C. difficile toxin as documented by the central laboratory, AND the need for antibiotic retreatment for CDI diagnosis.
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Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
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Time to CDI Recurrence
Time Frame: Through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
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Evaluating the time to CDI recurrence (if applicable) relative to the administration of study medication
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Through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
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Hospitalization for CDI
Time Frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
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Evaluating the proportion of subjects who are hospitalized due to a CDI recurrence
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Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
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ART24-positive Fecal Samples
Time Frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
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Proportion of subjects with ART24-positive fecal sample assessed at each study visit
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Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Renu Gupta, MD, Adiso Therapeutics, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ART24-1-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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