A Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)

Completed · Phase 1 · Has a placebo group

Conditions studied: Clostridium Difficile Infection Recurrence

In brief

This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent C. difficile infection (CDI) who have completed a standard of care course of CDI antibiotics 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.

Key facts

Study ID

NCT04891965

Run by

Adiso Therapeutics

People needed

36

Starts

2020-02-27

Expected to finish

2022-10-13

Last updated by the study team

2022-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Palmtree Clinical Research — Palm Springs, California, United States
• Gastro Florida — Clearwater, Florida, United States
• Doral Medical Research — Doral, Florida, United States
• Louisiana Research Center — Shreveport, Louisiana, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Mercury Street Medical Group — Butte, Montana, United States
• DiGiovanna Institute — Massapequa, New York, United States
• NYU Grossman School of Medicine — New York, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Frontier Clinical Research, LLC — Uniontown, Pennsylvania, United States
• Advanced Clinical Research — Riverton, Utah, United States
• Foothills Medical Centre — Calgary, Alberta, Canada
• Intermed Groupe Sante — Chicoutimi, Quebec, Canada

Full record on ClinicalTrials.gov

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