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

  • STATUS
    Recruiting
  • End date
    Feb 4, 2023
  • participants needed
    36
  • sponsor
    Artugen Therapeutics USA, Inc.
Updated on 6 October 2021

Summary

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.

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 (510^9 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.

Details
Condition Clostridium Difficile Infection Recurrence
Treatment Placebo, ART24
Clinical Study IdentifierNCT04891965
SponsorArtugen Therapeutics USA, Inc.
Last Modified on6 October 2021

Eligibility

Yes No Not Sure

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 >38C [100.4F]) 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
Intra-abdominal surgery, including laparoscopic procedures, within 8 weeks of Screening (appendectomy and cholecystectomy excluded)
Active gastroparesis, toxic megacolon, pseudomembranous colitis, colostomy, intestinal resection (except appendectomy), ileus or short gut syndrome
History of difficulty swallowing food or liquids
History of chronic diarrhea apart from prior CDI
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
Taking antidiarrheal agents (e.g., loperamide) or laxatives (e.g., senna) on a regular basis
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
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