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

NCT04891965 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ART24-1-001
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 15

Brief 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.

Conditions

Clostridium Difficile Infection Recurrence

Outcome Measures

Primary Outcomes (2)

• Assess the safety and tolerability of ART24 based on the percentage of subjects experiencing treatment-emergent adverse events (TEAEs).

  The percentage of subjects experiencing a TEAE will be summarized using the MedDRA system organ class and preferred term.

  Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)

• 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.

  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.

  Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)

Secondary Outcomes (4)

• Recurrence of CDI

  Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)

• Time to CDI Recurrence

  Through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)

• Hospitalization for CDI

  Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)

• ART24-positive Fecal Samples

  Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)

Study Arms (4)

ART24 (Cohort A)

EXPERIMENTAL

In Cohort A, subjects will receive ART24 or placebo daily for 7 days

Biological: ART24

Placebo (Cohort A)

PLACEBO COMPARATOR

In Cohort A, subjects will receive ART24 or placebo daily for 7 days

Drug: Placebo

ART24 (Cohort B)

EXPERIMENTAL

In Cohort B, subjects will receive ART24 or placebo daily for 28 days

Biological: ART24

Placebo (Cohort B)

PLACEBO COMPARATOR

In Cohort B, subjects will receive ART24 or placebo daily for 28 days

Drug: Placebo

Interventions

ART24 BIOLOGICAL

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.

Also known as: ADS024

ART24 (Cohort A); ART24 (Cohort B)

Placebo DRUG

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.

Placebo (Cohort A); Placebo (Cohort B)

Eligibility Criteria

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

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

Sponsors & Collaborators

• Adiso Therapeutics: lead

Study Sites (15)

Palmtree Clinical Research

Palm Springs, California, 92262, United States

Location

Gastro Florida

Clearwater, Florida, 33765, United States

Location

Doral Medical Research

Doral, Florida, 33166, United States

Location

Louisiana Research Center

Shreveport, Louisiana, 71105, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mercury Street Medical Group

Butte, Montana, 59701, United States

Location

DiGiovanna Institute

Massapequa, New York, 11758, United States

Location

NYU Grossman School of Medicine

New York, New York, 10016, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Frontier Clinical Research, LLC

Uniontown, Pennsylvania, 15401, United States

Location

Advanced Clinical Research

Riverton, Utah, 84065, United States

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Intermed Groupe Sante

Chicoutimi, Quebec, G7H 7Y8, Canada

Location

Study Officials

• Renu Gupta, MD

  Adiso Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 19, 2021
• Study Start: February 27, 2020
• Primary Completion: July 7, 2022
• Study Completion: October 13, 2022
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (13)