ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorAcurx Pharmaceuticals Inc.
About this trial
Single-arm trial to evaluate the safety and efficacy of ACX-362E \[ibezapolstat\] in patients with recurrent C. difficile infection (CDI).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of CDI as defined by 1) the presence of diarrhea, defined as passage of ≥ 3 UBMs within 24 hours before study Day 1, AND 2) a stool test result positive for the presence of C. difficile free toxins
Three or more CDI episodes in the past 12 months, including the current episode, with each episode defined as ≥ 3 unformed stools in 24 hours associated with positive C. difficile toxin test.
At least 1 of the protocol-qualifying prior CDI episodes, not including the current episode, has been treated with oral vancomycin or with fidaxomicin
Disqualifiers
Severe, complicated, or life-threatening fulminant CDI with evidence of hypotension (systolic blood pressure < 90 mmHg), septic shock, peritoneal signs or ileus, or toxic megacolon
Received a live biotherapeutic product (LBP) (Rebyota® or Vowst™) within the past 12 weeks
Received or current use of anti-C. difficile antibodies, eg, IV immunoglobulin [IVIG], bezlotoxumab
Active inflammatory bowel disease (Crohn's disease, ulcerative colitis) with chronic diarrhea within 12 weeks before Baseline, or with a history of symptoms > 12 weeks before Baseline without evidence of mucosal healing on colonoscopy within the past year.
Trial design
Design model
Single group
Treatments tested in this trial
Ibezapolstat
DrugIbezapolstat 450 mg po Q12H x14 days
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: IbezapolstatExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the rate of CDI Clinical Cure (CC)
Time frame
Day 162
Evaluate the rate of Sustained Clinical Cure (SCC)
Time frame
Day 423
Evaluate the rate of CDI recurrence (rCDI)
Time frame
Day 70Secondary outcomes
1
Assess the rate of CDI recurrence (rCDI)
Time frame
Day 422
Assess the effects of ibezapolstat on quantitative changes to the fecal microbiome
The Shannon Diversity Index and Inverse Simpson Diversity Index will be used to quantify biodiversity in a community like the gut microbiome, measuring how many different species are present in a community (richness) and how close in numbers different species in the community are to each other (evenness).
Time frame
Day 1 to Week 243
Assess time to resolution of diarrhea during the treatment period
Time frame
Day 164
Assess the incidence of Extended Clinical Cure (ECC)
Time frame
Weeks 8, 12, and 24Other outcomes
1
Determine the frequency and severity of adverse events
Time frame
Day 1 to Week 24Sponsors and contacts
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Source ClinicalTrials.gov