The Clostridioides Difficile Trial of REC-3964

Phase 2

Recruiting

• Conditions: Recurrent Clostridioides Difficile Infection
• Interventions: Drug: REC-3964

• Registration Number: NCT06536465
• Lead Sponsor: Recursion Pharmaceuticals Inc.

Brief Summary

This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of RE-3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction of Clostridioides Difficile infection (CDI)."

Detailed Description

"Approximately 80 individuals will be enrolled in this open-label Phase 2 study, randomized 1:2: 1 to receive oral doses of REC-3964, 250 mg, 500 mg or observation. The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC-3964 for the reduction of recurrent Clostridioides difficile infection (rCDI) after initial cure with vancomycin. Participants will receive treatment with REC-3964 for 28 days."

Study Timeline

• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-05
• Study Start: 2024-10-14
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-07
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Be 18 years of age or older with Clostridioides difficile infection (CDI) diarrhea associated with a positive stool test for C. difficile toxin[s] prior to randomization. The Clostridioides difficile infection (CDI) episode must have resolved upon receiving vancomycin with a standard duration of treatment. The participant must be randomized within 2 days of completing vancomycin.
• Have high risk for recurrent Clostridioides difficile infection (rCDI) for whom vancomycin would be acceptable therapy.

Read More

Exclusion Criteria

• Have a history of chronic diarrheal illness from other causes, such as ulcerative colitis or Crohn's disease
• Diarrhea cannot be medically controlled by agents that would confound the interpretation of the study results"

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REC-3964 High-dose	REC-3964	Participants will receive 500 mg REC-3964 q12h REC-3964 250 mg capsules
REC-3964 Low-dose	REC-3964	Participants will receive 250 mg REC-3964 q12h REC-3964 250 mg capsules"

Primary Outcome Measures

Name	Time	Method
Treatment-Emergent Adverse Events	Assessed from time of ICF signature through 28 days following the cessation of treatment or observation period)	Incidence of treatment emergent adverse events (AEs)
Serious and Related Treatment Emergent Adverse Events	56 days	Safety and tolerability will be assessed by the following endpoints: incidence , severity, and relatedness of adverse events (AEs) and serious adverse advents (SAEs); and incidence of treatment-emergent adverse events (TEAEs) leading to study drug discontinuation.

Secondary Outcome Measures

Name	Time	Method
Time to recurrence	From date of randomization until the date of recurrent Clostridioides difficile infection (rCDI) assessed up to eight weeks	From time after treatment with REC 3964 until time of confirmed recurrence
To characterize the pharmacokinetics (PK) of REC 3964	Pre-dose, 1 hour, 3 hours, and 6 hours the morning dose at the Day 1, and Day 15.	Plasma pharmacokinetics (PK) parameters, as appropriate, including but not limited to Ctrough
Rate of recurrent Clostridioides difficile infection (rCDI)	At least 4 weeks after EOT with REC 3964 upon resolution of the initial Clostridioides difficile infection (CDI) diarrheal episode with vancomycin.	Proportion of patients with severe recurrent Clostridioides difficile infection (rCDI), recurrent Clostridioides difficile infection (rCDI) associated hospital admissions
Evaluation of diarrheal episodes.	From date of randomization until the date of recurrent Clostridioides difficile infection (rCDI) assessed up to eight weeks	The number of unformed \[types 5-7 on the Bristol stool scale\] bowel movements per day

Trial Locations

Locations (6)

Snake River Research; 🇺🇸 Idaho Falls, Idaho, United States

Montefiore Medical Group - Family Care Center (FCC); 🇺🇸 Bronx, New York, United States

GANJ - Toms River - Ocean Family Gastroenterology; 🇺🇸 Toms River, New Jersey, United States

Frontier Clinical Research; 🇺🇸 Uniontown, Pennsylvania, United States

Southern Star Research Institute, LLC; 🇺🇸 San Antonio, Texas, United States

Medical Associates of Central Virginia; 🇺🇸 Lynchburg, Virginia, United States