The Clostridioides Difficile Trial of REC-3964 (ALDER)

Recursion Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Recurrent Clostridioides Difficile Infection

Treatments: Drug: REC-3964

Study type: Interventional

Funder types: Industry

Identifiers

NCT06536465

REC-3964-201

Details and patient eligibility

About

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)."

Full 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."

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 115 years old

Volunteers: No Healthy Volunteers

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, severe or otherwise, 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 rCDI (a recurrent CDI episode within the last 6 months for which, in the opinion of the treating physician, standard of care treatment is not an option, age ≥65 years, immunocompromised state, or severe CDI on initial presentation) for whom vancomycin would be acceptable therapy. Exceptions may be approved by the Medical Monitor.

Exclusion criteria

• Have an active chronic diarrheal illness from other causes, such as ulcerative colitis or Crohn's disease. Patients with controlled ulcerative colitis or Crohn's disease would be eligible per this Exclusion Criterion.
• Diarrhea cannot be medically controlled by agents that would confound the interpretation of the study results"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

REC-3964 High-dose

Experimental group

Description:

Participants will receive 500 mg REC-3964 q12h REC-3964 250 mg capsules

Treatment:

Drug: REC-3964

REC-3964 Low-dose

Experimental group

Description:

Participants will receive 250 mg REC-3964 q12h REC-3964 250 mg capsules"

Treatment:

Drug: REC-3964

Observation

No Intervention group

Description:

Participants will undergo watchful waiting