REC-4881 for Familial Adenomatous Polyposis
(TUPELO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new drug called REC-4881 in people with Familial Adenomatous Polyposis (FAP). The goal is to see if the drug can reduce or slow the growth of polyps in their intestines, making the condition easier to manage and potentially avoiding more surgeries.
Will I have to stop taking my current medications?
You will need to stop using non-steroidal anti-inflammatory drugs (NSAIDs), omega-3 fatty acids, oral corticosteroids, strong CYP3A inhibitors or inducers, and strong BCRP or MRP2 inhibitors before starting the study.
How does the drug REC-4881 differ from other treatments for familial adenomatous polyposis?
REC-4881 is unique because it is being studied specifically for its effects on familial adenomatous polyposis, whereas other treatments like sulindac and meloxicam are non-steroidal anti-inflammatory drugs (NSAIDs) used to manage polyps by targeting inflammation pathways. The novelty of REC-4881 lies in its potential to offer a new mechanism of action or treatment approach for this condition.12345
What data supports the effectiveness of the drug REC-4881 for treating Familial Adenomatous Polyposis?
Are You a Good Fit for This Trial?
Adults over 18 with Familial Adenomatous Polyposis (FAP) who've had a colectomy can join this trial. They must not use strong CYP3A affecting drugs, NSAIDs (except low-dose aspirin), or have had recent cancer treatments. Those with certain GI diseases or difficulty swallowing pills are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive either REC-4881 4mg or placebo once daily post-colectomy/proctocolectomy
Treatment Part 2
Participants receive escalating doses of REC-4881 (4mg, 8mg, or 12mg) to determine the RP2D
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- REC-4881
Find a Clinic Near You
Who Is Running the Clinical Trial?
Recursion Pharmaceuticals Inc.
Lead Sponsor