Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)
← catalyst calendarNCT05552755 · readout ≤ 315 d
Sponsored by Recursion Pharmaceuticals Inc. (industry) · RXRX — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
67estimated
Sites
17
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-07-10 | actual | When the study began enrolling |
| Primary completion | Jun 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-09-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Familial Adenomatous Polyposis
Interventions
- Drug: REC-4881
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFPart 1: Maximum (Peak) Plasma Drug Concentration (Cmax) of REC-4881
measured Day 1 through Day 43
Part 1: Time to Reach Cmax (Tmax) of REC-4881
measured Day 1 through Day 43
Part 1: Area Under the Plasma Concentration-time Curve (AUC) of REC-4881
measured Day 1 through Day 43
Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
measured Day 1 through up to Week 37
Part 2: Number of Participants With Dose-limiting Toxicities (DLTs)
measured First 28 days of treatment
Part 2: Number of Participants Who Discontinued Treatment
measured Day 1 through up to Week 37
Part 2: Number of Participants With Dose Modification Due to Toxicity
measured Day 1 through up to Week 37
Part 2: Percent Change From Baseline in Polyp Burden
measured Baseline, up to Week 37
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