Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05552755 | Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP) | PHASE1 | RECRUITING | 67 | — | — | Jul 10, 2023 | Sep 1, 2027 | Jun 5, 2026 | 17 | United States |
| Arm | Type | Description |
|---|---|---|
| Placebo (Part 1) | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo administered orally and then, following 14-28 days, participants will begin once daily (QD) dosing for another 14 days. |
| REC-4881 4 mg (Part 1) | EXPERIMENTAL | Participants will receive REC-4881 4 milligrams (mg) administered orally and then, following 14-28 days, participants will begin QD dosing for another 14 days. |
| REC-4881 4 mg (Part 2): QD Treatment Regimen | EXPERIMENTAL | Participants will receive REC-4881 4 mg administered orally QD for 12 weeks followed by a 12 week off-treatment period. |
| REC-4881 8 mg (Part 2): QD Treatment Regimen | EXPERIMENTAL | Participants will receive REC-4881 8 mg administered orally QD for 12 weeks followed by a 12 week off-treatment period. |
| REC-4881 4 mg (Part 2): Interval Dosing Treatment Regimen | EXPERIMENTAL | Participants will receive REC-4881 4 mg administered orally in a 7 day on and off schedule for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| REC-4881 | DRUG | REC-4881 capsules |
| Placebo | DRUG | Placebo capsules |
Inclusion Criteria: 1. Male or female and ≥ 18 years of age 2. Have provided written informed consent to participate in the study 3. Diagnosis of phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site. 4. Genetic diagnosis of...