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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05816395 | Safety and Efficacy of RHH646 for Knee Osteoarthritis | PHASE2 | COMPLETED | 82 | — | — | May 31, 2023 | Feb 24, 2025 | Mar 31, 2026 | 10 | United States, Argentina +3 |
Magnetic resonance images (MRI) were obtained from the target knee to visualize and quantify changes in the volume of cartilage in the index region. The index region was defined as the combination of the femoral medial anterior (FMA), central (FMC) and posterior (FMP) cartilage subregions in the knee.
Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.
| Arm | Type | Description |
|---|---|---|
| RHH646 75 mg | EXPERIMENTAL | RHH646 was administered orally once per day for a year. |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo was administered orally once per day for a year. |
| Name | Type | Description |
|---|---|---|
| RHH646 | DRUG | RHH646 capsule for oral use |
| Placebo | DRUG | RHH646 placebo capsule for oral use |
Inclusion Criteria: * Participant is ≥35 and ≤75 years old, at time of screening * Participants must weigh at least 50 kg to participate in the study and must have a body mass index (BMI) ≤35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2 * Diagnosis of tibiofemoral OA in at least one knee by stan...