NCT05816395

Safety and Efficacy of RHH646 for Knee Osteoarthritis

A Randomized, Placebo Controlled, Investigator and Participant-blinded Study Investigating Safety, Tolerability, and Efficacy of RHH646 in Participants With Knee Osteoarthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the articular cartilage-regenerating capacity of RHH646 in the knee as well as to assess safety and tolerability in participants with knee osteoarthritis.

Detailed description

This was a non-confirmatory, randomized, Investigator and participant blinded, two-arm, placebo controlled, Phase IIa study to assess safety, tolerability, and efficacy of orally administered RHH646 in adult participants with symptomatic, mild to moderate radiographic knee osteoarthritis in the target knee and with pain requiring analgesic therapy. The study comprised of a Screening period (up to 6 weeks), a treatment period (52 weeks) and a follow up period (4 weeks after the last administration of study treatment) before the End of Study (EOS) visit. The total duration for each participant was up to 62 weeks.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	RHH646	RHH646 capsule for oral use
DRUG	Placebo	RHH646 placebo capsule for oral use

Timeline

• Start date: 2023-05-31
• Primary completion: 2025-02-24
• Completion: 2025-02-24
• First posted: 2023-04-18
• Last updated: 2026-03-31
• Results posted: 2026-02-17

Locations

10 sites across 5 countries: United States, Argentina, Denmark, Poland, Spain

Regulatory

• FDA-regulated drug study