RHH646 for Knee Osteoarthritis

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing RHH646, a treatment aimed at repairing knee cartilage. It targets people with knee osteoarthritis, a condition where knee cartilage wears down. The treatment helps rebuild this cartilage, potentially reducing pain and improving movement.

Eligibility Criteria

This trial is for adults aged 35-75 with knee osteoarthritis, meeting specific criteria like weight over 50 kg, BMI ≤35 kg/m2, and certain levels of joint space width. They must have regular knee pain relieved by analgesics. Excluded are pregnant women not using contraception, those with recent or planned surgeries on the target knee, severe malalignment in the knee, other major knee pathologies or conditions affecting MRI procedures.

Inclusion Criteria

I weigh at least 50 kg and my BMI is 35 or less.

I have had knee pain at least 3 days a week for the last 3 months, relieved by painkillers.

I have been diagnosed with knee arthritis according to ACR criteria.

+3 more

Exclusion Criteria

I have had or will have a knee scope within 6 months around my screening.

My knee is severely misaligned by more than 7.5°.

I have other knee problems diagnosed by a doctor or through imaging.

+7 more

Participant Groups

The study tests RHH646's ability to regenerate cartilage in the knee against a placebo in participants with osteoarthritis. The treatment lasts up to one year and aims to assess both safety and effectiveness.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RHH646Experimental Treatment1 Intervention

RHH646

Group II: PlaceboPlacebo Group1 Intervention

RHH646 placebo