RHH646 for Knee Osteoarthritis

Recruiting at 7 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Women of child-bearing potential, Knee surgery, Severe malalignment, Autoimmune disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

82 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that knee pain should be relieved by analgesic therapy like acetaminophen or non-steroidal anti-inflammatory drugs, so these may be allowed.

What safety data exists for RHH646 or similar treatments for knee osteoarthritis?

The safety of treatments for knee osteoarthritis has been evaluated in various studies. For example, a study on the safety of benoxaprofen in patients with osteoarthritis found that gastrointestinal side effects were less frequent compared to aspirin and ibuprofen, and peptic ulcers were rare. Another study on a different treatment, JNJ-39439335, evaluated its safety in healthy men and those with knee osteoarthritis, but specific safety outcomes were not detailed in the abstract. ^{1 2 3 4 5}

How does the drug RHH646 differ from other treatments for knee osteoarthritis?

RHH646 may involve the use of high molecular weight hyaluronan (HMWHA), which has been studied for its potential to prevent joint contracture in immobilized knees, suggesting it might offer unique benefits in maintaining joint flexibility compared to other treatments. ^{6 7 8 9 10}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RHH646 or placebo for up to 52 weeks to evaluate cartilage-regenerating capacity and assess safety and tolerability

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RHH646

Trial Overview 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.

Participant Groups

Group I: RHH646 Experimental Treatment 1 Intervention

RHH646

Group II: Placebo Placebo Group 1 Intervention

RHH646 placebo

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

In a study of 143 patients with rheumatoid arthritis (RA) and osteoarthritis (OA), 35.7% experienced adverse drug events (ADEs), highlighting the commonality of these events in patients taking medications for these conditions.

Most ADEs were linked to disease-modifying anti-rheumatic drugs (59.4%) and non-steroidal anti-inflammatory drugs (14.5%), with 44.1% of the ADEs deemed preventable, indicating a need for better monitoring and management of drug safety in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. Tragulpiankit, P., Chulavatnatol, S., Rerkpattanapipat, T., et al.[2012]

References

1. England pubmed.ncbi.nlm.nih.gov

Characterization of adverse joint outcomes in patients with osteoarthritis treated with subcutaneous tanezumab. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Sustained-release diclofenac conjugated to hyaluronate (diclofenac etalhyaluronate) for knee osteoarthritis: a randomized phase 2 study. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

A multiple-dose double-blind randomized study to evaluate the safety, pharmacokinetics, pharmacodynamics and analgesic efficacy of the TRPV1 antagonist JNJ-39439335 (mavatrep). [2019]

4. England pubmed.ncbi.nlm.nih.gov

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. [2012]

5. Canada pubmed.ncbi.nlm.nih.gov

Long-term safety of benoxaprofen. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Preventing effects of joint contracture by high molecular weight hyaluronan injections in a rat immobilized knee model. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Knee Osteoarthritis Pain Management with an Innovative High and Low Molecular Weight Hyaluronic Acid Formulation (HA-HL): A Randomized Clinical Trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Histological Grade and Magnetic Resonance Imaging Quantitative T1rho/T2 Mapping in Osteoarthritis of the Knee: A Study in 20 Patients. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Associations of three-dimensional T1 rho MR mapping and three-dimensional T2 mapping with macroscopic and histologic grading as a biomarker for early articular degeneration of knee cartilage. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Heterogeneity of cartilage damage in Kellgren and Lawrence grade 2 and 3 knees: the MOST study. [2023]