RHH646 for Knee Osteoarthritis

No longer recruiting at 8 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, RHH646, can regenerate knee cartilage and is safe for individuals with knee osteoarthritis. Participants will receive either RHH646 or a placebo to compare results. The trial suits those who have experienced knee pain from osteoarthritis at least three days a week over the past three months and find relief with painkillers like acetaminophen or ibuprofen. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.

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.

Is there any evidence suggesting that RHH646 is likely to be safe for humans?

Research has shown that RHH646, the treatment under study for knee osteoarthritis, is safe and well-tolerated. In one study, researchers closely monitored participants who received RHH646 for any side effects. No major safety issues emerged, and participants generally tolerated the treatment well, with no reports of serious side effects. These findings suggest that RHH646 could be safe for people, but further research is necessary to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for knee osteoarthritis?

Unlike the standard treatments for knee osteoarthritis, which often include pain relievers like NSAIDs or corticosteroid injections, RHH646 offers a novel approach. Researchers are excited about RHH646 because it targets specific inflammatory pathways in the knee joint, potentially reducing inflammation and pain more effectively. This innovative mechanism of action could lead to better symptom management and improved quality of life for patients, making it a promising alternative to current options.

What evidence suggests that RHH646 might be an effective treatment for knee osteoarthritis?

Research shows that RHH646, which participants in this trial may receive, is under study for its potential to regrow knee cartilage and improve osteoarthritis symptoms. Early studies have examined its effectiveness in encouraging cartilage growth, crucial for managing knee osteoarthritis. Participants take this treatment as a pill once a day for a year, ensuring ease of use. Although detailed results on its efficacy are not yet available, ongoing research continues to explore its potential benefits. Initial findings suggest that RHH646 might reduce joint pain and stiffness by promoting healthier cartilage. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 been diagnosed with knee arthritis according to ACR criteria.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05816395

Safety and Efficacy of RHH646 for Knee Osteoarthritis

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

2.

clinicaltrials.eu

clinicaltrials.eu/inn/rhh646/

RHH646: A Potential New Treatment for Knee Osteoarthritis

This study is designed to determine whether RHH646 can actually regenerate cartilage in the knee and improve symptoms of osteoarthritis.

3.

withpower.com

withpower.com/trial/phase-2-osteoarthritis-4-2023-21a49

RHH646 for Knee Osteoarthritis · Info for Participants

Trial Overview The study tests RHH646's ability to regenerate cartilage in the knee against a placebo in participants with osteoarthritis. The treatment lasts ...

4.

hra.nhs.uk

hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/crhh646a12201-knee-oa-safety-and-efficacy-study/

CRHH646A12201 Knee OA safety and efficacy study

RHH646 and placebo are both capsules taken by mouth once daily for 12 months. This trial is for men and women with knee OA who are 35 to 75 years old and have ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11064315/

results from a 12-month follow up of an open-label study

The data gathered at 52 weeks show continued effectiveness of iPAAG in reducing the pain and stiffness of the treated knee joint and functional ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38698396/

results from a 12-month follow up of an open-label study

A novel injectable polyacrylamide hydrogel (iPAAG) previously demonstrated efficacy and safety up to week 26 in an open-label study of knee OA.