Study on the Effects of RHH646 for Patients with Knee Osteoarthritis

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What is this study about?

This clinical trial is focused on studying knee osteoarthritis, a common joint condition that causes pain and stiffness in the knee. The study will test a new treatment called RHH646, which is taken as a hard capsule by mouth. The purpose of the study is to evaluate the ability of RHH646 to help regenerate the cartilage in the knee over a period of one year, as well as to assess its safety and how well it is tolerated by participants.

Participants in the study will be randomly assigned to receive either the RHH646 capsules or a placebo, which looks like the RHH646 capsules but does not contain the active ingredient. The study is designed so that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, ensuring unbiased results. Over the course of the study, participants will have regular check-ups and tests, including MRI scans, to monitor changes in their knee cartilage and overall health.

The study will last for a total of 52 weeks, during which participants will take the capsules daily. The researchers will collect information on any side effects, changes in vital signs, and results from blood and urine tests to ensure the safety of the treatment. This trial aims to provide valuable insights into the potential benefits of RHH646 for people with knee osteoarthritis.

Who Can Join the Study?

You must be between 35 and 75 years old at the time of your initial evaluation.
You must weigh at least 50 kg (about 110 pounds) and have a body mass index (BMI) of 35 or less. BMI is a measure of your body weight relative to your height.
You must have been diagnosed with tibiofemoral osteoarthritis in at least one knee. This is a type of wear-and-tear in the main joint of the knee.
Your knee X-ray must show K&L grade 2 or 3 osteoarthritis. The K&L grade is a scale used by doctors to measure how much damage is visible on an X-ray.
The damage must be mostly in the medial compartment of the knee. This means the inner side of the knee joint shows more joint space narrowing (a sign that the protective cartilage is thinning) than the outer side.
You must have symptoms, meaning you have experienced knee pain at least 3 days per week during the last 3 months.
Your knee pain must be able to be eased by analgesic therapy. An analgesic is a type of medicine used to relieve pain, such as acetaminophen (APAP) or non-steroidal anti-inflammatory drugs (NSAIDs).

Who Cannot Join the Study?

Women who are able to become pregnant.
People who cannot have an MRI, which is a medical imaging test that uses magnets to take pictures of the inside of the body, due to fear of enclosed spaces, body size, or having metal objects in the body like pacemakers (devices that control heart rhythm) or defibrillators (devices that restore normal heart rhythm).
People who have had arthroscopy, a surgery where a doctor looks inside a joint using a small camera, in the knee being studied within the last 6 months or who plan to have this surgery during the study.
People who have had specific previous surgeries on the knee being studied, such as mosaicplasty (a procedure to replace damaged cartilage), microfracture (a procedure to stimulate bone marrow to heal cartilage), meniscectomy (removal of part of the meniscus, which is the cushion in the knee), or osteotomy (a surgery to reshape the bone).
People who have an unstable knee joint or ligaments, which are tissues that connect bones, that were not repaired well enough.
People with severe malalignment, meaning the leg is not straight, specifically a valgus deformity (knock-knees) or varus deformity (bow-leggedness) greater than 7.5 degrees as seen on an X-ray.
People with K&L grade 4 OA, which is the most advanced stage of osteoarthritis, a condition where the protective cartilage in the joints wears down.
People with severe osteoarthritis in the hip that changes how they walk or affects the pressure on the knee, or hip issues that will require medical or surgical treatment during the study.
People with other knee problems, such as subchondral insufficiency fractures (small cracks in the bone just below the cartilage), bone fractures, bone bruises, osteonecrosis (bone tissue death due to lack of blood supply), bone tumors, or patellofemoral dysplasia (improper development of the kneecap area).
People with autoimmune diseases, which are conditions where the immune system mistakenly attacks the body, such as inflammatory arthritis, gout (a type of painful joint swelling caused by crystals), Lyme disease, or fibromyalgia (a condition causing widespread pain).
People with active infections in the knee joint or known connective tissue diseases, which are disorders affecting the tissues that support the body.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher	Warsaw	Poland
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Sanos A/S	Gandrup	Denmark
Somed Cr Sp. z o.o. sp.k.	Lodz	Poland
Universitaetsklinikum Wuerzburg AöR	Wuerzburg	Germany
Clinical Research Hamburg GmbH	Hamburg	Germany
Hospital Hm Rosaleda Hm La Esperanza	Santiago De Compostela	Spain
Rheuma Medicus Sp. z o.o.	Warsaw	Poland
Mvnestmzh Ivefrqvarn Cwzbbljl Stwwvwvi Stw z okrq	Warsaw	Poland
Pjjgje fvsu Kzllyejpp Sivqayb Di mzw Akwhm ucb Dg moa Gnnpb Dezgmd	Hamburg	Germany
Mzfxuydxphmxnwkraexnokshuk Hpwyscdsnfnlorhh	Halle (Saale)	Germany
Hdpnyjaq Uazfthhqbqusd de A Cysnld	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	11.07.2023
Germany	Not recruiting	11.07.2023
Poland	Not recruiting	11.07.2023
Spain	Not recruiting	11.07.2023

Trial locations

Investigated drugs:

Rhh646

RHH646 is an experimental medicine taken by mouth in capsule form. This study is testing if this treatment can help regrow the cartilage in the knee joint for people living with knee osteoarthritis.

Knee Osteoarthritis – This condition involves the gradual breakdown of the protective cartilage that cushions the ends of the bones in the knee joint. As the cartilage wears away over time, the bones may begin to rub against each other. This process can lead to swelling and changes in the structure of the joint. The condition typically progresses slowly as the cushioning material continues to thin.

Trial ID:

2022-502821-16-00

Protocol code:

CRHH646A12201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of RHH646 for Patients with Knee Osteoarthritis

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