Phase 2 Osteoarthritis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have moderate knee osteoarthritis, specifically rated as Kellgren-Lawrence grade 2 or 3, in the affected knee
• People who have weakness in the quadriceps muscles (the large muscles at the front of the thigh), measured below a certain threshold
• People who are able to walk more than 50 feet (about 15 metres) without help from another person or a mobility aid
• People with a Body Mass Index (BMI) under 40
• Men who agree to use contraception during the treatment period and for at least 3 months after the last dose, and who agree not to donate sperm during this time
• Women who are not pregnant and not breastfeeding, and who are either past childbearing age/unable to become pregnant, or who agree to follow the trial's contraception guidelines during treatment and for at least 3 months after the last dose
• Women who have a negative pregnancy test at the screening visit and before receiving the study treatment
• People who are willing and able to follow all study requirements, as assessed by the trial investigator
• People who have stopped taking steroid tablets or steroid infusions (given by mouth or into a vein) for at least 6 months before the screening visit
• People whose vital signs at the baseline visit fall within these ranges: heart rate between 50 and 100 beats per minute, top blood pressure number between 100 and 170, bottom blood pressure number between 50 and 90, and blood oxygen level above 95%
• People who have already tried at least one treatment lasting 3 months or longer — such as activity changes, weight loss, physiotherapy, anti-inflammatory medicines, or joint injections — within the 2 years before the screening visit, and found it did not work well enough
• People who are able to speak, read, and understand English

Who may not be able to join:

• People who have severe knee osteoarthritis (Kellgren-Lawrence grade higher than 3) in the opposite knee
• People who have previously had a total knee replacement surgery
• People who have a known allergy or sensitivity to any ingredients in the study medication or comparison treatments
• People who have had a cancer diagnosis in the past 5 years, not including certain common skin cancers (non-melanoma skin cancer)
• People who have a neurological (nerve), vascular (blood vessel), or heart condition that limits their physical function or that, in the investigator's opinion, could affect their ability to safely participate
• People with uncontrolled ongoing health conditions, including: diabetes with a blood sugar control measure (HbA1c) above 7.0%, high blood pressure above the specified limits, cardiovascular disease, asthma, or chronic obstructive pulmonary disease (COPD)
• People who test positive for Hepatitis B, Hepatitis C, or HIV (people who test negative for active Hepatitis C virus in the blood may still be eligible — confirm with trial site)
• People who are currently taking, or have recently taken, certain medications that are not allowed in this trial, including narcotic pain medicines, local anti-inflammatory treatments, or other experimental drugs
• People whose medications for ongoing health conditions (such as diabetes, high blood pressure, asthma, or heart disease) were changed within 1 month before the screening visit
• People who received a cortisone injection or joint lubrication injection (such as Synvisc®) into the affected joint within 3 months before the first dose of study treatment
• People who have received a live, weakened vaccine within 28 days before starting the study treatment, or who expect to need one during the study
• People who have a current or long-term history of liver disease, or known problems with the liver or bile system (except for a harmless condition called Gilbert's syndrome, or gallstones that cause no symptoms)
• People who currently smoke, or who have smoked at any point in the past 10 years
• People who have had a history of ongoing alcohol or drug misuse within the past 3 months
• People who are currently using steroid tablets or steroid infusions on an ongoing basis (for example, for asthma or another long-term breathing condition), or who have recently had a short intense course of steroids (for example, for a flare-up of a non-joint condition or for COVID-19)

Important: Always verify eligibility with the trial site directly before applying.