Phase 3 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 are 18 years of age or older at the time of signing the consent form
• People who have been clinically diagnosed with osteoarthritis (OA) in the knee being studied, based on established medical criteria
• People whose knee OA has been confirmed by X-ray (reviewed by a radiologist) showing a moderate to severe level of joint damage (classified as grade 2, 3, or 4 on a standard scale)
• People whose knee OA has not responded adequately to at least two types of treatments over the previous 6 months — one being a non-drug approach (such as exercise, weight loss, or physical therapy) or simple pain relief (such as paracetamol), and the other being a prescription or over-the-counter medication (such as anti-inflammatory drugs or joint injections) — or people who are unable to take anti-inflammatory drugs (NSAIDs) for medical reasons
• People whose average daily knee pain score falls between 4 and 9 out of 10 at the screening visit
• People whose average weekly knee pain score falls between 4 and 9 out of 10 in the 7 days before the study start date
• People who have reported a maximum pain score of "10 out of 10" on no more than one day in the 7 days before the study start date
• People with a body mass index (a measure of body weight relative to height) between 18.0 and 39.0
• Women who could become pregnant, and men, who agree to follow the contraception requirements described in the study protocol
• People who are able to understand and sign the informed consent form and agree to follow all study rules
• People who have completed pain score recordings on at least 11 out of 14 days in the 14 days before the study start date
• People whose non-drug treatment routine for knee OA (not including a knee brace) has been unchanged for at least 2 weeks before the study start date, and who are willing to keep it unchanged for the whole study
• People who are willing to stop taking oral and topical anti-inflammatory medications and other systemic pain medicines (except the study's allowed rescue pain relief) from 2 weeks before the study start date until the end of the study
• People who agree to use paracetamol (acetaminophen) or topical pain relief creams (not topical anti-inflammatory drugs) as backup pain relief if needed during the study

Who may not be able to join:

• People with a history of a blood platelet disorder, including immune-related low platelet conditions or heparin-induced thrombocytopenia (a reaction to a blood-thinning medication)
• People with a history of major bleeding disorders, including haemophilia
• People with a current or recent (within the past 12 months) stomach or intestinal ulcer, or any suspicion of bleeding in the digestive system
• People who have had a brain bleed, or surgery on the brain, spine, or eyes within the past 12 months
• People who have had spinal anaesthesia within 14 days of the study start date
• People with fibromyalgia, nerve pain from the neck or lower back pressing on nerves, or another moderate to severe pain condition that could make it difficult to accurately assess knee pain; people with current sciatica are not eligible, though people with a past history of sciatica who have had no symptoms for 3 or more months and no nerve-related findings on examination may be considered eligible (confirm with trial site)
• People with a history of other diseases affecting the knee being studied, such as rheumatoid arthritis, gout, lupus, psoriatic arthritis, ankylosing spondylitis, joint infections, Paget's disease, or tumours of the joint
• People with a known allergy or sensitivity to the study drug (PPS), heparin, or similar medications
• People with a tendency toward allergic reactions due to having two or more allergic conditions (such as eczema, asthma, or chronic allergic hay fever) or two or more severe allergies
• People with an allergy or medical reason not to receive tetracosactide (Synacthen®) or cosyntropin (Cortrosyn®), which are used in a hormone test during the study
• People with an allergy or medical reason not to receive gadolinium, a contrast agent used in MRI scans
• People with certain ongoing medical conditions that have required a change in treatment within the past 60 days, including unstable heart or blood vessel disease, poorly controlled lung disease or asthma, blood clotting disorders, uncontrolled neurological conditions, active tuberculosis, active infections, irregular heart rhythms, adrenal insufficiency, kidney disease (nephrotic syndrome), advanced liver disease (cirrhosis), Gilbert syndrome, uncontrolled diabetes, uncontrolled thyroid conditions, or mental or emotional disorders that would prevent reliable participation in the study
• People with a history of radiation to the pituitary gland, or surgery through the nose to the pituitary gland within the past year
• People who have had any cancer in the past 5 years, except for a common and easily treated type of skin cancer (basal cell carcinoma)
• People with a history or current diagnosis of autoimmune polyglandular syndromes (a condition where the immune system attacks multiple hormone-producing glands)
• People with any physical or psychological condition that, in the study doctor's view, would make it unlikely they could complete the study as required
• People currently taking blood-thinning or anti-clotting medications within 2 weeks of the study start date (low-dose aspirin of 150 mg per day or less is allowed)
• People who have previously been treated with the study drug (PPS) in any form
• People who have used immune-suppressing or immune-modifying treatments in the past 90 days, including most forms of corticosteroids (steroid medications) — occasional use of topical, inhaled, or nasal spray steroids is acceptable (confirm with trial site)
• People who have used anti-inflammatory drugs (NSAIDs) within 2 weeks of the study start date
• People who have used opioid pain medications within 6 weeks of the study start date
• People who have used glucosamine or chondroitin supplements within 6 weeks of the study start date
• People who have used certain bone-strengthening medications (bisphosphonates or denosumab) within 12 weeks of the study start date
• People who have used iloprost (a medication for blood vessel conditions) within 12 weeks of the study start date
• People who have worn a knee brace on the study knee within 2 weeks of the study start date
• People who have received systemic steroid injections or tablets for any reason within 8 weeks of the study start date
• People who have had steroid injections into the study knee within 12 weeks, or hyaluronic acid (or any other) injections into the study knee within 24 weeks, of the study start date
• People who have received stem cell or platelet-rich plasma treatment within the past 12 months
• People who have used cannabinoids (including cannabis-based products) within 30 days of the study start date
• People who have used individual vitamins or supplements known to affect blood clotting within 2 weeks of the study start date — this includes garlic, ginger, fish oil (omega-3), ginkgo biloba, ginseng, turmeric, evening primrose oil, St. John's wort, vitamins C, E, and K, and several others listed in the protocol (standard multivitamins are allowed)
• People known to have been exposed to heparin in the past 100 days, including through heart bypass surgery or treatment for blood clots
• People who have used DHEA-S (a hormone supplement) within 6 weeks of the study start date
• People who have regularly used certain hormone-blocking medications (oral glucocorticoid receptor antagonists or cortisol synthesis inhibitors) within 12 weeks of the study start date
• People who have taken biotin (a vitamin supplement) within 72 hours before the screening visit
• People who have used megestrol acetate (a hormonal medication) within 6 weeks of the study start date
• People who have participated in another clinical trial or received an experimental treatment within the past 24 weeks, or within 5 times the half-life of that treatment — whichever is longer
• People whose blood test results at screening show abnormal clotting time, low platelet count, or elevated liver enzyme levels beyond certain thresholds
• People with a total bilirubin level (a marker of liver function) above a certain threshold on blood testing
• People with active or chronic hepatitis B, hepatitis C, or uncontrolled HIV infection; people with HIV who are on stable antiviral treatment may be considered eligible (confirm with trial site)
• People whose screening scans of the knee show certain specific structural or bone problems, as assessed by a radiologist or the study's medical monitor
• People with any other clinically significant abnormality in blood tests, physical examination, medical history, or vital signs, as judged by the study doctor at screening
• People with high blood pressure readings at screening (systolic pressure of 160 mmHg or above, or diastolic pressure of 100 mmHg or above) unless the condition has been treated and stable for at least one month
• People with certain eye conditions affecting the central part of the retina (the macula), as identified during eye examination or imaging — including moderate or advanced macular degeneration, diabetic eye disease, macular holes, retinal dystrophies, and several other conditions listed in the protocol
• People with a morning cortisol level (a hormone measured by blood test) below 3 μg/dL
• People with a very low level of ACTH (a hormone that signals the adrenal glands) below 10 pg/mL on blood testing
• People in the US or Canada whose morning cortisol falls within a borderline range and whose adrenal glands do not respond adequately to a hormone stimulation test (confirm with trial site)
• People with currently abnormal blood potassium (high) or sodium (low) levels
• People who are unable to have an MRI scan (for example, due to certain metal implants or severe claustrophobia)
• People who are largely or completely unable to care for themselves, such as those who are bedridden or confined to a wheelchair
• People who have had major surgery recently or are expected to have surgery during the study period
• People who are currently hospitalised or have planned hospitalisations during the study
• People who are planning to have a total knee replacement on the affected knee during the study
• People who have had surgery on or a significant injury to the study knee within the past year
• People with a history of drug or alcohol misuse or dependence within the 12 months before screening, where the study doctor believes this could affect their ability to follow the study requirements
• Employees of the study sponsor, the contract research organisation involved in the study, or staff directly involved in running the trial, or their immediate family members

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