ASKC200 for Knee Osteoarthritis Pain (NCT07742852) | Clinical Trial Compass
Active — Not RecruitingPhase 2
ASKC200 for Knee Osteoarthritis Pain
China175 participantsStarted 2025-09-12
Plain-language summary
This is a Phase II clinical trial designed to evaluate the efficacy and safety of ASKC200 Lotion in patients with knee osteoarthritis (KOA) pain. A total of 175 eligible patients will be randomly assigned to three groups at a 1:2:2:2 ratio: the experimental group1 (treated with 1% ASKC200 Lotion), the experimental group 2(treated with 5% ASKC200 Lotion), the active control group (treated with Diclofenac Diethylamine Emulgel), and the placebo group (treated with matching placebos).
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide signed informed consent before undergoing any examinations or assessments, and understand and comply with the study requirements;
. Aged 40 to 80 years (inclusive) at the time of signing the informed consent, male or female;
. Diagnosed with primary knee osteoarthritis based on clinical and radiological examinations;
. History of knee osteoarthritis pain lasting ≥ 6 months;
. Within 3 months prior to dosing, X-ray of the tibiofemoral joint shows Kellgren-Lawrence Grade II or III in the target knee, with the contralateral knee grade not higher than the target side;
. Before the first dose, the weekly average of the daily mean pain NRS score in the target knee is ≥ 4 and \< 8, and the weekly average of the daily mean pain NRS score in the contralateral knee is \< 4;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since ASKC200 is in Phase 2, what does that mean for how much we actually know about whether it's safe and effective compared to treatments that are already approved for knee osteoarthritis pain?
2The trial is 'active but not recruiting,' which means they're no longer enrolling new patients — does that close off this option for me, and are there similar Phase 2 trials for knee OA pain that I might still be able to join?
3The main thing this trial is measuring is a change in a pain score called the WAADPI using a numerical rating scale — can you help me understand what a meaningful improvement on that scale would actually feel like day-to-day for someone in my situation?
4Before considering a trial like this, would it make sense for me to try standard treatments for knee osteoarthritis pain first, and how would going that route affect my eligibility for this or similar studies?
5If this trial eventually publishes its results, what would the findings need to show for ASKC200 to become a realistic treatment option I could actually access in the future?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in WAADPI (NRS) of the target knee from baseline
. Before the first dose, the WOMAC pain scale score for the target knee is ≥ 20, and the WOMAC pain scale score for the contralateral knee is \< 20;
. Willing to discontinue the use of non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and other analgesics, and to use only study-provided acetaminophen as rescue medication for knee osteoarthritis pain during the study period;
Exclusion criteria
. Secondary arthritis due to other causes (e.g., psoriasis, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, etc.);
. The target knee has other conditions that may affect the function and pain assessment of the target knee (e.g., fractures, osteonecrosis, and chondrocalcinosis within 6 months prior to screening, etc.);
. Presence of other diseases causing pain in the target knee (e.g., hip pain, lumbar spinal stenosis, intermittent claudication, etc.) or pain in other areas that, in the investigator's judgment, may affect the assessment of knee osteoarthritis pain;
. Use of other medications for osteoarthritis within 1 week prior to the first dose, such as NSAIDs (except aspirin ≤ 325 mg/day for cardiac prophylaxis), analgesics (except rescue acetaminophen used continuously for ≤ 3 days), symptomatic slow-acting drugs for osteoarthritis (diacerein, glucosamine, chondroitin sulfate, etc.), anxiolytics (doxepin, amitriptyline, pregabalin, etc.), or traditional Chinese medicines (containing active ingredients such as artificial tiger bone powder, Psammosilene tunicoides, etc.), whether oral or topical;
. The target knee has pathological joint effusion requiring aspiration or has surgical indications;
. Presence of chronic pain in other body parts requiring long-term oral analgesic therapy, or need for concomitant systemic glucocorticoid therapy from 4 weeks prior to the first dose through the study period;
. Open knee injury or other knee surgeries (e.g., arthroscopy, arthroscopic debridement, knee replacement, etc.) on the target knee within 6 months prior to the first dose;
. Undergone any major surgical procedure within 3 months prior to the first dose;