HRS-2129 for knee osteoarthritis pain

A Multicenter, Randomized, Double-blind, Agent-positive and Placebo-controlled, Parallel-group Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

This trial will test different oral doses of HRS-2129 to see if it reduces moderate to severe knee osteoarthritis pain in adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07351968 on ClinicalTrials.gov

What this trial studies

This Phase Ib interventional trial tests multiple oral doses of HRS-2129 in adults with moderate to severe knee osteoarthritis pain. Participants will receive HRS-2129 tablets or matching placebo, with celecoxib and its placebo included as comparator arms, and will undergo safety monitoring and pharmacokinetic sampling. Pain intensity (Numerical Rating Scale) and use of rescue acetaminophen will be tracked while other analgesics are discontinued. Adverse events and changes in joint function will be recorded over the dosing period.

Who should consider this trial

Good fit: Adults with moderate to severe knee osteoarthritis pain (index-knee NRS ≥4) who can stop other pain treatments except acetaminophen, agree to use effective contraception if applicable, and can attend study visits at the trial site are ideal candidates.

Not a fit: Patients with other diseases affecting the target joint, recent major knee or hip trauma or surgery within the past year, planned surgery, most or complete loss of mobility, pregnancy, or unwillingness to stop prohibited analgesics are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, HRS-2129 could become a new oral option to reduce moderate to severe knee osteoarthritis pain with an acceptable safety profile.

How similar studies have performed: Standard NSAIDs such as celecoxib have proven benefit for knee osteoarthritis pain, but HRS-2129 appears to be a novel compound that has not yet been proven effective in patients.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign the informed consent form before starting the activities related to the trial;
2. The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4;
3. Subjects must be willing to discontinue all medical and non-medical treatments for osteoarthritis pain except rescue medication (acetaminophen) and not use prohibited analgesics throughout the study ;
4. Male and female subjects of childbearing potential must agree to use highly effective contraceptive measures with their partners from the signing of the informed consent form until 1 month after the last dose of investigational product.

Exclusion Criteria:

1. History of other diseases that may involve the target joint;
2. History of major trauma or surgery of knee joint and hip joint in the past year;
3. Plan to undergo surgical procedure during the study;
4. Most or complete loss of mobility;
5. There are other diseases that may confuse the assessment of osteoarthritis pain;
6. There is a neuropsychiatric disease, and the investigator's assessment may affect the evaluation of osteoarthritis (OA) or self-score;
7. There are serious or poorly controlled concomitant diseases;
8. Those who have a clear history of peptic ulcer, bleeding, perforation or obstruction within 1 year before screening, and have been clinically diagnosed;
9. Those who require drug treatment or surgical intervention;
10. History of malignant tumors within 5 years before screening;
11. Have a history of drug abuse, drug abuse and/or alcoholism within 2 years before screening.

Where this trial is running

Nanjing, Jiangsu

• Drum Tower Hospital affiliated to Nanjing University School of Medicine — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Zhuang Nie

Conditions Moderate Pain in Knee Osteoarthritis; Severe Pain in Knee Osteoarthritis