Recruiting NCT07351968
A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-2129 Tablet, Celecoxib capsule, Celecoxib Capsule Placebo, HRS-2129 Tablet Placebo.
- Who it may be relevant to
- Registry conditions: Moderate Pain in Knee Osteoarthritis, Severe Pain in Knee Osteoarthritis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
Primary Objective: To explore the effectiveness of different doses of HRS-2129 in the treatment of patients with moderate to severe pain in knee osteoarthritis. Secondary Objectives: To evaluate the safety of different doses of HRS-2129 for the treatment of patients with moderate to severe pain in knee osteoarthritis; To evaluate the population pharmacokinetic profile of HRS-2129 in patients with knee osteoarthritis.
Interventions
- Drug HRS-2129 Tablet
HRS-2129 tablet. - Drug Celecoxib capsule
Celecoxib capsule. - Drug Celecoxib Capsule Placebo
Celecoxib capsule placebo. - Drug HRS-2129 Tablet Placebo
HRS-2129 tablet placebo.
Primary outcome measures
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. [Time frame: At week 4.]
Secondary outcome measures (10)
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. [Time frame: From baseline to Week 1, 2 and 3.]
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) joint function subscale scores. [Time frame: From baseline to Week 1, 2, 3 and 4.]
- Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (resting). [Time frame: From baseline to Week 1, 2, 3 and 4.]
- Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (flat walking). [Time frame: From baseline to Week 1, 2, 3 and 4.]
- Change from baseline in the overall patient global assessment (PGA) of osteoarthritis condition using the 5-point Likert scale. [Time frame: From baseline to Week 1, 2, 3 and 4.]
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale scores. [Time frame: From baseline to Week 1, 2, 3 and 4.]
- Change from baseline in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. [Time frame: From baseline to Week 1, 2, 3 and 4.]
- Treatment response: WOMAC pain subscale scores decreased by ≥ 30%, ≥ 50%, ≥ 70% from baseline. [Time frame: At Week 1, 2, 3 and 4.]
- Adverse events (AEs) occurred during the study. [Time frame: During the study, approximately 8 months.]
- Serious adverse events (SAEs) occurred during the study. [Time frame: During the study, approximately 8 months.]
Eligibility criteria
Inclusion criteria
- Voluntarily sign the informed consent form before starting the activities related to the trial;
- The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4;
- 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 ;
- 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
- History of other diseases that may involve the target joint;
- History of major trauma or surgery of knee joint and hip joint in the past year;
- Plan to undergo surgical procedure during the study;
- Most or complete loss of mobility;
- There are other diseases that may confuse the assessment of osteoarthritis pain;
- There is a neuropsychiatric disease, and the investigator's assessment may affect the evaluation of osteoarthritis (OA) or self-score;
- There are serious or poorly controlled concomitant diseases;
- Those who have a clear history of peptic ulcer, bleeding, perforation or obstruction within 1 year before screening, and have been clinically diagnosed;
- Those who require drug treatment or surgical intervention;
- History of malignant tumors within 5 years before screening;
- Have a history of drug abuse, drug abuse and/or alcoholism within 2 years before screening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Drum Tower Hospital affiliated to Nanjing University School of Medicine — Nanjing
Identifiers
NCT: NCT07351968 · HRS-2129-106