A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

March 18, 2026 updated by: Shandong Suncadia Medicine Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210005
        • Recruiting
        • Drum Tower Hospital affiliated to Nanjing University School of Medicine
        • Principal Investigator:
          • Qing Jiang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HRS-2129 High Dose Group
HRS-2129 high dose group.
Drug: HRS-2129 Tablet
HRS-2129 tablet.
Drug: Celecoxib Capsule Placebo
Celecoxib capsule placebo.
Drug: HRS-2129 Tablet Placebo
HRS-2129 tablet placebo.
Experimental: HRS-2129 Low Dose Group
HRS-2129 low dose group.
Drug: HRS-2129 Tablet
HRS-2129 tablet.
Drug: Celecoxib Capsule Placebo
Celecoxib capsule placebo.
Drug: HRS-2129 Tablet Placebo
HRS-2129 tablet placebo.
Active Comparator: Celecoxib Group
Celecoxib group.
Drug: HRS-2129 Tablet Placebo
HRS-2129 tablet placebo.
Drug: Celecoxib capsule
Celecoxib capsule.
Placebo Comparator: Placebo Group
Placebo group.
Drug: Celecoxib Capsule Placebo
Celecoxib capsule placebo.
Drug: HRS-2129 Tablet Placebo
HRS-2129 tablet placebo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.
Time Frame: At week 4.
At week 4.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
At Week 1, 2, 3 and 4.
Adverse events (AEs) occurred during the study.
Time Frame: During the study, approximately 8 months.
To evaluate the safety and tolerability of HRS-2129 tablets.
During the study, approximately 8 months.
Serious adverse events (SAEs) occurred during the study.
Time Frame: During the study, approximately 8 months.
To evaluate the safety and tolerability of HRS-2129 tablets.
During the study, approximately 8 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRS-2129-106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Dietary Supplements

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