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

NCT07351968 | Recruiting Phase 1

• 1 other identifier: HRS-2129-106
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Moderate Pain in Knee Osteoarthritis; Severe Pain in Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.

  At week 4.

Secondary Outcomes (10)

• Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.

  From baseline to Week 1, 2 and 3.

• Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) joint function subscale scores.

  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).

  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).

  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.

  From baseline to Week 1, 2, 3 and 4.

Study Arms (4)

HRS-2129 High Dose Group

EXPERIMENTAL

HRS-2129 high dose group.

Drug: HRS-2129 Tablet; Drug: Celecoxib Capsule Placebo; Drug: HRS-2129 Tablet Placebo

HRS-2129 Low Dose Group

EXPERIMENTAL

HRS-2129 low dose group.

Drug: HRS-2129 Tablet; Drug: Celecoxib Capsule Placebo; Drug: HRS-2129 Tablet Placebo

Celecoxib Group

ACTIVE COMPARATOR

Celecoxib group.

Drug: Celecoxib capsule; Drug: HRS-2129 Tablet Placebo

Placebo Group

PLACEBO COMPARATOR

Placebo group.

Drug: Celecoxib Capsule Placebo; Drug: HRS-2129 Tablet Placebo

Interventions

HRS-2129 Tablet DRUG

HRS-2129 tablet.

HRS-2129 High Dose Group; HRS-2129 Low Dose Group

Celecoxib capsule DRUG

Celecoxib capsule.

Celecoxib Group

Celecoxib Capsule Placebo DRUG

Celecoxib capsule placebo.

HRS-2129 High Dose Group; HRS-2129 Low Dose Group; Placebo Group

HRS-2129 Tablet Placebo DRUG

HRS-2129 tablet placebo.

Celecoxib Group; HRS-2129 High Dose Group; HRS-2129 Low Dose Group; Placebo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Drum Tower Hospital affiliated to Nanjing University School of Medicine

Nanjing, Jiangsu, 210005, China

RECRUITING

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Zhuang Nie

CONTACT

+86-0518-82342973; zhuang.nie@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparison between HRS-2129 high dose group, HRS-2129 low dose group, Celecoxib positive control group, and Placebo control group.

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (1)