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

ConditionsModerate Pain in Knee OsteoarthritisSevere Pain in Knee Osteoarthritis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-2129 Tablet

    Drug

    HRS-2129 tablet.

  • Celecoxib capsule

    Drug

    Celecoxib capsule.

  • Celecoxib Capsule Placebo

    Drug

    Celecoxib capsule placebo.

  • HRS-2129 Tablet Placebo

    Drug

    HRS-2129 tablet placebo.

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: HRS-2129 High Dose GroupExperimental treatment 3 interventions
Group B: HRS-2129 Low Dose GroupExperimental treatment 3 interventions
Group C: Celecoxib GroupActive comparator 2 interventions
Group D: Placebo GroupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
At week 4.

Secondary outcomes

1

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.
2

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.
3

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.
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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