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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат HRS-2129 Tablet
  HRS-2129 tablet.
• Препарат Celecoxib capsule
  Celecoxib capsule.
• Препарат Celecoxib Capsule Placebo
  Celecoxib capsule placebo.
• Препарат HRS-2129 Tablet Placebo
  HRS-2129 tablet placebo.

Первичные конечные точки

• Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. [Срок оценки: At week 4.]

Вторичные конечные точки (10)

• Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. [Срок оценки: From baseline to Week 1, 2 and 3.]
• Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) joint function subscale scores. [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: From baseline to Week 1, 2, 3 and 4.]
• Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale scores. [Срок оценки: From baseline to Week 1, 2, 3 and 4.]
• Change from baseline in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. [Срок оценки: From baseline to Week 1, 2, 3 and 4.]
• Treatment response: WOMAC pain subscale scores decreased by ≥ 30%, ≥ 50%, ≥ 70% from baseline. [Срок оценки: At Week 1, 2, 3 and 4.]
• Adverse events (AEs) occurred during the study. [Срок оценки: During the study, approximately 8 months.]
• Serious adverse events (SAEs) occurred during the study. [Срок оценки: During the study, approximately 8 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Drum Tower Hospital affiliated to Nanjing University School of Medicine — Нанкин

Идентификаторы

NCT: NCT07351968 · HRS-2129-106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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