A Phase 3 Study to Assess the Efficacy and Safety of PK101 in Patients With Knee Osteoarthritis

Phase 3

• Conditions: Knee Osteoarthritis
• Interventions: Drug: PK101; Drug: PK101-002; Drug: PK101-002 placebo; Drug: PK101 placebo

• Registration Number: NCT04858659
• Lead Sponsor: PMG Pharm Co., Ltd

Brief Summary

The purpose of this study is to compare the efficacy and the safety of PK101 in patients with knee osteoarthritis.

Detailed Description

The primary purpose of this study is to evaluate the efficacy of PK101 compared with PK101-002 at Week 8 in osteoarthritis. Also evaluates the safety of PK101.

Study Timeline

• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-26
• Study Start: 2021-05-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-22
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

• Patients ≥40 and of age
• Patients who meets the American College Rheumatology (ACR) criteria and has lasted for at least three months after diagnosis of one-sided or bilateral knee osteoarthritis.
• Radiographic evidence of grade 1 ~ 3 osteoarthritis based on the Kellgren & Lawrence radiographic entry criteria at visit 1
• Score of 100mm pain VAS ≤ 80mm at visit 1
• Written consent form voluntarily
• Score of 100mm pain VAS ≥ 40mm at visit 3
• Patients with an individual medication compliance of 70% or more of the IP administered during the Run-in period

Exclusion Criteria

• Patients who has a history of hypersensitivity to components of IP, NSAIDs including COX-2 inhibitors, a history of hypersensitivity to aspirin, or allergic reactions to sulfonamides

• Patients with inflammatory, infectious, metabolic, septic arthritis or rheumatoid arthritis other than osteoarthritis

• Patients with a condition that can affect the joints

• Patients who have undergone arthroscopic surgery within 1 year , knee joint surgery within 5 years, synoviorthesis within 3 months prior to visit 1 to the target knee, or who have planned surgery during the trial period

• Patients who have used corticosteroids as follows:

  • Inj. of corticosteroid, including intraarticular administration, into the target knee within 3 months prior to visit 1
  • Oral corticosteroid administration within 1 month prior to visit 1

• Patients who have intraarticular injected hyaluronic acid or cell therapy products, gene therapy products, etc. for the treatment of osteoarthritis within 3 months prior to visit 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PK101 group	PK101	-
PK101 group	PK101-002 placebo	-
PK101-002 group	PK101 placebo	-
PK101-002 group	PK101-002	-

Primary Outcome Measures

Name	Time	Method
Change during activity in 100mm Pain VAS	baseline through week 8	Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever

Secondary Outcome Measures

Name	Time	Method
Change in WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index using the Visual Analogue Scale, Version 3.1) sub scale & total score	baseline through week 4, 8	Assessment of pain, stiffness and physical function. Score range 0-500 mm for Pain, 0-200 mm for Stiffness, and 0-1700 mm for Physical Function. Higher scores indicate worse pain, stiffness, and functional limitations.
Change during activity in 100mm Pain VAS	baseline through week 4	Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever
Change in PGA	baseline through week 8	PGA for disease severity (Patient's Global Assessment, 1=Very good, 2=Good, 3=Fair, 4=Poor, 5=Very Poor)
Change in SF-36 sub scale & PCS, MCS as measured by Health Survey(Short Form, SF-36 v2, Physical Component Summary, Mental Component Summary)	baseline through week 8	The SF-36 v2 is a 36-item, patient-reported survey of patient's health, consisting of 2 components(the PCS and the MCS) included 8 subscales.; Patients rated their QoL using a 2-6 point Likert Scale. Score is converting the original score to 0\~100 points.; The lower score means poor health status, and the higher score, the better.
Change at rest in 100mm Pain VAS	baseline through week 4, 8	Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever

Trial Locations

Locations (1)

Jeonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of