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

A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-designed, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of PK101 Compared With PK101-002 in Patients With Knee Osteoarthritis

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

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: PK101; Drug: PK101-002 placebo; Drug: PK101-002; Drug: PK101 placebo

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 Type: Interventional
• Enrollment (Anticipated): 354
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of, 54907
    • Recruiting
    • Jeonbuk National University Hospital
    • Contact: Wan-Hee Yoo; Phone Number: 82-63-250-2377; Email: ywhim@chonbuk.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PK101 group	Drug: PK101; 1 tablet at each time, 2 times a day; Drug: PK101-002 placebo; 1 tablet at each time, 2 times a day
Active Comparator: PK101-002 group	Drug: PK101-002; 1 tablet at each time, 2 times a day; Drug: PK101 placebo; 1 tablet at each time, 2 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change during activity in 100mm Pain VAS	Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever	baseline through week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change during activity in 100mm Pain VAS	Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever	baseline through week 4
Change at rest in 100mm Pain VAS	Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever	baseline through week 4, 8
Change in WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index using the Visual Analogue Scale, Version 3.1) sub scale & total score	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.	baseline through week 4, 8
Change in PGA	PGA for disease severity (Patient's Global Assessment, 1=Very good, 2=Good, 3=Fair, 4=Poor, 5=Very Poor)	baseline through week 8
Change in SF-36 sub scale & PCS, MCS as measured by Health Survey(Short Form, SF-36 v2, Physical Component Summary, Mental Component Summary)	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.	baseline through week 8

Collaborators and Investigators

• Sponsor: PMG Pharm Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Anticipated): March 15, 2022
• Study Completion (Anticipated): March 15, 2022

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PK101_P301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No