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

PMG Pharm

Status and phase: Unknown; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Drug: PK101-002; Drug: PK101; Drug: PK101-002 placebo; Drug: PK101 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04858659

PK101_P301

Details and patient eligibility

About

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

Full 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.

Enrollment: 354 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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354 participants in 2 patient groups

PK101 group

Experimental group

Treatment:

Drug: PK101

Drug: PK101-002 placebo

PK101-002 group

Active Comparator group

Treatment:

Drug: PK101 placebo

Drug: PK101-002