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.

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.

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