Phase 4 Study of Laybon Tab. in Knee Osteoarthritis

NCT07203547 | Not Yet Recruiting Phase 4

• 1 other identifier: MTS-RAY-401
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Phase 4, multicenter, randomized, double-blind, active-controlled, parallel study aims to evaluate the non-inferiority of Laybon Tab. compared to Layla Tab. (PMG Pharm Co., Ltd.) in patients with knee osteoarthritis. Participants will receive either Laybon Tab. or Layla Tab. for 8 weeks. The primary outcome is the change in knee pain during activity, assessed by a 100 mm pain VAS over the previous 24 hours.

Conditions

Osteoarthritis, Knee; Osteoarthritis

Keywords

Laybon Tab.; Knee Osteoarthritis; Osteoarthritis; OA; Non-inferiority; Randomized Trial; Double blind; Phase 4

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Knee Pain During Activity (100 mm Pain VAS)

  Change from baseline (Visit 2, prior to study drug administration) to Week 8 in activity-related knee pain over the past 24 hours, as assessed by a 100 mm pain Visual Analogue Scale (VAS).

  Baseline and Week 8

Secondary Outcomes (6)

• Change From Baseline in Knee Pain During Activity (100 mm Pain VAS) at Week 4

  Baseline and Week 4

• Change From Baseline in WOMAC Total Score

  Baseline, week 4 and week 8

• Change From Baseline in WOMAC Subscale Scores

  Baseline, Week 4, and Week 8

• Patient Global Assessment of Knee Osteoarthritis

  Week 4 and Week 8

• Quality of Life Assessment Using SF-36

  Week 4 and Week 8

Study Arms (2)

Test Drug Group

EXPERIMENTAL

Drug: Laybon Tab.

Control Drug Group

ACTIVE COMPARATOR

Drug: Layla Tab.

Interventions

Layla Tab. DRUG

Layla Tab., oral, twice daily, 8 weeks.

Control Drug Group

Laybon Tab. DRUG

Laybon Tab., oral, twice daily, 8 weeks.

Test Drug Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 40 to 80 years, male or female.
• Diagnosed with unilateral or bilateral knee osteoarthritis according to the American College of Rheumatology (ACR) clinical criteria, meeting at least 3 of the following:
• Age \> 50 years
• Morning stiffness \< 30 minutes
• Crepitus
• Bony tenderness
• Bony enlargement
• No warmth on palpation
• Knee osteoarthritis pain persisting for at least 3 months and requiring pharmacologic treatment at screening.
• Kellgren-Lawrence grade 1-3 on knee X-ray at screening.
• Knee pain during activity over the past 24 hours ≤ 80 mm on 100 mm pain VAS at screening.
• Knee pain during activity over the past 24 hours ≥ 40 mm on 100 mm pain VAS at baseline (Visit 2).
• Able to walk without assistance (walker, cane, etc.). Participants who have routinely used mobility aids for at least 6 months prior to screening may continue their usual aid throughout the study.
• Women of childbearing potential and men must agree to use medically acceptable contraception during the study, including hormonal contraception, IUD/IUS, bilateral tubal ligation, partner vasectomy, or sexual abstinence.
• Participants currently receiving treatment for knee osteoarthritis must agree to discontinue prior therapies and comply with a wash-out period before and during study participation

You may not qualify if:

• Screening BMI ≥ 35.0 kg/m².
• Presence of other joint disorders or systemic conditions that could affect safety or efficacy assessments, including:
• Rheumatoid arthritis, autoimmune diseases, septic arthritis, inflammatory joint diseases, gout, recurrent pseudogout, joint fracture, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondrodysplasia, genetic disorders (e.g., hypermobility), or secondary osteoarthritis
• Severe osteoarthritis of hip or other joints interfering with knee evaluation
• Painful conditions such as Sudeck's atrophy, Paget's disease, spinal disc herniation
• Active or suspected infection in the target knee
• History of the following conditions at screening:
• Upper gastrointestinal ulcer within 6 months, GI bleeding within 12 months, or gastrointestinal disorders affecting drug absorption
• Severe cardiovascular diseases (NYHA class ≥3, ischemic heart disease, arrhythmia, peripheral vascular disease, prior coronary interventions, cerebrovascular disorders)
• Severe liver impairment (ALT or AST \> 3× ULN)
• Severe renal impairment (eGFR \< 30 mL/min)
• Bronchial asthma
• Fluid retention
• Lipid metabolism disorders (hyperlipidemia, diabetic dyslipidemia, pancreatitis)
• Active systemic infection or viral infection (HCV, HBV)

Sponsors & Collaborators

• Mather's Pharm. Co., Ltd.: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants, investigators, and study staff are blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share