A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis

• Status: Completed
• Trial end date: 2020-07-14
• Target enrollment: 0
• Participant gender: All

Summary

This study is a phase 2, 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galapagos NV
• Collaborator: Institut de Recherches Internationales Servier

Criteria

Inclusion Criteria:

• Male participants or female participants of non-childbearing potential and not breastfeeding.

• Body weight > 40 kg, body mass index (BMI) < 40 kg/m^2.

• Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology.

• History of knee pain for at least 6 months and on the majority of days (> 50%) during the preceding month.

• Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on visual analogue scale (VAS, 100 mm) at screening and inclusion visits.

• Documented need for symptomatic as needed-treatment for osteoarthritis (OA) in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics

Exclusion Criteria:

• Severe clinical knee malalignment according to the investigator.

• Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral side).

• Knee prosthesis already foreseen within the study period (whichever side).

• Hip prosthesis recently implanted (< 1 year) or foreseen within the study period (whichever side).

• Previous osteotomy on the inferior limbs (whichever side).

• Surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study.

• Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study.

• Other pathologies affecting the target knee.

• Any contraindication to magnetic resonance imaging (MRI) including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil.