Overview

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.