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



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - 75
Updated:3/9/2019
Start Date:August 14, 2018
End Date:December 2020
Contact:Evelyn Fox
Email:evelyn.fox@glpg.com
Phone:0032 15 34 29 00

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Efficacy and Safety of 3 Doses of S201086/GLPG1972 Administered Orally Once Daily in Patients With Knee Osteoarthritis. A 52-week International, Multi-regional, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study

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


Inclusion Criteria:

- Male patients or female patients of non-childbearing potential Age between 40 to 75
years (both inclusive).

- Body weight > 40 kg, body mass index (BMI) < 40 kg/m2.

- 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 VAS (100 mm).

- Documented need for symptomatic as needed-treatment for 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.

- Arthroscopy of the target knee within the 6 months prior to the screening visit or
planned during the study.

- Other pathologies affecting the knee.

- Any contraindication to MRI including the inability to undergo a knee MRI exam because
of inability to fit in the scanner or knee coil.
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
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3800 Houma Blvd., Suite 335
Metairie, Louisiana 70006
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400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
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4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
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3212 Cove Bend Drive
Tampa, Florida 33613
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2001 Oriental Boulevard
Brooklyn, New York 11235
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Charlottesville, Virginia 22911
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303 East Superior Street
Chicago, Illinois 60611
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Duncansville, Pennsylvania 16635
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Durham, North Carolina 27703
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El Cajon, California 92020
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Evansville, Indiana 47714
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3901 Rainbow Blvd
Kansas City, Kansas 66160
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Orlando, Florida 32806
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