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

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT03595618

Run by

Lakefront Biotherapeutics NV

People needed

932

Starts

2018-08-14

Expected to finish

2020-07-14

Last updated by the study team

2021-07-28

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Central Research Associates, Inc. — Birmingham, Alabama, United States
• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• Elite Clinical Studies — Phoenix, Arizona, United States
• Hope Research Institute, LLC - Arizona — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Clinical Research Consortium Arizona — Tempe, Arizona, United States
• Samy Metyas MD, Inc - Covina Arthritis Clinic — Covina, California, United States
• TriWest Research Associates, LLC — El Cajon, California, United States
• BioSolutions Clinical Research Center — La Mesa, California, United States
• The Helm Center for Pain Management — Laguna Hills, California, United States
• Stanford University — Palo Alto, California, United States
• Artemis Institute for Clinical Research - San Diego — San Diego, California, United States
• Artemis Institute for Clinical Research - San Marcos — San Marcos, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Center for Musculoskeletal Care - Yale Medicine — New Haven, Connecticut, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Clinical Physiology Associates Clinical Study Center — Fort Myers, Florida, United States
• Health Awareness, Inc — Jupiter, Florida, United States
• Bioclinica Research — Orlando, Florida, United States
• Stedman Clinical Trials, LLC — Tampa, Florida, United States
• Compass Research, LLC — The Villages, Florida, United States
• Injury Care Research, LLC — Boise, Idaho, United States
• Millennium Pain Center - Bloomington — Bloomington, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• Medisphere Medical Research Center — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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