A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis
NCT ID: NCT03595618
Last Updated: 2021-07-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
932 participants
INTERVENTIONAL
2018-08-14
2020-07-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GLPG1972 75 mg
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
GLPG1972
Film-coated tablets of GLPG1972 for oral use.
Placebo
Film-coated tablets of matching placebo for oral use.
GLPG1972 150 mg
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
GLPG1972
Film-coated tablets of GLPG1972 for oral use.
Placebo
Film-coated tablets of matching placebo for oral use.
GLPG1972 300 mg
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
GLPG1972
Film-coated tablets of GLPG1972 for oral use.
Placebo
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Placebo
Film-coated tablets of matching placebo for oral use.
Interventions
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GLPG1972
Film-coated tablets of GLPG1972 for oral use.
Placebo
Film-coated tablets of matching placebo for oral use.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
75 Years
ALL
No
Sponsors
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Institut de Recherches Internationales Servier
OTHER
Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Galapagos Study Director
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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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
University of Kansas Medical Center
Kansas City, Kansas, United States
Phoenix Medical Reasearch
Prairie Village, Kansas, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Medpharmics
Metairie, Louisiana, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Clinical Research Consortium Nevada
Las Vegas, Nevada, United States
NY Scientific
Brooklyn, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Upstate Clinical Research Associates
Williamsville, New York, United States
Lillestol Research, LCC
Fargo, North Dakota, United States
Optimed Research, LTD
Columbus, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Pioneer Research Solutions Inc.
Houston, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Advanced Clinical Research
West Jordan, Utah, United States
Charlottesville Medical Research Center, LCC
Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc. - Newport News
Newport News, Virginia, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Countries
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References
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Chen L, Huang FL, Tang Q, Zhao ZK, Ye ZY, Liang JH. Targeted therapy for knee osteoarthritis: From basic to clinics. Medicine (Baltimore). 2025 Aug 15;104(33):e43686. doi: 10.1097/MD.0000000000043686.
Schnitzer T, Pueyo M, Deckx H, van der Aar E, Bernard K, Hatch S, van der Stoep M, Grankov S, Phung D, Imbert O, Chimits D, Muller K, Hochberg MC, Bliddal H, Wirth W, Eckstein F, Conaghan PG. Evaluation of S201086/GLPG1972, an ADAMTS-5 inhibitor, for the treatment of knee osteoarthritis in ROCCELLA: a phase 2 randomized clinical trial. Osteoarthritis Cartilage. 2023 Jul;31(7):985-994. doi: 10.1016/j.joca.2023.04.001. Epub 2023 Apr 13.
Brebion F, Gosmini R, Deprez P, Varin M, Peixoto C, Alvey L, Jary H, Bienvenu N, Triballeau N, Blanque R, Cottereaux C, Christophe T, Vandervoort N, Mollat P, Touitou R, Leonard P, De Ceuninck F, Botez I, Monjardet A, van der Aar E, Amantini D. Discovery of GLPG1972/S201086, a Potent, Selective, and Orally Bioavailable ADAMTS-5 Inhibitor for the Treatment of Osteoarthritis. J Med Chem. 2021 Mar 25;64(6):2937-2952. doi: 10.1021/acs.jmedchem.0c02008. Epub 2021 Mar 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-004581-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1205-0321
Identifier Type: OTHER
Identifier Source: secondary_id
GLPG1972-CL-201
Identifier Type: -
Identifier Source: org_study_id
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