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

NCT03595618 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: GLPG1972-CL-2012017-004581-10U1111-1205-0321
• Study Type: interventional
• Target: 932
• Locations: 1 country
• Sites: 44

Brief 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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52

  Reduction in cartilage loss was assessed by cartilage thickness as measured in the medial cMTFC of the target knee using qMRI.

  Baseline, Week 52

Secondary Outcomes (12)

• Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee

  Week 52

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score and Subscales Scores for Pain, Function, and Stiffness to Week 52

  Baseline, Week 52

• Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to Week 52

  Baseline, Week 52

• Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to Week 52

  Baseline, Week 52

• Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria

  Week 52

Study Arms (4)

GLPG1972 75 mg

EXPERIMENTAL

Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.

Drug: GLPG1972; Drug: Placebo

GLPG1972 150 mg

EXPERIMENTAL

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.

Drug: GLPG1972; Drug: Placebo

GLPG1972 300 mg

EXPERIMENTAL

Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.

Drug: GLPG1972

Placebo

PLACEBO COMPARATOR

Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.

Drug: Placebo

Interventions

GLPG1972 DRUG

Film-coated tablets of GLPG1972 for oral use.

GLPG1972 150 mg; GLPG1972 300 mg; GLPG1972 75 mg

Placebo DRUG

Film-coated tablets of matching placebo for oral use.

GLPG1972 150 mg; GLPG1972 75 mg; Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Galapagos NV: lead
• Institut de Recherches Internationales Servier: collaborator

Study Sites (44)

Central Research Associates, Inc.

Birmingham, Alabama, 35205, United States

Location

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States

Location

Elite Clinical Studies

Phoenix, Arizona, 85018, United States

Location

Hope Research Institute, LLC - Arizona

Phoenix, Arizona, 85018, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Clinical Research Consortium Arizona

Tempe, Arizona, 85283, United States

Location

Samy Metyas MD, Inc - Covina Arthritis Clinic

Covina, California, 91723, United States

Location

TriWest Research Associates, LLC

El Cajon, California, 92020, United States

Location

BioSolutions Clinical Research Center

La Mesa, California, 91942, United States

Location

The Helm Center for Pain Management

Laguna Hills, California, 92637, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Artemis Institute for Clinical Research - San Diego

San Diego, California, 92103, United States

Location

Artemis Institute for Clinical Research - San Marcos

San Marcos, California, 92078, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Center for Musculoskeletal Care - Yale Medicine

New Haven, Connecticut, 06519, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Clinical Physiology Associates Clinical Study Center

Fort Myers, Florida, 33912, United States

Location

Health Awareness, Inc

Jupiter, Florida, 33458, United States

Location

Bioclinica Research

Orlando, Florida, 32806, United States

Location

Stedman Clinical Trials, LLC

Tampa, Florida, 33613, United States

Location

Compass Research, LLC

The Villages, Florida, 32162, United States

Location

Injury Care Research, LLC

Boise, Idaho, 83713, United States

Location

Millennium Pain Center - Bloomington

Bloomington, Illinois, 61704, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Medisphere Medical Research Center

Evansville, Indiana, 47714, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Phoenix Medical Reasearch

Prairie Village, Kansas, 66208, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

Medpharmics

Metairie, Louisiana, 70006, United States

Location

The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Clinical Research Consortium Nevada

Las Vegas, Nevada, 89119, United States

Location

NY Scientific

Brooklyn, New York, 11235, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Upstate Clinical Research Associates

Williamsville, New York, 14221, United States

Location

Lillestol Research, LCC

Fargo, North Dakota, 58103, United States

Location

Optimed Research, LTD

Columbus, Ohio, 43235, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Pioneer Research Solutions Inc.

Houston, Texas, 77099, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Charlottesville Medical Research Center, LCC

Charlottesville, Virginia, 22911, United States

Location

Health Research of Hampton Roads, Inc. - Newport News

Newport News, Virginia, 23606, United States

Location

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

Related Publications (3)

• 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.

  PMID: 40826764 DERIVED

• 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.

  PMID: 37059327 DERIVED

• 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.

  PMID: 33719441 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Galapagos Medical Information
• Organization: Galapagos NV

medicalinfo@glpg.com

+32 15342900

Study Officials

• Galapagos Study Director

  Galapagos NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 23, 2018
• Study Start: August 14, 2018
• Primary Completion: July 14, 2020
• Study Completion: July 14, 2020
• Last Updated: July 28, 2021
• Results First Posted: May 12, 2021

Record last verified: 2021-07

Locations

US (44)