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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GLPG1972
Placebo
Sponsored by
Galapagos NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Central Research Associates, Inc.
  • Achieve Clinical Research, LLC
  • Elite Clinical Studies
  • Hope Research Institute, LLC - Arizona
  • Arizona Research Center
  • Clinical Research Consortium Arizona
  • Samy Metyas MD, Inc - Covina Arthritis Clinic
  • TriWest Research Associates, LLC
  • BioSolutions Clinical Research Center
  • The Helm Center for Pain Management
  • Stanford University
  • Artemis Institute for Clinical Research - San Diego
  • Artemis Institute for Clinical Research - San Marcos
  • Encompass Clinical Research
  • Center for Musculoskeletal Care - Yale Medicine
  • Avail Clinical Research, LLC
  • Clinical Physiology Associates Clinical Study Center
  • Health Awareness, Inc
  • Bioclinica Research
  • Stedman Clinical Trials, LLC
  • Compass Research, LLC
  • Injury Care Research, LLC
  • Millennium Pain Center - Bloomington
  • Northwestern University
  • Medisphere Medical Research Center
  • University of Kansas Medical Center
  • Phoenix Medical Reasearch
  • Central Kentucky Research Associates, Inc.
  • Medpharmics
  • The Center for Rheumatology and Bone Research
  • Tufts Medical Center
  • Clinical Research Consortium Nevada
  • NY Scientific
  • Rochester Clinical Research, Inc.
  • Upstate Clinical Research Associates
  • Lillestol Research, LCC
  • Optimed Research, LTD
  • Altoona Center for Clinical Research
  • Pioneer Research Solutions Inc.
  • Diagnostics Research Group
  • Advanced Clinical Research
  • Charlottesville Medical Research Center, LCC
  • Health Research of Hampton Roads, Inc. - Newport News
  • Clinical Research Associates of Tidewater

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

GLPG1972 75 mg

GLPG1972 150 mg

GLPG1972 300 mg

Placebo

Arm Description

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

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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee
A "structural progressor" was defined as a participant who had an 8% cartilage loss in cMTFC. Number of participants who met the criteria of "structural progressor" at Week 52 are provided.
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
Western Ontario and McMaster Universities Osteoarthritis Index is a questionnaire designed to assess health status and health outcomes in participants with OA of the knee. The questionnaire contains 24 questions targeting areas of pain, stiffness, and physical function. Pain subscale includes 5 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-20 with higher scores indicating worse symptoms and function. Stiffness subscale includes 2 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-8 with higher scores indicating worse symptoms and function. Physical function subscale includes 17 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-68 with higher scores indicating worse symptoms and function. The total score is the sum of all subscales (range: 0 to 96) with higher scores indicating worse symptoms and function.
Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to Week 52
The participant was asked "how would you rate the pain felt in the selected knee within the last 48 hours?". The participants rated the pain by marking the level of pain on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher pain intensity.
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to Week 52
The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated the disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.
Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria
OMERACT-OARSI criteria involves improvement based on WOMAC pain and function subscales and PGA. The responders according to OMERACT-OARSI criteria were participants who had: A high improvement in pain or in function ≥ 50% and absolute change ≥ 20, OR Improvement in at least 2 of the 3 following: Pain ≥ 20% and absolute change ≥ 10 Function ≥ 20% and absolute change ≥ 10 Patient's global assessment ≥ 20% and absolute change ≥ 10. WOMAC pain subscale score: range of 0 to 20, higher scores indicating more pain, WOMAC physical function subscale score: range of 0 to 68, higher scores indicating worse physical function), PGA: The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.
Change From Baseline in Cartilage Thickness of the Total Tibiofemoral Compartment (tTFC) of the Target Knee by qMRI to Week 52
Reduction of cartilage loss was measured by cartilage thickness of the tTFC of the target knee using qMRI.
Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 28
Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 52
Change From Baseline in Joint Space Width (JSW) of the Target Knee to Week 52
The JSW is the space measured between the 2 bones in the knee joint and this is assessed by x-ray.
Number of Participants Who Have Used at Least 1 Systemic Analgesic During the Study
Systemic analgesics included anti-inflammatory and anti-rheumatic products; analgesics; anti-diarrheals, intestinal, anti-inflammatory/anti-infective agents; and drugs for functional gastrointestinal disorders.
Plasma Concentrations of GLPG1972
Number of Participants With Treatment-emergent Adverse Event (TEAE)
TEAEs were defined as all adverse events (AEs) that occurred: between first IMP intake date (included) and last visit of participant, or before first IMP intake date and that worsened (in terms of intensity) or became serious according to investigator opinion between first IMP intake date (included) and last visit of participant. Number of participants with at least 1 TEAE (serious or non-serious) are reported.

Full Information

First Posted
July 11, 2018
Last Updated
July 27, 2021
Sponsor
Galapagos NV
Collaborators
Institut de Recherches Internationales Servier
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1. Study Identification

Unique Protocol Identification Number
NCT03595618
Brief Title
A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis
Acronym
Roccella
Official Title
Efficacy and Safety of 3 Doses of S201086/GLPG1972 Administered Orally Once Daily in Patients With Knee Osteoarthritis. A 52-week International, Multi-regional, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
July 14, 2020 (Actual)
Study Completion Date
July 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galapagos NV
Collaborators
Institut de Recherches Internationales Servier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
932 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLPG1972 75 mg
Arm Type
Experimental
Arm Description
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Arm Title
GLPG1972 150 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
GLPG1972 300 mg
Arm Type
Experimental
Arm Description
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
GLPG1972
Intervention Description
Film-coated tablets of GLPG1972 for oral use.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Film-coated tablets of matching placebo for oral use.
Primary Outcome Measure Information:
Title
Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52
Description
Reduction in cartilage loss was assessed by cartilage thickness as measured in the medial cMTFC of the target knee using qMRI.
Time Frame
Baseline, Week 52
Secondary Outcome Measure Information:
Title
Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee
Description
A "structural progressor" was defined as a participant who had an 8% cartilage loss in cMTFC. Number of participants who met the criteria of "structural progressor" at Week 52 are provided.
Time Frame
Week 52
Title
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
Description
Western Ontario and McMaster Universities Osteoarthritis Index is a questionnaire designed to assess health status and health outcomes in participants with OA of the knee. The questionnaire contains 24 questions targeting areas of pain, stiffness, and physical function. Pain subscale includes 5 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-20 with higher scores indicating worse symptoms and function. Stiffness subscale includes 2 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-8 with higher scores indicating worse symptoms and function. Physical function subscale includes 17 items rated on a Likert scale of 0 (none) to 4 (extreme) with a total range of 0-68 with higher scores indicating worse symptoms and function. The total score is the sum of all subscales (range: 0 to 96) with higher scores indicating worse symptoms and function.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to Week 52
Description
The participant was asked "how would you rate the pain felt in the selected knee within the last 48 hours?". The participants rated the pain by marking the level of pain on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher pain intensity.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to Week 52
Description
The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated the disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.
Time Frame
Baseline, Week 52
Title
Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria
Description
OMERACT-OARSI criteria involves improvement based on WOMAC pain and function subscales and PGA. The responders according to OMERACT-OARSI criteria were participants who had: A high improvement in pain or in function ≥ 50% and absolute change ≥ 20, OR Improvement in at least 2 of the 3 following: Pain ≥ 20% and absolute change ≥ 10 Function ≥ 20% and absolute change ≥ 10 Patient's global assessment ≥ 20% and absolute change ≥ 10. WOMAC pain subscale score: range of 0 to 20, higher scores indicating more pain, WOMAC physical function subscale score: range of 0 to 68, higher scores indicating worse physical function), PGA: The participant was asked "Considering all the ways in which your knee osteoarthritis affects you, please rate on this 100 mm scale how well you are doing today". The participants rated disease activity by marking on a 100-mm VAS, with 0 being no pain and 100 being extreme pain. Higher score indicated higher disease activity.
Time Frame
Week 52
Title
Change From Baseline in Cartilage Thickness of the Total Tibiofemoral Compartment (tTFC) of the Target Knee by qMRI to Week 52
Description
Reduction of cartilage loss was measured by cartilage thickness of the tTFC of the target knee using qMRI.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 28
Time Frame
Baseline, Week 28
Title
Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 52
Time Frame
Baseline, Week 52
Title
Change From Baseline in Joint Space Width (JSW) of the Target Knee to Week 52
Description
The JSW is the space measured between the 2 bones in the knee joint and this is assessed by x-ray.
Time Frame
Baseline, Week 52
Title
Number of Participants Who Have Used at Least 1 Systemic Analgesic During the Study
Description
Systemic analgesics included anti-inflammatory and anti-rheumatic products; analgesics; anti-diarrheals, intestinal, anti-inflammatory/anti-infective agents; and drugs for functional gastrointestinal disorders.
Time Frame
Baseline up to Week 52
Title
Plasma Concentrations of GLPG1972
Time Frame
Pre-dose at Weeks 4, 12, and 52; Pre-dose and one post-dose sample (2-4 hours interval) at Week 28; one post dose sample (interval 4-8 hours) at Week 40
Title
Number of Participants With Treatment-emergent Adverse Event (TEAE)
Description
TEAEs were defined as all adverse events (AEs) that occurred: between first IMP intake date (included) and last visit of participant, or before first IMP intake date and that worsened (in terms of intensity) or became serious according to investigator opinion between first IMP intake date (included) and last visit of participant. Number of participants with at least 1 TEAE (serious or non-serious) are reported.
Time Frame
Baseline up to 2-weeks after last dose of IMP (up to Week 54)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galapagos Study Director
Organizational Affiliation
Galapagos NV
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Associates, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Elite Clinical Studies
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Hope Research Institute, LLC - Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Clinical Research Consortium Arizona
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Samy Metyas MD, Inc - Covina Arthritis Clinic
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
TriWest Research Associates, LLC
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
BioSolutions Clinical Research Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
The Helm Center for Pain Management
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92637
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Artemis Institute for Clinical Research - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Artemis Institute for Clinical Research - San Marcos
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Center for Musculoskeletal Care - Yale Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Clinical Physiology Associates Clinical Study Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Health Awareness, Inc
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Bioclinica Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Stedman Clinical Trials, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Compass Research, LLC
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Injury Care Research, LLC
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Millennium Pain Center - Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Medisphere Medical Research Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Phoenix Medical Reasearch
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Central Kentucky Research Associates, Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Medpharmics
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Clinical Research Consortium Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
NY Scientific
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Upstate Clinical Research Associates
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Lillestol Research, LCC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Optimed Research, LTD
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pioneer Research Solutions Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Charlottesville Medical Research Center, LCC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Health Research of Hampton Roads, Inc. - Newport News
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33719441
Citation
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.
Results Reference
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A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis

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