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OsteoarthritisPhase 2RoccellaNCT03595618

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

A Phase 2 study testing GLPG1972 in people with Osteoarthritis, run by Lakefront Biotherapeutics NV at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Osteoarthritis
What is being tested?
GLPG1972
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
932 participants
Where
44 sitesUnited States
Study dates
14 Aug 2018to 14 Jul 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Central Research Associates, Inc.

    Birmingham, Alabama, 35205

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Millennium Pain Center - Bloomington

    Bloomington, Illinois, 61704

  • Injury Care Research, LLC

    Boise, Idaho, 83713

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • NY Scientific

    Brooklyn, New York, 11235

  • Charlottesville Medical Research Center, LCC

    Charlottesville, Virginia, 22911

  • Northwestern University

    Chicago, Illinois, 60611

  • Optimed Research, LTD

    Columbus, Ohio, 43235

  • Samy Metyas MD, Inc - Covina Arthritis Clinic

    Covina, California, 91723

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • TriWest Research Associates, LLC

    El Cajon, California, 92020

  • Medisphere Medical Research Center

    Evansville, Indiana, 47714

  • Lillestol Research, LCC

    Fargo, North Dakota, 58103

  • Clinical Physiology Associates Clinical Study Center

    Fort Myers, Florida, 33912

  • Pioneer Research Solutions Inc.

    Houston, Texas, 77099

  • Health Awareness, Inc

    Jupiter, Florida, 33458

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • BioSolutions Clinical Research Center

    La Mesa, California, 91942

  • The Helm Center for Pain Management

    Laguna Hills, California, 92637

  • Clinical Research Consortium Nevada

    Las Vegas, Nevada, 89119

  • Central Kentucky Research Associates, Inc.

    Lexington, Kentucky, 40509

  • Medpharmics

    Metairie, Louisiana, 70006

  • Center for Musculoskeletal Care - Yale Medicine

    New Haven, Connecticut, 06519

  • Health Research of Hampton Roads, Inc. - Newport News

    Newport News, Virginia, 23606

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Bioclinica Research

    Orlando, Florida, 32806

  • Stanford University

    Palo Alto, California, 94304

  • Elite Clinical Studies

    Phoenix, Arizona, 85018

  • Hope Research Institute, LLC - Arizona

    Phoenix, Arizona, 85018

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • Phoenix Medical Reasearch

    Prairie Village, Kansas, 66208

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research - San Diego

    San Diego, California, 92103

  • Artemis Institute for Clinical Research - San Marcos

    San Marcos, California, 92078

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Stedman Clinical Trials, LLC

    Tampa, Florida, 33613

  • Clinical Research Consortium Arizona

    Tempe, Arizona, 85283

  • Compass Research, LLC

    The Villages, Florida, 32162

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

Other trials in United States

About this study

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

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
Being tested
GLPG1972, Placebo
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLPG1972Drug

    Film-coated tablets of GLPG1972 for oral use.

  • PlaceboDrug

    Film-coated tablets of matching placebo for oral use.

Study groups in NCT03595618
Study groupRoleWhat they receive
GLPG1972 75 mgExperimentalParticipants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
Receives: Drug: GLPG1972; Drug: Placebo
GLPG1972 150 mgExperimentalParticipants 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.
Receives: Drug: GLPG1972; Drug: Placebo
GLPG1972 300 mgExperimentalParticipants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
Receives: Drug: GLPG1972
PlaceboPlacebo comparatorParticipants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 52

Secondary outcomes (12)

  1. 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.

    Measured: Week 52

  2. 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.

    Measured: Baseline, Week 52

  3. 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.

    Measured: Baseline, Week 52

  4. 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.

    Measured: Baseline, Week 52

  5. 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.

    Measured: Week 52

  6. 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.

    Measured: Baseline, Week 52

  7. Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 28

    Measured: Baseline, Week 28

  8. Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 52

    Measured: Baseline, Week 52

  9. 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.

    Measured: Baseline, Week 52

  10. 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.

    Measured: Baseline up to Week 52

  11. Plasma Concentrations of GLPG1972

    Measured: 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

  12. 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.

    Measured: Baseline up to 2-weeks after last dose of IMP (up to Week 54)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2018
  2. Study start14 Aug 2018
  3. Primary completion14 Jul 2020
  4. Study completion14 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
932 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03595618
Sponsor's protocol ID
GLPG1972-CL-201
Other IDs
2017-004581-10, U1111-1205-0321, 2017
Acronym
Roccella
Status last verified
Jul 2021
First submitted
11 Jul 2018
Last updated
28 Jul 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 40826764

  • Dulos J, Debruin DA, van der Aar E, Chaitanya VBS, Lecru L, Campelj D, Addinsall AB, Stupka N. ADAMTS-5 inhibition reduces muscle inflammation and fibrosis and improves function in mouse models of Duchenne muscular dystrophy. Sci Transl Med. 2025 Jun 18;17(803):eado2112. doi: 10.1126/scitranslmed.ado2112. Epub 2025 Jun 18.

    PubMed 40531968

  • Larsson S, Lalande A, Stefan Lohmander L, Soret P, Bernard K, Pueyo M, Struglics A. Serum ARGS-aggrecan in a phase 2 clinical trial targeting osteoarthritis. Osteoarthritis Cartilage. 2024 Nov;32(11):1463-1470. doi: 10.1016/j.joca.2024.06.003. Epub 2024 Jun 9.

    PubMed 38862084

  • 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.

    PubMed 37059327

  • 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.

    PubMed 33719441

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GLPG1972 in people with Osteoarthritis, run by Lakefront Biotherapeutics NV at 44 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52 (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03595618, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.

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