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

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ClinicalTrials.gov Identifier: NCT03595618
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Institut de Recherches Internationales Servier
Information provided by (Responsible Party):
Galapagos NV

Tracking Information
First Submitted Date  ICMJE July 11, 2018
First Posted Date  ICMJE July 23, 2018
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE August 14, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
Change from baseline in cartilage thickness of the central medial tibiofemoral compartment (cMTFC) assessed by quantitative MRI on the target knee. [ Time Frame: Between Week 0 and Week 52 ]
To demonstrate the efficacy of at least one dose (among 3 doses) of S201086/GLPG1972 compared to placebo in reducing cartilage loss measured by cartilage thickness of the cMTFC of the target knee.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03595618 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
  • Proportion of osteoarthritis (OA) structural progressors based on cartilage thickness in the central medial tibiofemoral compartment (cMTFC) assessed by quantitative MRI on the target knee. [ Time Frame: 52 weeks ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks of treatment on the proportion of structural progressors based on cartilage thickness in the CMTFC assessed of the target knee. A structural progressor is defined as a patient who had at least 8% cartilage loss in the cMTFC between baseline and Week 52.
  • Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscales scores for pain, function, and stiffness. [ Time Frame: Between Week 0 and Week 52 ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks on iso of pain, function, and stiffness measured with WOMAC.
  • Change from baseline in pain in the target knee measured with a 100-mm visual analog scale (VAS). [ Time Frame: Between Week 0 and Week 52 ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks of treatment on pain measured with a 100-mm visual analog scale (VAS).
  • Change from baseline in patient global assessment (PGA) of disease activity measured with 100-mm visual analog scale (VAS). [ Time Frame: Between Week 0 and Week 52 ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks of treatment on patient PGA of disease activity measured with 100-mm VAS.
  • Proportion of Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI) responders. [ Time Frame: Week 52 ]
    Based on OMERACT-OARSI Initiative: Osteoarthritis Research Society International set of responder criteria for OA clinical trials revisited Pham et al. 2004. A responder is defined according to WOMAC and PGA as a patient 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.
  • Change from baseline in cartilage thickness of the total tibiofemoral compartment (tTFC) of the target knee by quantitative MRI. [ Time Frame: Between Week 0 and Week 52. ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks of treatment on reduction of cartilage loss measured by cartilage thickness using quantitative MRI of the total tibiofemoral compartment (tTFC) of the target knee.
  • Change from baseline in bone area of the medial femoral condyle surface of the target knee by quantitative MRI. [ Time Frame: Between Week 0 and Week 28 ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo on the bone area of the target knee using quantitative MRI of the medial femoral condyle surface.
  • Change from baseline in bone area of the medial femoral condyle surface of the target knee by quantitative MRI. [ Time Frame: Between Week 0 and Week 52 ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo on the bone area of the target knee using quantitative MRI of the medial femoral condyle surface.
  • The change from baseline in Joint Space Width (JSW) of the target knee measured by X-Ray. [ Time Frame: Between Week 0 and Week 52. ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks of treatment on the target knee using X-ray.
  • Pain: analgesic consumption throughout the study. [ Time Frame: Between Week 0 and Week 52. ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks of treatment on analgesic consumption.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
  • Proportion of OA structural progressors based on cartilage thickness in the central medial tibiofemoral compartment (cMTFC) assessed by quantitative MRI on the target knee. [ Time Frame: 52 weeks ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks of treatment on the proportion of structural progressors based on cartilage thickness in the CMTFC assessed of the target knee. A structural progressor is defined as a patient who had at least 8% cartilage loss in the cMTFC between baseline and Week 52.
  • Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscales scores for pain, function, and stiffness. [ Time Frame: Between Week 0 and Week 52 ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks on iso of pain, function, and stiffness measured with WOMAC.
  • Change from baseline in pain in the target knee measured with a 100-mm visual analog scale (VAS). [ Time Frame: Between Week 0 and Week 52 ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks of treatment on pain measured with a 100-mm visual analog scale (VAS).
  • Change from baseline in patient global assessment (PGA) of disease activity measured with 100-mm visual analog scale (VAS). [ Time Frame: Between Week 0 and Week 52 ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks of treatment on patient PGA of disease activity measured with 100-mm VAS.
  • Proportion of OMERACT-OARSI responders. [ Time Frame: Week 52 ]
    Based on OMERACT-OARSI Initiative: Osteoarthritis Research Society International set of responder criteria for OA clinical trials revisited Pham et al. 2004. A responder is defined according to WOMAC and PGA as a patient 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.
  • Change from baseline in cartilage thickness of the total tibiofemoral compartment (tTFC) of the target knee by quantitative MRI. [ Time Frame: Between Week 0 and Week 52. ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks of treatment on reduction of cartilage loss measured by cartilage thickness using quantitative MRI of the total tibiofemoral compartment (tTFC) of the target knee.
  • Change from baseline in bone area of the medial femoral condyle surface of the target knee by quantitative MRI. [ Time Frame: Between Week 0 and Week 28 ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo on the bone area of the target knee using quantitative MRI of the medial femoral condyle surface.
  • Change from baseline in bone area of the medial femoral condyle surface of the target knee by quantitative MRI. [ Time Frame: Between Week 0 and Week 52 ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo on the bone area of the target knee using quantitative MRI of the medial femoral condyle surface.
  • The change from baseline in Joint Space Width (JSW) of the target knee measured by X-Ray. [ Time Frame: Between Week 0 and Week 52. ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks of treatment on the target knee using X-ray.
  • Pain: analgesic consumption throughout the study. [ Time Frame: Between Week 0 and Week 52. ]
    To assess efficacy of 3 doses of S201086/GLPG1972 versus placebo after 52 weeks of treatment on analgesic consumption.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Patients With Knee Osteoarthritis
Official Title  ICMJE Efficacy and Safety of 3 Doses of S201086/GLPG1972 Administered Orally Once Daily in Patients With Knee Osteoarthritis. A 52-week International, Multi-regional, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study
Brief Summary This study is a phase 2, 52-week international, multi-regional, multicenter, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of Osteoarthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: GLPG1972
    Film-coated tablets of GLPG1972 for oral use.
  • Drug: Placebo
    Film-coated tablets of matching placebo for oral use.
Study Arms  ICMJE
  • Experimental: GLPG1972 Dose A
    A daily dose of 1 film-coated tablet of GLPG1972 for oral use.
    Interventions:
    • Drug: GLPG1972
    • Drug: Placebo
  • Experimental: GLPG1972 Dose B
    A daily dose of 2 film-coated tablets of GLPG1972 for oral use.
    Interventions:
    • Drug: GLPG1972
    • Drug: Placebo
  • Experimental: GLPG1972 Dose C
    A daily dose of 4 film-coated tablets of GLPG1972 for oral use.
    Intervention: Drug: GLPG1972
  • Placebo Comparator: Placebo
    A daily dose of film-coated tablets for oral use.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 20, 2018)
852
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male patients or female patients of non-childbearing potential Age between 40 to 75 years (both inclusive).
  • Body weight > 40 kg, body mass index (BMI) < 40 kg/m2.
  • 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 VAS (100 mm).
  • Documented need for symptomatic as needed-treatment for 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.
  • Arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study.
  • Other pathologies affecting the knee.
  • Any contraindication to MRI including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Galapagos Medical Information +32 15 342900 medicalinfo@glpg.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03595618
Other Study ID Numbers  ICMJE GLPG1972-CL-201
2017-004581-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galapagos NV
Study Sponsor  ICMJE Galapagos NV
Collaborators  ICMJE Institut de Recherches Internationales Servier
Investigators  ICMJE
Study Director: Henri Deckx Galapagos NV
PRS Account Galapagos NV
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP