Phase 2
Completed N=932
A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis
Source: ClinicalTrials.gov NCT03595618 ↗Enrolled (actual)
932
Serious AEs
7.5%
Results posted
May 2021
Primary outcomePrimary: Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52 — -0.06791; -0.09693; -0.08545; -0.11562 mm — p=0.165
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52 |
-0.06791; -0.09693; -0.08545; -0.11562 | 0.165 |
| SECONDARY Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee |
22; 34; 25; 35 | 0.396 |
| SECONDARY 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 |
48.0; 48.7; 47.0; 48.3; -16.3; -16.9 | 0.467 |
| SECONDARY Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to Week 52 |
63.3; 63.8; 63.3; 63.5; -27.2; -25.6 | 0.705 |
| SECONDARY Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to Week 52 |
47.1; 47.9; 49.4; 50.4; 19.4; 14.3 | 0.890 |
| SECONDARY Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria |
125; 119; 103; 127 | 0.991 |
| SECONDARY Change From Baseline in Cartilage Thickness of the Total Tibiofemoral Compartment (tTFC) of the Target Knee by qMRI to Week 52 |
6.49218; 6.57424; 6.51256; 6.45879; -0.03572; -0.02401 | 0.193 |
| SECONDARY Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 28 |
2343.32026; 2346.17547; 2354.77368; 2333.67525; 8.21893; 11.11178 | 0.627 |
| SECONDARY Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 52 |
2343.32026; 2346.17547; 2354.77368; 2333.67525; 15.45592; 22.06801 | 0.789 |
| SECONDARY Change From Baseline in Joint Space Width (JSW) of the Target Knee to Week 52 |
2.504; 2.500; 2.577; 2.483; -0.087; -0.167 | 0.141 |
| SECONDARY Number of Participants Who Have Used at Least 1 Systemic Analgesic During the Study |
216; 213; 211; 212; 173; 167 | — |
| SECONDARY Plasma Concentrations of GLPG1972 |
0.445; 1; 2.013; 0.474; 0.952; 1.788 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Event (TEAE) |
174; 177; 174; 174 | — |
Eligibility Criteria
Inclusion Criteria
- Male participants or female participants of non-childbearing potential and not breastfeeding.
- Body weight > 40 kg, body mass index (BMI) 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.
Data sourced from ClinicalTrials.gov (NCT03595618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.