Phase 2
Completed N=244
A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT02705625 ↗
Enrolled (actual)
244
Serious AEs
2.5%
Results posted
Jun 2019
Primary outcomePrimary: Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26 — -1.7; -1.5; -1.3 score — p=0.4055
Summary
This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel, Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with knee osteoarthritis (OA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26 |
-1.7; -1.5; -1.3 | 0.4055 |
| SECONDARY Magnetic Resonance Imaging (MRI) Bone Area of the Target Knee at Week 26 |
8.1290; 8.2142; 23.2234 | 0.0036 sig |
| SECONDARY Magnetic Resonance Imaging (MRI) of Cartilage Thickness (Femur) at Week 26 |
0.0077; -0.0171; -0.0658 | 0.1253 |
| SECONDARY Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain Score |
-16.6; -13.0; -9.8 | 0.2887 |
| SECONDARY Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Difficulty Score |
-16.39; -13.95; -9.9 | 0.2898 |
| SECONDARY Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score |
-17; -14.5; -9.8 | 0.2 |
| SECONDARY Serum C-terminal Telopeptide of Collagen Type I (CTX-I) at Week 26 |
-0.1209; -0.2575; 0.0000 | <0.0001 sig |
| SECONDARY Creatinine Corrected Urine C-terminal Telopeptide of Collagen Type II (CTX-II) at Week 26 |
-138.0; -242.5; 28.4 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Current average knee pain, defined as pain in either knee, within 1 week before visit 1, for which the patient gives a severity score of ≥4, <10 on a 0-10 NRS (Numeric Rating Scale).
- Inclusive of 40-80 years old.
- Diagnosis of primary knee osteoarthritis
Exclusion Criteria
- The presence of any inflammatory arthritis
- Any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator.
- Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study.
- Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
Data sourced from ClinicalTrials.gov (NCT02705625). 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.