E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031161 |
E.1.2 | Term | Osteoarthritis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study the efficacy of SMC021 versus placebo to prevent knee joint deterioration and decrease knee pain in patients with knee osteoarthritis.
To study the safety of SMC021 versus placebo in patients with knee osteoarthritis |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives include the study of: 1. Function to be assessed by WOMAC function sub-score in the signal knee. 2. Stiffness sub-score and Total WOMAC score in the signal knee 3. Pain assessed by a visual analogue scales (VAS) in the signal knee 4. Physical activity assessed by a visual analogue score (VAS) 5. Subject’s global assessment of disease activity (VAS) 6. Physician’s global assessment of disease activity (VAS) 7. Disease progression in the signal knee evaluated by magnetic resonance imaging (MRI) (volume, area, thickness, curvature, smoothness, homogeneity)
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Population Pharmaco-kinetic (PopPK) sub study
Same data and version as main protocol (Per the protocol participant will only be recruited in Denmark, Czech Republic and Romania)
The aim of the PopPK substudy is to study the intestinal absorption of oral salmon calcitonin. The total number of subjects participating in the pharmacokinetic blood sampling will be approximately 250. |
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E.3 | Principal inclusion criteria |
Ambulatory men and women with knee osteoarthritis, between 51 and 80 years old, in general good health. |
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E.4 | Principal exclusion criteria |
• Any disease or medication affecting the bone or cartilage metabolism (osteoporosis is allowed). • Conditions causing secondary osteoarthritis of the study joint • Obese study subjects with unilateral aggressive progressing knee OA. • Malignancy (except basal cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years. • Any clinical signs or laboratory evidence for severe renal/liver/pulmonary, neurologic, cardiovascular, metabolic, hematological or psychiatric condition, which in the Investigator’s opinion would preclude the participant from adhering to the Protocol or completing the trial. • Diagnostic arthroscopy with a surgical procedure within 6 moths prior to the screening or plan to have a surgery during the clinical trial. • History of drug abuse or active alcoholism. • Any investigational drug(s) within 30 days prior to screening.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Joint Space Width in the medial tibio-femoral knee joint in the signal knee measured by X-ray change from baseline over 24 months
2. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain sub-score change from baseline over 24 months
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |