E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary Sjögren's syndrome |
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E.1.1.1 | Medical condition in easily understood language |
Autoimmune condition of unknown cause where the body's own self-defenses attack glands that secrete fluids resulting in inflammation of the glands. The inflammatory process can involve other organs. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10040767 |
E.1.2 | Term | Sjogren's syndrome |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 assess the safety and tolerability of CDZ173 in patients with primary Sjögren’s syndrome.
• To compare the effect of CDZ173 versus placebo on the patient-reported outcomes of primary Sjögren’s syndrome patients after 12 weeks of treatment (study week 13).
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E.2.2 | Secondary objectives of the trial |
• To assess the pharmacokinetics of CDZ173 in primary Sjögren’s
syndrome patients
• To evaluate the effect of CDZ173 versus placebo on clinical disease
outcomes in primary Sjögren’s syndrome patients after 12 weeks of
treatment
• To evaluate the changes in the physician global assessment of the
patient’s overall disease activity after 12 weeks of treatment.
• To evaluate the changes in the patients global assessment of their
disease activity after 12 weeks of treatment |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Diagnosis of primary Sjögren’s syndrome
• ESSDAI score ≥ 6 at screening visit;
Other protocol-defined inclusion criteria may apply. |
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E.4 | Principal exclusion criteria |
• Secondary Sjögren’s syndrome
Other protocol-defined exclusion criteria may apply. |
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E.5 End points |
E.5.1 | Primary end point(s) |
EULAR Sjögren’s Syndrome Patient Reported Intensity (ESSPRI) change from baseline |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Primary endpoint evaluation after 12 week treatment. |
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E.5.2 | Secondary end point(s) |
● EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) change from baseline
● Physician global assessment of the patient's overall disease activity (VAS) change from baseline
● Patient’s global assessment of their disease activity (VAS) change from baseline |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary endpoint evaluation after 12 week treatment. |
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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 | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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 | |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 20 |