Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CFZ533
- Conditions
- primary Sjögren’s syndromeMedDRA version: 20.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-004808-19-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 69
1. Written informed consent must be obtained before any assessment is performed;
2.Male and female patients 18 to 75 years of age included;
3.Subjects must have a body weight of 50 –150 kg (inclusive);
4.Diagnosis of primary Sjögren’s syndromeaccording to revised EU/US consensus criteria (Vitalietal2002);
5.Moderate to severe disease activity as determined by ESSDAI score = 6;
6.Presence of autoantibodies at screening as determined by any of the following: ?
-Elevated serum titers of ANA (=1:160) and positive rheumatoid factor (RF);or,?
-Positive anti-SSA
7.Stimulated whole salivary flow rate>0 mL/min for Cohort 1 and 2;
unstimulated whole salivary flow rate > 0 mL/min for Cohort 3;
8.If the patient is on oral glucocorticoid treatment at screening, the dose must NOT exceed 10 mg prednisone or equivalent per day, and must be stable for at least 2 weeks prior to randomizationand for the duration of the study;
9.If the patient is on chloroquine or hydroxychloroquine at screening, the dose must be stable for at least 4 weeks prior to randomization and for the duration of thestudy;
10.If the patient is treated with oral or parenteral methotrexate at screening, the dose must NOT exceed 25 mg per week for at least 3 months prior to randomizationand must be stable for the duration of the study;
11.If the patient is treated with oral azathioprine at screening, the dose must NOT exceed 100mg per day for at least 3 months prior to randomization and must be stable for the duration of the study;
12.Subject must be able to communicate well with the investigator, to understand and comply with the requirements of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 58
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
1.Secondary Sjögren’s syndrome. Patients with laboratory or clinical signs of another connective tissue disease(e.g.,systemic lupus erythematous) may be eligible at the investigators discretion;
2.Use other investigational drugs at the time of enrollment, or is within five half-lives of usingother investigational drugs or longer if required by local regulations, at the time of enrollment;
3.History of hypersensitivity to study drug or to drugs of similar chemical classes;
4.Patients having received the following treatments (within given timeframe before randomization):?
-Oral or i.v. cyclosphosphamide treatment within 6 months;
-i.v. corticosteroid bolus with dose > 1 mg/kg within 3 months;
-Rituximab within 12months. For patient who received rituximab earlier, B cell count should be within normal range;
-Belimumab within 6 month;
-Any other biologic within 1 month or five times the half-life, whichever is longer;?
-Any other immunosuppressives (despite methotrexate, glucocorticoids, and hydroxychloroquine on stable doses as described in the inclusion criteria 8, 9, 10, 11) such as cyclosporine A or mycophenolate within 3months;
5. Patients where the primary cause of sicca symptoms (e.g. dry mouth,dry eyes)as judged by the investigator, is attributable to a medication used regularly or intermittently (ratherthan to primary Sjogren`s syndrome);
6.Patients who are at significant risk for thromboembolic events as judged by the investigator or have any one of the following:
-History of either thrombosis or 3 or more spontaneous abortionswith or without the presence of anti-cardiolipin autoantibodies;
-Presence of lupus anticoagulant or prolonged partial thromboplastin time (PTT);
7.Pancreatic injury or pancreatitis as indicated by abnormal signs or symptoms of pancreatitis or clinically significant elevations in amylase or lipase;
8.History or presence of any medically significant cardiac condition which according to the investigator may jeopardize the patient in case of participation in the study, including ischemic heart disease, heart failure,cardiomyopathy, myocardial infarction or stroke;
9.Sitting vital signs outside of the following ranges at screening orbaseline: bodytemperature:35.0-37.5°C, systolic blood pressure: 90-145mmHg, diastolic blood pressure:50-90 mmHg, pulse rate50 -100 bpm.
10.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases;
11.Signs orsymptoms of a clinically significant systemic viral, bacterial or fungal infection within 30 days of randomization;
Other protocol defined exclusion criteria ma apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method