A single dose study to assess the effect of VAY736 in patients with primary Sjögren’s syndrome

Phase 1

• Conditions: Seropositive primary Sjögren’s syndrome; MedDRA version: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-000250-22-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-16
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed
2. Male and female subjects age 18 to 75 years of age included
3. Fulfilled revised European US consensus criteria for pSS (Vitali et al 2002); if key inclusion criteria are missing from medical history, information will be obtained at screening and may be used as a baseline value if required
4. ESSDAI value = 6
5. Elevated serum titers at screening of ANA (= 1:160) and of RF
OR
Seropositive at screening for anti-SSA (± anti-SSB) antibodies
6. Stimulated whole salivary flow rate at screening of > 0 mL/min
7. Subjects must weigh at least 50 kg and no more than 150 kg to
participate in the study, and must have a body mass index (BMI) within
the range of 18 - 35 kg/m2
8. 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 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

- Prior or previous use of (specific dosages and intervals prior to study start may apply): B-cell depleting therapy (e.g., rituximab), Prednisone, anti-BAFF mAb, CTLA4-Fc Ig (abatacept), anti-TNF-a mAb, cyclophosphamide, methotrexate, azathioprine and medications known to cause dry mouth. Hydroxychloroquine or methotrexate in a consistent dose for = 3 months prior to randomization is allowed.
- Active or recent history of clinically significant infection
- Vaccination within 2 month prior to study
- History of primary or secondary immunodeficiency
- Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified