Clinical Trials List
2017-05-01 - 2020-03-04
Phase II
Terminated5
ICD-10M35.00
Sicca syndrome, unspecified
ICD-9710.2
Sicca syndrome
A randomized, double blind, placebo controlled multicenter Phase 2 doseranging study to assess the safety and efficacy of multiple VAY736 doses administered subcutaneously in patients with moderate to severe primary Sjögren’s syndrome
-
Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
-
Sponsor
Novartis
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- WEN-NAN HUANG Division of Rheumatology
- 林靖才 Division of Rheumatology
- 譚國棟 Division of Rheumatology
- 謝祖怡 Division of Rheumatology
- 謝佳偉 Division of Rheumatology
- Yi-Ming Chen Division of Rheumatology
- 洪維廷 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Jeng-Hsien Yen 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 呂聆音 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Wen Chan Tsai 未分科
Audit
None
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
The Actual Total Number of Participants Enrolled
1 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
To demonstrate a dose response of VAY736 defined as change in ESSDAI from baseline at 24 weeks.
Secondary Objectives
To assess a dose response of VAY736 in the change from baseline of
ESSPRI at 24 weeks
To assess a dose response of VAY736 in the change from baseline of the
Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACITF) at 24 weeks
To assess changes from baseline in PhGA of the patient’s overall disease
activity at week 24
To assess a dose response of VAY736 in the change from baseline of SF36 at 24 weeks
To evaluate the effects of VAY736 on salivary gland function at 24 weeks
To evaluate CD19+ B-cell counts before and after VAY736 treatment, and
time to recovery
To assess safety and tolerability of VAY736 through incidence of AEs,
SAEs, and monthly safety laboratory tests
To assess immunogenicity (IG) of VAY736 by measuring serum antiVAY736 antibodies
To assess PK of VAY736 after multiple s.c. doses at multiple time points
Inclution Criteria
Fulfilled revised American European Consensus Group criteria for pSS
ESSDAI value ≥6 at baseline, based on weighted scores of the 7
domains: biologic, hematologic, articular, cutaneous, glandular, lymphadenopathy and constitutional
ESSPRI value ≥5 at baseline
Seropositive at screening for anti-Ro/SSA antibodies
Stimulated whole salivary flow rate at screening of >0.1 mL/min
Documented salivary/lacrimal gland biopsy result confirming pSS diagnosis prior to the baseline visit
Exclusion Criteria
Use of other investigational drugs within 5 half-lives of enrollment or within 30 days whichever is longer, or longer if required by local regulations
Prior use of any B-cell depleting therapy (e.g., rituximab or other anti-CD20 mAb, anti-CD22 mAb or anti-CD52 mAb)
o within 1 year prior to randomization
o or as long as B-cell count <50 cells/µL
Current use of prednisone >10 mg/day [or equivalent other
corticosteroid] or dose change within 2 weeks prior to
randomization
Prior treatment with any of the following within 180 days prior to
randomization (anti-BAFF mAb; CTLA4-Fc Ig (abatacept); antiTNF-α mAb; intravenous/subcutaneous immunoglobulin (Ig);
plasmapheresis; i.v. or oral cyclophosphamide; oral cyclosporine
Active viral, bacterial or other infections requiring systemic
treatment at the time of screening or enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
Receipt of live/attenuated vaccine within a 2 month period before baseline
Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening
The Estimated Number of Participants
-
Taiwan
8 participants
-
Global
180 participants
