Sjogren syndrome
Conditions
Interventions
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Participants must have participated in the TWINSS core study, CCFZ533B2201, and must have completed the entire treatment period up to Week 48 and the follow-up period up to Week 60 2. Signed informed consent must be obtained prior to participation in the extension study (i.e. before commencement of the Week 60 assessments of the core study) 3. In the judgement of the Investigator, participants must be expected to clinically benefit from continued iscalimab therapy
Exclusion criteria
Exclusion criteria: 1. Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principle illness, specifically: Moderate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNA positivity and renal involvement, or other organ involvement that impedes on ability to score ESSDAI domains - Active rheumatoid arthritis (RA) that impedes on the ability to score the ESSDAI articular domain - Systemic sclerosis - Any other concurrent connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's Syndrome organ domain assessments 2. Use of other investigational drugs other than iscalimab during the core study 3. Active uncontrolled viral, bacterial or other infections requiring systemic treatment at the time of enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence of Treatment-emergent adverse events (TEAEs)/ serious adverse events (SAEs) - Routine hematology and clinical chemistry laboratory test results at analysis visits up to end of study - Vital signs at analysis visits up to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| - Free iscalimab concentration in plasma during the treatment (Ctrough) and follow-up (up to end of study) periods - Incidence of anti-iscalimab antibodies in plasma at analysis visits up to end of study - The full list of exploratory endpoints to be included in the Clinical Study Report (CSR) and corresponding analysis methods will be detailed in the Statistical Analysis Plan (SAP) - Biomarker levels during the treatment and follow-up (up to end of study) periods - Free or total soluble CD40 in the absence or presence of iscalimab, respectively, at analysis visits up to end of study -Biomarker levels during the treatment and follow-up (up to end of study) periods - Physical activity and vital sign parameters levels as measured with wearable device during the treatment and follow-up (up to end of study) periods Patient Health Questionnaire-2 (PHQ-2) total score and cognitive tests scores as measured with smartphone application during the treatment and follow-up (up to end of study) periods | — |
Countries
Netherlands
Outcome results
None listed