Sjögren syndrome MedDRA version: 21.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: iscalimab
Product Code: CFZ533
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ISCALIMAB
Current Sponsor code: CFZ533
Concentration unit: mg/ml mil
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion in this study must meet all of the following 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 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 136 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria are not eligible for inclusion in this study. 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 Other protocol-defined inclusion/exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of iscalimab in patients with Sjogren's, who participated in the TWINSS core study, CCFZ533B2201;Secondary Objective: To assess the pharmacokinetics (PK trough levels) and dose-exposure relationship of iscalimab; To assess immunogenicity of iscalimab;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: repeatedly until study completion (60 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Free iscalimab concentration in plasma during the treatment (Ctrough) and follow-up (up to end of study) periods 2. Incidence of anti-iscalimab antibodies in plasma at analysis visits up to end of study;Timepoint(s) of evaluation of this end point: repeatedly until study completion (60 weeks) | — |
Countries
Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, Portugal, Romania, Russian Federation, Slovenia, Sweden, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed