A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren*s Syndrome
- Conditions
- Sjogren syndrome10003816
- Registration Number
- NL-OMON51920
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Incidence of Treatment-emergent adverse events (TEAEs)/ serious adverse<br /><br>events (SAEs)<br /><br>- Routine hematology and clinical chemistry laboratory test results at analysis<br /><br>visits up to end of study<br /><br>- Vital signs at analysis visits up to end of study</p><br>
- Secondary Outcome Measures
Name Time Method