Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients … (NCT03905525) | Clinical Trial Compass
CompletedPhase 2
Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome
United States, Argentina, Australia273 participantsStarted 2019-10-01
Plain-language summary
This study was to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome (SjS).
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent must be obtained prior to participation in the study
. Male or female patient \>= 18 years of age
. Classification of Sjögren's Syndrome according to ACR/EULAR 2016 criteria (Shiboski et al 2016)
. Seropositive for anti-Ro/SSA antibodies
. Stimulated whole salivary flow rate of \>= 0.1 mL/min
. Able to communicate well with the Investigator to understand and comply with the requirements of the study
. Screening ESSDAI value \>= 5 within the following 8 organ domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematologic and biologic
. Screening ESSPRI score of \>= 5
Exclusion criteria
. Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principal illness
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 2 trial testing CFZ533 in Sjögren's Syndrome — since Phase 2 is still an early stage, what do the results so far tell us about whether the drug appears safe and whether it actually reduced disease activity or symptom scores compared to placebo?
2The trial measured two different things in two different groups — one focused on physician-assessed disease activity (ESSDAI) and the other on how patients felt (ESSPRI) — which of those outcomes is most relevant to my specific situation, and does the data suggest CFZ533 helped with either?
3Since this trial is now completed, has the results data been published anywhere, and based on what you've seen, do you think the findings are strong enough to support moving forward to a larger Phase 3 trial or any other access pathway?
4Are there currently any other trials or approved treatments for Sjögren's Syndrome that I should consider alongside or instead of anything related to CFZ533, given that standard treatment options are limited?
5The trial ran for 24 weeks, which is about six months — if a future trial or access program based on this research became available, how disruptive would that kind of commitment realistically be for someone in my situation, and is my disease activity level even in the right range to be considered?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cohort 1: Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) Score From Baseline at 24 Weeks as Compared to Placebo
Timeframe: Baseline, Week 24
2
Cohort 2: Change in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) Score From Baseline at 24 Weeks as Compared to Placebo.