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Completed Phase 2 Interventional Results available

Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome

ClinicalTrials.gov ID: NCT03905525

Public ClinicalTrials.gov record NCT03905525. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 8:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjogren's Syndrome (TWINSS)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT03905525
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
273 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 100 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 1, 2019 (Actual)
Primary completion
Sep 28, 2022 (Actual)
Completion
Jun 6, 2023 (Actual)
Last update posted
May 18, 2026

2019 – 2023

United States locations

U.S. sites
8
U.S. states
8
U.S. cities
8
Facility City State ZIP Site status
North GA Rheumatology Group PC Suwanee Georgia 30024 —
Indiana Univ School of Dentistry Indianapolis Indiana 46202 —
Ochsner Health System Baton Rouge Louisiana 70809 —
The John Hopkins Jerome L Greene Sjogren Baltimore Maryland 21224 —
Tufts School of Dental Medicine Boston Massachusetts 02111 —
Winthrop University Hospital Mineola New York 11501 —
Perelman School of Medicine Philadelphia Pennsylvania 19104 —
Uni Wisconsin School Med Pub Health Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 63 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03905525, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 18, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03905525 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →