Sjögren's drug iscalimab shows promise in safety extension trial

NCT ID NCT04541589

Completed Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This extension study tested the safety and tolerability of two doses of iscalimab in 206 people with Sjögren's syndrome who had already completed a prior study. Participants received weekly injections for three weeks, then bi-weekly doses. The goal was to see if the drug is safe and to gather more information on how it works in the body.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Iscalimab (also called CFZ533)
What this could lead to: If it works, this could point toward a treatment that controls Sjögren's syndrome symptoms and reduces disease activity.
What could go wrong: This is an early-phase extension trial focused on safety, not proof of effectiveness. The results may not confirm benefit, and side effects are possible.

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Conditions

The condition(s) this trial relates to.

Sjogren syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SJOGREN'S SYNDROME

Contacts and locations

Locations

North GA Rheumatology Group PC

Suwanee, Georgia, 30024, United States
Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, C1055AAF, Argentina
Novartis Investigative Site

CABA, 1426, Argentina
Novartis Investigative Site

Nedlands, Western Australia, 6009, Australia
Novartis Investigative Site

Graz, 8036, Austria
Novartis Investigative Site

Vienna, 1090, Austria
Novartis Investigative Site

Vitória, Espírito Santo, 29055 450, Brazil
Novartis Investigative Site

Juiz de Fora, Minas Gerais, 36010 570, Brazil
Novartis Investigative Site

São Paulo, São Paulo, 01244-030, Brazil
Novartis Investigative Site

Toronto, Ontario, M5T 2S8, Canada
Novartis Investigative Site

Rimouski, Quebec, G5L 5T1, Canada
Novartis Investigative Site

Trois-Rivières, Quebec, G9A 3Y2, Canada
Novartis Investigative Site

Valdivia, Los Ríos Region, 5110683, Chile
Novartis Investigative Site

Santiago, RM, 7500588, Chile
Novartis Investigative Site

Santiago, 7500571, Chile
Novartis Investigative Site

Santiago, 7500710, Chile
Novartis Investigative Site

Medellín, Antioquia, 050001, Colombia
Novartis Investigative Site

Barranquilla, Atlántico, 080002, Colombia
Novartis Investigative Site

Brest, 29200, France
Novartis Investigative Site

Le Kremlin-Bicêtre, 94275, France
Novartis Investigative Site

Lille, 59037, France
Novartis Investigative Site

Strasbourg, 67000, France
Novartis Investigative Site

Bonn, 53105, Germany
Novartis Investigative Site

Dresden, 01307, Germany
Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany
Novartis Investigative Site

Würzburg, 97080, Germany
Novartis Investigative Site

Athens, 115 27, Greece
Novartis Investigative Site

Székesfehérvár, Fejér, 8000, Hungary
Novartis Investigative Site

Szeged, 6720, Hungary
Novartis Investigative Site

Haifa, 3104802, Israel
Novartis Investigative Site

Kfar Saba, 4428164, Israel
Novartis Investigative Site

Ramat Gan, 5265601, Israel
Novartis Investigative Site

Milan, MI, 20132, Italy
Novartis Investigative Site

Pisa, PI, 56124, Italy
Novartis Investigative Site

Nagoya, Aichi-ken, 457 8510, Japan
Novartis Investigative Site

Sasebo, Nagasaki, 857-1195, Japan
Novartis Investigative Site

Kurashiki, Okayama-ken, 710-0824, Japan
Novartis Investigative Site

Chuo Ku, Tokyo, 104 8560, Japan
Novartis Investigative Site

Rotterdam, South Holland, 3015 GD, Netherlands
Novartis Investigative Site

Groningen, 9713 GZ, Netherlands
Novartis Investigative Site

Lisbon, 1050-034, Portugal
Novartis Investigative Site

Lisbon, 1649 035, Portugal
Novartis Investigative Site

Ponte de Lima, 4990 041, Portugal
Novartis Investigative Site

Brasov, 500283, Romania
Novartis Investigative Site

Cluj-Napoca, 400006, Romania
Novartis Investigative Site

Kazan', 420097, Russia
Novartis Investigative Site

Moscow, 115522, Russia
Novartis Investigative Site

Saint Petersburg, 195257, Russia
Novartis Investigative Site

Tomsk, 634009, Russia
Novartis Investigative Site

Yekaterinburg, 620028, Russia
Novartis Investigative Site

Seoul, Seocho Gu, 06591, South Korea
Novartis Investigative Site

Stockholm, SE, 113 65, Sweden
Novartis Investigative Site

Ankara, 06500, Turkey (Türkiye)
Novartis Investigative Site

Birmingham, B15 2TH, United Kingdom
Novartis Investigative Site

Doncaster, DN2 5LT, United Kingdom
Novartis Investigative Site

Manchester, M13 9WL, United Kingdom
Ochsner Health System

Baton Rouge, Louisiana, 70809, United States
Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States
The John Hopkins Jerome L Greene Sjogren

Baltimore, Maryland, 21224, United States
Tufts School of Dental Medicine

Boston, Massachusetts, 02111, United States
Uni Wisconsin School Med Pub Health

Madison, Wisconsin, 53792, United States
Winthrop University Hospital

Mineola, New York, 11501, United States

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