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Sjögren's drug iscalimab shows promise in safety extension trial

NCT ID NCT04541589

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

206 people

The number who actually took part.

Started

Jan 2021

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants had to have participated in the TWINSS core study, CCFZ533B2201 (NCT03905525), and had to have completed the entire treatment period up to Week 48 and the follow-up period up to Week 60. 2. Signed informed consent had to 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 judgment of the Investigator, participants had to be expected to clinically benefit from continued iscalimab therapy. Exclusion Criteria: 1. Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constituted the principle illness, specifically: * Moderate-to-severe active systemic lupus erythematosus (SLE) with anti-dsDNA positivity and renal involvement, or other organ involvement that impeded on the ability to score ESSDAI domains * Active rheumatoid arthritis (RA) that impeded 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 was active and required 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 4. Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test 5. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they were using highly effective methods of contraception during dosing and for 14 weeks after stopping the investigational drug. 6. Missing ESSDAI (Cohort 1 and Cohort 2) or ESSPRI (Cohort 2) scores in the core study at Weeks 0 and 4 or Weeks 40 and 48.

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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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