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New drug shows promise for Sjögren's syndrome in Mid-Stage trial

NCT ID NCT03905525

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tested a drug called CFZ533 (iscalimab) in 273 adults with Sjögren's syndrome, an autoimmune disease causing dryness, pain, and fatigue. Participants received either the drug or a placebo for 24 weeks. The study measured changes in disease activity and symptoms to see if the drug is safe and effective.

What this could mean

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

Active substance
iscalimab (CFZ533)
What this could lead to
If successful, this could lead to a new treatment option that reduces disease activity and symptoms like pain and fatigue for people with Sjögren's syndrome.
What could go wrong
This is a Phase 2 trial, so results are still early. The drug may not work better than placebo, and there may be side effects. It is not yet proven as a standard therapy.

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

273 people

The number who actually took part.

Started

Oct 2019

Finished

Jun 2023

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 100 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: Both cohorts must have met all the following criteria: 1. Signed informed consent must be obtained prior to participation in the study 2. Male or female patient \>= 18 years of age 3. Classification of Sjögren's Syndrome according to ACR/EULAR 2016 criteria (Shiboski et al 2016) 4. Seropositive for anti-Ro/SSA antibodies 5. Stimulated whole salivary flow rate of \>= 0.1 mL/min 6. Able to communicate well with the Investigator to understand and comply with the requirements of the study Inclusion criteria specific for Cohort 1: 7. Screening ESSDAI value \>= 5 within the following 8 organ domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematologic and biologic * Patients with involvement of one or more of the remaining 4 domains are eligible but scores of these domains will not contribute to the assessment for eligibility for Cohort 1 * At selected sites participating in Cohort 2, patients who based on the above criterion 7, do not qualify for Cohort 1, should be further evaluated for Cohort 2 8. Screening ESSPRI score of \>= 5 Inclusion criteria specific for Cohort 2: 9. Screening ESSDAI value \< 5 within 8 domains scored for inclusion criterion #7 Cohort 1 10. Screening ESSPRI fatigue subscore \>= 5 or ESSPRI dryness subscore \>= 5 11. Hypergammaglobulinemia defined by IgG greater than upper limit of normal (ULN) or lymphocytopenia (less than lower limit of normal (LLN)) or hypocomplementemia (low C3, or low C4 - when considered due to disease activity and not due to genetic factors) 12. Score of \>= 30 on IDEEL symptom bother questionnaire at Screening Exclusion Criteria: 1. Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principal illness 2. 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 3. Prior treatment with any of the following within 6 months prior to randomization: * B-cell depletors (e.g. rituximab, ianalumab) unless CD19+ B cell count have returned to ≥ 50 cells/µL * abatacept * anti-tumor necrosis factor alpha monoclonal anti-body * intravenous/subcutaneous Ig; plasmapheresis; i.v. or oral cyclophosphamide * i.v. or oral cyclosporine A * any other immunosuppressants unless explicitly allowed in criterion #5 4. Use of steroids (predniso(lo)ne or equivalent corticosteroid) at dose \> 10 mg/day 5. Use of steroids and synthetic DMARDS at inconsistent dose and within 3 months prior to randomization

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Conditions

The condition(s) this trial relates to.

autoimmune disease Fatigue Sjogren syndrome

As listed by the trial registrant

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

Sjögren syndrome

Contacts and locations

Locations

  • Indiana Univ School of Dentistry

    Indianapolis, Indiana, 46202, United States

  • North GA Rheumatology Group PC

    Suwanee, Georgia, 30024, United States

  • Novartis Investigative Site

    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, Santiago Metropolitan, 7500571, Chile

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 7500710, Chile

  • Novartis Investigative Site

    Concepción, 6740, Chile

  • Novartis Investigative Site

    Medellín, Antioquia, 050001, Colombia

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080002, Colombia

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760012, Colombia

  • Novartis Investigative Site

    Brest, 29200, France

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, 94275, France

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Paris, 75014, France

  • Novartis Investigative Site

    Strasbourg, 67000, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Bonn, 53105, Germany

  • Novartis Investigative Site

    Athens, 115 27, Greece

  • Novartis Investigative Site

    Székesfehérvár, Fejér, 8000, Hungary

  • Novartis Investigative Site

    Budapest, 1023, 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, 56126, Italy

  • Novartis Investigative Site

    Udine, UD, 33100, 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

    Shinjuku-ku, Tokyo, 160 8582, Japan

  • Novartis Investigative Site

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Novartis Investigative Site

    Groningen, 9713 GZ, Netherlands

  • Novartis Investigative Site

    Almada, 2805-267, Portugal

  • 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

    Orenburg, 460000, 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, Yenimahalle, 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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