Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug aims to tame Sjogren's syndrome in major trial

NCT ID NCT05349214

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tests whether ianalumab, a biologic drug, can reduce disease activity and symptoms in people with active Sjogren's syndrome. About 506 adults with a recent diagnosis (within 7.5 years) and positive anti-Ro/SSA antibodies are randomly assigned to receive ianalumab or a placebo. The main goal is to see if the drug improves scores on a standard disease activity scale after 48 weeks.

What this could mean

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

Active substance
ianalumab (a biologic drug given as an injection under the skin)
What this could lead to
If it works, this could provide a new treatment option to control disease activity and ease symptoms for people with active Sjogren's syndrome.
What could go wrong
This is a phase 3 trial, but results are not yet available. The drug may not prove more effective than placebo, 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

506 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

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 * Signed informed consent must be obtained prior to participation in the study * Women and men ≥ 18 years of age * Classification of Sjögren's syndrome according to the ACR/EULAR 2016 criteria * Time since diagnosis of Sjögren's of ≤ 7.5 years at screening * Positive anti-Ro/SSA antibody at screening * Patients negative for anti-Ro/SSA antibody are eligible, if they have a positive salivary gland biopsy confirmed by central expert review * Enrollment of anti-Ro/SSA-negative patients will be limited up to ≤10% of the study population * Screening ESSDAI score of ≥ 5 within the following 8 domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematological and biologic. * Stimulated whole salivary flow (sSF) rate of ≥ 0.05 mL/min at screening * Ability to communicate well with the Investigator, understand and agree to comply with the requirements of the study * Patients taking hydroxychloroquine (≤ 400 mg/day), methotrexate (≤ 25 mg/week) or azathioprine (≤ 150 mg/day) alone or in combination, are allowed to continue their medication, and must have been on a stable dose for at least 30 days prior to randomization. * Patients taking systemic corticosteroids have to be on a stable dose of ≤ 10 mg/day predniso(lo)ne or equivalent for at least 30 days before randomization. * Patients taking * disease-modifying antirheumatic drugs (DMARDs) other than specifically allowed in inclusion criterion #9 or * the following Traditional Chinese Medicines: Total glucoside of peony (TGP) or Tripterium glycosides (TG) must discontinue these medications at least 30 days prior to randomization, except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed. Exclusion Criteria: * Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness * Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer3. Prior treatment with ianalumab * Prior use of a B-cell depleting therapy other than ianalumab within 36 weeks prior to randomization or as long as B-cell count is less than the lower limit of normal or baseline value prior to receipt of previous B cell-depleting therapy (whichever is lower) * Prior treatment with any of the following: 1. Within 24 weeks prior to randomization: iscalimab (anti CD-40 mAb), belimumab , abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins plasmapheresis; 2. Within 12 weeks prior to randomization: i.v. or oral cyclophosphamide, mycophenolate mofetil, i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors) unless explicitly allowed by protocol * Use of corticosteroids (predniso(lo)ne or equivalent corticosteroid) at dose \>10 mg/day * Any one of the following laboratory values at screening: * Hemoglobin levels \< 8.0 g/dL * White blood cells (WBC) count \< 2.0 x 10E3/µL * Platelet count \< 80 x 10E3/µL * Absolute neutrophil count (ANC) \< 0.8 x 10E3/µL * Active viral, bacterial or other infections requiring systemic treatment at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infections with encapsulated organisms * History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose, L-histidine hydrochloride/ L-histidine, polysorbate 20) * History of major organ, hematopoietic stem cell or bone marrow transplant * Required regular use of medications known to cause dry mouth/eyes as a regular and major side effect, and which have not been on a stable dose for at least 30 days prior to Screening, or any anticipated change in the treatment regimen during the course of the study. * Use of topical ocular prescription medications (excluding artificial tears, gels, lubricants) that have not been on a stable dose for at least 90 days prior to randomization, or any anticipated change in the treatment regimen during the course of the study * Receipt of live/attenuated vaccine within a 4-week period prior to randomization * History of primary or secondary immunodeficiency, including a positive human immunodeficiency virus (HIV) test result * History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer or Sjögren's related lymphoma), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. * History of sarcoidosis * Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes mellitus), psychiatric or additional physical condition that the Investigator feels may jeopardize the patient in case of participation in this study * Chronic infection with hepatitis B (HBV) or hepatitis C (HCV) virus. Positive serology for hepatitis B surface antigen (HBsAg) excludes the subject. * HBsAg negative subjects who are hepatitis B core antibody (HBcAb) positive are also excluded unless all of the following criteria are met: 1. HBV DNA is negative 2. hepatitis B monitoring is implemented - in these subjects, monthly testing of HBsAg and HBV DNA must be performed while on study treatment and at least every 12 weeks after end of treatment for the entire duration of safety follow-up. 3. Antiviral prophylaxis must be implemented before the first administration of the study treatment, and continued up to 12 months after end of study treatment. If antiviral therapy cannot be given or if the patient is not willing to comply with the antiviral treatment requirement, the patient is not eligible for the study. * Hepatitis C: patients with positive hepatitis C antibody and HCV-RNA at screening are excluded. Chronic hepatitis C patients who have completed HCV anti-viral treatment must be HCV-RNA negative at least 12 weeks after treatment before randomization to be eligible. Cases of spontaneous HCV clearance should be discussed with sponsor before enrollment. * Evidence of active tuberculosis (TB) infection is exclusionary. Patient with previously treated TB and previously treated or newly diagnosed latent TB may be eligible. * Pregnant or nursing (lactating) women, * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while on study treatment and for 6 months after stopping of investigational medication. * Patients with a known history of non-compliance to medication, or who were unable or unwilling to complete PRO questionnaires, or who are unable or unwilling to use the device for collection of PROs. * United States (and other countries, if locally required): Sexually active males, unless they agree to use barrier protection during intercourse with a woman of childbearing potential, while taking study treatment. As condom use alone has a reported failure rate exceeding 1% per year, it is recommended that female partners of male study participants use a second method of birth control. Although ianalumab is not teratogenic and/or genotoxic, and not transferred to semen, male contraception is required, as requested by FDA. Globally, for all sexually active males, contraception should be used in accordance with locally approved prescribing information of concomitant medications administered.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Sjogren syndrome are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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 syndrome

Contacts and locations

Locations

  • Advanced Medical Research

    La Palma, California, 90623, United States

  • Advanced Rheumatology of Houston

    Spring, Texas, 77382, United States

  • Arthritis Northwest PLLC

    Spokane, Washington, 99216, United States

  • Arthritis Osteoporosis Assoc of NM

    Las Cruces, New Mexico, 88011, United States

  • Arthritis and Osteoporosis

    Charlotte, North Carolina, 28202, United States

  • Augusta University Georgia

    Augusta, Georgia, 30912, United States

  • Bay Area Arthritis And Osteoporosis

    Brandon, Florida, 33511, United States

  • Clin Invest Specialists Inc

    Orland Park, Illinois, 60467, United States

  • Clinic of Robert Hozman

    Skokie, Illinois, 60176, United States

  • Clinical Investigation Specialists, Inc.

    Wauconda, Illinois, 60084, United States

  • First Outpatient Research Unit

    San Antonio, Texas, 78229, United States

  • GNP Research

    Cooper City, Florida, 33024, United States

  • North Georgia Rheumatology Group

    Lawrenceville, Georgia, 30046, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1405BCH, Argentina

  • Novartis Investigative Site

    Quilmes, Buenos Aires, 1878, Argentina

  • Novartis Investigative Site

    San Miguel Tucuman, Tucumán Province, T4000DPK, Argentina

  • Novartis Investigative Site

    Buenos Aires, 1646, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1055AAF, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1428DQG, Argentina

  • Novartis Investigative Site

    Maroochydore, Queensland, 4558, Australia

  • Novartis Investigative Site

    Woodville South, South Australia, 5011, Australia

  • Novartis Investigative Site

    Hobart, Tasmania, 7000, Australia

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40150 150, Brazil

  • Novartis Investigative Site

    Curitiba, Paraná, 80030-110, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04266 010, Brazil

  • Novartis Investigative Site

    Burgas, 8000, Bulgaria

  • Novartis Investigative Site

    Plovdiv, 4002, Bulgaria

  • Novartis Investigative Site

    Sofia, 1606, Bulgaria

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1L7, Canada

  • Novartis Investigative Site

    Sydney, Nova Scotia, B1P 1P3, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5T 2S8, Canada

  • Novartis Investigative Site

    Rimouski, Quebec, G5L 5T1, Canada

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G9A 3Y2, Canada

  • Novartis Investigative Site

    Concepción, Biobio, 4070280, Chile

  • Novartis Investigative Site

    Valdivia, Los Ríos Region, 5110683, Chile

  • Novartis Investigative Site

    Santiago, RM, 7500588, Chile

  • Novartis Investigative Site

    Hefei, Anhui, 230001, China

  • Novartis Investigative Site

    Chongqing, Chongqing Municipality, 400010, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210008, China

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006, China

  • Novartis Investigative Site

    Pingxiang, Jiangxi, 337000, China

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Taiyuan, Shanxi, 030001, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Yinchuan, The Ningxia Hui Autonomous Reg, 750000, China

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830001, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310006, China

  • Novartis Investigative Site

    Beijing, 100029, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Shanghai, 200011, China

  • Novartis Investigative Site

    Shanghai, 200040, China

  • Novartis Investigative Site

    Tianjin, 300052, China

  • Novartis Investigative Site

    Xinxiang, 453099, China

  • Novartis Investigative Site

    Medellín, Antioquia, 050001, Colombia

  • Novartis Investigative Site

    Barranquilla, Atlántico, 080002, Colombia

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110221, Colombia

  • Novartis Investigative Site

    Bucaramanga, Santander Department, 680003, Colombia

  • Novartis Investigative Site

    Angers, 49933, France

  • Novartis Investigative Site

    Brest, 29200, France

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, 94275, France

  • Novartis Investigative Site

    Le Mans, 72000, France

  • Novartis Investigative Site

    Strasbourg, 67000, France

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Berlin, 13125, Germany

  • Novartis Investigative Site

    Hanover, 30625, Germany

  • Novartis Investigative Site

    Herne, 44649, Germany

  • Novartis Investigative Site

    Athens, 115 21, Greece

  • Novartis Investigative Site

    Athens, 115 27, Greece

  • Novartis Investigative Site

    Székesfehérvár, Fejér, 8000, Hungary

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Eger, 3300, Hungary

  • Novartis Investigative Site

    Gyula, 5700, Hungary

  • Novartis Investigative Site

    Szeged, 6725, Hungary

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380013, India

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380015, India

  • Novartis Investigative Site

    Bangalore, Karnataka, 560 002, India

  • Novartis Investigative Site

    Pune, Maharashtra, 411001, India

  • Novartis Investigative Site

    New Delhi, 110029, India

  • Novartis Investigative Site

    Kfar Saba, 4428164, Israel

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Ancona, AN, 60126, Italy

  • Novartis Investigative Site

    Milan, MI, 20100, Italy

  • Novartis Investigative Site

    Salerno, SA, 84131, Italy

  • Novartis Investigative Site

    Udine, UD, 33100, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 455-8530, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4578510, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4578511, Japan

  • Novartis Investigative Site

    Kitakyushu, Fukuoka, 8078556, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608543, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 245-8575, Japan

  • Novartis Investigative Site

    Kuwana, Mie-ken, 511-0061, Japan

  • Novartis Investigative Site

    Sasebo, Nagasaki, 857-1195, Japan

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 7100824, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138431, Japan

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 104-8560, Japan

  • Novartis Investigative Site

    Itabashi-ku, Tokyo, 1738610, Japan

  • Novartis Investigative Site

    Meguro-ku, Tokyo, 152-8902, Japan

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 1608582, Japan

  • Novartis Investigative Site

    Culiacán, Sinaloa, 80000, Mexico

  • Novartis Investigative Site

    Mérida, Yucatán, 97070, Mexico

  • Novartis Investigative Site

    México, 07029, Mexico

  • Novartis Investigative Site

    Poznan, Greater Poland Voivodeship, 61-397, Poland

  • Novartis Investigative Site

    Krakow, Lesser Poland Voivodeship, 30-727, Poland

  • Novartis Investigative Site

    Wroclaw, Lower Silesian Voivodeship, 52-416, Poland

  • Novartis Investigative Site

    Warsaw, 00-874, Poland

  • Novartis Investigative Site

    Wroclaw, 50367, Poland

  • Novartis Investigative Site

    Cluj-Napoca, Cluj, 400006, Romania

  • Novartis Investigative Site

    Brasov, 500283, Romania

  • Novartis Investigative Site

    Bucharest, 010825, Romania

  • Novartis Investigative Site

    Bucharest, 011172, Romania

  • Novartis Investigative Site

    Bratislava, 811 08, Slovakia

  • Novartis Investigative Site

    Košice, 040 11, Slovakia

  • Novartis Investigative Site

    Partizánske, 958 01, Slovakia

  • Novartis Investigative Site

    Zvolen, 960 01, Slovakia

  • Novartis Investigative Site

    Panorama, Western Cape, 7500, South Africa

  • Novartis Investigative Site

    Stellenbosch, Western Cape, 7600, South Africa

  • Novartis Investigative Site

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    Vigo, Pontevedra, 36214, Spain

  • Novartis Investigative Site

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Stockholm, SE, 113 65, Sweden

  • Novartis Investigative Site

    Kaohsiung City, 81346, Taiwan

  • Novartis Investigative Site

    Kaohsiung City, 83301, Taiwan

  • Novartis Investigative Site

    Taichung, 40447, Taiwan

  • Novartis Investigative Site

    Taichung, 407219, Taiwan

  • Novartis Investigative Site

    Doncaster, DN2 5LT, United Kingdom

  • Novartis Investigative Site

    Leeds, LS1 3EX, United Kingdom

  • Novartis Investigative Site

    Liverpool, L9 7AL, United Kingdom

  • Novartis Investigative Site

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Novartis Investigative Site

    Swindon, SN3 6BB, United Kingdom

  • On Site Clinical Solutions Llc

    Charlotte, North Carolina, 28202, United States

  • Prolato Clinical Research Center

    Houston, Texas, 77054, United States

  • Providence Medical Foundation

    Fullerton, California, 92835, United States

  • RAO Research LLC

    Oklahoma City, Oklahoma, 73116, United States

  • Ramesh C Gupta MD Memphis TN

    Memphis, Tennessee, 38119, United States

  • Sarasota Arthritis Res Ctr

    Sarasota, Florida, 34239, United States

  • St Lawrence Health System

    Potsdam, New York, 13676, United States

  • Tufts School of Dental Medicine

    Boston, Massachusetts, 02111, United States

  • University of Kansas Hospital

    Kansas City, Kansas, 66160, United States

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.