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

Sjögren's drug ianalumab tested for Long-Term safety in 600-Patient trial

NCT ID NCT05985915

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 20, 2026 · Updated 5 times

Summary

This phase 3 study tests the long-term safety of ianalumab in 612 people with Sjögren's syndrome who already completed a year of treatment in earlier trials. Participants receive ianalumab or placebo injections for up to several more years. The goal is to see if the drug remains safe and helps control disease activity over time.

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 monoclonal antibody given as a shot under the skin)
What this could lead to
If successful, this could confirm that ianalumab is safe and effective for long-term control of Sjögren's syndrome symptoms.
What could go wrong
This is an extension study, so it builds on earlier results—but long-term safety and effectiveness are still being checked. Side effects or lack of sustained benefit remain 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

612 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Apr 2033

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 75 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. Signed informed consent prior to participation in the extension study. 2. Participants must have participated in either one of the two NEPTUNUS core studies, CVAY736A2301 or CVAY736A2302, and must have completed the entire treatment up to Week 48 without treatment discontinuation in core NEPTUNUS studies. 3. In the judgement of the Investigator, participants must be expected to clinically benefit from continued ianalumab therapy. Exclusion Criteria: 1. Use of therapies excluded by the NEPTUNUS-1 and NEPTUNUS-2 study protocols (see NEPTUNUS studies protocols exclusion criteria in Section 5.2 for details). 2. Plans for administration of live vaccines during the study period. 3. Pregnant or nursing (breastfeeding) women, where pregnancy is 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. 4. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms). WOCBP are excluded unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment during dosing and for 6 months after stopping of investigational drug. Highly effective contraception methods include: * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post- ovulation methods) and withdrawal are not acceptable methods of contraception. * Bilateral tubal occlusion or bilateral tubal ligation (at least six weeks before taking study treatment). * Sterilization (vasectomy) of male partner (s) of the female participant at least 6 months prior to screening provided partner(s) has(have) received medical confirmation of surgical process. * Use of hormonal contraception methods: * Combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal. * Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable. * Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Contraception should be used in accordance with locally approved prescribing information of concomitant medications administered. If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the informed consent form (ICF). 5. United States (and other countries, if male contraception is locally required): Sexually active males, unless they agree to use barrier protection during intercourse with a woman of child-bearing 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 the 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 Sjogrens 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.

Sjogrens syndrome

Contacts and locations

Locations

  • Advanced Medical Research

    La Palma, California, 90623, United States

  • Advanced Rheumatology of Houston

    The Woodlands, Texas, 77382, United States

  • Altoona Center for Clin Res

    Duncansville, Pennsylvania, 16635, 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

  • Baylor College Of Medicine

    Houston, Texas, 77030, United States

  • Carolina Arthritis Associates

    Wilmington, North Carolina, 28401, United States

  • Clin Invest Specialists Inc

    Orland Park, Illinois, 60467, United States

  • First Outpatient Research Unit

    San Antonio, Texas, 78229, United States

  • GNP Research

    Cooper City, Florida, 33024, United States

  • Houston Rheumatology and Arthrit

    Katy, Texas, 77494, United States

  • Medvin Clinical Research

    Van Nuys, California, 91405, United States

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501, United States

  • North GA Rheumatology Group PC

    Suwanee, Georgia, 30024, 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

    CABA, C1428DZF, 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

    Graz, 8036, Austria

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Vitória, Espírito Santo, 29055-450, Brazil

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Novartis Investigative Site

    Juiz de Fora, Minas Gerais, 36010-570, Brazil

  • Novartis Investigative Site

    Ribeirão Preto, São Paulo, 14048-900, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04266-010, Brazil

  • Novartis Investigative Site

    São Paulo, 01409-902, Brazil

  • Novartis Investigative Site

    Burgas, Bulgaria, 8000, Bulgaria

  • Novartis Investigative Site

    Sofia, 1431, Bulgaria

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1L7, Canada

  • Novartis Investigative Site

    Sydney, Nova Scotia, B1P 1P3, 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

    Santiago, Santiago Metropolitan, 7500571, Chile

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 7500710, Chile

  • Novartis Investigative Site

    Hefei, Anhui, 230001, China

  • Novartis Investigative Site

    Chongqing, Chongqing Municipality, 400010, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510630, China

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518020, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430030, China

  • Novartis Investigative Site

    Baotou, Inner Mongolia, 014010, 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

    Shenyang, Liaoning, 110011, China

  • Novartis Investigative Site

    Linyi, Shandong, 276000, China

  • Novartis Investigative Site

    Taiyuan, Shanxi, 030000, China

  • Novartis Investigative Site

    Taiyuan, Shanxi, 030001, China

  • Novartis Investigative Site

    Xian, Shanxi, 710061, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Yinchuan, The Ningxia Hui Autonomous Reg, 750000, China

  • Novartis Investigative Site

    Beijing, 100029, China

  • Novartis Investigative Site

    Beijing, 100050, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Shanghai, 200011, 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

    Brno, 638 00, Czechia

  • Novartis Investigative Site

    Uherské Hradiště, 686 01, Czechia

  • Novartis Investigative Site

    Angers, France, 49933, France

  • Novartis Investigative Site

    Brest, 29200, France

  • Novartis Investigative Site

    Dijon, 21000, France

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, 94275, France

  • Novartis Investigative Site

    Le Mans, 72000, France

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Paris, 75010, France

  • Novartis Investigative Site

    Paris, 75013, France

  • Novartis Investigative Site

    Saint-Priest-en-Jarez, 42270, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    Ludwigshafen, Germany, 67063, Germany

  • 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

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Erlangen, 91056, 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

    Guatemala City, Departamento de Guatemala, 01010, Guatemala

  • Novartis Investigative Site

    Guatemala City, Departamento de Guatemala, 01011, Guatemala

  • Novartis Investigative Site

    Quetzaltenango, Departamento de Quetzaltenango, 09001, Guatemala

  • Novartis Investigative Site

    Guatemala City, 01009, Guatemala

  • Novartis Investigative Site

    Guatemala City, 01010, Guatemala

  • 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

    New Delhi, New Delhi, 110029, India

  • Novartis Investigative Site

    Kfar Saba, 4428164, Israel

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Ancona, AN, 60020, Italy

  • Novartis Investigative Site

    Milan, MI, 20100, Italy

  • Novartis Investigative Site

    Salerno, SA, 84131, 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

    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

    Vilnius, 08406, Lithuania

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44650, Mexico

  • Novartis Investigative Site

    Mexico City, Mexico City, 06700, Mexico

  • 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, 52-210, Poland

  • Novartis Investigative Site

    Wroclaw, Lower Silesian Voivodeship, 52-416, Poland

  • Novartis Investigative Site

    Bydgoszcz, 85-168, Poland

  • Novartis Investigative Site

    Krakow, 30-002, Poland

  • Novartis Investigative Site

    Warsaw, 00-874, Poland

  • Novartis Investigative Site

    Wroclaw, 50367, Poland

  • Novartis Investigative Site

    Braga, 4710243, Portugal

  • Novartis Investigative Site

    Guarda, 6301-858, Portugal

  • Novartis Investigative Site

    Lisbon, 1050-034, Portugal

  • Novartis Investigative Site

    Lisbon, 1349-019, Portugal

  • Novartis Investigative Site

    Lisbon, 1649-035, Portugal

  • Novartis Investigative Site

    Cluj-Napoca, Cluj, 400006, Romania

  • Novartis Investigative Site

    Brasov, 500283, Romania

  • Novartis Investigative Site

    Bucharest, 011172, Romania

  • Novartis Investigative Site

    Singapore, Singapore, 308433, Singapore

  • Novartis Investigative Site

    Bratislava, 811 08, Slovakia

  • Novartis Investigative Site

    Košice, 040 11, Slovakia

  • Novartis Investigative Site

    Zvolen, 960 01, Slovakia

  • Novartis Investigative Site

    Cape Town, Western Cape, 7500, South Africa

  • Novartis Investigative Site

    Somerset West, Western Cape, 7130, South Africa

  • Novartis Investigative Site

    Gwangju, 61469, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Badalona, Barcelona, 08916, Spain

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208, Spain

  • Novartis Investigative Site

    Bilbao, Bizkaia, 48013, Spain

  • Novartis Investigative Site

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    Vigo, Pontevedra, 36214, Spain

  • Novartis Investigative Site

    A Coruña, 15006, Spain

  • Novartis Investigative Site

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Madrid, 28034, 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, 833, Taiwan

  • Novartis Investigative Site

    Taichung, 40447, Taiwan

  • Novartis Investigative Site

    Taichung, 407219, Taiwan

  • Novartis Investigative Site

    Ankara, Bilkent Cankaya, 06800, Turkey (Türkiye)

  • Novartis Investigative Site

    Köseköy, Kocaeli, 41380, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • 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

  • Ochsner Health System

    Baton Rouge, Louisiana, 70809, United States

  • On Site Clinical Solutions Llc

    Charlotte, North Carolina, 28202, United States

  • Precision Comprehensive Research

    Colleyville, Texas, 76034, 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

  • STAT Research Inc

    Dayton, Ohio, 45402, United States

  • Sarasota Arthritis Res Ctr

    Sarasota, Florida, 34239, United States

  • Shelby Research LLC

    Memphis, Tennessee, 38119, United States

  • St Lawrence Health System

    Potsdam, New York, 13676, United States

  • The John Hopkins Jerome L Greene Sjogren

    Baltimore, Maryland, 21224, United States

  • Tufts School of Dental Medicine

    Boston, Massachusetts, 02111, United States

  • University of Kansas Hospital

    Kansas City, Kansas, 66160, United States

  • West Broward Rheumatology Associates Inc

    Tamarac, Florida, 33321, 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.