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New drug shows promise for Sjögren's syndrome in early trial

NCT ID NCT04572841

Disease control Sponsor: Sanofi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 study tested an experimental drug called SAR441344 in 84 adults with primary Sjögren's syndrome, a condition causing dry eyes, dry mouth, and fatigue. Participants received either the drug or a placebo by injection over 12 weeks. The goal was to see if the drug could reduce disease activity and improve symptoms like fatigue, while also checking its safety and how the body processes it.

What this could mean

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

Active substance
SAR441344 (an experimental drug given as an injection)
What this could lead to
If successful, this could point toward a new treatment option to control disease activity and reduce fatigue in people with Sjögren's syndrome.
What could go wrong
This is an early Phase 2 study with only 84 participants, so results may not apply to everyone. The drug may not show significant benefit over placebo, and side effects are still being evaluated.

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

84 people

The number who actually took part.

Started

Nov 2020

Finished

Feb 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 80 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: * Participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent. * Diagnosis of pSjS according to the American College of Rheumatology/EULAR 2016 criteria at Screening. * Disease duration since first diagnosis of pSjS ≤15 years based on medical history. * Participants with moderate to severe disease activity set with ESSDAI total score ≥5, based on the following domains at Screening: glandular, articular, muscular, hematological, biological, and constitutional, lymphadenopathy. * Seropositive for anti-Ro/SSA antibodies. * IgG \> lower limit of normal (ULN) at Screening. * Stimulated salivary flow rate of ≥0.1 mL/min at Screening or Baseline. * Body weight within 45 to 120 kg (inclusive) and body mass index within the range of 18.0 to 35.0 kg/m2 (inclusive) at Screening. * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Capable of giving signed informed consent. Exclusion Criteria: * Any autoimmune disease (except pSjS and Hashimoto thyroiditis) with or without secondary SjS. * History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment. * Active life threatening or organ threatening complications of pSjS disease at the time of Screening based on treating physician evaluation including but not restricted to: * Vasculitis with renal, digestive, cardiac, pulmonary, or CNS involvement characterized as severe, * Active central nervous system (CNS) or peripheral nervous system (PNS) involvement requiring high dose steroids, * Severe renal involvement defined by objective measures, * Lymphoma. * Cardiac heart failure Stage III or IV according to the New York Heart Association. * Severe pulmonary impairment documented by an abnormal pulmonary function test. * Serious systemic viral, bacterial or fungal infection (eg, pneumonia, pyelonephritis), infection requiring hospitalization or IV antibiotics or significant chronic viral (including history of recurrent or active herpes zoster), bacterial, or fungal infection (eg, osteomyelitis) 30 days before and during Screening. * Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution. * Evidence of active or latent tuberculosis (TB) as documented by medical history (eg, chest X rays) and examination, and TB testing: A positive or 2 indeterminate QuantiFERON® TB Gold tests at Screening (regardless of prior treatment status). * Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection or medical condition (eg, cerebral, cardiac, pulmonary, renal, hepatic, gastrointestinal, neurologic, or any known immune deficiency) or previous, active or pending surgical disorder, or any condition that may affect participant safety in the judgment of the Investigator (including vaccinations which are not updated based on local regulation). * History or presence of diseases which exclude diagnosis of SjS as per the American College of Rheumatology/EULAR 2016 criteria including, but not limited to, sarcoidosis, amyloidosis, graft-versus-host disease, IgG4 related disease, and history of head and neck radiation treatment. * History of systemic hypersensitivity reaction or significant allergies, other than localized injection site reaction, to any humanized monoclonal antibody. * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis). * Any prior history of malignancy or active malignancy, including lymphoproliferative diseases and lymphoma (except successfully treated carcinoma in situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin) within 5 years prior to Baseline. * Unstable dose of nonsteroidal anti inflammatory drugs (NSAIDs) and/or unstable use of topical and/or pharmacological stimulant treatment for salivary and lacrimal glands 4 weeks before Screening. * High dose steroids, or a change in steroid dose within 4 weeks prior to Day 1/Randomization or expected changes during the course of the study. * High dose of hydroxychloroquine or chloroquine, or methotrexate or change in hydroxychloroquine, chloroquine or methotrexate dose within 12 weeks prior to Day 1/Randomization or expected changes during the course of the study. * Participants treated with the following medications/procedures prior to Screening: * Previous treatment with azathioprine and other thiopurines, mycophenolate mofetil, sulfasalazine, or cyclosporine A within 3 months. * Previous treatment with cyclophosphamide, leflunomide, or belimumab within 6 months. * Previous treatment with rituximab within 12 months. * Previous bone marrow transplantation, total lymphoid irradiation or ablative ultra high dose cyclophosphamide or IV Ig. * Previous treatment with any other biologic drug within 5 times the half life of the drug. * Received administration of any live (attenuated) vaccine within 3 months prior to Day 1/Randomization (eg, varicella zoster vaccine, oral polio, rabies). * Clinically significant abnormal ECG or vital signs at Screening. * Abnormal laboratory test(s) at Screening. * Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission. * Positive result on any of the following tests: hepatitis B surface antigen (HBsAg), anti hepatitis B core antibodies (anti HBc Ab), anti hepatitis C virus antibodies (HCV-Ab). * If female, pregnant and/or breastfeeding. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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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 Sjögren's syndrome

Contacts and locations

Locations

  • Altoona Center For Clinical Research Site Number : 8400001

    Duncansville, Pennsylvania, 16635, United States

  • Investigational Site Number : 0320001

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • Investigational Site Number : 0320002

    CABA, Buenos Aires, C1111, Argentina

  • Investigational Site Number : 0320003

    Pergamino, Buenos Aires, B2700CPM, Argentina

  • Investigational Site Number : 0320004

    CABA, Buenos Aires, 1430, Argentina

  • Investigational Site Number : 0560001

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    Ghent, 9000, Belgium

  • Investigational Site Number : 1240001

    Sherbrooke, Quebec, J1L 0H8, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7640881, Chile

  • Investigational Site Number : 1520002

    Osorno, Los Lagos Region, 5311092, Chile

  • Investigational Site Number : 1520004

    Viña del Mar, Valparaiso, 2520598, Chile

  • Investigational Site Number : 1580001

    Taipei, 100, Taiwan

  • Investigational Site Number : 1580002

    Taichung, 40447, Taiwan

  • Investigational Site Number : 1580003

    Tainan, 704, Taiwan

  • Investigational Site Number : 1580005

    Taoyuan County, 33305, Taiwan

  • Investigational Site Number : 2500001

    Montpellier, 34295, France

  • Investigational Site Number : 2500002

    Strasbourg, 67098, France

  • Investigational Site Number : 2500003

    Limoges, 87042, France

  • Investigational Site Number : 2500004

    Paris, 75010, France

  • Investigational Site Number : 2500005

    Marseille, 13003, France

  • Investigational Site Number : 2500006

    Paris, 75013, France

  • Investigational Site Number : 2760001

    Berlin, 10117, Germany

  • Investigational Site Number : 3480001

    Debrecen, 4032, Hungary

  • Investigational Site Number : 3480003

    Budapest, 1036, Hungary

  • Investigational Site Number : 3480004

    Székesfehérvár, 8000, Hungary

  • Investigational Site Number : 4100001

    Seoul, 06591, South Korea

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100004

    Daegu, Daegu, 561-712, South Korea

  • Investigational Site Number : 4840001

    Monterrey, Nuevo León, 64460, Mexico

  • Investigational Site Number : 4840002

    Mexicali, Estado de Baja California, 21200, Mexico

  • Investigational Site Number : 4840003

    Chihuahua City, 31020, Mexico

  • Investigational Site Number : 7240002

    Málaga, 29010, Spain

  • Investigational Site Number : 7240003

    Seville, Andalusia, 41010, Spain

  • Omega Research Consultants Debary Site Number : 8400005

    DeBary, Florida, 32713, United States

  • Prolato Clinical Research Center Site Number : 8400009

    Houston, Texas, 77054, United States

  • Ramesh C. Gupta, M.D. Site Number : 8400007

    Memphis, Tennessee, 38119, United States

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