Primary Sjögren disease

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ORPHA:289390OMIM:270150M35.0
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12Active trials21Specialists8Treatment centers

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UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Primary Sjögren disease (also called primary Sjögren's syndrome or pSS) is a chronic autoimmune condition in which the body's immune system mistakenly attacks its own moisture-producing glands, especially the tear glands and salivary glands. This leads to the hallmark symptoms of persistent dry eyes and dry mouth. However, Sjögren disease is much more than just dryness — it is a systemic condition that can affect many parts of the body, including the joints, skin, lungs, kidneys, nervous system, and blood vessels. The disease is called "primary" when it occurs on its own, rather than alongside another autoimmune condition like rheumatoid arthritis or lupus. It predominantly affects women, with about 9 out of 10 patients being female, and it most commonly develops in middle adulthood, typically between ages 40 and 60. Fatigue is one of the most common and debilitating symptoms, often significantly affecting quality of life. There is currently no cure for primary Sjögren disease. Treatment focuses on managing symptoms and preventing complications. This includes artificial tears and saliva substitutes for dryness, medications to stimulate saliva production (such as pilocarpine and cevimeline), and immunosuppressive drugs for more serious organ involvement. Patients with Sjögren disease also have a slightly increased risk of developing a type of cancer called non-Hodgkin lymphoma, so regular monitoring is important. With proper management, most people with Sjögren disease can lead full and active lives, though the chronic nature of the condition requires ongoing care.

Also known as:

Key symptoms:

Persistent dry eyes that feel gritty or burningDry mouth making it hard to swallow or speakSevere fatigue that does not improve with restJoint pain and stiffnessSwollen salivary glands (near the jaw and ears)Dry skinVaginal drynessPersistent dry coughDifficulty concentrating or brain fogNumbness or tingling in hands and feetSkin rashes, especially on the legsFrequent dental cavities and tooth decayRecurrent oral yeast infections (thrush)Muscle pain

Clinical phenotype terms (50)— hover any for plain English
Reduced circulating complement concentrationHP:0004431Polyarticular arthropathyHP:0005195ParotitisHP:0011850Chronic painHP:0012532Usual interstitial pneumoniaHP:0031950Anti-Ro/SS-A antibody positivityHP:0033555Anti-salivary protein antibody positivityHP:0034064Anti-carbonic anhydrase VI antibody positivityHP:0034066Anti-parotid secretory protein antibody positivityHP:0034069
Inheritance

Multifactorial

Caused by a mix of several genes and environmental factors

Age of Onset

Adult

Begins in adulthood (age 18 or older)

Orphanet ↗OMIM ↗NORD ↗

FDA & Trial Timeline

10 events
Jun 2026Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification (Ro-SjS)

Central Hospital, Nancy, France

TrialNOT YET RECRUITING
Mar 2026A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren Syndrome

Shanghai Escugen Biotechnology Co., Ltd — PHASE2

TrialNOT YET RECRUITING
Dec 2025Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors

Christian von Buchwald — PHASE2

TrialNOT YET RECRUITING
Sep 2025A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE

Lubris Bio Pty Ltd — PHASE2

TrialRECRUITING
Sep 2025Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome

Guangdong ProCapZoom Biosciences Co., Ltd. — EARLY_PHASE1

TrialNOT YET RECRUITING
Sep 2025Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging

Peking Union Medical College Hospital — NA

TrialRECRUITING
May 2025Photodynamic Treatment as Part of Oral Healthcare on Persons With Sjögren's Syndrome

Koite Health Oy — NA

TrialACTIVE NOT RECRUITING
Feb 2025"Core Stabilization Strenght and Pelvic Floor Functions in Primary Sjogren's"

Pamukkale University

TrialENROLLING BY INVITATION
Jan 2025A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome

argenx — PHASE3

TrialRECRUITING
Dec 2024A Study of RSLV-132 in Females With Sjögren's Disease

Resolve Therapeutics — PHASE2

TrialRECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

No FDA-approved treatments are currently listed for Primary Sjögren disease.

12 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

12 recruitingView all trials with filters →
Phase 33 trials
A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
Phase 3
Actively Recruiting
· Sites: Scottsdale, Arizona; Sun City, Arizona +302 more · Age: 1899 yrs
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
Phase 3
Active
PI: Bristol-Myers Squibb (Bristol-Myers Squibb) · Sites: Fullerton, California; La Palma, California +197 more · Age: 1899 yrs
Comparing Efficacy of Autologous Serum Eye Drops With and Without Insulin in Autoimmune Dry Eye: A Randomized Clinical Trial
Phase 3
Active
· Sites: Mexico City · Age: 1899 yrs
Phase 23 trials
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Phase 2
Actively Recruiting
· Sites: Sydney, New South Wales; Sydney, New South Wales +4 more · Age: 1875 yrs
A Study of RSLV-132 in Females With Sjögren's Disease
Phase 2
Actively Recruiting
PI: James Posada (Resolve Therapeutics LLC) · Sites: Chula Vista, California; Tustin, California +22 more · Age: 1875 yrs
Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for pSS Glandular Damage
Phase 2
Enrolling by Invitation
PI: Qingwem Tao (China-Japan Friendship Hospital) · Sites: Beijing, Beijing Municipality · Age: 1875 yrs
N/A3 trials
Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging
N/A
Actively Recruiting
· Sites: Beijing · Age: 1880 yrs
Photodynamic Treatment as Part of Oral Healthcare on Persons With Sjögren's Syndrome
N/A
Active
PI: Saila Pakarinen, DDS (Metropolia University of Applied Sciences) · Sites: Helsinki · Age: 1899 yrs
Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome
N/A
Active
· Sites: São Paulo, São Paulo; São Paulo, São Paulo +1 more · Age: 1899 yrs
Other3 trials
Construction of Clinical Model of Primary Sjogren's Syndrome Combined Traditional Chinese and Western Medicine
Actively Recruiting
· Sites: Beijing, Beijing Municipality · Age: 1875 yrs
"Core Stabilization Strenght and Pelvic Floor Functions in Primary Sjogren's"
Enrolling by Invitation
· Sites: Denizli, Denizli · Age: 1865 yrs
Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy
Actively Recruiting
PI: Damien SÈNE (Assistance Publique - Hôpitaux de Paris) · Sites: Paris · Age: 1899 yrs

Specialists

21 foundView all specialists →
JP
James Posada
Specialist
PI on 1 active trial2 Primary Sjögren disease publications
HP
H. Bootsma, MD, PhD
Specialist
PI on 1 active trial
XP
Xavier Mariette, PhD
Specialist
PI on 1 active trial
DS
Damien SÈNE
Specialist
PI on 1 active trial3 Primary Sjögren disease publications
MM
Marc Odrich, MD
CHARLOTTESVILLE, VA
Specialist
PI on 1 active trial
OM
Ozge Kenis-Coskun, MD
Specialist
PI on 1 active trial
MG
Murat Gözüküçük
Specialist
PI on 1 active trial1 Primary Sjögren disease publication
AM
Anne-Laure FAUCHAIS, MD
Specialist
PI on 2 active trials1 Primary Sjögren disease publication
AP
ANNE-LAURE FAUCHAIS, PH
Specialist
PI on 1 active trial
SM
songlou yin, master
Specialist
PI on 1 active trial1 Primary Sjögren disease publication
PP
Philippe GUILPAIN, MD, PhD
Specialist
PI on 2 active trials
JP
Jacques MOREL, Professor
Specialist
PI on 1 active trial
SP
Sirui Yang, MD and PhD
Specialist
PI on 1 active trial
SP
Sandra Pasoto, MD, PhD
Specialist
PI on 1 active trial
XZ
Xinyao Zhou
SAN JOSE, CA
Specialist
PI on 1 active trial
MR
Maria Soledad Retamozo
Specialist
PI on 1 active trial
VT
Virginia M Trevisani
Specialist
PI on 1 active trial
MH
Mandana Hosseini
Specialist
PI on 1 active trial
EM
Eugen Feist, Dr. med.
Specialist
PI on 1 active trial
PM
Paulo A Minali
Specialist
PI on 1 active trial

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Travel Grants

No travel grants are currently matched to Primary Sjögren disease.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Primary Sjögren disease

Disease timeline:

New recruiting trial: Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging

A new clinical trial is recruiting patients for Primary Sjögren disease

New recruiting trial: Construction of Clinical Model of Primary Sjogren's Syndrome Combined Traditional Chinese and Western Medicine

A new clinical trial is recruiting patients for Primary Sjögren disease

New recruiting trial: Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy

A new clinical trial is recruiting patients for Primary Sjögren disease

New recruiting trial: A Study of RSLV-132 in Females With Sjögren's Disease

A new clinical trial is recruiting patients for Primary Sjögren disease

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Questions for your doctor

Bring these to your next appointment

  • Q1.What type of Sjögren disease do I have, and how severe is my case?,Which of my organs are affected, and how will you monitor for complications?,What is my risk of developing lymphoma, and how will you screen for it?,What treatments do you recommend for my specific symptoms, and what are the side effects?,Should I see other specialists, such as an eye doctor or dentist, and how often?,Are there any clinical trials or newer treatments I should consider?,What lifestyle changes can I make to help manage my symptoms and protect my teeth and eyes?

Common questions about Primary Sjögren disease

What is Primary Sjögren disease?

Primary Sjögren disease (also called primary Sjögren's syndrome or pSS) is a chronic autoimmune condition in which the body's immune system mistakenly attacks its own moisture-producing glands, especially the tear glands and salivary glands. This leads to the hallmark symptoms of persistent dry eyes and dry mouth. However, Sjögren disease is much more than just dryness — it is a systemic condition that can affect many parts of the body, including the joints, skin, lungs, kidneys, nervous system, and blood vessels. The disease is called "primary" when it occurs on its own, rather than alongsid

How is Primary Sjögren disease inherited?

Primary Sjögren disease follows a multifactorial inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

At what age does Primary Sjögren disease typically begin?

Typical onset of Primary Sjögren disease is adult. Age of onset can vary across affected individuals.

Are there clinical trials for Primary Sjögren disease?

Yes — 12 recruiting clinical trials are currently listed for Primary Sjögren disease on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Primary Sjögren disease?

21 specialists and care centers treating Primary Sjögren disease are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.