Clinical trials: Sjogren's Syndrome
Dry Eye Disease
Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease
Primary Objectives: To compare the efficacy of cenegermin vs vehicle in Schirmer I test (without anaesthesia) > 10 mm/5 min at Week 4 by testing the superiority.
- Trial name
- PROTEGO-2 (NCT05136170)
- Testing
- Cenegermin, Vehicle
- Where
- 10 sites in United States, Italy
- Volunteers
- 85 people
- Sponsor
- Dompé Farmaceutici S.p.A
Sjogren Syndrome, Mixed Connective Tissue Disease
A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)
This study was a basket trial designed to establish safety, tolerability and efficacy of MHV370 in Sjögren's Syndrome (SjS) and Mixed Connective Tissue Disease (MCTD).
- Trial name
- NCT04988087
- Testing
- MHV370
- Where
- 10 sites in China, Germany and 4 more
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Sjogren's Disease
Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax
The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®) on the surface of the eye and tear film (a film that coats the eye which is made up of oil and water).
- Trial name
- NCT02322528
- Testing
- Administration of Lotemax
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Rochester
Xerostomia, Sjogren Syndrome
Green Tea Lozenges for the Management of Dry Mouth
The goal of this proposal is to investigate the effectiveness of a Medical College of Georgia patent pending formulation of natural plant extracts on patients with xerostomia.
- Conditions
- Xerostomia, Sjogren Syndrome, Dry Mouth
- Trial name
- NCT01647737
- Testing
- MighTeaFlow, Xylitol
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Augusta University
Dry Eye, Sjogren Syndrome
Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops.
- Trial name
- NCT02257957
- Testing
- PRP injection, Standard care Hyaluronic acid eye drops
- Volunteers
- 30 people
- Sponsor
- Universidad Nacional de Colombia
Sjögren Syndrome
Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome
This study was to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome (SjS).
- Trial name
- TWINSS (NCT03905525)
- Testing
- CFZ533
- Where
- 71 sites in United States, Argentina and 21 more
- Volunteers
- 273 people
- Sponsor
- Novartis Pharmaceuticals
Sjogren's Syndrome
Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome
This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who participated in the TWINSS core study, CCFZ533B2201 (NCT03905525).
- Trial name
- TWINSS Extn (NCT04541589)
- Testing
- Iscalimab
- Where
- 62 sites in United States, Argentina and 21 more
- Volunteers
- 206 people
- Sponsor
- Novartis Pharmaceuticals
Corneal Erosion
Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients
The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.
- Trial name
- NCT06381986
- Testing
- SHJ002, Vehicle
- Where
- 6 sites in Taiwan
- Volunteers
- 116 people
- Sponsor
- Sunhawk Vision Biotech, Inc.
Sjogren's Syndrome
Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's Syndrome
This study is a multi-national, multi-center, double-blind (sponsor open), randomized, placebo-controlled trial in subjects with active primary Sjögren's syndrome designed to understand the safety and tolerability profile of…
- Trial name
- NCT02631538
- Testing
- Belimumab, Rituximab
- Where
- 36 sites in Argentina, Canada and 8 more
- Volunteers
- 86 people
- Sponsor
- GlaxoSmithKline
Primary Sjögren's Syndrome
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary Sjögren's syndrome(pSS)
- Trial name
- NCT02291029
- Testing
- CFZ533 active - Cohort 1, CFZ533 active - Cohort 2, CFZ533 active -Cohort 3
- Where
- 9 sites in United States, Germany and 3 more
- Volunteers
- 69 people
- Sponsor
- Novartis Pharmaceuticals
Sjogren's Syndrome
Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and tirabrutinib in adults with active Sjogren's Syndrome (SjS).
- Trial name
- NCT03100942
- Testing
- Lanraplenib, Filgotinib, Tirabrutinib
- Where
- 53 sites in United States, Poland and 2 more
- Volunteers
- 152 people
- Sponsor
- Gilead Sciences
Sjogren's Syndrome
Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
The primary purpose of this study is to quantify the change in expression of biomarkers on the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex.
- Trial name
- NCT00631358
- Testing
- Maxidex, No treatment
- Where
- 2 sites in Canada
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Alcon Research
Dry Eye
DNase Treatment for Dry Eyes
The purpose of this study is to evaluate the tolerability and preliminary efficacy of DNase eye drops in patients with Sjogren's and Non-Sjogren Dry Eye Disease.
- Trial name
- NCT02193490
- Testing
- DNase, Vehicle
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- University of Illinois Chicago
Sjögren Syndrome
A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome
This was an adaptive design phase 2 study to establish safety and efficacy; and to characterize the dose-response of LOU064 in subjects with moderate to severe Sjögren's syndrome.
- Trial name
- LOUiSSe (NCT04035668)
- Testing
- Remibrutinib
- Where
- 26 sites in United States, Australia and 10 more
- Volunteers
- 73 people
- Sponsor
- Novartis Pharmaceuticals
Vasculitis
Hematopoietic Stem Cell Support in Vasculitis
The systemic vasculitis is a wide-ranging group of diseases that are characterized by the presence of blood vessel inflammation (1).
- Trial name
- NCT00278512
- Testing
- Autologous Stem Cell Transplant, Allogeneic Stem Cell Transplant, Cyclophosphamide
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Northwestern University
Primary Sjögren's Syndrome
Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients
The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.
- Trial name
- NCT04605978
- Testing
- S95011 concentrate for solution for infusion
- Where
- 19 sites in United States, Australia and 5 more
- Volunteers
- 48 people
- Sponsor
- Institut de Recherches Internationales Servier
Sjogren's Syndrome
A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
The present study will examine the role of circulating RNA complexed with autoantibodies and immune complexes and its role in activation of inflammatory pathways in patients with primary Sjogren's syndrome.
- Trial name
- RSLV-132 (NCT03247686)
- Testing
- RSLV-132
- Where
- 2 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- Resolve Therapeutics
Dry Eye, Sjogren's Syndrome
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort.
- Conditions
- Dry Eye, Sjogren's Syndrome, Graft vs. Host Disease
- Trial name
- NCT01393132
- Testing
- Thymosin Beta 4 eye drops, Vehicle Control
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Michigan Cornea Consultants, PC
Sjogren's Syndrome
Pilot Study of Raptiva to Treat Sjogren's Syndrome
This study will examine the effect of the drug Raptiva (efalizumab) in patients with Sjögren's syndrome (SS), an autoimmune disease affecting the glands producing saliva \& tears.
- Trial name
- NCT00344448
- Testing
- Raptiva
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
Stevens-Johnson Syndrome, Graft Versus Host Disease in Eye
Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease
The goal of this research is to determine if the Tangible Boost system adequately replenishes the Hydra-PEG coating on the surface of a rigid contact lens.
- Conditions
- Stevens-Johnson Syndrome, Graft Versus Host Disease in Eye, Sjogren's Syndrome, Dry Eye
- Trial name
- NCT04313725
- Testing
- Tangible Boost
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Tangible Science