Sjogren's Syndrome  >>  Phase 2
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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Sjogren's Syndrome
ACTRN12605000396628: A Phase II study of Rituxmab for the treatment of Sjogrens Syndrome

Recruiting
2
10
 
St Vincent's Hospital / University of New South Wales, Roche Product, St Vincent's Hospital
Sjogrens Syndrome
 
 
2016-001586-87: A Phase 2 Study of RSLV-132 in Subjects with Sjogren’s Syndrome

Ongoing
2
28
Europe
RSLV-132, Concentrate for solution for infusion
Resolve Therapeutics, LLC, Resolve Therapeutics, LLC
Primary Sjogrens Syndrome, Sjogrens Syndrome, Body processes [G] - Immune system processes [G12]
 
 
NCT02679612: Safety, Pharmacokinetics and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome

Not yet recruiting
2
27
Europe
CDZ173, Placebo
Novartis Pharmaceuticals
Primary Sjögren's Syndrome
12/17
12/17
2019-003131-31: Ravagalimab Vs Placebo in Subjects with Moderately to Severely Active Primary Sjogren's Syndrome

Not yet recruiting
2
45
Europe
Ravagalimab, ABBV-323, Powder for concentrate for solution for injection/infusion
AbbVie Deutschland GmbH & Co. KG, AbbVie Inc.
Moderately to Severely Active Primary Sjogren's Syndrome, An autoimmune disease affecting the entire body; symptoms include dry mouth, and serious complications such as profound fatigue, chronic pain, major organ involvement, neuropathies and lymphomas., Diseases [C] - Immune System Diseases [C20]
 
 
NCT03411850: Sjogrens Syndrome Measured by Ultrasound

Active, not recruiting
2
20
US
Orencia, Abatacept, Placebo, Saline
Arthritis & Rheumatism Associates, P.C., Bristol-Myers Squibb
Sjogren's Syndrome
05/21
12/21
2020-001933-11: Leflunomide and Hydroxychloroquine combination therapy for primary Sjögren’s Syndrome

Ongoing
2
52
Europe
Leflunomide, Hydroxychloroquine, Film-coated tablet, Tablet, Leflunomide, Plaquenil
University Medical Center Utrecht, ZonMw
Primary Sjogren Syndrome, Primary Sjogren Syndrome, Diseases [C] - Immune System Diseases [C20]
 
 
2020-004937-19: A study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)

Ongoing
2
60
Europe
MHV370, MHV370, Capsule, hard
Novartis Pharma AG, Novartis Pharma AG
Sjögren’s syndrome Mixed connective tissue disease, Sjögren’s syndrome Mixed connective tissue disease, Diseases [C] - Immune System Diseases [C20]
 
 
2019-002470-32: Nuovi end-points clinici in pazienti con sindrome di Sjögren primaria (pSS): uno studio interventistico basato sulla stratificazione dei pazienti. NEw Clinical End-points in patients with primary Sjögren's Syndrome (pSS): an Interventional Trial based on stratifYing patients

Ongoing
2
300
Europe
Leflunomide, mycophenolate mofetil, Hydroxychloroquine, [Leflunomide], [mycophenolate mofetil], [Hydroxychloroquine], Tablet, Arava, Mycophenolate mofetil TEVA, PLAQUENIL
ASSITANCE PUBLIQUE DES HOPITAUX DE PARIS, Innovative Medicines Initiative 2
Primary Sjögren's syndrome (pSS) sindrome di Sjögren primaria (pSS), Primary Sjögren's syndrome (pSS) sindrome di Sjögren primaria (pSS), Body processes [G] - Immune system processes [G12]
 
 
2021-000665-32: A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) Un estudio de nipocalimab en adultos con síndrome de Sjögren primario (SSp)

Ongoing
2
150
Europe
Nipocalimab, M281, Solution for infusion
Janssen-Cilag International NV, Janssen Research & Development, LLC
Primary Sjogren's Syndrome Síndrome de Sjögren primario, Primary Sjogren's Syndrome Síndrome de Sjögren primario, Diseases [C] - Immune System Diseases [C20]
 
 
NCT04884217: Treatment of Dry Eye Disease Using Pro-ocularâ„¢ - A Proof of Concept, Safety, and Efficacy Study

Enrolling by invitation
2
80
RoW
Pro-ocularâ„¢ Topical Gel, PG101, Placebo Topical Gel
PharmaDax Inc., Glia, LLC
Dry Eye Syndrome, Keratoconjunctivitis Sicca
10/21
12/21
NCT04830644: A Study to Evaluate the Efficacy and Safety of Iguratimod Compared to Placebo in Patients With Active Primary Sjogren's Syndrome.

Recruiting
2
144
RoW
Iguratimod, Placebo
Jiangsu Simcere Pharmaceutical Co., Ltd.
Primary Sjögren Syndrome
04/22
06/22
2020-005055-20: A clinical study with biopsy to investigate how ianalumab works in Sjögren`s and how safe it is Une étude clinique avec biopsie pour étudier comment l'ianalumab agit dans la maladie de Sjögren et à quel point il est sûr

Not yet recruiting
2
24
Europe
Ianalumab, VAY736, Solution for injection
Novartis Pharma AG, Novartis Pharma AG
Sjögren's syndrome Syndrome de Sjögren, Sjögren's syndrome Syndrome de Sjögren, Diseases [C] - Immune System Diseases [C20]
 
 
2022-000609-28: Efficacy and safety of anifrolumab treatment for 24 weeks in patients with primary Sjögren’s syndrome compared to placebo

Not yet recruiting
2
30
Europe
Anifrolumab, Infusion, Saphnelo
University Medical Centre Groningen, AstraZeneca BV
Primary Sjögren's syndrome. Patients will be included if the fulfil the 2016 ACR/EULAR classification criteria for pSS and if they have active disease according to an ESSDAI score of 5 or more and/or an ESSPRI score of 5 or more., Primary Sjögren's syndrome, a systemic, auto-immune disease., Diseases [C] - Immune System Diseases [C20]
 
 
NCT04129164 / 2019-002713-19: A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome

Completed
2
183
Europe, US, RoW
VIB4920, Dazodalibep, Placebo
Amgen
Sjögren's Syndrome
09/22
03/23
TWINSS, NCT03905525 / 2018-004476-35: Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome

Completed
2
273
Europe, Canada, Japan, US, RoW
CFZ533, iscalimab, Placebo
Novartis Pharmaceuticals
Sjögren Syndrome
09/22
06/23
AMASS, NCT04615455 / 2020-002804-38: Mesenchymal Stem Cell Therapy of Dry Eye Disease in Patients With Sjögren's Syndrome

Completed
2
40
Europe
ASCs, Allogeneic adipose-derived mesenchymal stem cells, Cryostor CS10
Rigshospitalet, Denmark
Keratoconjunctivitis Sicca, in Sjogren's Syndrome
12/22
01/23
2019-002205-22: "Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment."

Not yet recruiting
2
185
Europe
Branebrutinib, Abatacept, BMS-986195, BMS-188667, Capsule, hard, Solution for injection in pre-filled syringe, ORENCIA 125 mg solution for injection in pre-filled syringe
Bristol-Myers Squibb International Corporation, Bristol-Myers Squibb Research and Development, Bristol-Myers Squibb Company
SLE Sub-protocol: Systemic Lupus Erythematosus pSS Sub-protocol: Primary Sjögren’s Syndrome RA Sub-protocol: Rheumatoid Arthritis, Lupus, Sjögren’s Syndrome and Arthritis are autoimmune diseases that develops when body's immune system overreacts to unknown stimulus making antibodies/proteins directed against own's body tissues., Diseases [C] - Immune System Diseases [C20]
 
 
2021-005911-30: A Study of the safety and effectiveness of Efgartigimod in Patients with Primary Sjögren’s Syndrome (pSS)

Not yet recruiting
2
30
Europe
efgartigimod, ARGX-113, Concentrate for solution for infusion
argenx BV, argenx BV
Primary Sjögren’s Syndrome, Primary Sjögren’s Syndrome, Body processes [G] - Immune system processes [G12]
 
 
NCT05087589: Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome

Recruiting
2
10
RoW
Tofacitinib
Peking University People's Hospital
Primary Sjögren's Syndrome
01/23
10/23
NCT04605978: Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients

Completed
2
48
Europe, US, RoW
S95011 concentrate for solution for infusion, Placebo concentrate for solution for infusion
Institut de Recherches Internationales Servier, ADIR, a Servier Group company
Primary Sjögren's Syndrome
01/23
05/23
2022-001484-27: Basta 2 Basta 2

Not yet recruiting
2
30
Europe
[89Zr]Zr-Df-crefmirlimab berdoxam, IND 127861, Solution for infusion
radboudumc, Radboudumc, Health Holland Match PPS, ReumaNederland, GSK, Galapagos
Systemic Sclerosis Sjögren's SyndromeCutaneous Lupus Erythematodus Systemische Sclerose Syndroom van SjögrenCutane Lupus Erythematodus, SclerodermaSjögren's SyndromeCLE SclerodermieSyndroom van SjögrenCLE, Diseases [C] - Immune System Diseases [C20]
 
 
NCT04988087 / 2020-004937-19: A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)

Terminated
2
30
Europe, RoW
MHV370, Placebo
Novartis Pharmaceuticals, Novartis Pharma AG
Sjogren Syndrome, Mixed Connective Tissue Disease
02/23
03/23
NCT05311514: Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease

Recruiting
2
30
RoW
Allogeneic platelet lysate eye drops
St. Petersburg State Pavlov Medical University
Ocular Graft-versus-host Disease
04/23
04/24
2020-001526-59: Efficacy and safety of S95011 in primary Sjögren’s Syndrome patients

Not yet recruiting
2
45
Europe
S95011, S95011, Concentrate for solution for infusion
Institut de Recherches Internationales Servier, Servier Research and Development Ltd, ADIR
Primary Sjögren’s Syndrome, Primary Sjögren’s Syndrome, Diseases [C] - Immune System Diseases [C20]
 
 
Rho plus, NCT06203457: Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

Active, not recruiting
2
24
Europe
Efgartigimod
argenx, Iqvia Pty Ltd
Primary Sjögren's Syndrome
02/25
08/25
DAHLIAS, NCT04968912 / 2021-000665-32: A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

Completed
2
163
Europe, Japan, US, RoW
Placebo, Nipocalimab, JNJ-80202135, M281, Standard of Care Treatment
Janssen Research & Development, LLC, Janssen Research & Development, LLC
Sjogren's Syndrome
10/23
11/23
phaethuSA, NCT04572841 / 2020-000511-77: Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)

Completed
2
84
Europe, Canada, US, RoW
SAR441344, Placebo
Sanofi
Sjögren's Syndrome, Sjogren's Syndrome
11/23
02/24
NECESSITY, NCT05113004: New Clinical End-points in Patients With Primary Sjögren's Syndrome

Recruiting
2
300
Europe
Hydroxychloroquine 400mg/d, Leflunomide 20mg/d, Mycophenolate mofetil 2000mg/d, Placebo of Hydroxychloroquine 400mg/d, Placebo of Leflunomide 20mg/d, Placebo of Mycophenolate mofetil 2000mg/d
Assistance Publique - Hôpitaux de Paris
Primary Sjögren's Syndrome (pSS)
02/24
04/25
rho, NCT05817669: A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

Completed
2
34
Europe
Efgartigimod, Placebo
argenx, Iqvia Pty Ltd
Primary Sjögren's Syndrome
01/24
02/24
ANISE-II, NCT05383677: Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome

Recruiting
2
30
Europe
Anifrolumab, Saphnelo, Placebo
University Medical Center Groningen, AstraZeneca
Sjogren's Syndrome
05/24
08/24
NCT06381986: Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients

Not yet recruiting
2
122
RoW
SHJ002, Vehicle
Sunhawk Vision Biotech, Inc.
Corneal Erosion
01/25
02/25
TWINSS Extn, NCT04541589 / 2020-001942-20: Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome

Active, not recruiting
2
206
Europe, Canada, Japan, US, RoW
CFZ533 (iscalimab), iscalimab, CFZ533 Placebo, Placebo
Novartis Pharmaceuticals
Sjogren's Syndrome
07/24
07/24
NCT06312020: A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome

Recruiting
2
262
US
HZN-1116, VIB1116, Placebo
Amgen
Sjogren's Syndrome
09/26
12/26
NCT05016297: Efficacy and Safety of Baricitinib in Sjogren's Syndrome

Active, not recruiting
2
90
RoW
Baricitinib, Hydroxychloroquine
Peking Union Medical College Hospital, Eli Lilly and Company
Sjogren's Syndrome
08/24
11/24
alLEViate, NCT03953703: Levocarnitine for Dry Eye in Sjogren's Syndrome

Recruiting
2
15
US
Levocarnitine, Placebo
Vanderbilt University Medical Center
Sjogren's Syndrome, Keratoconjunctivitis Sicca
03/25
03/25
NCT06440525: A Phase 2 Study of RSLV-132 in Females With Primary Sjögren's Syndrome

Not yet recruiting
2
106
NA
RSLV-132, Placebo
Resolve Therapeutics
Primary Sjögren Syndrome
05/26
07/26
NCT05781451: Anti-BTLA Agonist Therapy in Subjects With Primary Sjogren's Syndrome

Withdrawn
2
12
NA
LY3361237, Venanprubart
Stanford University
Primary Sjogren's Syndrome
01/27
01/28
NCT05124925: Biopsy Based Study to Understand Mechanism of Action of Ianalumab in Salivary Glands and Explore Relationships With Clinical Assessments.

Active, not recruiting
2
21
Europe
Ianalumab
Novartis Pharmaceuticals
Sjogren Syndrome
06/26
06/26
NCT05605665: Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome

Recruiting
1/2
30
RoW
low-dose interleukin-2, Recombinant Human Interleukin-2, rapamycin, sirolimus
Peking University People's Hospital
Sjögren's Syndrome
11/23
12/23
NCT06049368: 68Ga-P16-093 PET/CT Imaging in the Salivary Gland

Not yet recruiting
1/2
40
NA
68Ga-P16-093
Peking Union Medical College Hospital
Primary Sjögren Syndrome
12/23
03/24
BAH247, NCT06428188: Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases

Recruiting
1/2
60
RoW
BCMA/CD19 CAR-T cells
Essen Biotech
Autoimmune Diseases, Systemic Lupus Erythematosus, Systemic Lupus Erythematosus Acute, Sjogren's Syndrome
12/25
12/26
BAH242, NCT06350110: Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)

Not yet recruiting
1/2
75
RoW
CD19- BCMA CAR-T cells, EB-BH2024-2
Essen Biotech
Systemic Lupus Erythematosus, Lupus Nephritis, Autoimmune Diseases, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatous Polyangiitis, Microscopic Polyangiitis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Sjogren's Syndrome
12/25
12/25
NCT04496960: Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome

Recruiting
1/2
76
US
tofacitinib, Placebo
National Institute of Dental and Craniofacial Research (NIDCR)
Sjogren's Syndrome
09/25
09/25

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