Sjogren's Syndrome Clinical Trial
Official title:
ANIfrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome - Efficacy and Safety Assessment in a Randomized, Double-blind, Placebo-controlled Phase-IIa Proof-of-concept Trial (ANISE-II)
The ANISE-II study is a randomized, double-blind, placebo-controlled phase IIa proof-of-concept trial. Thirty patients with primary Sjögren's syndrome (pSS) are randomized in a 2:1 ratio to either anifrolumab or placebo treatment for 24 weeks. Main inclusion criteria are fulfilment of the ACR/EULAR classification criteria for pSS, disease duration of ≤10 years, and an ESSDAI and/or ESSPRI of ≥5 (at least 50% of patients need to fulfil the ESSDAI ≥5 criterion). The primary outcome measure is Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) response at week 24.
The aim is to evaluate safety and determine the effects of anifrolumab on essential clinical and biological parameters in patients with primary Sjögren's syndrome (pSS). Although the pathogenesis of pSS has not been fully elucidated, one of the key immune pathways involved is type-I IFN signalling. Since anifrolumab is a fully human, IgG1κ monoclonal antibody to type-I interferon receptor subunit 1, the hypothesis is that inhibition of type-I IFN signalling by anifrolumab may reduce glandular and systemic inflammation and attenuate disease activity in patients with pSS. The study population will consist of patients who fulfil 2016 ACR-EULAR criteria for pSS and have active disease, defined by a EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score ≥5 and/or an unacceptable patient symptom state (EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) score ≥5. The primary endpoint is the Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) at week 24. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
| Completed |
NCT04968912 -
A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
|
Phase 2 | |
| Completed |
NCT03203382 -
Corneal Nerve Structure in Sjogren's
|
||
| Completed |
NCT00809003 -
Assessment of Inflammatory and Functional Changes in the Ocular Surface Associated With Dry Eye Disease
|
N/A | |
| Completed |
NCT00023491 -
Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells
|
N/A | |
| Completed |
NCT05005806 -
Fish Oil (Omega 3 ) in Sjogren's Syndrome
|
Phase 2/Phase 3 | |
| Enrolling by invitation |
NCT03436576 -
Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye
|
Phase 3 | |
| Terminated |
NCT04143841 -
Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease
|
N/A | |
| Completed |
NCT03611283 -
Topical Management of Xerostomia With Dry Mouth Products
|
N/A | |
| Recruiting |
NCT06104124 -
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
|
Phase 3 | |
| Recruiting |
NCT05115487 -
Evaluation of Hand Functions in Newly Diagnosed Primary Sjögren's Syndrome
|
||
| Recruiting |
NCT06437652 -
An AI Algorithm for Lymphocyte Focus Score of Minor Salivary Gland Biopsy Samples for Diagnosing Sjogren's Syndrome
|
||
| Not yet recruiting |
NCT03938207 -
Dry Eye Syndrome, Healthy Control, Sjögren's Syndrome and Other Inflammation Disease in Taiwan Biobank
|
||
| Completed |
NCT04239521 -
The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
|
||
| Completed |
NCT04546542 -
Hydroxychloroquine Blood Levels in Primary Sjögren Syndrome Patients
|
||
| Recruiting |
NCT05085431 -
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome
|
Early Phase 1 | |
| Completed |
NCT00565526 -
Evaluation of the Role of the Autonomic Nervous System in Sj(SqrRoot)(Delta)Gren s Syndrome
|
||
| Completed |
NCT01369589 -
An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness
|
Phase 1/Phase 2 | |
| Completed |
NCT00001953 -
The Functioning of Immune and Hormonal Systems in Patients With Sjogren's Syndrome and in Healthy Volunteers
|
N/A | |
| Completed |
NCT00001731 -
Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops
|
Phase 2 |