Efgartigimod for Sjogren's Syndrome (Unity Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: argenx
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used cyclophosphamide within 24 weeks before screening or received anti-CD20 or anti-CD19 antibodies within 6 months before screening.
How does the drug Efgartigimod differ from other treatments for Sjogren's Syndrome?
Efgartigimod is unique because it is designed to modulate the immune system by targeting and reducing specific antibodies, which is different from other treatments that focus on reducing inflammation or increasing glandular secretions. This approach may offer a novel way to manage the autoimmune aspects of Sjogren's Syndrome.
12345Eligibility Criteria
This trial is for adults over 18 with moderate-to-severe Primary Sjögren's Disease who meet specific criteria, including a clinESSDAI score of at least 6 and positive Anti-Ro/SS-A. Participants must have some natural salivary flow and consent to the study.Inclusion Criteria
I meet the specific criteria for a type of joint disease, have active symptoms, tested positive for Anti-Ro/SS-A, and have a certain level of salivary flow.
Exclusion Criteria
I have Sjögren's syndrome as a result of another autoimmune condition.
Participant Groups
The trial is testing Efgartigimod PH20 SC against a placebo in patients with Primary Sjögren's Syndrome. It includes a double-blind period where neither doctors nor patients know who gets what, followed by an open-label phase for up to 105 weeks.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-label treatment periodExperimental Treatment1 Intervention
Participants receiving efgartigimod PH20 SC during the open-label treatment period
Group II: Double-blinded treatment period: Efgartigimod PH20 SCExperimental Treatment1 Intervention
Participants receiving efgartigimod PH20 SC during the double-blinded treatment period
Group III: Double-blinded treatment period: Placebo PH20 SCPlacebo Group1 Intervention
Participants receiving placebo PH20 SC during the double-blinded treatment period
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Clinical Research of West Florida, Inc.Clearwater, FL
Accurate Clinical Research Inc.Lake Charles, LA
Accurate Clinical ManagementBaytown, TX
Accurate Clinical Research, Inc.Houston, TX
More Trial Locations
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Who is running the clinical trial?
argenxLead Sponsor
References
Sjögren's syndrome. [2005]Sjögren's syndrome is an autoimmune disease characterized by inflammation of the exocrine glands, leading to impaired function. Here, I review the relatively short history of the syndrome and explain why it is frequently underdiagnosed, undertreated and under-researched. Attempts to provide classification criteria have culminated in the revised American-European Consensus Criteria, which provide a sound basis for both clinical management and research. The recognition that Sjögren's syndrome is a disease of considerable morbidity has led to a more aggressive approach to therapy ranging from topical therapies to systemic treatment with secretagogues such as pilocarpine and cemiveline, and immunomodulatory drugs such as hydroxychloroquine and interferon-alpha. The central role of the glandular epithelial cell is identified as the key to understanding the pathogenesis of the disease. Hypofunction rather than destruction of these cells is now regarded as the main mechanism of secretory failure in Sjögren's syndrome.
Fingolimod reduces salivary infiltrates and increases salivary secretion in a murine Sjögren's model. [2023]Sjögren's Syndrome (SjS) is a chronic, systemic autoimmune disease causing xerostomia, xerophthalmia, and systemic symptoms. The principal pathological finding in SjS is the accumulation of lymphocytes in exocrine glandular tissue and elsewhere, leading to secretory dysfunction and other abnormalities. A rational therapeutic approach might be to interfere with lymphocyte migration to the periphery from central lymphoid tissues. We thus examined in an animal model of SjS the effects of Fingolimod (FTY720, Gilenya™), which interferes with migration of lymphocytes to peripheral sites. Fingolimod induces sequestration of lymphocytes in lymphoid organs by altering lymphocyte expression of sphingosine-1-phosphate receptors. In the C57Bl/6. NOD.Aec1Aec2 (AEC) model of SjS, Fingolimod reduced circulating T and B cell numbers. Treatment of AEC mice with Fingolimod increased salivary output and decreased the size of salivary gland infiltrates. Oral Fingolimod thus merits further consideration in the management of SjS in humans.
Cenerimod, a selective S1P1 receptor modulator, improves organ-specific disease outcomes in animal models of Sjögren's syndrome. [2021]Sjögren's syndrome is a systemic autoimmune disease characterized by immune cells predominantly infiltrating the exocrine glands and frequently forming ectopic lymphoid structures. These structures drive a local functional immune response culminating in autoantibody production and tissue damage, associated with severe dryness of mucosal surfaces and salivary gland hypofunction. Cenerimod, a potent, selective and orally active sphingosine-1-phosphate receptor 1 modulator, inhibits the egress of lymphocytes into the circulation. Based on the mechanism of action of cenerimod, its efficacy was evaluated in two mouse models of Sjögren's syndrome.
A Systematic Review and Meta-Analysis of 19 Randomized Controlled Trials of Iguratimod Combined With Other Therapies for Sjogren's Syndrome. [2022]To explore the efficacy and safety of Iguratimod intervention in Primary Sjogren's syndrome (pSS).
Efficacy and safety of iguratimod combined with methylprednisolone for primary Sjögren's syndrome: a meta-analysis and trial sequential analysis. [2023]The purpose of this study is to evaluate the combination of iguratimod (IGU) and methylprednisolone (MP) for the efficacy and safety of primary Sjögren's syndrome (pSS) by a meta-analysis and a trial sequential analysis (TSA).