What side effects are associated with this type of intervention?

Common treatments for Sjogren's Syndrome, such as rituximab, glucocorticoids, and conventional DMARDs, have various side effects. Rituximab can cause infusion reactions, serum-sickness-like reactions, and in rare cases, interstitial lung disease and progressive multifocal encephalopathy. Glucocorticoids are associated with osteoporosis, hyperglycemia, weight gain, agitation, increased risk of infections, oral candidiasis, and dental decay. Conventional DMARDs like methotrexate and hydroxychloroquine may cause gastrointestinal issues, liver toxicity, and hematologic abnormalities. These side effects highlight the need for careful monitoring and individualized treatment plans.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting the CD40-CD40L interaction for Sjögren's Syndrome. Treatments for Sjögren's Syndrome often involve managing symptoms with medications such as hydroxychloroquine, methotrexate, and rituximab, which are used to treat systemic manifestations and are borrowed from therapies for other autoimmune diseases like rheumatoid arthritis and systemic lupus erythematosus. These treatments aim to reduce inflammation and manage extraglandular symptoms but do not specifically target the CD40-CD40L pathway.

What other types of research exist?

Promising novel alternatives to Dazodalibep for Sjogren's Syndrome patients include Janus kinase (JAK) inhibitors like upadacitinib and abrocitinib, as well as biologics targeting B-cells such as ocrelizumab and atacicept. These therapies are being explored for their efficacy in various autoimmune diseases and may offer new treatment options for Sjogren's Syndrome.

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Dazodalibep for Sjögren's Syndrome

Phase 3

Recruiting

Research Sponsored by Horizon Therapeutics Ireland DAC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria.

Have an European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of >= 5 despite symptomatic or local therapy at screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing dazodalibep, a medication, to see if it can help people with moderate-to-severe Sjögren's Syndrome. The goal is to reduce their symptoms and improve their quality of life. Researchers will also check if the medication is safe and well-tolerated by patients.

Who is the study for?

This trial is for people with Sjögren's Syndrome who have moderate-to-severe symptoms despite treatment. Participants must meet specific diagnostic criteria, have a certain disease activity score (ESSDAI >= 5), and test positive for anti-Ro autoantibodies or rheumatoid factor.

What is being tested?

The study tests Dazodalibep's effectiveness on systemic symptoms of Sjögren's Syndrome compared to a placebo. It also looks at how well patients feel after the treatment (patient reported outcomes) and checks the safety and comfort of using Dazodalibep.

What are the potential side effects?

While not specified here, potential side effects may include reactions where the drug is injected, flu-like symptoms, changes in blood tests, fatigue, or other immune-related conditions due to its action on the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Sjögren's syndrome according to the 2016 ACR/EULAR criteria.

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My Sjögren's Syndrome is active with a score of 5 or more despite treatment.

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My blood test shows I have anti-Ro antibodies or rheumatoid factor.

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I am 18 years old or older.

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I have been diagnosed with Sjogren's syndrome by a doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Dazodalibep Dose 2Experimental Treatment1 Intervention

Participants will be administered dose 2 of dazodalibep by IV infusion.

Group II: Dazodalibep Dose 1Experimental Treatment1 Intervention

Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.

Group III: PlaceboPlacebo Group1 Intervention

Participants will be administered placebo by IV infusion.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Sjögren's Syndrome often involve immunosuppressive and biologic agents that target various aspects of the immune system. Dazodalibep, for example, inhibits the CD40-CD40L interaction, which is crucial in the activation of B cells and T cells, thereby reducing systemic inflammation and autoimmune activity. Other treatments, such as Rituximab, target CD20 on B cells to deplete them, reducing autoantibody production and inflammation. Hydroxychloroquine modulates the immune response by inhibiting toll-like receptors, which decreases the activation of immune cells. These mechanisms are vital for Sjögren's Syndrome patients as they help manage systemic disease activity, reduce symptoms, and prevent organ damage, thereby improving quality of life.

Systemic monoclonal antibody therapy (daclizumab) in the treatment of cicatrizing conjunctivitis in stevens-johnson syndrome, refractory to conventional therapy.