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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 week 12 and week 24
Awards & highlights

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 weeks
Treatment ~ Varies
Follow Up ~week 12 and week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score
Secondary study objectives
Change from baseline in DASPRI total score
Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) dryness domain score
Change from baseline in ESSDAI score
+9 more

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.

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.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Horizon Therapeutics Ireland DACLead Sponsor
20 Previous Clinical Trials
1,966 Total Patients Enrolled
1 Trials studying Sjogren's Syndrome
262 Patients Enrolled for Sjogren's Syndrome
MDStudy DirectorAmgen
961 Previous Clinical Trials
928,355 Total Patients Enrolled
3 Trials studying Sjogren's Syndrome
880 Patients Enrolled for Sjogren's Syndrome
~302 spots leftby Feb 2026
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