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Dazodalibep for Sjögren's Syndrome

Phase 3
Recruiting
Research Sponsored by Horizon Pharma Ireland, Ltd., Dublin Ireland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial aims to study the impact of dazodalibep on symptoms reported by patients with Sjogren's Syndrome. Additionally, it will assess the effects of dazodalibep on

Who is the study for?
This trial is for people with Sjögren's Syndrome who have moderate-to-severe symptoms. Participants must meet the 2016 ACR/EULAR criteria, have certain levels of symptom severity scores (ESSPRI ≥ 5 and ESSDAI < 5), test positive for specific autoantibodies, and still produce some saliva. They should be vaccinated against COVID-19 unless they opt out, not have a history of TB or recent exposure to it, and test negative for TB.
What is being tested?
The study tests Dazodalibep's impact on patient-reported symptoms in those with Sjögren's Syndrome versus a placebo. It also looks at how well Dazodalibep improves systemic activity indicators, patient outcomes, and salivary flow. Safety and tolerability after multiple doses are evaluated as secondary objectives.
What are the potential side effects?
While the side effects of Dazodalibep aren't detailed here, similar trials may involve risks like injection site reactions, flu-like symptoms, potential immune system changes leading to increased infection risk or allergic reactions.

Timeline

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.

Find a Location

Who is running the clinical trial?

Horizon Pharma Ireland, Ltd., Dublin IrelandLead Sponsor
30 Previous Clinical Trials
3,372 Total Patients Enrolled
AmgenLead Sponsor
1,466 Previous Clinical Trials
1,401,061 Total Patients Enrolled
1 Trials studying Sjögren's Syndrome
183 Patients Enrolled for Sjögren's Syndrome
Medical DirectorStudy DirectorHorizon Pharma Ireland, Ltd
2,905 Previous Clinical Trials
8,091,034 Total Patients Enrolled
2 Trials studying Sjögren's Syndrome
232 Patients Enrolled for Sjögren's Syndrome
MDStudy DirectorAmgen
1,003 Previous Clinical Trials
944,805 Total Patients Enrolled
1 Trials studying Sjögren's Syndrome
183 Patients Enrolled for Sjögren's Syndrome
~290 spots leftby Aug 2026
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