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Dazodalibep Dose 1 for Sjogren'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

Study Summary

This trial aims to study the effects of dazodalibep on the symptoms of Sjögren's Syndrome in participants with moderate-to-severe disease activity. It also aims to assess the impact

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.Check my eligibility
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.See study design
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.
Select...
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score
Secondary outcome measures
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.

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to participate in this ongoing medical study?

"Indeed, the information available on clinicaltrials.gov confirms that this trial is currently actively seeking participants. The study was initially posted on October 26th, 2023 and received its most recent update on December 14th, 2023. A total of nine different sites are involved in recruiting approximately 510 patients for this trial."

Answered by AI

What is the upper limit on the number of individuals who can participate in this medical trial?

"To successfully carry out this research, a total of 510 eligible participants must be enrolled. The sponsor, Horizon Therapeutics Ireland DAC, will oversee the trial at various locations such as the Denver Arthritis Clinic in Denver, Colorado and the Wallace Rheumatic Studies Center, LLC in Beverly Hills, California."

Answered by AI

Has the Food and Drug Administration (FDA) granted approval for Dose 1 of Dazodalibep?

"Based on the phase of this trial and the available safety data, our team at Power rates Dazodalibep Dose 1 with a score of 3 in terms of safety."

Answered by AI

Are there numerous sites across North America where this clinical trial is being conducted?

"At present, this trial is underway at 9 different sites. These locations include Denver, Beverly Hills, and Amarillo, as well as several others. To reduce travel requirements for enrolled participants, it is important to choose the clinic nearest to your location."

Answered by AI

Who else is applying?

What site did they apply to?
Bradenton Research Center Inc
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I am always looking for ways to improve my sjogrens and to be able to help others with this condition.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is there any compensation for driving from Jacksonville to Bradenton for the trials?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Bradenton Research Center Inc: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
2023. "A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06104124.
All > Sjogrens Syndrome
~340 spots leftby Feb 2026
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