Dazodalibep for Sjögren's Syndrome

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Amgen

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.

Eligibility Criteria

This trial is for individuals who have Sjögren's Syndrome and participated in previous phase 3 studies of dazodalibep (HZNP-DAZ-301 or HZNP-DAZ-303), completing up to Week 48. They must be able to start this extension study within 28 days after their last dose from the prior study and give informed consent.

Inclusion Criteria

I have given my consent for study-related procedures.

I can receive the first dose of the study drug at Week 48 from my previous phase 3 trial participation.

I completed a phase 3 study with dazodalibep or placebo.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dazodalibep or placebo for 48 weeks in prior trials, followed by 144 weeks of dazodalibep treatment

144 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Participant Groups

The trial is testing the long-term safety and tolerability of a drug called dazodalibep in patients with Sjögren's Syndrome, which is an autoimmune disorder that affects moisture-producing glands.

2Treatment groups

Experimental Treatment

Group I: Placebo/DazodalibepExperimental Treatment1 Intervention

Participants who completed the 48-week placebo treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will be randomized 1:1 to dazodalibep (dose 1 or 2) for an additional 144 weeks.

Group II: Dazodalibep/DazodalibepExperimental Treatment1 Intervention

Participants who completed the 48-week dazodalibep treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will continue with their assigned dose (1 or 2) for an additional 144 weeks.