Dazodalibep for Sjögren's Syndrome

Recruiting at 24 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must not be taking: Antibiotics, Antivirals

Disqualifiers: Active infection, Pregnancy, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 144 weeks

844 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Dazodalibep

Trial Overview 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.

How Is the Trial Designed?

Group I: Placebo/Dazodalibep Experimental Treatment 1 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/Dazodalibep Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London