Dazodalibep for Sjögren's Syndrome

Recruiting at 107 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?

This trial focuses on assessing the long-term safety and tolerability of dazodalibep, an experimental treatment for Sjögren's Syndrome, a condition causing dry eyes and mouth. It targets participants who have completed a prior 48-week study with dazodalibep or a placebo. To join, participants must have finished those initial studies and begin the new treatment within a specific timeframe. The trial aims to ensure the treatment remains safe over an extended period while monitoring any side effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that dazodalibep is likely to be safe for humans?

Research has shown that dazodalibep has been tested for safety in people with Sjögren's Syndrome. In an earlier study, dazodalibep was compared to a placebo, and no major safety problems emerged. Participants tolerated the treatment well, experiencing side effects similar to those who took a placebo. Another study also examined its safety and found that most side effects were mild, such as headaches and mild nausea.

Since this trial is in a later stage, dazodalibep has likely undergone earlier tests to assess its safety, suggesting confidence in its safety profile. However, discussing any concerns with a healthcare provider before joining a clinical trial is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Sjögren's Syndrome?

Dazodalibep is unique for treating Sjögren's Syndrome because it offers a novel approach by targeting the CD40/CD40L pathway, which is involved in the immune system's regulation. This mechanism is different from the current standard treatments like corticosteroids or immunosuppressants, which generally work by broadly dampening the immune response. Researchers are excited about dazodalibep because it has the potential to provide more targeted and effective relief with fewer side effects, aiming to improve patient outcomes by directly modulating specific immune interactions.

What evidence suggests that dazodalibep might be an effective treatment for Sjögren's Syndrome?

Research has shown that dazodalibep, the treatment under study in this trial, may help treat Sjögren's syndrome. Studies have found that it significantly reduces key symptoms such as dryness, fatigue, and pain. Patients taking dazodalibep experienced greater improvement in these symptoms compared to those not receiving the treatment. The drug blocks a protein called CD40 ligand, which plays a role in the disease. Early results suggest that dazodalibep could become an important new treatment for people with Sjögren's syndrome. ^{1 2 4 5 6}

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: Dazodalibep Experimental Treatment 1 Intervention

Participants who completed the 48-week dazodalibep or placebo treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive assigned dose Dose A of dazodalibep for an additional 132 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

Citations

1. nature.com nature.com/articles/s41591-024-03009-3

CD40 ligand antagonist dazodalibep in Sjögren's disease Our results show a significant benefit of DAZ therapy in reducing systemic disease activity and symptoms of dryness, fatigue and pain and, ...

2. the-rheumatologist.org the-rheumatologist.org/article/dazodalibep-for-sjogrens-disease/

Dazodalibep for Sjögren's Disease found that patients with Sjögren's disease treated with dazodalibep experienced greater improvement in key symptoms of dryness, fatigue and pain ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06245408

A Safety and Efficacy Study of Dazodalibep in Participants ... Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38839899/

CD40 ligand antagonist dazodalibep in Sjögren's disease DAZ appears to be a potential new therapy for SjD and its efficacy implies an important role for the CD40/CD40 ligand pathway in its pathogenesis.

5. amgen.com amgen.com/newsroom/press-releases/2023/11/amgen-presents-new-data-from-phase-2-trial-of-dazodalibep-in-sjgrens-syndrome-at-acr-2023

AMGEN PRESENTS NEW DATA FROM PHASE 2 TRIAL ... Patients who transitioned from placebo to dazodalibep experienced an improvement in their disease activity from Day 169 (4.1-point reduction in ...

6. ard.bmj.com ard.bmj.com/content/82/Suppl_1/95.1

OP0143 EFFICACY AND SAFETY OF DAZODALIBEP ... The objective of this study was to evaluate the efficacy and safety of DAZ therapy in adult SS subjects with moderate-to-high systemic disease activity.