Dazodalibep for Sjögren's Syndrome

Not currently recruiting at 358 trial locations

Overseen By Amar Majjhoo

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Horizon Therapeutics Ireland DAC

Must not be taking: Biologics, B-cell therapies

Disqualifiers: Cancer, Cardiovascular, HIV, others

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: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called dazodalibep for people with Sjögren's syndrome, a condition causing dry eyes and mouth, along with other systemic issues. The goal is to determine if dazodalibep can reduce these symptoms and improve daily life for those with moderate-to-severe cases. Participants will receive either one of two doses of dazodalibep or a placebo (a treatment with no active drug). This trial may suit individuals diagnosed with Sjögren's syndrome who have persistent symptoms despite treatment and test positive for certain antibodies. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on certain biologic therapies, you may need to stop them for a specific period before joining the trial.

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

Research shows that dazodalibep is generally safe for people with Sjögren's Syndrome. Earlier studies found that patients using dazodalibep experienced improvements in key symptoms such as dryness, tiredness, and pain. These studies also assessed the safety and tolerability of dazodalibep, and most participants found it manageable. Some side effects occurred, but they were not serious enough to outweigh the benefits for most patients. Those considering joining a trial for dazodalibep can feel reassured that previous research supports its safety in treating Sjögren's Syndrome. ^{1 2 3 4 5}

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

Unlike current treatments for Sjögren's syndrome, which often focus on symptom management with medications like pilocarpine or cevimeline to increase saliva production, dazodalibep offers a novel approach. Researchers are excited because dazodalibep targets the underlying immune processes by modulating T-cell activity, which could potentially alter the disease course itself rather than just alleviating symptoms. This immunomodulatory action, delivered via intravenous infusion, might provide a more comprehensive treatment option for patients, addressing both symptoms and disease progression.

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

Research has shown that dazodalibep may help treat Sjögren's Syndrome (SS). In this trial, participants will receive either Dazodalibep Dose 1, Dazodalibep Dose 2, or a placebo. Studies have found that patients using dazodalibep experienced improvements in key symptoms like dryness, suggesting it might reduce the overall effects of SS. The treatment targets a specific pathway in the body involved in the disease. Early results suggest it could offer a new option for people with moderate-to-severe SS. ^{2 3 5 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My Sjögren's Syndrome is active with a score of 5 or more despite treatment.

I have been diagnosed with Sjögren's syndrome according to the 2016 ACR/EULAR criteria.

My blood test shows I have anti-Ro antibodies or rheumatoid factor.

Exclusion Criteria

I have been diagnosed with Sjogren's syndrome by a doctor.

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 by IV infusion to evaluate the effect on systemic manifestations of Sjögren's Syndrome

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dazodalibep

Trial Overview 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.

How Is the Trial Designed?

Group I: Dazodalibep Dose 2 Experimental Treatment 1 Intervention

Participants will be administered dose 2 of dazodalibep by IV infusion.

Group II: Dazodalibep Dose 1 Experimental Treatment 1 Intervention

Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.

Group III: Placebo Placebo Group 1 Intervention

Participants will be administered placebo by IV infusion.

Who Is Running the Clinical Trial?

Horizon Therapeutics Ireland DAC

Lead Sponsor

Trials

21

Recruited

2,500+

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

Published Research Related to This Trial

The EULAR Task Force developed the first evidence-based recommendations for managing Sjögren syndrome (SjS), focusing on symptom relief and addressing dryness, fatigue, and pain, based on a comprehensive review of studies involving primary SjS patients over the last 16 years.

The recommendations include a range of treatment options, from topical therapies like saliva substitutes and artificial tears to systemic medications such as hydroxychloroquine and biological therapies, providing a structured approach for healthcare professionals worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EULAR recommendations for the management of Sjögren's syndrome with topical and systemic therapies. Ramos-Casals, M., Brito-Zerón, P., Bombardieri, S., et al.[2022]

Recent advancements in understanding the pathophysiology of Sjögren Syndrome (SS) have led to the development of targeted treatment options, particularly focusing on B-cell targeted therapies, which show promise for managing systemic manifestations of the disease.

While B-cell therapies are currently the most promising, other treatment pathways, including T-cell co-stimulation and cytokine-based therapies, are also being explored, indicating a potential for significant therapeutic advancements in the next decade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating the Underlying Pathophysiology of Primary Sjögren Syndrome: Recent Advances and Future Prospects. Brito-Zerón, P., Retamozo, S., Gheitasi, H., et al.[2018]

In a study of patients with Primary Sjögren's Syndrome (PSS) using data from the UK Primary Sjögren's Syndrome Registry, it was found that patients with high symptom burden (HSB) and pain dominated fatigue (PDF) had significantly more comorbidities and were prescribed more medications compared to those with low symptom burden (LSB) and dryness dominated fatigue (DDF).

The research indicates that comorbidities and polypharmacy scores increase with age and body mass index (BMI) across all PSS subgroups, suggesting that these factors may complicate disease management and should be considered in clinical trial designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbidities in the UK Primary Sjögren's Syndrome Registry. Tarn, J., Lendrem, D., Barnes, M., et al.[2022]

In a study of 15 French patients with primary Sjögren's syndrome, higher baseline levels of natural killer cells were linked to a lack of response to belimumab treatment, suggesting these cells may play a significant role in the disease.

The findings highlight the importance of considering natural killer cell levels when determining treatment strategies for patients, indicating a need for personalized therapy approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stratifying primary Sjögren's syndrome: killers in the balance? Bowman, SJ., Fisher, BA.[2018]

Current studies on oral and biologic disease-modifying antirheumatic drugs for Sjögren's syndrome have not shown significant positive outcomes, indicating a need for better treatment options.

Future improvements in trial design, including multicenter studies and standardized measures, along with new drug developments, may enhance the effectiveness of treatments for Sjögren's syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues related to clinical trials of oral and biologic disease-modifying agents for Sjögren's syndrome. Carsons, SE.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04129164

NCT04129164 | A Study to Evaluate the Efficacy and ... The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS) ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724635983

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.

3. the-rheumatologist.org the-rheumatologist.org/article/dazodalibep-for-sjogrens-disease/3/

Dazodalibep for Sjögren's Disease - Page 3 of 3 St.Clair et al. found that patients with Sjögren's disease treated with dazodalibep experienced greater improvement in key symptoms of dryness, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06104124

A Study to Evaluate the Efficacy and Safety of Dazodalibep ... Primary Objective: To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe ...

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

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.

6. 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.

7. ard.bmj.com ard.bmj.com/content/82/Suppl_1/201

LB0003 Dazodalibep (VIB4920/HZN4920) in Sjögren's ... DAZ-treated subjects experienced a statistically significant and clinically meaningful improvement in the key subjective symptoms of Sjögren's relative to PBO ...