Baminercept for Sjögren's Syndrome

No longer recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Anticholinergics, Rituximab, Cyclophosphamide, others

Disqualifiers: Active infection, Immunodeficiency, RA, others

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

Compensation: Varies

Number of Visits: 24

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether baminercept, a new drug, can help treat symptoms of Sjögren's syndrome, which often causes dry eyes, dry mouth, and fatigue. Researchers seek to determine the safety of baminercept and its effects on the body, particularly the immune system. The trial includes two groups: one receiving baminercept injections and the other receiving a placebo (a substance with no active drug). Individuals experiencing dry eyes or mouth, fatigue, joint pain, or other symptoms related to Sjögren's syndrome may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial requires that if you are taking prednisone, hydroxychloroquine, or cholinergic stimulants, your dose must be stable for a certain period before screening. Some medications like rituximab, cyclophosphamide, and others must not have been taken within specific time frames before the trial. If you are on anticoagulants or certain anticholinergic agents, you may need to stop them to participate.

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

Research has shown that baminercept has been tested in people with primary Sjögren's syndrome. Although it didn't significantly improve symptoms, safety remains a key concern. Studies found that baminercept caused a noticeable decrease in certain immune cells and proteins in the blood, indicating an effect on the immune system. However, detailed information on side effects or adverse events isn't available in the sources.

Since baminercept is in a Phase 2 trial for this condition, it has passed initial safety checks in earlier phases. This generally means it is considered safe enough for further testing, but risks may still exist. Prospective participants should discuss possible side effects with the research team for more clarity. ^{1 2 3 4 5}

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

Baminercept is unique because it targets the lymphotoxin-beta receptor, a novel approach for treating Sjögren's Syndrome. Unlike standard treatments like artificial tears, saliva substitutes, or medications that only manage symptoms, Baminercept aims to address the underlying immune process by modulating lymphocyte activity. Researchers are excited about its potential to not just alleviate symptoms but also modify the disease's progression, offering hope for more comprehensive treatment outcomes.

What evidence suggests that baminercept might be an effective treatment for Sjögren's syndrome?

This trial will compare baminercept with a placebo. Research has shown that baminercept, designed to block certain immune signals, has not effectively improved symptoms of Sjögren's syndrome. Studies have found it does not significantly alleviate symptoms, whether affecting glands or other body parts. It also failed to reduce specific blood proteins linked to the disease. Additionally, concerns arose about increased liver problems with its use. These findings suggest that baminercept might not be the best option for treating Sjögren's syndrome based on current evidence. ^{1 2 3 6 7}

Who Is on the Research Team?

E. William St. Clair, MD

Principal Investigator

Duke University

Judith A. James, MD

Principal Investigator

Oklahoma Medical Research Foundation

Are You a Good Fit for This Trial?

Inclusion Criteria

Has provided written informed consent;

Body weight ≥ 40 kg;

ocular symptoms;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of either baminercept or placebo every week

24 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Baminercept

How Is the Trial Designed?

Group I: Baminercept Experimental Treatment 1 Intervention

Subcutaneous injections of 100 mg every week for 24 weeks

Group II: Placebo Placebo Group 1 Intervention

Subcutaneous injections of matched placebo every week for 24 weeks

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Autoimmunity Centers of Excellence

Collaborator

Trials

23

Recruited

1,400+

Biogen

Industry Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6115299/

The Clinical Efficacy and Safety of Baminercept, a ... In this trial, baminercept treatment failed to significantly improve glandular and extraglandular disease in patients with primary SS.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29604186/

Clinical Efficacy and Safety of Baminercept, a Lymphotoxin β ... Baminercept did not significantly improve disease in primary Sjögren's Syndrome, and was associated with higher liver toxicity, despite blocking LTβR signaling.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01552681?term=AREA%5BConditionSearch%5D(%22Mouth%20Disease%22)%20AND%20AREA%5BInterventionSearch%5D(%22immunoglobulins,%20intravenous%22)&rank=7&tab=results

Study Results | Baminercept, a Lymphotoxin-Beta Receptor ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01552681

Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein ... The purpose of the study is to find out if the experimental study agent, baminercept, is effective in treating patients with Sjögren's syndrome.

5. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/10.1002/art.40513

Clinical Efficacy and Safety of Baminercept, a Lymphotoxin β ... In contrast, baminercept treatment failed to significantly diminish the serum levels of BAFF, LIGHT, or IP-10 as compared to the placebo group ( ...

6. medchemexpress.com medchemexpress.com/baminercept.html?srsltid=AfmBOopQJaI9VIQiXwRu6P5FnCzOQVC_za51fyZa-yMMOWK121AnOpPH

Baminercept (BG 9924) | LTβR IgG fusion protein Clinical Efficacy and Safety of Baminercept, a Lymphotoxin β Receptor ... SAFETY DATA SHEET (SDS). English - EN (251 KB) Français - FR (251 KB) Deutsch ...

7. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/abs/10.1002/art.40513

Clinical Efficacy and Safety of Baminercept, a Lymphotoxin β ... Baminercept also produced a significant decrease in plasma levels of CXCL13 and significant changes in the number of circulating B and T cells, ...