Nipocalimab for Sjogren's Syndrome

No longer recruiting at 108 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must not be taking: Cyclophosphamide

Disqualifiers: Asthma, COPD, RA, SLE, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called nipocalimab (an anti-FcRn monoclonal antibody) for primary Sjogren's syndrome, a condition where the immune system attacks moisture-producing glands, causing dry mouth and eyes. The study aims to determine if nipocalimab can effectively reduce symptoms and ensure safety compared to a placebo. Participants will receive either one of two doses of nipocalimab or a placebo, alongside their usual treatments like eye drops or medication for dry mouth. Individuals with primary Sjogren's syndrome for at least six months and who test positive for specific antibodies might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have taken oral cyclophosphamide in the last 3 months or intravenous cyclophosphamide in the last 6 months, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that nipocalimab, a treatment under study for Sjogren's syndrome, appears safe. In studies, most patients tolerated it well, experiencing no severe side effects.

Some studies found that nipocalimab significantly improved symptoms compared to a placebo. Importantly, these studies did not report any major safety issues, suggesting that nipocalimab is fairly safe for humans based on current data.

Since this treatment is in a Phase 2 trial, earlier tests demonstrated it was safe enough for broader testing. This supports the idea that nipocalimab is generally safe, although more research is needed to confirm this. ^{1 2 3 4 5}

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

Nipocalimab is unique because it targets the neonatal Fc receptor (FcRn), which plays a key role in regulating the immune system by recycling antibodies. Unlike standard treatments for Sjogren's Syndrome, which often include immunomodulators, anti-inflammatory drugs, and artificial tears, nipocalimab works by reducing the levels of harmful antibodies, potentially offering a more direct way to address the root cause of the disease. Researchers are excited about nipocalimab because it offers a novel mechanism of action that could lead to more effective management of Sjogren's Syndrome symptoms and possibly halt disease progression.

What evidence suggests that nipocalimab might be an effective treatment for Sjogren's syndrome?

Research has shown that nipocalimab may help treat primary Sjogren's syndrome (pSS). One study demonstrated that nipocalimab greatly reduced disease activity and severity by lowering levels of harmful proteins that attack the body's tissues. In this trial, participants will receive either nipocalimab at different doses or a placebo. Previous studies found that patients who received nipocalimab improved significantly more than those who received a placebo. These findings suggest that nipocalimab could effectively manage pSS symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

Meets classification criteria for primary Sjogren's syndrome (pSS) by the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) at the time of screening, and was diagnosed with pSS no less than 26 weeks prior to screening

Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) score greater than or equal to (>=) 6

At least one abnormal laboratory marker of pSS-related inflammatory disease activity, and at least low activity in one or more specified European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) domains

Exclusion Criteria

You have another autoimmune condition like rheumatoid arthritis, lupus, scleroderma, or inflammatory bowel disease that could make it difficult to accurately evaluate your symptoms of Sjogren's syndrome.

Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her pSS or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant

Comorbidities (for example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 6 weeks

Treatment

Participants receive either nipocalimab or placebo intravenously every 2 weeks for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nipocalimab
• Placebo
• Standard of Care Treatment

How Is the Trial Designed?

Group I: Group 3: Nipocalimab Dose 2 Experimental Treatment 2 Interventions

Participants will receive nipocalimab dose 2 IV q2w through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).

Group II: Group 2: Nipocalimab Dose 1 Experimental Treatment 2 Interventions

Participants will receive nipocalimab dose 1 IV q2w through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).

Group III: Group 1: Placebo Placebo Group 2 Interventions

Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 22 along with standard of care treatments (\[including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues\], and/or one immunomodulator with or without low-dose glucocorticosteroids).

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

In a study of 66 patients with primary Sjögren's syndrome and 44 healthy controls, anti-Fc gamma RIII autoantibodies were detected, with a higher frequency in patients experiencing complications like nonerosive arthritis and lung involvement.

The presence of these autoantibodies may worsen the handling of immune complexes in patients with Sjögren's syndrome, particularly in those sharing the HLA-DR3 alloantigen, suggesting a potential mechanism for disease exacerbation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The presence of anti-Fc gamma receptor autoantibodies is related to the clinical presentation of primary Sjögren's syndrome. Lamour, A., Le Corre, R., Pennec, YL., et al.[2004]

In a study of 350 patients, the combination of anti-α-fodrin antibodies (AFA) with rheumatoid factor (RF) or antinuclear antibodies (ANA) proved to be a useful alternative for diagnosing Sjögren syndrome (SS) in patients who tested negative for anti-Ro/La antibodies.

Using AFA alongside RF or ANA improved the sensitivity of SS diagnosis from 56.9% to 70.7%, indicating that these combinations can enhance diagnostic accuracy, although this came with a decrease in specificity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of IgA Anti-α-fodrin Antibodies in Combination with Rheumatoid Factor and/or Antinuclear Antibodies as Substitute Immunological Criterion in Sjögren Syndrome with Negative Anti-SSA/SSB Antibodies. Hernández-Molina, G., Nuñez-Alvarez, C., Avila-Casado, C., et al.[2022]

A new sandwich enzyme-linked immunosorbent assay successfully detected Fc-gamma receptor III (Fc gamma RIII) in the serum of 8 out of 23 patients with primary Sjögren's syndrome, indicating its potential role in this condition.

Patients with Sjögren's syndrome showed a lower proportion of Fc gamma RIII-carrying polymorphonuclear (PMN) cells and impaired PMN functions, such as reduced adherence and chemotaxis, suggesting that the release of Fc gamma RIII may contribute to the inefficiency of immune responses in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fc-gamma receptor III shedding by polymorphonuclear cells in primary Sjögren's syndrome. Lamour, A., Soubrane, C., Ichen, M., et al.[2019]

In a study of 66 patients with primary Sjögren's syndrome, 45% had autoantibodies against cell-free Fc-gamma receptor IIIb, indicating an immune response linked to the disease.

The presence of these autoantibodies suggests that they are produced after the activation and shedding of Fc-gamma receptor IIIb from polymorphonuclear leukocytes, potentially triggered by IgG-containing immune complexes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-Fc gamma receptor autoantibodies from patients with Sjögren's syndrome do not react with native receptor on human polymorphonuclear leukocytes. Lamour, A., Le Corre, R., Soubrane, C., et al.[2015]

Ianalumab (VAY736) demonstrated significant efficacy in reducing disease activity in patients with active primary Sjögren's syndrome, as shown by improvements in multiple clinical outcomes compared to placebo, including the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI).

The treatment resulted in rapid and sustained B cell depletion after a single infusion, with mild to moderate infusion reactions being the main side effects, indicating a favorable safety profile for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of primary Sjögren's syndrome with ianalumab (VAY736) targeting B cells by BAFF receptor blockade coupled with enhanced, antibody-dependent cellular cytotoxicity. Dörner, T., Posch, MG., Li, Y., et al.[2020]

Citations

1. jnj.com jnj.com/media-center/press-releases/published-in-the-lancet-nipocalimab-significantly-decreased-sjogrens-disease-sjd-activity-and-severity-through-substantial-reduction-in-sjogrens-related-autoantibodies

Nipocalimab significantly decreased Sjögren's disease ... Nipocalimab, a first-in-class FcRn blocker being investigated for SjD, met its primary endpoint in the Phase 2 DAHLIAS study with ...

2. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)01430-8/fulltext

a randomised, phase 2, placebo-controlled, double-blind trial Exploratory efficacy outcomes were generally similar between nipocalimab 5 mg/kg and placebo. No data are available regarding the direct effects ...

3. academic.oup.com academic.oup.com/rheumatology/article/64/Supplement_3/keaf142.025/8115100

OA25 Efficacy and safety of nipocalimab, an anti-FcRn ... OA25 Efficacy and safety of nipocalimab, an anti-FcRn monoclonal antibody, in primary Sjogren's disease: results from a Phase 2, multicenter ...

4. ard.bmj.com ard.bmj.com/content/83/Suppl_1/240.2

LBA0010 EFFICACY AND SAFETY OF NIPOCALIMAB, AN ... DAHLIAS is the first study of a FcRn blocker in SjD and shows that nipocalimab treatment led to significant improvement over placebo in clinESSDAI.

5. jnjmedicalconnect.com jnjmedicalconnect.com/media/attestation/congresses/immunology/2025/rhapp/efficacy-and-safety-of-nipocalimab-an-antifcrn-monoclonal-antibody-in-primary-sjogrens-disease-resul.pdf

Efficacy and Safety of Nipocalimab, an Anti-FcRn ... Efficacy and Safety of Nipocalimab, an Anti-FcRn Monoclonal Antibody, in. Primary Sjögren's Disease: Results From a Phase 2, Multicenter, Randomized,. Placebo ...

6. acrabstracts.org acrabstracts.org/abstract/efficacy-and-safety-of-nipocalimab-an-anti-fcrn-monoclonal-antibody-in-primary-sjogrens-disease-results-from-a-phase-2-multicenter-randomized-placebo-controlled-double-blind-study-dah/

Efficacy and Safety of Nipocalimab, an Anti-FcRn ... The first study of a FcRn blocker in SjD, showed that nipocalimab led to significant improvement vs PBO in clinESSDAI and similar trends in other key efficacy ...