163 Participants Needed

Nipocalimab for Sjogren's Syndrome

Recruiting at 95 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Janssen Research & Development, LLC
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing nipocalimab, a medicine that targets harmful immune proteins, in people with primary Sjogren's syndrome. The goal is to see if it can reduce inflammation and improve symptoms in these patients.

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.

How is the drug Nipocalimab different from other treatments for Sjogren's Syndrome?

Nipocalimab is unique because it is an anti-FcRn monoclonal antibody, which means it works by blocking a specific receptor involved in the immune system, potentially reducing harmful antibodies. This mechanism is different from other treatments that may target B cells or other immune pathways.12345

Who Is on the Research Team?

JR

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
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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
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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?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3: Nipocalimab Dose 2Experimental Treatment2 Interventions
Group II: Group 2: Nipocalimab Dose 1Experimental Treatment2 Interventions
Group III: Group 1: PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

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 profile image

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

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.
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.
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.
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

Fc-gamma receptor III shedding by polymorphonuclear cells in primary Sjögren's syndrome. [2019]
Anti-Fc gamma receptor autoantibodies from patients with Sjögren's syndrome do not react with native receptor on human polymorphonuclear leukocytes. [2015]
Treatment of primary Sjögren's syndrome with ianalumab (VAY736) targeting B cells by BAFF receptor blockade coupled with enhanced, antibody-dependent cellular cytotoxicity. [2020]
The presence of anti-Fc gamma receptor autoantibodies is related to the clinical presentation of primary Sjögren's syndrome. [2004]
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. [2022]
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