Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Nipocalimab in Adults with Moderate to Severe Sjögren's Disease

The primary objective of this study is to evaluate the **efficacy** of nipocalimab compared to placebo in participants with moderate to severe **Sjögren's Disease**. This is clinically relevant as it aims to determine the potential therapeutic benefits of nipocalimab, which could lead to improved management of symptoms and quality of life for patients suffering from this autoimmune condition.

The clinical trial involves a total of **507 participants** diagnosed with **Sjögren's Disease**, aiming to assess the efficacy of nipocalimab compared to placebo in individuals with moderate to severe conditions. The study population includes both male and female subjects, with an age range encompassing adults and older adults. Participants were selected based on their medical stability, confirmed diagnosis according to the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria, and seropositivity for antibodies to Ro/SSA. The trial includes individuals who are medically stable, as determined by physical examination, medical history, vital signs, ECG, and clinical laboratory tests. Participants of childbearing potential were required to have negative pregnancy tests at screening and prior to randomization. The trial also considers vulnerable populations, ensuring comprehensive representation within the study cohort.

The clinical trial is designed to evaluate the **efficacy** and safety of **nipocalimab** in adults with moderate to severe **Sjogren's Disease**. This is a randomized, placebo-controlled, double-blind, multicenter Phase 3 study. Participants will be randomly assigned to receive either the investigational product, JNJ-80202135, which contains nipocalimab, or a placebo. Both treatments will be administered via subcutaneous injection. The trial is expected to last until May 29, 2030, with recruitment starting on June 4, 2025. The maximum treatment period for participants is 144 weeks.

The study will include several key visits: an inclusion (screening) visit, multiple follow-up visits, and an end-of-study visit. During the screening visit, participants will undergo a comprehensive evaluation to confirm eligibility, including a physical examination, medical history review, vital signs assessment, 12-lead electrocardiogram (ECG), and clinical laboratory tests. Participants must meet specific inclusion criteria, such as being medically stable and seropositive for antibodies to Ro/SSA, and must have a total ClinESSDAI score of 5 or greater. Women of childbearing potential must have a negative pregnancy test at screening and prior to randomization.

Follow-up visits will occur at regular intervals to monitor the participants' health and response to treatment. The primary endpoint is the change from baseline in the Clinical European League Against Rheumatism Sjogren’s Syndrome Disease Activity Index (ClinESSDAI) score at Week 48. The end-of-study visit will involve a final assessment of the participants' health and the collection of data for analysis. Participant involvement is expected to last up to 144 weeks, depending on individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include significant adverse events, non-compliance with study procedures, or withdrawal of consent by the participant.

The clinical trial involves the administration of **Nipocalimab**, an investigational medication, under the product code JNJ-80202135. This medication is formulated as a **solution for injection** and is administered via the **subcutaneous route**. The active substance in JNJ-80202135 is Nipocalimab, a protein-based therapeutic agent. The trial protocol specifies a maximum treatment period of 144 days. The dosing schedule and specific dosage amounts are not detailed in the provided data. The investigational product is manufactured by Janssen-Cilag International N.V.

In addition to the experimental treatment, a **placebo** is utilized as a comparator in this study. The placebo is administered subcutaneously and is designed to mimic the administration of the investigational product without containing the active substance, Nipocalimab. The placebo serves as a control to assess the efficacy and safety of Nipocalimab in participants with moderate to severe Sjögren's Disease. The pharmaceutical form of the placebo is not specified in the data provided.

The efficacy of nipocalimab in the treatment of moderate to severe **Sjögren's Disease (SjD)** will be assessed in a randomized, placebo-controlled, double-blind, multicenter Phase 3 clinical trial. The primary endpoint for evaluating efficacy is the change from baseline in the Clinical European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index (ClinESSDAI) score at Week 48. This endpoint will be measured using a validated scale to quantify disease activity, providing a standardized method for assessing symptom improvement.