A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults With Moderate to Severe Sjogren's Disease (SjD)
Nipocalimab for Moderate to Severe Sjogren's Disease
Plain English Summary
Nipocalimab in Moderate to Severe Sjogren's Disease is a Phase 3 clinical trial sponsored by Janssen Research & Development, LLC studying Sjogrens Syndrome. Tests the effectiveness and safety of nipocalimab in treating moderate to severe Sjogren's disease. For adults diagnosed with moderate to severe Sjogren's disease, meeting specific criteria. Participation involves receiving nipocalimab or placebo injections and standard care treatments. Alternative treatments include standard care options, but this trial aims to find a more effective therapy. The trial aims to enroll 655 participants.
Official Summary
The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible participants are adults with moderate to severe Sjogren's disease, medically stable, and seropositive for Ro/SSA antibodies. Excluded are those with severe, uncontrolled medical conditions, allergies to nipocalimab, or a history of severe hypersensitivity reactions. Age range is not specified, but participants must be of childbearing potential and must have a negative pregnancy test. Health requirements include meeting specific diagnostic criteria and having a total ClinESSDAI score of at least 5. This trial is studying Sjogrens Syndrome, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures the change in ClinESSDAI score, which means it tracks how well the treatment improves symptoms and disease activity. The specific primary outcome measures are: Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48 (Baseline to Week 48). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial is crucial as it aims to fill a treatment gap for those with moderate to severe Sjogren's disease, offering a potential new therapy. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Sjogrens Syndrome, where improved treatment options are needed.
Investor Insight
The market for Sjogren's disease treatments is growing, with limited options available, making this trial significant for investors. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 655 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you meet the eligibility criteria and if nipocalimab is right for you. Participation involves regular clinic visits, injections, and monitoring of symptoms and side effects. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 655 participants
Interventions
- DRUG: Nipocalimab — Nipocalimab SC.
- DRUG: Placebo — Placebo SC.
- DRUG: Standard of care treatment — Protocol-defined topical and systemic standard of care background treatments.
Primary Outcomes
- Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48 (Baseline to Week 48)
Secondary Outcomes
- Improvement from Baseline in Minimal Clinically Important Improvement (MCII) in ClinESSDAI Score at Week 48 (Baseline to Week 48)
- Improvement from Baseline in ClinESSDAI Score at Week 48 in Participants with High Immunoglobulin (IgG) Levels at Baseline (Baseline to Week 48)
- Change from Baseline in ClinESSDAI Score at Week 8 (Baseline to Week 8)
- Change from Baseline in Stimulated Salivary Flow Rate at Week 48 (Baseline to Week 48)
- Change from Baseline in Sjogren's Symptoms Dryness Score at Week 48 (Baseline to Week 48)
Full Eligibility Criteria
Inclusion Criteria:- * Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening * Meets criteria for diagnosis of SjD by the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria * Seropositive for antibodies to Ro/SSA (Ro60 and/or Ro52) at screening * Total ClinESSDAI score greater than or equal to (\>=) 5 at screening * Participants of childbearing potential must have a negative highly sensitive serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0 prior to randomization Exclusion Criteria: * Has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory * Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation * Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her SjD or has a family history of congenital or hereditary immunodeficiency * Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example \[e.g.\], monoclonal antibodies, intravenous immunoglobulin) * Has any unstable or progressive manifestation of SjD that is likely to warrant escalation in therapy beyond permitted background medications
Trial Locations
- Advanced Clinical Research Center, Chula Vista, California, United States
- Providence Medical Foundation, Fullerton, California, United States
- Arthritis & Osteoporosis Medical Center - La Palma, La Palma, California, United States
- NovaMed Research, Monterey Park, California, United States
- Medvin Clinical Research San Leandro, San Leandro, California, United States
- Providence Saint John s Health Center, Santa Monica, California, United States
- Solace Clinical Research California, Tustin, California, United States
- Inland Rheumatology Clinical Trials Inc., Upland, California, United States
- Denver Arthritis Clinic, Denver, Colorado, United States
- Clinical Research of West Florida Inc, Clearwater, Florida, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06741969?
NCT06741969 is a Phase 3 INTERVENTIONAL study titled "Nipocalimab in Moderate to Severe Sjogren's Disease." It is currently active, not recruiting and is sponsored by Janssen Research & Development, LLC. The trial targets enrollment of 655 participants.
What conditions does NCT06741969 study?
This trial investigates treatments for Sjogrens Syndrome. The primary condition under study is Sjogrens Syndrome.
What treatments are being tested in NCT06741969?
The interventions being studied include: Nipocalimab (DRUG), Placebo (DRUG), Standard of care treatment (DRUG). Nipocalimab SC.
What does Phase 3 mean for NCT06741969?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06741969?
This trial is currently "Active, Not Recruiting." It started on 2024-12-04. The estimated completion date is 2029-08-02.
Who is sponsoring NCT06741969?
NCT06741969 is sponsored by Janssen Research & Development, LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06741969?
The trial aims to enroll 655 participants. The trial status is active, not recruiting.
How is NCT06741969 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06741969?
The primary outcome measures are: Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48 (Baseline to Week 48). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06741969 being conducted?
This trial is being conducted at 20 sites, including Chula Vista, California; Fullerton, California; La Palma, California; Monterey Park, California and 16 more sites (United States).
Where can I find official information about NCT06741969?
The official record for NCT06741969 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06741969. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06741969 testing in simple terms?
Tests the effectiveness and safety of nipocalimab in treating moderate to severe Sjogren's disease. For adults diagnosed with moderate to severe Sjogren's disease, meeting specific criteria.
Why is this trial significant?
This trial is crucial as it aims to fill a treatment gap for those with moderate to severe Sjogren's disease, offering a potential new therapy. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06741969?
Key risks include potential side effects from the drug, such as injection site reactions, and the possibility of no improvement or worsening of symptoms. Monitor for any unusual symptoms and report them to your healthcare provider. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06741969?
Ask your doctor if you meet the eligibility criteria and if nipocalimab is right for you. Participation involves regular clinic visits, injections, and monitoring of symptoms and side effects. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06741969 signal from an investment perspective?
The market for Sjogren's disease treatments is growing, with limited options available, making this trial significant for investors. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves receiving nipocalimab or placebo injections and standard care treatments. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.