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NCT06741969RECRUITINGIRB Ready

Nipocalimab in Moderate to Severe Sjogren's Disease

(DAFFODIL)

Sponsored by Janssen Research & Development, LLC

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 600 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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

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 a

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

600 participants

โšง

Gender

ALL

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Sponsor

Janssen Research & Development, LLC

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Chula Vista

California

Location available
View Chula Vista location page
RECRUITING

Fullerton

California

Location available
View Fullerton location page
RECRUITING

La Palma

California

Location available
View La Palma location page
RECRUITING

Monterey Park

California

Location available
View Monterey Park location page
RECRUITING

San Leandro

California

Location available
View San Leandro location page
RECRUITING

Santa Monica

California

Location available
View Santa Monica location page
RECRUITING

Tustin

California

Location available
View Tustin location page
RECRUITING

Upland

California

Location available
View Upland location page
RECRUITING

Denver

Colorado

Location available
View Denver location page

๐Ÿ“ And 34 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Sjogren's Syndrome Treatment in Chula Vista?

Join others in California exploring innovative treatment options through clinical research

Sjogren's Syndrome Treatment Options in Chula Vista, California

If you're searching for Sjogren's Syndrome treatment in Chula Vista, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Chula Vista, Fullerton, La Palma and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Sjogren's Syndrome. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 600 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Sjogren's Syndrome?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Sjogren's Syndrome

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Sjogren's Syndrome Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06741969. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.