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NCT06928142RECRUITINGIRB Ready

A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's

(EnVISage)

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
📊
1 of 80 participants interested
1% 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

This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment in participants with Sjögren's disease.

Who Can Participate

Inclusion Criteria

Diagnosed with Sjögren's disease.
ESSDAI score (which measures disease activity) must be 5 or higher.
Salivary flow rate must be at least 0.05 mL/min.
Serum IgG level must be higher than 900 mg/dL.
Must be able to communicate well with the investigator and agree to follow the trial requirements.
Participants can continue certain medications (hydroxychloroquine, methotrexate, leflunomide, or azathioprine) if they have been on a stable dose for at least 30 days.
Corticosteroid dose must be stable and no more than 10 mg/day for at least 30 days.
Test positive for anti-Ro52 and/or anti-Ro60 antibodies. Key

Exclusion Criteria

Another active autoimmune rheumatic disease.
Prior use of B-cell depleting therapy or prohibited immunosuppressants.
Significant comorbidities including uncontrolled type 2 diabetes, malignancy, and chronic and/or acute infections.
Suicidal ideation or behavior based on the Patient Health Questionnaire-9 (PHQ-9).

❓ 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

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Target Enrollment

80 participants

🎂

Age Range

18 Years - 75 Years

Gender

ALL

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Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Birmingham

Alabama

Location available
RECRUITING

Riverside

California

Location available
RECRUITING

Tujunga

California

Location available
RECRUITING

Brandon

Florida

Location available
RECRUITING

Clearwater

Florida

Location available
RECRUITING

Cooper City

Florida

Location available
RECRUITING

Tampa

Florida

Location available
View Tampa location page
NOT_YET_RECRUITING

Skokie

Illinois

Location available
RECRUITING

Baton Rouge

Louisiana

Location available

📍 And 13 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

🔒 Secure · 🏥 Expert Care

Looking for Sjogren's Disease Treatment in Riverside?

Join others in California exploring innovative treatment options through clinical research

Sjogren's Disease Treatment Options in Riverside, California

If you're searching for Sjogren's Disease treatment in Riverside, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Riverside, Tujunga, Brandon 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 Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 80 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Sjogren's Disease?

Potential Benefits

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

What to Expect

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

Frequently Asked Questions About This Sjogren's Disease 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: NCT06928142. 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.