⚑Your ready-to-use recruitment solution: IRB-compliant, SEO-optimized website that automatically routes qualified patient leads to your clinical study (14-day free trial, then $44/mo)

NCT06293365RECRUITINGIRB Ready

Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

Sponsored by Novartis Pharmaceuticals

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
πŸ“Š
1 of 140 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

The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), SjΓΆgren's disease (SjD), or systemic lupus erythematosus (SLE).

Who Can Participate

Inclusion Criteria

Signed informed consent must be obtained before any assessment is performed.
Male and female patients aged 18 years to 70 years (inclusive).
Body weight at least 35 kg and not more than 150 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2 at screening.
Diagnosed with RA, SjD and/or SLE as determined by the investigator.
Have active disease (RA, SjD or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator.
Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment.
Ability to communicate well with the investigator, understand and agree to comply with the requirements of the study. Key

Exclusion Criteria

Use of prohibited therapies.
Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history

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

Study Details

πŸ“‹

Study Type

INTERVENTIONAL

πŸ‘₯

Target Enrollment

140 participants

πŸŽ‚

Age Range

18 Years - 70 Years

⚧

Gender

ALL

🏒

Sponsor

Novartis Pharmaceuticals

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Anniston

Alabama

Location available
View Anniston location page
Unknown

Fullerton

California

Location available
View Fullerton location page
Unknown

La Palma

California

Location available
View La Palma location page
Unknown

Winter Park

Florida

Location available
View Winter Park location page
Unknown

Lawrenceville

Georgia

Location available
View Lawrenceville location page
Unknown

Indianapolis

Indiana

Location available
View Indianapolis location page
Unknown

Baton Rouge

Louisiana

Location available
View Baton Rouge location page
Unknown

Grand Blanc

Michigan

Location available
View Grand Blanc location page
Unknown

Middleburg Heights

Ohio

Location available

πŸ“ And 8 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

πŸ”’ Secure Β· πŸ₯ Expert Care

Looking for Autoimmune Disease Treatment in Anniston?

Join others in Alabama exploring innovative treatment options through clinical research

Autoimmune Disease Treatment Options in Anniston, Alabama

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

Local Sites
3 locations in Alabama
Now Enrolling
Up to 140 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Autoimmune Disease?

Potential Benefits

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

What to Expect

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

Frequently Asked Questions About This Autoimmune 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: NCT06293365. 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.