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NCT04961567RECRUITINGIRB Ready

A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

(TOPAZ-2)

Sponsored by Biogen

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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

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease.

Who Can Participate

Inclusion Criteria

Participant must be diagnosed with SLE at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, at screening by a qualified physician.
Participant has a modified Systemic Lupus Erythematosus Disease Activity Index-200 (SLEDAI-2K) score โ‰ฅ6 (excluding alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated).
Participant has a modified clinical SLEDAI-2K score โ‰ฅ4 (excluding anti-dsDNA, low complement component 3 \[C3\] and/or complement component 4 \[C4\], alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated) and randomization.
Participant has BILAG-2004 grade A in โ‰ฅ1 organ system or BILAG-2004 grade B in โ‰ฅ2 organ systems at screening (adjudicated) and randomization.
Participants must be treated with one of the following background nonbiologic lupus SOC thera

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

540 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Biogen

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Birmingham

Alabama

Location available
View Birmingham location page
Unknown

Glendale

Arizona

Location available
View Glendale location page
Unknown

Huntington Beach

California

Location available
View Huntington Beach location page
Unknown

Los Alamitos

California

Location available
View Los Alamitos location page
Unknown

Los Angeles

California

Location available
View Los Angeles location page
Unknown

Monterey Park

California

Location available
View Monterey Park location page
Unknown

Napa

California

Location available
View Napa location page
Unknown

Orange

California

Location available
View Orange location page
Unknown

Whittier

California

Location available
View Whittier location page

๐Ÿ“ And 35 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 Systemic Lupus Erythematosus Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Systemic Lupus Erythematosus Treatment Options in Birmingham, Alabama

If you're searching for Systemic Lupus Erythematosus treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Glendale, Huntington Beach 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 Systemic Lupus Erythematosus. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 540 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Systemic Lupus Erythematosus?

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 Systemic Lupus Erythematosus

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 Systemic Lupus Erythematosus 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: NCT04961567. 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.