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NCT05648500RECRUITINGIRB Ready

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

(OPUS-1)

Sponsored by Viatris Innovation GmbH

Quick Self-Assessment

See if you qualify and express your interest

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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 goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms. The main questions it aims to answer are: * How well cenerimod works on top of the treatment already being administered. * How safe cenerimod is for adult patients with Systemic Lupus Erythematosus.

Who Can Participate

Inclusion Criteria

Signed Informed Consent Form (ICF) prior to any study-mandated procedure.
Diagnosis of Systemic Lupus Erythematosus (SLE) made at least 6 months prior to Screening, according to 2019 European League Against Rheumatism / American College of Rheumatology Criteria.
A modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score โ‰ฅ 6 and clinical mSLEDAI-2K score โ‰ฅ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers). The mSLEDAI-2K score does not include "leukopenia".
British Isles Lupus Assessment Group-2004 (BILAG) Grade B in โ‰ฅ 2 organ systems or a BILAG Grade A in โ‰ฅ 1 organ system.
Physician's Global Assessment (PGA) score โ‰ฅ 1.0 on a 0 to 3 visual analog scale.
Currently treated with one or more of the following SLE background medications:
Anti-malarials (โ‰ค 400 mg/day hydroxychloroquine, โ‰ค 500 mg/day chloroquin

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

420 participants

๐ŸŽ‚

Age Range

18 Years - 75 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Viatris Innovation GmbH

Study Locations

Choose your preferred location or select flexible during enrollment

WITHDRAWN

Fullerton

California

Location available
View Fullerton location page
RECRUITING

Huntington Park

California

Location available
View Huntington Park location page
RECRUITING

Aurora

Colorado

Location available
View Aurora location page
WITHDRAWN

Boca Raton

Florida

Location available
View Boca Raton location page
RECRUITING

Clearwater

Florida

Location available
View Clearwater location page
RECRUITING

DeBary

Florida

Location available
View DeBary location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Plantation

Florida

Location available
View Plantation location page
WITHDRAWN

Tampa

Florida

Location available
View Tampa location page

๐Ÿ“ And 20 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 Fullerton?

Join others in California exploring innovative treatment options through clinical research

Systemic Lupus Erythematosus Treatment Options in Fullerton, California

If you're searching for Systemic Lupus Erythematosus treatment in Fullerton, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Fullerton, Huntington Park, Aurora 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 California
Now Enrolling
Up to 420 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: NCT05648500. 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.