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ACTIVE NOT RECRUITING Phase 3

A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus

NCT05672576 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous 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. Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered. In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.

Interventions

  • DRUG Placebo
  • DRUG Cenerimod

Study Locations (20)

Florida

  • Hope Clinical Trials, Inc. — Coral Gables
  • Vital Pharma Research — Hialeah
  • Tectum Medical Research — Hollywood
  • Alloy Clinical Research, LLC — Kissimmee
  • Allied Biomedical Research Institute — Miami
  • D&H National Research Centers INC — Miami
  • Professional research Center INC — Miami
  • San Marcus Research Clinic, Inc. — Miami Lakes

California

  • UCSD Perlman Medical Offices — La Jolla
  • Amicis Research Center — Northridge
  • BioSolutions Clinical Research Center — Poway

Texas

  • Precision Comprehensive Clinical Research Solutions — Colleyville
  • Texas Arthritis Center — El Paso
  • Northwest Houston Arthritis Center — Houston

Other

  • Biomedica Research Group — Providencia
  • Sociedad Médica del Aparato Locomotor S. A. — Providencia

Arizona

  • Tucson Clinical Research Institute, LLC — Tucson

Louisiana

  • Tandem Clinical Research — Marrero

Nevada

  • RB Wellness Clinic — Las Vegas

New York

  • Columbia University Medical Center — New York

Trial Details

FieldValue
Enrollment Target 451 participants
Start Date 2023-06-26
Est. Completion 2027-05-01
Phase Phase 3

Sponsor

Viatris Innovation

35 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05672576

The ClinicalTrials.gov registry entry for NCT05672576 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 451 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Viatris Innovation, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05672576 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05672576 about?

NCT05672576 is a clinical study titled "A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus". The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous 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 ceneri...

What is the current status of trial NCT05672576?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 451 participants. The study started on 2023-06-26. Estimated completion is 2027-05-01.

What conditions does trial NCT05672576 study?

This clinical trial studies the following conditions: Lupus Erythematosus, Systemic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05672576?

The interventions under investigation include: Placebo (DRUG), Cenerimod (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05672576?

This trial is sponsored by Viatris Innovation, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05672576 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Louisiana, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial