Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus

Part of paid clinical trials in Clearwater, Florida.

Sponsor
Viatris Innovation GmbH
Study ID
NCT06475742
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Lupus Erythematosus, Systemic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cenerimod — DRUG
    Film-coated tablets at a dose of 4 mg.

Study Details

The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus. The main questions it aims to answer are: * Whether cenerimod causes any adverse effects ('side effects') when given on top of drugs already being given for systemic lupus erythematosus. * How well cenerimod works to reduce symptoms of systemic lupus erythematosus when taken for at least 1 year and up to 3 years. Participants taking part in this study will have already taken part in another study, where they received either cenerimod or placebo (look-alike substance containing no active drug) for 1 year. In this clinical study approximately 680 participants will receive cenerimod (on top of drugs already being given for systemic lupus erythematosus) for at least 1 year and up to 3 years.

Key Dates

Start date
Jul 30, 2024
Status verified
Aug 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
680 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cenerimod 4 mg
    Participants will receive oral cenerimod once daily in addition to background systemic lupus erythematosus therapy, for at least 1 year and up to a maximum of 3 years.

Primary Outcome Measure

Treatment-emergent adverse events [ Time Frame: Day 1 (post dose) to a maximum of 3.5 years ]

Locations (13)

FacilityCityStateZIPSite coordinators
Clinical Research of West Florida, Inc.ClearwaterFlorida33765-
Omega Research MetroWest, LLCDeBaryFlorida32713-
Allied Biomedical Research InstituteMiamiFlorida33155-
D&H National Research Centers INCMiamiFlorida33155-
Professional research Center INCMiamiFlorida33172-
SouthCoast Research Center, Inc.MiamiFlorida33136-
San Marcus Res Clin Inc.Miami LakesFlorida33014-
Accurate Clinical Research Inc. - Lake CharlesLake CharlesLouisiana70605-
RB Wellness ClinicLas VegasNevada89102-
Accurate Clinical Research Inc - (Najam)BaytownTexas77521-
Novel Research LLCBellaireTexas77401-
Accurate Clinical Research Inc.HoustonTexas77089-
Sun ResearchSan AntonioTexas78215-

Find similar trials in Clearwater, FL

By research site
Clinical Research of West Florida, Inc.· Clearwater, FLOmega Research MetroWest, LLC· DeBary, FLAllied Biomedical Research Institute· Miami, FLD&H National Research Centers INC· Miami, FLProfessional research Center INC· Miami, FLSouthCoast Research Center, Inc.· Miami, FL

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