A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment

Part of paid clinical trials in Doral, Florida.

Sponsor
Viatris Innovation GmbH
Study ID
NCT07201129
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Lupus Erythematosus, Systemic
  • Nephritis, Lupus

Eligibility Criteria

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

Interventions

  • Cenerimod — DRUG
    Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg.
  • Placebo — DRUG
    Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.

Study Details

The goal of this clinical trial is to learn if cenerimod, on top of regular treatment, works to treat active lupus nephritis in adults with systemic lupus erythematosus and active lupus nephritis. It will also learn about the safety of cenerimod. The main questions it aims to answer are: * Does cenerimod improve kidney function in participants? * What medical problems do participants have when taking cenerimod? Researchers will compare cenerimod to a placebo (a look-alike substance that contains no drug) to see how well cenerimod works when it is added to regular treatment. Participants will: * Take cenerimod or a placebo every day for 76 weeks (approximately 1.5 years), on top of regular treatment. * Visit the clinic every 1 to 3 months for checkups and tests.

Key Dates

First listed
Oct 1, 2025
Start date
Feb 9, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cenerimod 4 mg
    Participants will receive cenerimod once daily in addition to background lupus nephritis (LN) therapy.
  • Placebo Comparator: Matching placebo
    Participants will receive matching placebo once daily in addition to background LN therapy.

Primary Outcome Measure

Complete renal response (CRR) [ Time Frame: At Week 76 ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Dolphin Medical ResearchDoralFlorida33172-
Alloy Clinical Research LLCKissimmeeFlorida34741-
Allied Biomedical Research InstituteMiamiFlorida33155-
DH NationalResearchCenters INCMiamiFlorida33155-
ProfessionalResearchCenter INCMiamiFlorida33172-
SouthCoast Research CenterMiamiFlorida33136-
San Marcus Research Clinic, Inc.Miami LakesFlorida33014-
Revive Research Institute, LLCSterling HeightsMichigan48313-
Rheumatology Care Center, PLLCBellaireTexas77401-
Texas Arthritis CenterEl PasoTexas79902-
Northwest Houston ArthritisHoustonTexas77090-
Novel Research, LLC.HoustonTexas77024-
Discovery Clinical Trials LLCSan AntonioTexas78229-
Azul Bioresearch LlcSugarlandTexas77479-

Find similar trials in Doral, FL

By research site
Dolphin Medical Research· Doral, FLAlloy Clinical Research LLC· Kissimmee, FLAllied Biomedical Research Institute· Miami, FLDH NationalResearchCenters INC· Miami, FLProfessionalResearchCenter INC· Miami, FLSouthCoast Research Center· Miami, FL

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