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

NCT07201129 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: ID-064B301
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Lupus Erythematosus, Systemic; Nephritis, Lupus

Outcome Measures

Primary Outcomes (1)

• Complete renal response (CRR)

  CRR at Week 76, defined as (both must be met): * Urine protein to creatinine ratio (UPCR) ≤ 0.5 mg/mg AND * No decrease from baseline of ≥ 20% in estimated glomerular filtration rate (eGFR)

  At Week 76

Secondary Outcomes (2)

• CRR while maintaining a low dose of corticosteroids

  At Week 76

• Sustained CRR

  Up to Week 76

Study Arms (2)

Cenerimod 4 mg

EXPERIMENTAL

Participants will receive cenerimod once daily in addition to background lupus nephritis (LN) therapy.

Drug: Cenerimod

Matching placebo

PLACEBO COMPARATOR

Participants will receive matching placebo once daily in addition to background LN therapy.

Drug: Placebo

Interventions

Cenerimod DRUG

Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg.

Also known as: ACT-334441

Cenerimod 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.

Matching placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Classification of systemic lupus erythematosus (SLE) made according to the 2019 European Alliance of Associations for Rheumatology / American College of Rheumatology (EULAR/ACR) criteria.

You may not qualify if:

• Active renal disease defined as urine protein/creatinine ratio ≥ 1 mg/mg, assessed on a 24h urine collection.
• eGFR ≥ 15 mL/min/1.73 m\^2. Enrollment of participants with eGFR between ≥ 15 and \< 30 mL/min/1.73 m\^2 requires:
• a renal biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli,
• activity index ≥ 2, and chronicity index \< 4, on the National Institutes for Health 2018 activity and chronicity indices. These indices must be assessed on the kidney biopsy dated less than 6 months prior to Screening and confirmed by a nephropathologist.
• Initiation of the induction therapy with the mandatory following background therapy:
• Mycophenolate mofetil 1-3 g/day orally or mycophenolate sodium 720-2160 mg/day orally at Randomization. This treatment can be in place before Screening or started at Screening.
• Corticosteroids: 1-3 intravenous (i.v.) pulses of methylprednisolone at 250 to 1000 mg/pulse/day (maximum cumulative 3000 mg) followed by oral prednisone (or equivalent) at 0.5 mg/kg/day with a cap at 40 mg/day. Pulses can be administered during screening and up to 2 weeks prior to screening. Participants who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/kg/day (max 80 mg/day) oral prednisone (or equivalent), within the same window as i.v. pulses.
• Note: If treatment with an antimalarial or belimumab is taken, it must be initiated at least 4 weeks prior to Screening and must be at stable dose during these 28 days prior to Randomization and continued at a stable dose until End-of-Treatment. Participants on azathioprine must be switched to mycophenolate mofetil or mycophenolate sodium prior to Randomization.
• Participants of childbearing potential must agree to:
• Use a highly effective method of contraception from the Screening visit up to at least 24 weeks after discontinuation of trial intervention.
• Undertake monthly urine pregnancy tests during the trial and up to at least 24 weeks after discontinuation of trial intervention.
• Severe active central nervous system lupus
• History of, or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with the LN assessment and confound the disease activity assessment (e.g., diabetic nephropathy), or require dialysis, transplantation or end-stage renal disease.
• History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia, or syncope associated with cardiac disorders.
• Participants who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure defined by the New York Heart Association Class III/IV within 6 months prior to Screening.

Sponsors & Collaborators

• Viatris Innovation GmbH: lead

Study Sites (9)

Alloy Clinical Research LLC

Kissimmee, Florida, 34741, United States

RECRUITING

SouthCoast Research Center

Miami, Florida, 33136, United States

RECRUITING

Allied Biomedical Research Institute

Miami, Florida, 33155, United States

RECRUITING

DH NationalResearchCenters INC

Miami, Florida, 33155, United States

RECRUITING

ProfessionalResearchCenter INC

Miami, Florida, 33172, United States

RECRUITING

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014, United States

RECRUITING

Rheumatology Care Center, PLLC

Bellaire, Texas, 77401, United States

RECRUITING

Novel Research, LLC.

Houston, Texas, 77024, United States

RECRUITING

Northwest Houston Arthritis

Houston, Texas, 77090, United States

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Interventions

cenerimod

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Viatris Innovation GmbH

  STUDY DIRECTOR

Central Study Contacts

Viatris Innovation Clinical Trial Information

CONTACT

+1 908 435 2675; viatrisinnovationclinicaltrials@viatris.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: April 28, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)