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Cenerimod

Phase 3

Lupus Erythematosus, Systemic | Small molecule | Immunology |Viatris Inc.|Last Updated: Jul 14, 2026

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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment1,601
FDA Designations
No designations recorded
Clinical trial landscape

Cenerimod · 12 trials · 9 indications

Phase 3 4Phase 2 2Phase 1 6
NCT07201129A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular TreatmentNephritis, Lupus
RECRUITING300 Analytics
NCT06475742Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus ErythematosusLupus Erythematosus, Systemic
ENROLLING BY_INVITATION680 Analytics
NCT05672576A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus ErythematosusLupus Erythematosus, Systemic
ACTIVE NOT_RECRUITING451 Analytics
NCT05648500A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus ErythematosusLupus Erythematosus, Systemic
ACTIVE NOT_RECRUITING470 Analytics
PHASE3RECRUITING
A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment
Nephritis, LupusUnlock trial analytics
PHASE3ENROLLING BY_INVITATION
Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
Lupus Erythematosus, SystemicUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
Lupus Erythematosus, SystemicUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus
Lupus Erythematosus, SystemicUnlock trial analytics
Study Endpoints
Primary Endpoints
Complete renal response (CRR)
At Week 76

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)

Treatment-emergent adverse events
Day 1 (post dose) to a maximum of 3.5 years

Occurrence of treatment-emergent adverse events up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period).

Serious adverse events
Day 1 (post dose) to a maximum of 3.5 years

Occurrence of serious adverse events up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period).

Adverse events of special interest
Day 1 (post dose) to a maximum of 3.5 years

Occurrence of adverse events of special interest up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period). Adverse events of special interest include the anticipated risks of treatment with cenerimod, known class effects, and events that may be related to systemic lupus erythematosus comorbidities, i.e., adverse events related to: * Effects on heart rate and rhythm * Hypotension * Hypertension * Cardiovascular * Hepatobiliary disorders / liver enzyme abnormalities * Pulmonary * Eye disorders * Infections * Skin malignancies * Non-skin malignancies

Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline
At Month 12 compared to Day 1 (pre-dose baseline)

Response on SRI-4 is defined as: * Reduction from baseline of at least 4 points in the modified Systemic Lupus Erythematosus Disease Activity Index-2000 score (mSLEDAI-2K \[SLEDAI-2K modified to exclude leukopenia, thus mSLEDAI-2K\]), and * No new British Isles Lupus Assessment Group-2004 (BILAG) A organ domain score and not more than one new BILAG B organ domain score compared to baseline, and * No worsening from baseline in subjects' lupus disease activity, where worsening is defined as an increase ≥ 0.30 points on a 3-point Physician's Global Assessment visual analog scale (PGA VAS), and * No violation of specified medication rules detailed in the core protocol.

Number of participants with treatment-emergent adverse events (AEs)
From first dose of study treatment up to 180 days after the last dose

Treatment-emergent AEs are defined as any adverse event that occurs after the first dose of study treatment and up to 180 days after the last dose. This includes serious AEs (SAEs), AEs of special interest (AESIs), and AEs leading to permanent discontinuation of study treatment. AEs are coded using MedDRA and assessed by the investigator.

Occurrence of adverse events leading to permanent discontinuation of study treatment
From first dose of study treatment up to end of treatment,maximum duration of 12 months.

Number of participants who permanently discontinue study treatment due to adverse events.

Change from baseline in vital signs (systolic and diastolic blood pressure) and body weight
Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12

Change in systolic blood pressure (SBP), diastolic blood pressure (DBP), and body weight from baseline to each post-baseline assessment. Measurements are performed in duplicate under standardized conditions.

Change from baseline in 12-lead electrocardiogram (ECG) parameters
Baseline, Month 1, Month 2, Month 3, Month 4,Month 5,Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12

Change in heart rate (HR), PR interval, QRS interval, QTcB interval, and QTcF interval from baseline to each post-baseline assessment.ECG abnormalities are assessed based on pre-defined criteria.

Change from baseline in laboratory parameters
Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12

Change in hematology, blood chemistry, and urinalysis variables from baseline to each post-baseline assessment. Marked laboratory abnormalities are defined based on central laboratory reference ranges.

Cenerimod Plasma Concentration
Pre-dose (0h), and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose on Day 1; Pre-dose on Day 30 (Month 1); Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose on Day 60 (Month 2); Pre-dose on Day 120 (Month 4); Pre-dose on Day 180

Plasma concentrations of cenerimod are measured at multiple time points to characterize the pharmacokinetic profile. Concentrations are determined using a validated bioanalytical method (e.g., LC-MS/MS).

Maximum plasma concentration (Cmax) of cenerimod
Day 1 and Month 2

Cmax is derived from plasma concentration-time profiles using non-compartmental analysis. Assessed during the first dosing interval on Day 1 and at steady state (Month 2).

Time to maximum plasma concentration (tmax) of cenerimod
Day 1 and Month 2

tmax is derived from plasma concentration-time profiles using non-compartmental analysis. Assessed during the first dosing interval on Day 1 and at steady state (Month 2). Time Frame: Day 1 and Month 2

Area under the plasma concentration-time curve from time zero to 24 hours (AUC0-24) of cenerimod
Day 1

AUC0-24 is derived during the first dosing interval on Day 1 using non-compartmental analysis.

Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ) of cenerimod
Month 2

AUCτ is derived at steady state (Month 2) using non-compartmental analysis.

Accumulation index (AI) of cenerimod
Between Day 1 and Month 2

AI is calculated as the ratio of AUC at steady state (Month 2) to AUC after the first dose (Day 1).

Change from baseline in total blood lymphocyte count
Baseline to Month 12

Change in total blood lymphocyte count from baseline to each post-baseline assessment. This is a key pharmacodynamic marker for cenerimod.

Number of participants with treatment-emergent medically relevant ECG abnormalities
Baseline to Month 12

Treatment-emergent medically relevant ECG abnormalities are defined as new or worsening abnormalities from baseline to each post-baseline assessment, as determined by central reading.

Number of participants with treatment-emergent marked laboratory abnormalities
Baseline to Month 12

Treatment-emergent marked laboratory abnormalities are defined as new or worsening abnormalities in hematology, blood chemistry, or urinalysis from baseline to each post-baseline assessment, based on central laboratory criteria.

Change From Baseline to Month 6 in the Modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) Score
Baseline (Day 1) and Month 6

The primary endpoint is the absolute change from baseline in the modified Systemic Lupus Erythematosus Activity Index 2000 (mSLEDAI-2K) score. The SLEDAI-2K is a cumulative index of lupus disease activity scored by the physician. It is calculated from 24 individual descriptors across 9 organ systems, with weighted scores of 2-8, and measures disease activity within the last 10 days. 0 points indicates inactive disease, and 105 points is the maximum possible score. In this study the SLEDAI-2K was modified, to exclude leucopenia (minus 1 point), due to the mechanism of action of cenerimod. Improvement in systemic lupus erythematosus disease activity is defined as a reduction in SLEDAI-2K score of greater than or equal to 4. A decreased score, i.e., a negative change, indicates an improvement in systemic lupus erythematosus disease activity from baseline to Month 6.

Absolute bioavailability
Up to 98 days post-dose

Absolute bioavailability of a single oral dose of 4 mg cenerimod, calculated as: area under the plasma concentration-time curve from zero to infinity (AUC0-∞) of the oral dose / AUC0-∞ of the intravenous dose, normalized by dose.

Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of cenerimod
Total duration: up to 52 days
Area under the plasma concentration-time curve (AUC from 0 to infinity) of cenerimod
Total duration: up to 52 days
The maximum plasma concentration (Cmax) of cenerimod
Total duration: up to 52 days
The time to reach Cmax (tmax) of cenerimod
Total duration: up to 52 days
Terminal half-life (t½) of cenerimod
Total duration: up to 52 days
Apparent oral clearance (CL/F) of cenerimod
Total duration: up to 52 days
Extent of cenerimod protein plasma binding (PPB)
Total duration: up to 52 days
Apparent volume of distribution (Vz/F) of cenerimod
Total duration: up to 52 days
Area under the plasma concentration-time curves (AUC0-t): cenerimod
Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Area under the plasma concentration-time curve from zero to infinity (AUC0-inf): cenerimod
Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Maximum plasma concentration (Cmax): cenerimod.
Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Time to reach Cmax (tmax): cenerimod
Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Terminal half-life (t½): cenerimod
Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Plasma protein binding of cenerimod
Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Apparent clearance (CL/F) of cenerimod
Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
The area under the plasma concentration-time curve (AUC) for cenerimod
From Day 1 to Day 49

The plasma PK parameter of cenerimod will be derived by non-compartmental analysis of plasma concentration-time profiles.

Cumulative excretion calculated by summing up the daily radioactivity excretion measured by means of liquid scintillation counting in urine, feces, and expired air (if applicable)
From baseline up to a maximum of 99 days
Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT)
Baseline to end-of-treatment (EOT) (up to 12 weeks)

The primary objective of the clinical study was to asses whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.

Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment
Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks)

The primary objective of the clinical study was to assess whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The change was defined as: Total lymphocyte count at visit minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.

Secondary Endpoints
CRR while maintaining a low dose of corticosteroids
At Week 76
Sustained CRR
Up to Week 76
Response on BILAG-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline
At Month 12 compared to Day 1 (pre-dose baseline)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cenerimod 4 mgEXPERIMENTALParticipants will receive cenerimod once daily in addition to background lupus nephritis (LN) therapy.
Matching placeboPLACEBO_COMPARATORParticipants will receive matching placebo once daily in addition to background LN therapy.
PlaceboPLACEBO_COMPARATORParticipants will receive matching placebo once daily in addition to background SLE therapy.
cenerimodEXPERIMENTALcenerimod 4 mg once daily
Cenerimod 0.5 mgEXPERIMENTALParticipants will receive cenerimod 0.5 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 0.5 mg for a further 6 months and end study treatment at the Month 12 visit.
Cenerimod 1 mgEXPERIMENTALParticipants will receive cenerimod 1 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 1 mg for a further 6 months and end study treatment at the Month 12 visit.
Cenerimod 2 mgEXPERIMENTALParticipants will receive cenerimod 2 mg once daily in addition to background SLE therapy. Treatment Period 1 is 6 months long. It will start with the administration of the first dose of study treatment, after randomization, and end at the Month 6 visit. All randomized participants need to complete Treatment Period 1 before continuing in Treatment Period 2. In Treatment Period 2 participants will continue with cenerimod 2 mg for a further 6 months and end study treatment at the Month 12 visit.
Cenerimod 2 mg (Ex-4mg)EXPERIMENTALHalf the participants that complete treatment with cenerimod 4 mg in Treatment Period 1 will be re-randomized to cenerimod 2 mg once daily in addition to background SLE therapy during Treatment Period 2. Participants will receive cenerimod 2 mg for 6 months and end study treatment at the Month 12 visit.
Placebo (Ex-4mg)PLACEBO_COMPARATORHalf the participants that complete treatment with cenerimod 4 mg in Treatment Period 1 will be re-randomized to placebo (matching cenerimod) once daily in addition to background SLE therapy during Treatment Period 2. Participants will receive cenerimod 2 mg for 6 months and end study treatment at the Month 12 visit.
Group A (severe renal function impairment)EXPERIMENTALEight (8) participants with severe renal impairment.
Group B (healthy)EXPERIMENTALEight (8) control participants, matched to the 8 severe renal impaired participants enrolled in Group A.
Group A: Participants with mild hepatic impairmentEXPERIMENTALParticipants with mild hepatic impairment (Child-Pugh Score of 5 to 6).
Group B: Participants with moderate hepatic impairmentEXPERIMENTALParticipants with moderate hepatic impairment (Child-Pugh Score of 7 to 9).
Group C:Healthy participantsEXPERIMENTALHealthy participants will be matched to the participants with hepatic impairment based on age and body weight.
Cenerimod / ACT-334441EXPERIMENTAL -
Treatment and observation periodEXPERIMENTALOn Day 1, subjects will receive a single oral dose of 2 mg 14C-radiolabeled cenerimod. Subjects will be followed for 21 days during which blood, urine, feces, and expired air samples will be collected
Extended observation periodEXPERIMENTALIn case, radioactivity recovery does not meet the stopping criteria described in the protocol, the subjects will have to come for a maximum of 7 24-h in-clinic visits during which blood, urine, feces, and expired air samples will be collected
Cenerimod 0.5 mg (Part A)EXPERIMENTALParticipants will receive cenerimod 0.5 mg capsules orally once daily for 12 weeks.
Cenerimod 1 mg (Part A)EXPERIMENTALParticipants will receive cenerimod 1 mg capsules orally once daily for 12 weeks.
Cenerimod 2 mg (Part A)EXPERIMENTALParticipants will receive cenerimod 2 mg capsules orally once daily for 12 weeks.
Cenerimod 4 mg (Part B)EXPERIMENTALParticipants will received cenerimod 4 mg capsules orally once daily for 12 weeks. This treatment arm will start after all patients in Part A have completed 4 weeks of placebo, 0.5 mg, 1 mg and 2 mg cenerimod treatment.
Matching placebo (Part A and B)PLACEBO_COMPARATORCapsules of matching placebo taken orally once daily for 12 weeks.
Interventions
NameTypeDescription
CenerimodDRUGCenerimod will be supplied as a film-coated tablets at the dose of 4 mg.
PlaceboDRUGMatching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.
cenerimod 4 mgDRUGcenerimod 4 mg once daily for 12 months
Cenerimod 0.5 mgDRUGCenerimod will be supplied as a film-coated tablets at the dose of 0.5 mg
Cenerimod 1 mgDRUGCenerimod will be supplied as a film-coated tablets at the dose of 1 mg
Cenerimod 2 mgDRUGCenerimod will be supplied as a film-coated tablets at the dose of 2 mg
cenerimod 2 mg (ex-4 mg)DRUGCenerimod will be supplied as a film-coated tablets at the dose of 2 mg
Cenerimod (oral)DRUGA single dose of cenerimod, administered as an oral tablet at a strength of 4 mg
14C-Cenerimod (i.v.)DRUGA single i.v. dose of 7.5 µg 14C-radiolabeled cenerimod (34.5 kBq), with administration starting 6 h after administration of the oral dose.
Matching PlaceboDRUGA single oral dose of matching placebo will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions.
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Eligibility Criteria
Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites11

Main Inclusion Criteria: * Classification of systemic lupus erythematosus (SLE) made according to the 2019 European Alliance of Associations for Rheumatology / American College of Rheumatology (EULAR/ACR) criteria. * Renal biopsy within 6 months prior to Screening visit indicating Class III or IV a...

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Recent Changes (Last 90 Days)
LOWJul 14, 2026NCT07201129lastUpdatePostDate: changed
LOWJul 14, 2026NCT06475742lastUpdatePostDate: changed
LOWJul 14, 2026NCT05648500lastUpdatePostDate: changed
LOWJul 14, 2026NCT05672576lastUpdatePostDate: changed
LOWJul 14, 2026NCT07201129lastUpdatePostDate: changed
LOWJul 14, 2026NCT06475742lastUpdatePostDate: changed
LOWJul 14, 2026NCT05672576lastUpdatePostDate: changed
LOWJul 14, 2026NCT05648500lastUpdatePostDate: changed
LOWJun 18, 2026NCT07201129lastUpdatePostDate: changed
LOWJun 18, 2026NCT07201129lastUpdatePostDate: changed
LOWJun 18, 2026NCT07201129lastUpdatePostDate: changed
LOWJun 18, 2026NCT07201129lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT07301723TRIAL_REMOVED: changed
LOWMay 26, 2026NCT07201129primaryCompletionDate: changed
LOWMay 26, 2026NCT06475742primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT05648500Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMMay 26, 2026NCT07266090Status: ENROLLING_BY_INVITATION → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT05672576primaryCompletionDate: changed