A Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE)

NCT07266090 | Enrolling By Invitation Phase 2

• 1 other identifier: ID-064A204
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 7

Brief Summary

The goal of this clinical trial is to learn about the safety, how the body processes the drug, and its effects of a drug called cenerimod in adult Chinese participants (aged 18-75) with moderate to severe Systemic Lupus Erythematosus (SLE) who are already receiving standard background therapy. The main questions it aims to answer are:

• What is the safety and tolerability of a daily 4 mg dose of cenerimod in Chinese participants with SLE?
• How is cenerimod processed by the body (pharmacokinetics) in this population?
• What is the effect of cenerimod on the level of lymphocytes in the blood (pharmacodynamics)? This is a single-arm study without a comparison group. Participants will:
• Take one 4 mg cenerimod tablet by mouth once daily for up to 12 months.
• Continue their stable, pre-existing background SLE medications throughout the study.
• Attend regular clinic visits over a period of up to 22 months for tests and check-ups, including blood draws, heart monitoring (12-lead electrocardiogram), vital signs(blood pressure),and physical examinations.
• Undergo a final safety follow-up 6 months after their last dose of the study drug.

Conditions

SLE - Systemic Lupus Erythematosus

Keywords

cenerimod; ACT-334441; safety; tolerability; pharmacokinetics; pharmacodynamics; Chinese participants

Outcome Measures

Primary Outcomes (14)

• Number of participants with treatment-emergent adverse events (AEs)

  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.

  From first dose of study treatment up to 180 days after the last dose

• Occurrence of adverse events leading to permanent discontinuation of study treatment

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

  From first dose of study treatment up to end of treatment,maximum duration of 12 months.

• Change from baseline in vital signs (systolic and diastolic blood pressure) and body weight

  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.

  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 from baseline in 12-lead electrocardiogram (ECG) parameters

  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.

  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 from baseline in laboratory parameters

  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.

  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

• Cenerimod Plasma Concentration

  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).

  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

• Maximum plasma concentration (Cmax) of cenerimod

  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).

  Day 1 and Month 2

• Time to maximum plasma concentration (tmax) of cenerimod

  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

  Day 1 and Month 2

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

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

  Day 1

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

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

  Month 2

• Accumulation index (AI) of cenerimod

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

  Between Day 1 and Month 2

• Change from baseline in total blood lymphocyte count

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

  Baseline to Month 12

• Number of participants with treatment-emergent medically relevant ECG abnormalities

  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.

  Baseline to Month 12

• Number of participants with treatment-emergent marked laboratory abnormalities

  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.

  Baseline to Month 12

Other Outcomes (6)

• Proportion of participants achieving Systemic Lupus Erythematosus Responder Index 4 (SRI-4) response

  Baseline to Month 12

• Proportion of participants achieving response on modified Systemic Lupus Erythematosus Disease Activity Index 2000 (mSLEDAI-2K)

  Baseline to Month 12

• Proportion of participants achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response

  Baseline to Month 12

Study Arms (1)

cenerimod

EXPERIMENTAL

cenerimod 4 mg once daily

Drug: cenerimod 4 mg

Interventions

cenerimod 4 mg DRUG

cenerimod 4 mg once daily for 12 months

cenerimod

Eligibility Criteria

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

You may qualify if:

• Signed and dated ICF prior to any study-mandated procedure.
• Male and female Chinese participants aged from 18 to 75 years old (inclusive) at the time of signing the ICF.
• Diagnosis of SLE made at least 6 months prior to Screening, according to 2019 European League Against Rheumatism / American College of Rheumatology Criteria.
• An mSLEDAI-2K score ≥ 6 and clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).
• PGA score ≥ 1.0 on a 0 to 3 VAS.
• Currently treated with one or more of the following SLE background medications:
• Antimalarials: (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine),
• Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤ 1.44 g/day),
• Azathioprine (≤ 2 mg/kg/day),
• Methotrexate (≤ 25 mg/week),
• Oral corticosteroid(s) (OCS):
• If OCS is the only SLE background medication:
• ≥ 7.5 mg/day and ≤ 30 mg/day prednisone or equivalent.
• If OCS is not the only SLE background medication:
• mg/day prednisone or equivalent.

You may not qualify if:

• Pregnant, planning to be become pregnant up to 6 months after the last dose of cenerimod in this study, or lactating women.
• Active severe SLE-driven renal disease (within 90 days prior to Screening or during Screening) where, in the judgment of the investigator, protocol-specified SLE background therapy is insufficient and the use of a more aggressive therapeutic approach or other treatments not permitted in the protocol is indicated.
• Urine protein/creatinine ratio\> 3000 mg/g (i.e., \> 339.45 mg/mmol) at Screening assessment based on central assessment.
• Severe active central nervous system lupus or active severe or unstable neuropsychiatric SLE including but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; or mononeuritis multiplex:
• That would make the participant unable to fully understand the ICF. or
• Where, in the opinion of the investigator/delegate, protocol-specified standard of care is insufficient and the use of a more aggressive therapeutic approach, such as adding i.v. cyclophosphamide and/or high dose i.v. pulse corticosteroid (CS) therapy or other treatments not permitted in the protocol is indicated.
• Severe forms of vasculitis (e.g., retinal vasculitis, coronary vasculitis, pulmonary vasculitis, mesenteric vasculitis) requiring systemic immunosuppressive treatment within 90 days prior to Screening or during Screening.
• A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with psoriasis, rheumatoid arthritis, erosive arthritis, scleroderma, autoimmune hepatitis, or uncontrolled autoimmune thyroid 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 (see Appendix 14) within 6 months prior to Screening.
• Resting HR \< 50 beats per minute as measured by the 12-lead ECG at Screening or at Day 1 prior to study treatment administration.
• An elevated QTcF interval of \> 470 ms (females) / \> 450 ms (males) at Screening or at Day 1 prior to study treatment administration.
• History or presence of severe respiratory disease or pulmonary fibrosis, based on medical history, lung function, and chest X-ray (or CT scan as per local guidelines), performed at Screening or within 6 months prior to Screening.
• History of clinically relevant bronchial asthma or chronic obstructive pulmonary disease that has required treatment with oral or parenteral CS for more than a total of 2 weeks within the last 6 months prior to Screening.
• Have had household contact with a person with active Tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB.

Sponsors & Collaborators

• Viatris Pharmaceuticals Co., Ltd.: lead

Study Sites (7)

The First Affiliated Hospital Of Jinan University

Guangzhou, Guangdong, 510630, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Jiujiang NO.1 peple's hospital

Jiujiang, Jiangxi, 332000, China

Location

First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330200, China

Location

Peking Union Medical College Hospital

Beijing, 100010, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

cenerimod

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 5, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): October 8, 2027
• Study Completion (Estimated): October 8, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (7)