Clinical Trials List
Protocol NumberID-064B301
NCT Number(ClinicalTrials.gov Identfier)NCT07201129
Not yet recruiting
2026-05-31 - 2030-06-30
Phase III
Not yet recruiting9
A Phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial evaluating the efficacy, safety, and tolerability of cenerimod in combination with background therapy in adult patients with systemic lupus erythematosus and active lupus nephritis.
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Trial Applicant
-
Sponsor
Novartis Taiwan Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/24
Investigators and Locations
Co-Principal Investigator
- 周昱百 無
- 程子珩 無
- Chien-Chih Lai 無
- 范乃文 無
- Yi-Syuan Sun 無
- 黎思源 無
- 歐朔銘 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Te-Chao Fang Division of Nephrology
- Hsi-Hsien Chen Division of Nephrology
- Tzn-Min Lin Division of Nephrology
- Yen-Chung Lin Division of Nephrology
- 陳靜怡 Division of Nephrology
- Chih-Chin Kao Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- YUNG-HO HSU Division of Nephrology
- 林冠宏 Division of Nephrology
- 賴史忠 Division of Nephrology
- Mei-Yi Wu Division of Nephrology
- Chia-Te Liao 無
- Li-Yee Hong Division of Nephrology
- 高芷華 Division of Nephrology
- Cai-Mei Zheng Division of Nephrology
- Yu-Wei Chen Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 王品逸 無
- Chia-Chun Tseng Division of Rheumatology
- 林憲忠 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
Yao-Fan Fang
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Nephritis and nephropathy not specified as acute or chronic, classified elsewhere | Systemic lupus erythematosus
Objectives
Primary Objective
• To evaluate the efficacy of cenerimod (once daily) versus placebo in achieving complete renal response (CRR) in participants with SLE and active lupus nephritis.
Secondary Objectives
• To evaluate the efficacy of cenerimod (once daily) versus placebo in achieving CRR while maintaining a low corticosteroid dose in participants with SLE and active lupus nephritis.
• To evaluate the efficacy of cenerimod (once daily) versus placebo in achieving sustained CRR in participants with SLE and active lupus nephritis (LN).
Test Drug
Cenerimod
Active Ingredient
Cenerimod
Dosage Form
tablet
Dosage
4mg
Endpoints
Week 76 CRR, defined as (both criteria must be met):
• UPCR ≤ 0.5 mg/mg
and
• eGFR decline from baseline < 20%
• UPCR ≤ 0.5 mg/mg
and
• eGFR decline from baseline < 20%
Inclution Criteria
1. Sign and date the Informed Consent Form (ICF) prior to any study-mandated procedures.
2. Male or female patients aged 18 to 75 years (inclusive) at the time of signing the informed consent.
3. Classified as having systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR criteria.
4. Renal biopsy within 6 months prior to the screening visit showing active Class III or IV glomerulonephritis (with or without concurrent Class V features) or isolated Class V membranous LN. If a biopsy was not performed within 6 months prior to screening, it will be performed during the screening period after confirming all other inclusion/exclusion criteria.
5. Active renal disease defined as: urine protein/creatinine ratio ≥ 1 mg/mg, assessed via 24-hour urine collection.
6. eGFR (estimated glomerular filtration rate) ≥ 15 mL/min/1.73 m².
To enroll participants with an eGFR ≥ 15 and < 30 mL/min/1.73 m², the following are required:
Renal biopsy during screening shows ≤ 50% sclerotic glomeruli;
Activity Index ≥ 2 and Chronicity Index < 4, based on the 2018 NIH Activity and Chronicity Indices. The renal biopsy used for index assessment must have been obtained within 6 months prior to screening, and the indices must be confirmed by a renal pathologist.
7. Initiation of induction therapy, including the following background therapy:
a) At randomization: MMF (mycophenolate mofetil) 1–3 g/day orally, or MPS (mycophenolate sodium) 720–2160 mg/day orally. This treatment may be administered prior to screening or initiated at the time of screening.
b) Corticosteroids: 1 to 3 intravenous (i.v.) pulses of methylprednisolone at a dose of 250 to 1000 mg/pulse/day (maximum cumulative dose of 3000 mg), followed by oral prednisone (or equivalent) at 0.5 mg/kg/day, up to a maximum of 40 mg/day. Pulses may be administered during screening or within the 2 weeks prior to screening. Participants unable to receive pulse i.v. corticosteroid therapy should initiate oral prednisone (or equivalent) directly at 0.8–1.0 mg/kg/day (maximum 80 mg/day) during the same timeframe as the i.v. pulses.
7. Participants of childbearing potential must agree to:
• Use a highly effective method of contraception starting from the first visit and continuing for at least 24 weeks after the cessation of the study intervention.
• Undergo monthly urine pregnancy testing during the study and for at least 24 weeks after the cessation of the study intervention.
2. Male or female patients aged 18 to 75 years (inclusive) at the time of signing the informed consent.
3. Classified as having systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR criteria.
4. Renal biopsy within 6 months prior to the screening visit showing active Class III or IV glomerulonephritis (with or without concurrent Class V features) or isolated Class V membranous LN. If a biopsy was not performed within 6 months prior to screening, it will be performed during the screening period after confirming all other inclusion/exclusion criteria.
5. Active renal disease defined as: urine protein/creatinine ratio ≥ 1 mg/mg, assessed via 24-hour urine collection.
6. eGFR (estimated glomerular filtration rate) ≥ 15 mL/min/1.73 m².
To enroll participants with an eGFR ≥ 15 and < 30 mL/min/1.73 m², the following are required:
Renal biopsy during screening shows ≤ 50% sclerotic glomeruli;
Activity Index ≥ 2 and Chronicity Index < 4, based on the 2018 NIH Activity and Chronicity Indices. The renal biopsy used for index assessment must have been obtained within 6 months prior to screening, and the indices must be confirmed by a renal pathologist.
7. Initiation of induction therapy, including the following background therapy:
a) At randomization: MMF (mycophenolate mofetil) 1–3 g/day orally, or MPS (mycophenolate sodium) 720–2160 mg/day orally. This treatment may be administered prior to screening or initiated at the time of screening.
b) Corticosteroids: 1 to 3 intravenous (i.v.) pulses of methylprednisolone at a dose of 250 to 1000 mg/pulse/day (maximum cumulative dose of 3000 mg), followed by oral prednisone (or equivalent) at 0.5 mg/kg/day, up to a maximum of 40 mg/day. Pulses may be administered during screening or within the 2 weeks prior to screening. Participants unable to receive pulse i.v. corticosteroid therapy should initiate oral prednisone (or equivalent) directly at 0.8–1.0 mg/kg/day (maximum 80 mg/day) during the same timeframe as the i.v. pulses.
7. Participants of childbearing potential must agree to:
• Use a highly effective method of contraception starting from the first visit and continuing for at least 24 weeks after the cessation of the study intervention.
• Undergo monthly urine pregnancy testing during the study and for at least 24 weeks after the cessation of the study intervention.
Exclusion Criteria
1. Participants with a confirmed pregnancy (via serum pregnancy test at Visit 1 or urine/serum pregnancy test at Visit 2) or those planning to become pregnant.
2. Participants who are breastfeeding.
3. Severe active central nervous system (CNS) lupus, including but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelinating syndrome; acute confusional state; altered level of consciousness; psychosis; acute stroke; cranial neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis multiplex.
...resulting in the participant's inability to fully understand the Informed Consent Form (ICF).
OR
...determined by the Investigator/authorized personnel that the standard of care specified in the protocol is insufficient for treatment, or that more aggressive treatment is required (e.g., addition of i.v. cyclophosphamide and/or high-dose i.v. pulse corticosteroid therapy, or other treatments not permitted by the protocol).
4. History or presence of renal disease (other than LN) that the Investigator considers likely to interfere with LN assessment results or confound the assessment of disease activity.
5. Severe renal impairment, defined as oliguria (confirmed urine output < 400 mL/24 h) or end-stage renal disease requiring dialysis or kidney transplantation.
Cardiovascular
6. History or presence of Mobitz Type II or third-degree atrioventricular (AV) block, sick sinus syndrome, symptomatic bradycardia, or syncope associated with cardiac disease.
7. Participants who have experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure classified as NYHA Class III or IV within 6 months prior to screening.
8. Resting heart rate (HR) < 50 bpm measured by 12-lead ECG at screening or randomization. 9. QTcF interval prolongation > 470 ms (females) / > 450 ms (males) at screening or randomization.
Pulmonary
10. History of severe respiratory disease or pulmonary fibrosis, based on medical history, pulmonary function tests, and chest X-ray (or CT scan, if substituted per local guidelines) performed at screening or within the 6 months prior to screening.
11. Clinically significant bronchial asthma or chronic obstructive pulmonary disease (COPD) requiring treatment with oral or parenteral corticosteroids for a total duration of more than 2 weeks within the 6 months prior to screening.
Infection and Infection Risk
12. Meets any of the following TB criteria:
Diagnosis of active TB at screening or within the 6 months prior to screening, unless documented evidence exists that the participant has been successfully treated (treatment completed in accordance with national policy or the latest World Health Organization [WHO] guidelines).
Diagnosis of latent TB at screening or within the 6 months prior to screening, unless documented evidence exists that the participant has been successfully treated (treatment completed in accordance with national policy or the latest WHO guidelines) or has completed one month of prophylactic treatment in accordance with the same guidelines.
13. Current bacterial, viral, parasitic, or fungal infection considered clinically concerning by the investigator, or a history of any of the following:
Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to screening.
Any infection requiring hospitalization or treatment with intravenous (i.v.) anti-infective medication that was not completed at least 4 weeks prior to screening.
14. Positive serological markers for Hepatitis A, B, C, or E indicating acute or chronic infection:
Anti-Hepatitis A virus (HAV) immunoglobulin M (IgM).
Hepatitis B surface antigen. Anti-hepatitis C virus (HCV) IgG or IgM (if positive for IgM and/or IgG, confirmation via HCV-RNA polymerase chain reaction [PCR] is required; if this assessment is negative, the participant may undergo randomization).
Anti-hepatitis E virus (HEV) IgG or IgM (if positive for IgM and/or IgG, confirmation via HEV-RNA polymerase chain reaction [PCR] is required; if this assessment is negative, the participant may undergo randomization).
15. Participants who test positive for HIV or have any other congenital or acquired immunodeficiency.
16. Negative test result for varicella-zoster virus (chickenpox) antibodies.
Malignancy
17. History or current presence of malignancy (excluding surgically resected, non-recurrent basal cell carcinoma, squamous cell carcinoma, or cervical cancer) or lymphoproliferative disease; or receipt of total lymphoid irradiation within 10 years prior to screening.
Transplantation
18. History or current status of allogeneic bone marrow or solid organ transplantation.
Ophthalmologic
19. Presence of any of the following, as assessed by the study site ophthalmologist during the ophthalmologic evaluation and/or detected via OCT:
Macular edema of any etiology: diabetic, cystoid, or tractional.
Foveal abnormalities: macular hole, macular pseudohole, or hereditary/degenerative maculopathy.
Active uveitis or papilledema.
Retinal neovascularization of any etiology or location.
Metabolic
20. Poorly controlled diabetes (i.e., HbA1c > 8.0% at screening as reported by the central laboratory, or unstable glycemic control/poor treatment adherence as determined by the investigator), or diabetes with organ involvement (e.g., diabetic nephropathy or retinopathy) as assessed by the investigator. Liver
21. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN), or total bilirubin (TBIL) >1.5 times the ULN; or participants with a history of chronic hepatobiliary disease (excluding Gilbert's syndrome).
Hematology
22. Significant hematologic abnormalities at screening assessment:
Lymphocyte count < 500/μL (0.5 x 10⁹/L);
Hemoglobin < 7 g/dL;
White blood cell count < 1500/μL (1.5 x 10⁹/L); or
Platelets < 25,000/μL (25 x 10⁹/L).
Medications
23. Treatment with the following medications within 15 days or 5 drug half-lives (whichever is longer) prior to randomization:
Beta-blockers, diltiazem, verapamil, digoxin, digitoxin, or any other systemic therapy for anti-arrhythmia or heart rate (HR) reduction.
QT-prolonging drugs or drugs known to carry a risk of polymorphic ventricular tachycardia, regardless of indication.
24. Treatment with the following Breast Cancer Resistance Protein (BCRP) inhibitors within 5 drug half-lives prior to randomization: curcumin, eltrombopag, elacridar, gefitinib, and teriflunomide.
25. Treatment with the following medications within 5 drug half-lives prior to randomization:
• Cyclosporine, voclosporin, tacrolimus, sirolimus, cyclophosphamide.
• Administration of live vaccines.
26. Treatment with the following medications within 90 days prior to randomization:
• Leflunomide.
• Intravenous (i.v.) immunoglobulin.
• Methotrexate.
• Tyrosine kinase inhibitors. 27. Treatment with any investigational drug within 90 days prior to randomization.
28. Treatment with anifrolumab within 6 months prior to randomization.
29. Treatment with biological immunosuppressants (e.g., anti-TNF, anti-IL1, or anti-IL6 therapies) within 90 days prior to randomization.
30. Treatment with B-cell depleting biologics (e.g., rituximab, obinutuzumab, or ocrelizumab) within 12 months prior to randomization.
31. Treatment with any of the following drugs at any time prior to screening:
• Alemtuzumab.
• Sphingosine-1-phosphate receptor modulators (e.g., fingolimod).
• Participants previously randomized to cenerimod or placebo in any trial involving cenerimod.
Other categories
32. Recent clinically significant drug or alcohol abuse, in the opinion of the investigator.
33. Known hypersensitivity to sphingosine-1-phosphate receptor modulators or any excipients of the cenerimod formulation.
34. Any clinically significant medical condition that would place the participant at risk during the trial, or any other disease that might interfere with the assessment of disease activity.
35. Participants weighing < 40 kg at screening or randomization.
2. Participants who are breastfeeding.
3. Severe active central nervous system (CNS) lupus, including but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelinating syndrome; acute confusional state; altered level of consciousness; psychosis; acute stroke; cranial neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis multiplex.
...resulting in the participant's inability to fully understand the Informed Consent Form (ICF).
OR
...determined by the Investigator/authorized personnel that the standard of care specified in the protocol is insufficient for treatment, or that more aggressive treatment is required (e.g., addition of i.v. cyclophosphamide and/or high-dose i.v. pulse corticosteroid therapy, or other treatments not permitted by the protocol).
4. History or presence of renal disease (other than LN) that the Investigator considers likely to interfere with LN assessment results or confound the assessment of disease activity.
5. Severe renal impairment, defined as oliguria (confirmed urine output < 400 mL/24 h) or end-stage renal disease requiring dialysis or kidney transplantation.
Cardiovascular
6. History or presence of Mobitz Type II or third-degree atrioventricular (AV) block, sick sinus syndrome, symptomatic bradycardia, or syncope associated with cardiac disease.
7. Participants who have experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure classified as NYHA Class III or IV within 6 months prior to screening.
8. Resting heart rate (HR) < 50 bpm measured by 12-lead ECG at screening or randomization. 9. QTcF interval prolongation > 470 ms (females) / > 450 ms (males) at screening or randomization.
Pulmonary
10. History of severe respiratory disease or pulmonary fibrosis, based on medical history, pulmonary function tests, and chest X-ray (or CT scan, if substituted per local guidelines) performed at screening or within the 6 months prior to screening.
11. Clinically significant bronchial asthma or chronic obstructive pulmonary disease (COPD) requiring treatment with oral or parenteral corticosteroids for a total duration of more than 2 weeks within the 6 months prior to screening.
Infection and Infection Risk
12. Meets any of the following TB criteria:
Diagnosis of active TB at screening or within the 6 months prior to screening, unless documented evidence exists that the participant has been successfully treated (treatment completed in accordance with national policy or the latest World Health Organization [WHO] guidelines).
Diagnosis of latent TB at screening or within the 6 months prior to screening, unless documented evidence exists that the participant has been successfully treated (treatment completed in accordance with national policy or the latest WHO guidelines) or has completed one month of prophylactic treatment in accordance with the same guidelines.
13. Current bacterial, viral, parasitic, or fungal infection considered clinically concerning by the investigator, or a history of any of the following:
Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to screening.
Any infection requiring hospitalization or treatment with intravenous (i.v.) anti-infective medication that was not completed at least 4 weeks prior to screening.
14. Positive serological markers for Hepatitis A, B, C, or E indicating acute or chronic infection:
Anti-Hepatitis A virus (HAV) immunoglobulin M (IgM).
Hepatitis B surface antigen. Anti-hepatitis C virus (HCV) IgG or IgM (if positive for IgM and/or IgG, confirmation via HCV-RNA polymerase chain reaction [PCR] is required; if this assessment is negative, the participant may undergo randomization).
Anti-hepatitis E virus (HEV) IgG or IgM (if positive for IgM and/or IgG, confirmation via HEV-RNA polymerase chain reaction [PCR] is required; if this assessment is negative, the participant may undergo randomization).
15. Participants who test positive for HIV or have any other congenital or acquired immunodeficiency.
16. Negative test result for varicella-zoster virus (chickenpox) antibodies.
Malignancy
17. History or current presence of malignancy (excluding surgically resected, non-recurrent basal cell carcinoma, squamous cell carcinoma, or cervical cancer) or lymphoproliferative disease; or receipt of total lymphoid irradiation within 10 years prior to screening.
Transplantation
18. History or current status of allogeneic bone marrow or solid organ transplantation.
Ophthalmologic
19. Presence of any of the following, as assessed by the study site ophthalmologist during the ophthalmologic evaluation and/or detected via OCT:
Macular edema of any etiology: diabetic, cystoid, or tractional.
Foveal abnormalities: macular hole, macular pseudohole, or hereditary/degenerative maculopathy.
Active uveitis or papilledema.
Retinal neovascularization of any etiology or location.
Metabolic
20. Poorly controlled diabetes (i.e., HbA1c > 8.0% at screening as reported by the central laboratory, or unstable glycemic control/poor treatment adherence as determined by the investigator), or diabetes with organ involvement (e.g., diabetic nephropathy or retinopathy) as assessed by the investigator. Liver
21. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN), or total bilirubin (TBIL) >1.5 times the ULN; or participants with a history of chronic hepatobiliary disease (excluding Gilbert's syndrome).
Hematology
22. Significant hematologic abnormalities at screening assessment:
Lymphocyte count < 500/μL (0.5 x 10⁹/L);
Hemoglobin < 7 g/dL;
White blood cell count < 1500/μL (1.5 x 10⁹/L); or
Platelets < 25,000/μL (25 x 10⁹/L).
Medications
23. Treatment with the following medications within 15 days or 5 drug half-lives (whichever is longer) prior to randomization:
Beta-blockers, diltiazem, verapamil, digoxin, digitoxin, or any other systemic therapy for anti-arrhythmia or heart rate (HR) reduction.
QT-prolonging drugs or drugs known to carry a risk of polymorphic ventricular tachycardia, regardless of indication.
24. Treatment with the following Breast Cancer Resistance Protein (BCRP) inhibitors within 5 drug half-lives prior to randomization: curcumin, eltrombopag, elacridar, gefitinib, and teriflunomide.
25. Treatment with the following medications within 5 drug half-lives prior to randomization:
• Cyclosporine, voclosporin, tacrolimus, sirolimus, cyclophosphamide.
• Administration of live vaccines.
26. Treatment with the following medications within 90 days prior to randomization:
• Leflunomide.
• Intravenous (i.v.) immunoglobulin.
• Methotrexate.
• Tyrosine kinase inhibitors. 27. Treatment with any investigational drug within 90 days prior to randomization.
28. Treatment with anifrolumab within 6 months prior to randomization.
29. Treatment with biological immunosuppressants (e.g., anti-TNF, anti-IL1, or anti-IL6 therapies) within 90 days prior to randomization.
30. Treatment with B-cell depleting biologics (e.g., rituximab, obinutuzumab, or ocrelizumab) within 12 months prior to randomization.
31. Treatment with any of the following drugs at any time prior to screening:
• Alemtuzumab.
• Sphingosine-1-phosphate receptor modulators (e.g., fingolimod).
• Participants previously randomized to cenerimod or placebo in any trial involving cenerimod.
Other categories
32. Recent clinically significant drug or alcohol abuse, in the opinion of the investigator.
33. Known hypersensitivity to sphingosine-1-phosphate receptor modulators or any excipients of the cenerimod formulation.
34. Any clinically significant medical condition that would place the participant at risk during the trial, or any other disease that might interfere with the assessment of disease activity.
35. Participants weighing < 40 kg at screening or randomization.
The Estimated Number of Participants
-
Taiwan
30 participants
-
Global
300 participants
