Clinical Trials List
2023-06-16 - 2026-07-31
Phase III
Not yet recruiting1
Recruiting10
ICD-10M32.0
Drug-induced systemic lupus erythematosus
ICD-10M32.10
Systemic lupus erythematosus, organ or system involvement unspecified
ICD-10M32.11
Endocarditis in systemic lupus erythematosus
ICD-10M32.12
Pericarditis in systemic lupus erythematosus
ICD-10M32.13
Lung involvement in systemic lupus erythematosus
ICD-10M32.14
Glomerular disease in systemic lupus erythematosus
ICD-10M32.15
Tubulo-interstitial nephropathy in systemic lupus erythematosus
ICD-10M32.19
Other organ or system involvement in systemic lupus erythematosus
ICD-10M32.8
Other forms of systemic lupus erythematosus
ICD-10M32.9
Systemic lupus erythematosus, unspecified
ICD-9710.0
Systemic lupus erythematosus
A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel- group study to evaluate the efficacy, safety, and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy
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Trial Applicant
-
Sponsor
Idorsia Pharmaceuticals Ltd
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
- 黃建中 風濕免疫科
- 張詩欣 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 郭佑民 Division of General Internal Medicine
- TSO-TING LAI Division of General Internal Medicine
- SONG-CHOU HSIEH Division of General Internal Medicine
- 鄭喬峰 Division of General Internal Medicine
- 呂政勳 Division of General Internal Medicine
- CHIEH-YU SHEN Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ping-Han Tsai Division of Rheumatology
- 陳彥輔 Division of Rheumatology
- Shue-Fen Lo Division of Rheumatology
- Yih-Shiou Hwang Division of Rheumatology
- 張哲慈 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 歐燦騰 風濕免疫科
- Jeng-Hsien Yen 風濕免疫科
- Chia-Chun Tseng 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- De-Kuang Hwang 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• Response on Response on Systemic Lupus Erythematosus
Responder Index 4 (SRI-4) at Month 12 compared to baseline,
defined as meeting all of the following criteria:
– Reduction from baseline of at least 4 points in the
modified Systemic Lupus Erythematosus Disease
Activity Index-2000 (mSLEDAI-2K; i.e., based on the
SLEDAI-2K, modified to exclude leukopenia).
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
Inclution Criteria
2. Male and female subjects aged from 18 (or higher if the local
age of consent is greater) to 75 years old (inclusive) at the
time of signing the ICF.
3. Diagnosis of SLE made at least 6 months prior to Screening,
according to 2019 European League Against Rheumatism /
American College of Rheumatology Criteria.
4. 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).
Note: The mSLEDAI-2K score does not include
“leukopenia”. The clinical mSLEDAI-2K is the
mSLEDAI-2K assessment score without the inclusion of
points attributable to hematuria, proteinuria, pyuria, urinary
casts, low complement, increased DNA binding, and
thrombocytopenia.
Exclusion Criteria
1. Pregnant, planning to be become pregnant up to FSV, or
lactating women.
SLE and other immune diseases
2. 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.
3. Urine protein/creatinine ratio > 3000 mg/g (i.e.,
> 339.45 mg/mmol) at screening assessment based on central
assessment.
4. 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 subject 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.
5. 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.
6. A diagnosis of mixed connective tissue disease or any history
of overlap syndromes of SLE with psoriasis, rheumatoid
The Estimated Number of Participants
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Taiwan
27 participants
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Global
420 participants
