Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2023
• Main ID: NCT03742037
• Date of registration: 12/11/2018
• Prospective Registration: Yes
• Primary sponsor: Idorsia Pharmaceuticals Ltd.
• Public title: Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
• Scientific title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: December 21, 2018
• Target sample size: 427
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03742037
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Chile, Czechia, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Japan, Lithuania, Mexico, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: ClinicalTrials
• Affiliation: Idorsia Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed Informed Consent Form prior to any study-mandated procedure

- Diagnosis of SLE made at least 6 months prior to Screening, by fulfilling at least 4
of the 11 criteria for SLE as defined by the American College of Rheumatology (ACR)
criteria

- A mSLEDAI-2K score = 6 of at least 2 points for musculoskeletal or mucocutaneous
manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).

- Currently treated with stable doses of one or more of the following background
medications:

- NSAIDs

- Anti-malarials (= 400 mg/day hydroxychloroquine, = 500 mg/day chloroquine, = 100
mg/day quinacrine)

- Mycophenolate mofetil (= 2 g/day)

- Mycophenolic acid (= 1440 mg/day)

- Azathioprine (= 2 mg/kg/day)

- Methotrexate (= 20 mg/week)

- Corticosteroids (= 40 mg/day prednisone or equivalent)

- Belimumab (=10 mg/kg every 4 weeks intravenously, or 200 mg/week subcutaneously).

- History or presence of positive autoantibodies measured by central laboratory defined
as follows: (a) Positive antinuclear antibody (ANA) test measured by
immunofluorescence assay (IFA) with titre =1:80; AND/OR (b) positive anti-double
stranded deoxyribonucleic acid (anti-dsDNA) antibodies with titre =30 IU/mL

- Women of childbearing potential:

- Must have a negative serum pregnancy test at Screening

- Must agree to undertake monthly urine pregnancy tests during the study

- Must use highly effective methods of contraception from the screening visit until
6 months after taking the last dose of study treatment.

Exclusion Criteria:

- Active lupus nephritis or a renal biopsy demonstrating immune complex mediated
glomerulonephritis compatible with lupus nephritis.

- CNS (Central Nervous System) lupus and severe forms of vasculitis requiring systemic
immunosuppressive treatment

- A diagnosis of mixed connective tissue disease or any history of overlap syndromes of
SLE with rheumatoid arthritis, erosive arthritis, scleroderma or autoimmune hepatitis

- History or presence of Mobitz type II or third-degree atrioventricular block, sick
sinus syndrome, symptomatic bradycardia or syncope associated with cardiac disorders

- Subjects 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 six months prior to Screening

- An elevated QT corrected for HR (Heart Rate) on the basis of Fridericia's formula
interval of > 470 ms (females) / > 450 ms (males)

- History or presence of severe respiratory disease or pulmonary fibrosis

- Active or latent tuberculosis

- Ongoing bacterial, viral or fungal infection that is of clinical concern in the
judgment of the investigator or history of any serious infection

- Subjects who have congenital or acquired severe immunodeficiency or known HIV
infection or positive HIV testing

- Presence of macular edema or active uveitis

- Type 1 or 2 diabetes that is poorly controlled according to investigator judgment, or
diabetes complicated with organ involvement such as diabetic nephropathy or
retinopathy

- Significant hematology abnormality: Lymphocyte count < 800 /µL (0.8 × 10e9/L);
hemoglobin < 9 g/dL; WBC (White Blood Cell) count < 2500/µL (2.5 × 10e9/L) or
platelets < 75000/µL (75 × 10e9/L)

- Estimated glomerular filtration rate < 60 mL/min/1.73 m2

- Known allergy to S1P (sphingosine-1-phosphate) receptor modulators or any of the
cenerimod formulation excipients



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Cenerimod 1 mg

Drug: Cenerimod 0.5 mg

Drug: Placebo

Drug: Cenerimod 2 mg

Drug: cenerimod 2 mg (ex-4 mg)

Drug: Cenerimod 4 mg

Primary Outcome(s)

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

Secondary Outcome(s)

British Isles Lupus Assessment Group-2004 (BILAG) Disease Activity Index Response at Month 6 [Time Frame: Baseline (Day 1) and Month 6]

Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 6 as Compared to Baseline [Time Frame: Baseline (Day 1) and Month 6]

Secondary ID(s)

ID-064A202

2018-001808-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/09/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03742037