for people ages 18-75 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:



The purpose of the study is to assess the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with systemic lupus erythematosus (SLE).

Official 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)


This is a Phase 2b, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 4 doses of cenerimod versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

Approximately 500 adult subjects with SLE will be randomized in a 1:1:1:1:1 ratio to placebo, 0.5, 1, 2, or 4 mg o.d. of cenerimod, in addition to background SLE therapy.


Systemic Lupus Erythematosus Musculoskeletal and connective tissue disorders Lupus Erythematosus, Systemic Cenerimod 0.5 mg Cenerimod 1 mg Cenerimod 2 mg Cenerimod 4 mg


You can join if…

Open to people ages 18-75

  • Signed ICF 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)
  • Azathioprine (≤ 2 mg/kg/day)
  • Methotrexate (≤ 20 mg/week)
  • Corticosteroids (≤ 40 mg/day prednisone or equivalent)
  • Belimumab (≤10 mg/kg every 4 weeks)
  • 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 (antidsDNA) 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 4 months after taking the last dose of study treatment

You CAN'T join if...

  • Active lupus nephritis or a renal biopsy demonstrating immune complex mediated glomerulonephritis compatible with lupus nephritis.
  • CNS 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 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 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 receptor modulators or any of the cenerimod formulation excipients


  • University of California San Diego not yet accepting patients
    La Jolla California 92037 United States
  • Desert Medical Advances not yet accepting patients
    Palm Desert California 92260 United States


accepting new patients
Start Date
Completion Date
Idorsia Pharmaceuticals Ltd.
Phase 2
Study Type
Last Updated