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

  • STATUS
    Recruiting
  • End date
    Sep 15, 2021
  • participants needed
    500
  • sponsor
    Idorsia Pharmaceuticals Ltd.
Updated on 2 December 2020
corticosteroids
methotrexate
prednisone
myositis
hydroxychloroquine
nsaids
arthritis
azathioprine
lupus
rash
mycophenolate
chloroquine
antinuclear antibody
belimumab
antimalarials
quinacrine

Summary

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).

Description

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.

Details
Treatment Placebo, Cenerimod 0.5 mg, Cenerimod 1 mg, Cenerimod 2 mg, Cenerimod 4 mg
Clinical Study IdentifierNCT03742037
SponsorIdorsia Pharmaceuticals Ltd.
Last Modified on2 December 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: CONNECTIVE TISSUE DISEASE or Autoimmune disease or Dermatomyositis (Connective Tissue Disease) or SYSTEMIC LUPUS ERYTHEMATOSUS or Connective Tissue Di...?
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)
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 (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

Exclusion Criteria

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 /L (0.8 10e9/L); hemoglobin < 9 g/dL; WBC count < 2500/L (2.5 10e9/L) or platelets < 75000/L (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
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