Summary

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

Description

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).

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)

Details

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.

Keywords

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

Eligibility

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

Locations

  • 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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Idorsia Pharmaceuticals Ltd.
ID
NCT03742037
Phase
Phase 2
Study Type
Interventional
Last Updated