A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease

Phase 1

• Conditions: Moderate to severe systemic lupus erythematosus; MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-001808-11-ES
• Lead Sponsor: Idorsia Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-16
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

- 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). The mSLEDAI-2K score does not take into account leukopenia”
- 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 (anti-dsDNA) antibodies with titre =30 IU/mL
- Women of childbearing potential (WOCBP):
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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 /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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified