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



Status:Recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:3/10/2019
Start Date:December 21, 2018
End Date:September 15, 2021
Contact:Clinical Trial Disclosure desk
Email:clinical-trials-disclosure@idorsia.com
Phone:+41 58 844 0000

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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)

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).

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.

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).

- 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

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
We found this trial at
20
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1255 Hillrise Circle
Las Cruces, New Mexico 88011
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2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
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Clearwater, Florida 33765
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Duncansville, Pennsylvania 16635
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Fort Lauderdale, Florida 33334
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Houston, TX
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Idaho Falls, Idaho 83404
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Las Vegas, Nevada 89128
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500 Medical Center Boulevard
Lawrenceville, Georgia 30045
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Memphis, Tennessee 38119
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Miami Lakes, Florida 33014
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Middleburg Heights, Ohio 44130
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Ormond Beach, Florida 32174
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Palm Desert, California 92260
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Plovdiv,
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San Antonio, Texas 78215
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Stafford, Texas 77477
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