A Phase 3, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy

Primary Objective

Primary objective is to evaluate the effectiveness of cenerimod 4mg at reducing disease activity compared to placebo. The secondary objective is to evaluate the effect of cenerimod 4mg to control the disease compared to placebo. The safety objective is to evaluate the safety and tolerability of cenerimod 4mg.

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Description

The study comprises of screening period that lasts upto 60 days and ends with the participant's randomization, the treatment period starts with the administration of first dose of study drug and lasts 12 months. Participants who complete the treatment period will be offered to enter a 12 month long open label extension period where they will receive cenerimod 4mg.

Details
Age
Adult
Eligibility
All Male or female aged 18 to 75 years old with diagnosis of Systemic Lupus Erythematosus for at least 6 months are eligible. A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with psoriasis, rheumatoid arthritis, erosive arthritis, scleroderma, autoimmune hepatitis or uncontrolled autoimmune thyroid disease is excluded.Inclusion: A modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score ≥ 6 and clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers). The mSLEDAI-2K score does not include "leukopenia". British Isles Lupus Assessment Group-2004 (BILAG) Grade B in ≥ 2 organ systems or a BILAG Grade A in ≥ 1 organ system. Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 visual analog scale. Currently treated with one or more of the following SLE background medications: Anti-malarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine). Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤1.44 g/day). Azathioprine (≤ 2 mg/kg/day). Methotrexate (≤ 25 mg/week). Oral Corticosteroids (OCS): if OCS is the only SLE background medication: ≥ 7.5 mg/day and ≤ 30 mg/day prednisone or equivalent. if OCS is not the only SLE background medication: ≤ 30 mg/day prednisone or equivalent. Belimumab (≤10 mg/kg every 4 weeks intravenously [i.v.], or 200 mg/week subcutaneously [s.c.]). Treatment with antimalarials, mycophenolate mofetil, mycophenolic acid, azathioprine, methotrexate or belimumab must have been started at least 90 days prior to Screening. Treatment with OCS must have been started at least 30 days prior to Screening. • For women of childbearing potential (WoCBP): Negative serum pregnancy test at Screening. Agreement to undertake monthly urine pregnancy tests from Randomization up to 6 months after study treatment discontinuation. Agreement to use a highly effective method of contraception from Screening (Visit 1) up to 6 months after study treatment discontinuation. Inclusion criteria at randomization: A clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers). BILAG Grade B in 2 or more organ systems or a BILAG Grade A in 1 or more organ system. PGA score ≥ 1.0 on a 0 to 3 visual analog scale. Presence of at least one of the following biomarkers of serological evidence of active SLE (in a Screening sample as measured by central laboratory): Anti-dsDNA antibodies elevated above normal, Antinuclear antibodies with a titer of at least 1:160, Anti-Smith antibody elevated above normal. Currently treated with one or more of the following SLE background medications that must be stable for at least 30 days prior to Randomization (except OCS, which must be stable for at least 15 days prior to Randomization): Antimalarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine); Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤ 1.44g/day); Azathioprine (≤ 2 mg/kg/day); Methotrexate (≤ 25 mg/week); OCS: if OCS is the only SLE background medication: ≥ 7.5 mg/day and ≤ 30 mg/day prednisone or equivalent. if OCS is not the only SLE background medication: ≤ 30 mg/day prednisone or equivalent. Belimumab (≤ 10 mg/kg every 4 weeks i.v. or ≤ 200 mg/week s.c.).
Locations

University of Colorado Hospital

Principal Investigator
Photograph of Christopher Striebich

Christopher Striebich

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