Phase 2 double blind study of cenerimod

JRCT ID: jRCT2011210019

Registered date:30/06/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Systemic lupus erythematosus
• Date of first enrollment: 06/11/2021
• Target sample size: 16
• Study type: Interventional
• Intervention(s): Administration of two doses of cenerimod (2 and 4 mg) given orally once daily for 3 months in adult subjects with moderate to severe SLE concurrently receiving SLE background treatment

Outcome(s)

Primary Outcome

Occurrence of treatment-emergent AEs/SAEs, and AEs of following special interest:
HR and rhythm-related AEs
Hypotension-related AEs
Hypertension-related AEs
etc.

• Secondary Outcome: Change from baseline to each post-baseline assessment up to EOS in total lymphocyte count

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

(1) Signed ICF prior to any study-mandated procedure.
(2) 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.
(3) Male and female subjects, age 18 to 75 years old (both inclusive).
(4) A mSLEDAI-2K score >= 6 of at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).
Note: The mSLEDAI-2K score does not consider the factor leukopenia in SLEDAI-2K.

Exclude criteria

(1) Female subjects who are lactating or planning to become pregnant during the study.
(2) Active lupus nephritis (defined by proteinuria > 1.5 g/24 h, or equivalent using spot urine protein-to-creatinine ratio > 150 mg/mmol) or a renal biopsy demonstrating immune complex-mediated glomerulonephritis compatible with lupus nephritis within 90 days prior to Screening.
(3) Severe active central nervous system (CNS) lupus requiring therapeutic intervention (including aseptic meningitis, seizures, psychosis, cerebritis, cerebrovascular accident [CVA], organic brain syndrome, CNS vasculitis)
(4) Severe forms of vasculitis requiring systemic immunosuppressive treatment (including retinal vasculitis, coronary vasculitis, pulmonary vasculitis, mesenteric vasculitis) within 90 days prior to Screening.
(5) A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with rheumatoid arthritis, erosive arthritis, scleroderma or autoimmune hepatitis.

Related Information

• Primary Sponsor: Yokoyama Yoshinari