Phase 2 double blind study of cenerimod

• Register: JPRN
• Last refreshed on: 1 April 2024
• Main ID: JPRN-jRCT2011210019
• Date of registration: 30/06/2021
• Prospective Registration: Yes
• Primary sponsor: Yokoyama Yoshinari
• Public title: Phase 2 double blind study of cenerimod
• Scientific title: A randomized, double-blind, parallel-group, multicenter, phase 2 study to investigate the safety and PD of cenerimod in Japanese subjects with moderate to severe systemic lupus erythematosus (SLE)
• Date of first enrolment: 06/11/2021
• Target sample size: 16
• Recruitment status: Complete
• URL: https://jrct.niph.go.jp/latest-detail/jRCT2011210019
• Study type: Interventional
• Study design: randomized controlled trial, double blind, dose comparison control, parallel assignment, treatment purpose
• Phase: 2

Contacts

• Name: Yoshinari Yokoyama
• Affiliation: Idorsia Pharmaceuticals Japan Ltd

• Name: Yoshinari Yokoyama
• Affiliation: Idorsia Pharmaceuticals Japan Ltd

Key inclusion & exclusion criteria

Inclusion 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.
Exclusion 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.

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

Health Condition(s) or Problem(s) studied

Systemic lupus erythematosus

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

Primary Outcome(s)

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(s)

Change from baseline to each post-baseline assessment up to EOS in total lymphocyte count

Ethics review

Status: Approval
Approval date:
Contact:

[e-mail]

Hokkaido University Hospital Institutional Review Board

[phone]

[e-mail]

Results

• Results available: Yes
• Date Completed: 16/02/2023