Phase 2 double blind study of cenerimod

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011210019

Enrollment

Registered

2021-06-30

Start date

2021-11-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Change from baseline to each post-baseline assessment up to EOS in total lymphocyte count	—

Contacts

Public ContactYoshinari Yokoyama

Idorsia Pharmaceuticals Japan Ltd

chiken.info-jp@idorsia.com+81-03-5962-5616

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026