A Phase 3, multicenter, open-label, single-arm, extension study to evaluate the long-term safety and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy (OPUS OLE)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514354-67-00

Acronym

ID-064A303

Enrollment

172

Registered

2024-09-20

Start date

2024-11-01

Completion date

Unknown

Last updated

2026-01-09

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

Conditions

Systemic lupus erythematosus

Brief summary

Occurrence of treatment-emergent adverse events up to the final study visit., Occurrence of serious adverse events up to the final study visit., Occurrence of adverse events of special interest (i.e., anticipated risks of treatment with cenerimod, known class effects, and events that may be related to systemic lupus erythematosus comorbidities) up to the final study visit.

Interventions

DRUGCenerimod 4 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of treatment-emergent adverse events up to the final study visit., Occurrence of serious adverse events up to the final study visit., Occurrence of adverse events of special interest (i.e., anticipated risks of treatment with cenerimod, known class effects, and events that may be related to systemic lupus erythematosus comorbidities) up to the final study visit.	—

Countries

Bulgaria, Czechia, France, Germany, Greece, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026