LSO-092 Safety, efficacy and pharmacodynamics of cenerimod in patients with systemic lupus erythematosus: two randomised, double-blind phase 2 clinical trials

• Published in: Lupus science & medicine Vol. 10; no. Suppl 1; p. A93
• Main Authors: Navarra, Sandra V, Cornelisse, Peter, Cahuzac, Clélia, Yokoyama, Yoshinari, Togo, Osamu, Ouali Berkani
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group LTD 01.07.2023; BMJ Publishing Group
• Subjects: Clinical trials; Double-blind studies; Lupus; Pharmacodynamics
• ISSN: 2053-8790
• DOI: 10.1136/lupus-2023-KCR.133

BackgroundTwo Phase 2 studies investigating once-daily cenerimod, a selective sphingosine 1-phosphate 1 receptor modulator, in adults with SLE were recently completed: CARE (NCT03742037) and ID-064A203.MethodsThe CARE study was previously described.1 Adults with moderate to severe SLE were randomised to placebo or cenerimod (0.5, 1, 2 or 4 mg). At Month (M) 6, patients receiving cenerimod 4 mg were re-randomised to placebo or cenerimod 2 mg for M7-12; patients from other groups continued their initial treatment to M12. The primary endpoint was change from baseline to M6 in SLEDAI-2K score modified to exclude leukopenia (mSLEDAI-2K).ID-064A203, performed in Japan, randomised adults with moderate to severe SLE to 2 or 4 mg cenerimod for 3 months with end-of-study at M9. The primary endpoint was occurrence of treatment-emergent adverse events (AEs), serious AEs and AEs of special interest. The secondary endpoint was change from baseline to each post-baseline assessment (PBA) until M9 in total lymphocyte count. Exploratory endpoints included change from baseline to each PBA until M9 in mSLEDAI-2K, physician’s global assessment and biomarkers.In both studies, patients continued their SLE background therapies, and oral corticosteroid (OCS) dose should have been maintained stable for ≥15 days before randomisation. It was preferable for OCS dose to be maintained stable until M3 in ID-064A203, and to the end of M6 in CARE.ResultsResults from ID-064A203 will be available in 2023.CARE results were presented;1 the primary endpoint was not met after adjustment for multiplicity (nominal p=0.0291 for cenerimod 4 mg versus placebo), although reduction in disease activity at M6 was observed.ConclusionsThese Phase 2 clinical trials increase our knowledge of the efficacy, safety and pharmacodynamics of cenerimod in SLE. Two Phase 3 trials of 4 mg cenerimod in patients with SLE are underway (OPUS, NCT05648500, NCT05672576).