RT Journal Article
SR Electronic
T1 LSO-092 Safety, efficacy and pharmacodynamics of cenerimod in patients with systemic lupus erythematosus: two randomised, double-blind phase 2 clinical trials
JF Lupus Science & Medicine
JO Lupus Sci Med
FD Lupus Foundation of America
SP A93
OP A93
DO 10.1136/lupus-2023-KCR.133
VO 10
IS Suppl 1
A1 Navarra, Sandra V
A1 Cornelisse, Peter
A1 Cahuzac, Clélia
A1 Yokoyama, Yoshinari
A1 Togo, Osamu
A1 Berkani, Ouali
YR 2023
UL http://lupus.bmj.com/content/10/Suppl_1/A93.1.abstract
AB Background Two 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.Methods The 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.Results Results 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.Conclusions These 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).