The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908\_0001) (NCT07332481) and Elowen-2 (MS504908\_0008) (NCT07355218) study treatment and to provide participants an opportunity to receive active treatment with enpatoran for up to 108 weeks in this open-label study. Study details include:
Study Duration: 120 weeks. Treatment Duration: 108 weeks. Visit Frequency: Every 4 weeks (from Week 4 to Week 24) and every 12 weeks (from Week 36 to Week 120).
Study Intervention: Enpatoran. Intervention Form: Film-coated tablet.
Are up to date according to local guidelines/ recommendations. Recombinant zoster vaccination is encouraged but not mandatory.
Are participants with active cutaneous manifestations of lupus erythematosus that have successfully completed the 24-week treatment of the Elowen-1 or Elowen-2 study, including the Week 24 end of treatment (EOT) visit.
Participants who experienced serious event(s) related to the study intervention during the Elowen-1 and Elowen-2 studies, an unstable medical condition, or any other reason, in the opinion of the Investigator that would preclude participation in this LTE study.
Other severe acute or chronic medical or psychiatric condition. Clinically significant ECG findings or laboratory abnormality that may increase the risk associated with LTE study participation or study intervention administration and, in the judgment of the Investigator, would make the participant inappropriate to participate in this LTE study.
Active clinically significant viral (including Severe Acute Respiratory Syndrome Coronavirus [SARS CoV] 2), bacterial (including active tuberculosis or untreated latent tuberculosis), parasitic, or fungal infection or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered sufficiently controlled will not be exclusionary.
Received LTE-prohibited medication during participation in Elowen 1 or Elowen-2 study or after Elowen-1 or Elowen-2 study Week 24/EOT visit (may require prior discussion with Medical Monitor).
Single group
Enpatoran
DrugParticipants will receive a dose of Enpatoran orally for 108 weeks.
Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
Number of Participants With Abnormalities in Laboratory Parameters (greater than or equal to [>=] Grade 3)
Number of Participants With Abnormalities in Vital Signs
Number of Participants With Abnormalities in Electrocardiogram (ECG) Parameter
Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-70 Response, Defined as >= 70 Percent (%) Decrease in CLASI-A Score From Elowen-1/Elowen-2 study Baseline
Elowen-1 (MS504908\_0001) (NCT07332481) / Elowen-2 (MS504908\_0008) (NCT07355218) study Baseline values will be used as a reference for calculation.
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EMD Serono Research & Development Institute, Inc.
Lead sponsor
Merck KGaA, Darmstadt, Germany
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
