Long-Term Extension of enpatoran for cutaneous lupus symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm extension study evaluating long-term safety and efficacy of oral enpatoran in participants with cutaneous lupus who completed prior Elowen-1 or Elowen-2 treatments. The study spans up to 120 weeks, with treatment for 108 weeks and visits every 4 weeks early, then every 12 weeks later. Participants receive film-coated tablets of enpatoran and are followed to monitor ongoing responses and any adverse events. Eligible participants should be up to date with vaccinations per local guidelines and must have had active cutaneous lupus manifestations that completed prior studies. Exclusion criteria include prior serious adverse events related to the intervention, unstable medical conditions, or other factors that could increase risk during extended exposure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Are up to date according to local guidelines/ recommendations. Recombinant zoster vaccination is encouraged but not mandatory.
2. 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.

Exclusion Criteria:

1. 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.
2. 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.
3. 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.

   Note: if sign/symptoms suggest any underlying infection (at Investigator discretion), a negative or normal test result must be provided and discussed with the Medical Monitor.

   • All participants who entered Elowen-1 and Elowen-2 studies with positive anti-hepatitis B core (HBc) antibody and/or anti hepatitis B surface (HBs) antibody with non-detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at Screening must provide a negative HBV DNA polymerase chain reaction (PCR) result.
4. 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).
5. Participation in any other investigational drug study after Elowen-1 or Elowen-2 study Week 24/EOT visit.
6. Withdrawn during participation in Elowen-1 or Elowen-2 study due to any of the predefined criteria for study intervention or study withdrawal.
7. Planned major elective medical or surgical procedure.

Where it's running

• Revival Research Institute, LLC
  Troy, Michigan, United States Recruiting

Study contacts

• Study coordinator: US Medical Information
• Email: eMediUSA@emdserono.com
• Phone: 888-275-7376

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.