RightFit
Not yet recruitingPhase 3

A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]

A Phase 3, Single-Arm, Open-Label, Long-Term Extension Study To Evaluate The Safety And Efficacy Of Enpatoran In Participants With Active Cutaneous Manifestations Of Lupus Erythematosus With Or Without Systemic Disease Receiving Standard Of Care [Elowen-LTE]

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 76 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Intervention Form: Film-coated tablet."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the long-term safety of enpatoran tablets and how well they treat lupus that affects the skin. It is for people who finished treatment in Elowen-1 or Elowen-2, whether or not lupus also affects other parts of their body. The study lasts 120 weeks, with treatment for up to 108 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have active skin symptoms from lupus and have finished all 24 weeks of treatment in Elowen-1 or Elowen-2, including the final visit.
  • Be up to date under local guidelines. The listing does not say what must be up to date. A shingles vaccine is encouraged but not required.

Who can't join

  • Had a serious problem linked to the study drug in Elowen-1 or Elowen-2, have an unstable health condition, or have another reason the study doctor thinks makes joining unsafe.
  • Have a severe physical or mental health condition, or abnormal heart tracing or lab results that the study doctor thinks make joining unsafe.
  • Have an active, important infection, including COVID-19 or active or untreated inactive tuberculosis (TB). A major infection needing hospital care or anti-infection medicine by injection also rules you out. Well-controlled vaginal yeast, nail fungus, or oral or genital herpes infections may be allowed.
  • If earlier tests showed certain hepatitis B antibodies, you must have a negative test for hepatitis B virus genetic material.
  • Took a medicine not allowed in this study during Elowen-1 or Elowen-2 or after its final treatment visit.
  • Joined another study of an experimental drug after the final treatment visit in Elowen-1 or Elowen-2.
  • Were withdrawn from Elowen-1 or Elowen-2 under its rules for stopping treatment or leaving the study.
  • Plan to have a major, non-emergency medical procedure or surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

MA