Systemic Lupus Erythematosus study: Enpatoran
Official title A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]
ClinicalTrials.gov ID: NCT07840287
What this study is testing
What is Enpatoran?
Enpatoran is an investigational medicine, taken by mouth, being studied as a potential treatment for systemic lupus erythematosus (sle).
Also referred to as M5049.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to look at the long-term safety and how well it works of orally administered enpatoran in people 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 people an opportunity to receive active treatment with enpatoran for up to 108 weeks in this study.
- Phase 3: a large, late-stage study
- Time commitment: about 108 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 76
You may be able to join if
- 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...
You likely can't join if
- Participants who experienced serious event(s) related to the study intervention during the Elowen-1 and Elowen-2 studies, an unstable medical...
- Other severe acute or chronic medical or psychiatric condition. Clinically significant ECG findings or laboratory abnormality that may increase the...
- Active clinically significant viral (including Severe Acute Respiratory Syndrome Coronavirus [SARS CoV] 2), bacterial (including active tuberculosis...
- 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)...
- 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...
- Participation in any other investigational drug study after Elowen-1 or Elowen-2 study Week 24/EOT visit.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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).
- Participation in any other investigational drug study after Elowen-1 or Elowen-2 study Week 24/EOT visit.
- Withdrawn during participation in Elowen-1 or Elowen-2 study due to any of the predefined criteria for study intervention or study withdrawal.
- Planned major elective medical or surgical procedure.
The study team makes the final eligibility decision.
Where it is enrolling
- Troy, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 108 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 76 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Troy, Michigan, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.