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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 3

Age range

18 years - 76 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

404 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

EMD Serono Research & Development Institute, Inc.

Study start

Oct 22, 2026 Actual

Primary completion

Sep 1, 2031 Estimated

Study completion

Sep 1, 2031 Estimated

First posted

Sep 25, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts