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

Merck KGaA (EMD Serono)

Status and phase: Not yet enrolling; Phase 3

Conditions: Cutaneous Lupus Erythematosus (CLE); Systemic Lupus Erythematosus (SLE)

Treatments: Drug: Enpatoran

Study type: Interventional

Funder types: Industry

Identifiers

NCT07840287

MS504908_0002

2026-525294-39-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 404 estimated patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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404 participants in 1 patient group

Enpatoran

Experimental group

Treatment:

Drug: Enpatoran