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Enpatoran for Lupus

Not yet recruiting at 1 trial location
UM
CC
Overseen ByCommunication Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: EMD Serono Research & Development Institute, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

MR

Medical Responsible

Principal Investigator

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Are You a Good Fit for This Trial?

This trial is for people with skin symptoms of lupus (with or without systemic involvement) who have already completed the earlier Elowen-1 or Elowen-2 studies. Participants must be able to take oral medication and continue regular study visits.

Inclusion Criteria

Are up to date according to local guidelines/recommendations; recombinant zoster vaccination is encouraged but not mandatory
I have lupus skin symptoms and finished 24 weeks of treatment in Elowen-1 or Elowen-2.

Exclusion Criteria

Participants who experienced serious event(s) related to the study intervention during the Elowen-1 and Elowen-2 studies, have an unstable medical condition, or any other reason, in the opinion of the Investigator, that would preclude participation in this LTE study
Other severe acute or chronic medical or psychiatric condition, clinically significant ECG findings or laboratory abnormality that may increase risk associated with LTE study participation or intervention administration, making participant inappropriate for LTE study in Investigator's judgment
Participants with positive anti-hepatitis B core (HBc) antibody and/or anti-hepatitis B surface (HBs) antibody with non-detectable HBV DNA at Screening must provide a negative HBV DNA PCR result
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What Are the Treatments Tested in This Trial?

Interventions

  • Enpatoran

Trial Overview

The study tests long-term use of enpatoran, an oral tablet, in treating skin-related lupus symptoms. All participants receive enpatoran for up to about two years in this open-label extension study.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: EnpatoranExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

EMD Serono Research & Development Institute, Inc.

Lead Sponsor

Trials
86
Recruited
22,700+

Miguel Fernández Alcalde

EMD Serono Research & Development Institute, Inc.

Chief Executive Officer

Bachelor’s Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master’s Degree in Management from IESE Business School

Danny Bar-Zohar

EMD Serono Research & Development Institute, Inc.

Chief Medical Officer since 2022

MD

Merck KGaA, Darmstadt, Germany

Industry Sponsor

Trials
449
Recruited
122,000+
Danny Bar-Zohar profile image

Danny Bar-Zohar

Merck KGaA, Darmstadt, Germany

Chief Medical Officer since 2022

MD

Belén Garijo profile image

Belén Garijo

Merck KGaA, Darmstadt, Germany

Chief Executive Officer since 2021

MD

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