The WILLOW LTE study with enpatoran in participants with SCLE, DLE and/or SLE

A Phase II, Double-blind, Dose-Ranging, Parallel, Long-term Extension Study to Evaluate the Safety and Efficacy of Enpatoran in Participants with Subacute Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus and/or Systemic Lupus Erythematosus Having Completed the WILLOW (MS200569_0003) Study Treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071220084

Enrollment

Registered

2023-01-06

Start date

2023-01-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus

Interventions

Study drug (enpatoran 25, 50 or 100 mg) will be administered orally twice daily for up to 192 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are SCLE, DLE and/or SLE participants that have completed the 24-week Treatment of the WILLOW study.

Exclusion criteria

Exclusion criteria: Participants who experienced serious event(s) related to the study intervention during the WILLOW study, an unstable medical condition, or any other reason, in the opinion of the Investigator or Sponsor/designee that would preclude participation in this LTE study.

Design outcomes

Primary

Measure	Time frame
Occurrence of adverse events (TEAEs, SAEs, and AESIs)	—

Countries

Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Greece, Israel, Japan, Korea, Mauritius, Mexico, Moldova, Philippines, Poland, Puerto Rico, Romania, Serbia, South Africa, Spain, Sweden, Taiwan, Ukrine, United States

Contacts

Public ContactClinical Trial Information Contact

Merck Biopharma Co., Ltd.

MBJ_clinicaltrial_information@merckgroup.com+81-3-6756-0800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026