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

JRCT ID: jRCT2071220084

Registered date:06/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
• Date of first enrollment: 17/01/2023
• Target sample size: 16
• Countries of recruitment: Argentina,Japan,Australia,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Colombia,Japan,Greece,Japan,Israel,Japan,Korea,Japan,Mauritius,Japan,Mexico,Japan,Moldova,Japan,Philippines,Japan,Poland,Japan,Puerto Rico,Japan,Romania,Japan,Serbia,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Ukrine,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Study drug (enpatoran 25, 50 or 100 mg) will be administered orally twice daily for 48 weeks.

Outcome(s)

• Primary Outcome: Occurrence of adverse events (TEAEs, SAEs, and AESIs) from Day 1 through the end of the Safety Follow-up period (up to Week 50)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both
• Include criteria: Are SCLE, DLE and/or SLE participants that have completed the 24-week Treatment of the WILLOW study.
• Exclude 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.

Related Information

• Primary Sponsor: Ishii Kyoko
• Secondary ID(s): NCT05540327