A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)

Summary

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus. The study will consist of 3 periods: Period 1: eligible participants will be randomized 1:1 to IMVT-1402 Dose 1 or placebo SC QW for 12 weeks. Period 2: participants who completed Period 1 will receive IMVT-1402 Dose 1 SC QW for 14 weeks. Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks.

Timeline

Start

2025-02-19

Primary completion

2026-10

Completion

2027-04

Outcome

Missed primary endpoint

release “아이메로프루바트는 투약 12주차 피부 루푸스 활성도 지수(CLASI-A)의 변화율에서 위약 대비 통계적 유의성을 확보하지 못했다.” daewoong.co.kr ↗

Drugs

Indications