NCT06980805

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

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Immunovant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The total study duration per participant is approximately 61 weeks.

Conditions

• Subacute Cutaneous Lupus Erythematosus
• Chronic Cutaneous Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	IMVT-1402	Dose 1 or Dose 2 SC QW
DRUG	Placebo	Matching Placebo SC QW

Timeline

• Start date: 2025-02-19
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-05-20
• Last updated: 2026-03-25

Locations

85 sites across 13 countries: United States, Argentina, Bulgaria, Canada, Chile, Georgia, Germany, Greece, Poland, Puerto Rico, Serbia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study