A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE) (NCT06980805)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Site Number - 1010 — Anniston, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (86 Sites)
Showing the first 25 of 86 sites.
- Site Number - 1010 — Anniston, Alabama
- Site Number - 1020 — Birmingham, Alabama
- Site Number - 1038 — Phoenix, Arizona
- Site Number - 1034 — Scottsdale, Arizona
- Site Number - 1022 — Beverly Hills, California
- Site Number - 1018 — Chula Vista, California
- Site Number - 1039 — Corona, California
- Site Number - 1005 — Fremont, California
- Site Number - 1023 — Los Angeles, California
- Site Number - 1000 — Aurora, Colorado
- Site Number - 1033 — Castle Rock, Colorado
- Site Number - 1021 — Farmington, Connecticut
- Site Number - 1014 — Hialeah, Florida
- Site Number - 1017 — Jacksonville, Florida
- Site Number - 1028 — Miami, Florida
- Site Number - 1024 — Miami, Florida
- Site Number - 1027 — Miami, Florida
- Site Number - 1011 — Miami Lakes, Florida
- Site Number - 1025 — Orlando, Florida
- Site Number - 1009 — Buford, Georgia
- Site Number - 1030 — Brighton, Massachusetts
- Site Number - 1019 — Auburn Hills, Michigan
- Site Number - 1003 — Saint Clair Shores, Michigan
- Site Number - 1013 — Troy, Michigan
- Site Number - 1004 — Saint Joseph, Missouri
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.