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NCT06980805 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
A Phase 2 study of Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus, sponsored by Immunovant Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 20
- Study locations
NCT06980805 is a Phase 2 study of Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus that is actively recruiting participants, run by Immunovant Sciences. The registered enrollment target is 56 participants. The trial reports 20 study locations across 7 states.
The verdict
NCT06980805, a Phase 2 study of Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus, is actively recruiting participants, sponsored by Immunovant Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG IMVT-1402
Study Locations (20)
Florida
- Site Number - 1014 - Hialeah
- Site Number - 1017 - Jacksonville
- Site Number - 1028 - Miami
- Site Number - 1024 - Miami
- Site Number - 1027 - Miami
- Site Number - 1011 - Miami Lakes
- Site Number - 1025 - Orlando
California
- Site Number - 1022 - Beverly Hills
- Site Number - 1018 - Chula Vista
- Site Number - 1039 - Corona
- Site Number - 1005 - Fremont
- Site Number - 1023 - Los Angeles
Alabama
- Site Number - 1010 - Anniston
- Site Number - 1020 - Birmingham
Arizona
- Site Number - 1038 - Phoenix
- Site Number - 1034 - Scottsdale
Colorado
- Site Number - 1000 - Aurora
- Site Number - 1033 - Castle Rock
Connecticut
- Site Number - 1021 - Farmington
Georgia
- Site Number - 1009 - Buford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2025-02-19 |
| Est. Completion | 2027-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06980805
The ClinicalTrials.gov registry entry for NCT06980805 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Immunovant Sciences, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Subacute Cutaneous Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06980805 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT06980805 about?
NCT06980805 is a clinical study titled "A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)". 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. P...
What is the current status of trial NCT06980805?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2025-02-19. Estimated completion is 2027-04.
What conditions does trial NCT06980805 study?
This clinical trial studies the following conditions: Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus.
What interventions are being tested in trial NCT06980805?
The interventions under investigation include: Placebo (DRUG), IMVT-1402 (DRUG).
Who is sponsoring clinical trial NCT06980805?
This trial is sponsored by Immunovant Sciences, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06980805 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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