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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: Recruiting Phase 2 study of Subacute Cutaneous Lupus Erythematosus and Chronic Cutaneous Lupus Erythematosus, sponsored by Immunovant Sciences.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The CLASI-A score represents the overall severity of cutaneous lupus erythematosus (CLE) dermatologic involvement. It is used to assess the activity of mucocutaneous lesions in patients with lupus. The score ranges from 0 (no active lesions) to a maximum of 70. Values between 1 and 9 indicate mild inflammation, 10 to 20 indicate moderate inflammation, and 21 or higher indicate severe inflammation.
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 |
What NCT06980805 shows while recruiting
NCT06980805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
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 names 20 study sites across 7 states, led by 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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Where NCT06980805's enrollment target sits among peer trials
56 1146th of 2000 higher than 849 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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