A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
Public ClinicalTrials.gov record NCT06980805. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06980805
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 56 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 18, 2025
- Primary completion
- Sep 30, 2026
- Completion
- Mar 31, 2027
- Last update posted
- Aug 27, 2026
2025 – 2027
United States locations
- U.S. sites
- 33
- U.S. states
- 13
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site Number - 1010 | Anniston | Alabama | 36207-4780 | — |
| Site Number - 1020 | Birmingham | Alabama | 35203-4050 | — |
| Site Number - 1038 | Phoenix | Arizona | 85037 | — |
| Site Number - 1034 | Scottsdale | Arizona | 85260 | — |
| Site Number - 1022 | Beverly Hills | California | 90211 | — |
| Site Number - 1018 | Chula Vista | California | 91910 | — |
| Site Number - 1039 | Corona | California | 92882 | — |
| Site Number - 1005 | Fremont | California | 94538 | — |
| Site Number - 1023 | Los Angeles | California | 90045 | — |
| Site Number - 1000 | Aurora | Colorado | 80045-2541 | — |
| Site Number - 1033 | Castle Rock | Colorado | 80109-8034 | — |
| Site Number - 1021 | Farmington | Connecticut | 06030-2840 | — |
| Site Number - 1014 | Hialeah | Florida | 33012 | — |
| Site Number - 1017 | Jacksonville | Florida | 32256 | — |
| Site Number - 1028 | Miami | Florida | 33122 | — |
| Site Number - 1024 | Miami | Florida | 33133 | — |
| Site Number - 1027 | Miami | Florida | 33136 | — |
| Site Number - 1011 | Miami Lakes | Florida | 33014-5602 | — |
| Site Number - 1025 | Orlando | Florida | 32819 | — |
| Site Number - 1009 | Buford | Georgia | 30518-8721 | — |
| Site Number - 1030 | Brighton | Massachusetts | 02135 | — |
| Site Number - 1019 | Auburn Hills | Michigan | 48326-3396 | — |
| Site Number - 1003 | Saint Clair Shores | Michigan | 48081-1274 | — |
| Site Number - 1013 | Troy | Michigan | 48084 3536 | — |
| Site Number - 1004 | Saint Joseph | Missouri | 64506-2459 | — |
| Site Number - 1026 | St Louis | Missouri | 63104 | — |
| Site Number - 1007 | Charlotte | North Carolina | 28211-1064 | — |
| Site Number - 1008 | Durham | North Carolina | 27713-8505 | — |
| Site Number - 1006 | Smithfield | North Carolina | 27577-4664 | — |
| Site Number - 1002 | Hershey | Pennsylvania | 17033 | — |
| Site Number - 1015 | Philadelphia | Pennsylvania | 19103-4708 | — |
| Site Number - 1035 | Houston | Texas | 77030 | — |
| Site Number - 1012 | Irving | Texas | 75061 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06980805, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06980805 live on ClinicalTrials.gov.