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RECRUITING Phase 2

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

NCT06980805 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 56 participants
Start Date 2025-02-19
Est. Completion 2027-04
Phase Phase 2

Sponsor

Immunovant Sciences

12 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06980805 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06980805?

The interventions under investigation include: Placebo (DRUG), IMVT-1402 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06980805?

This trial is sponsored by Immunovant Sciences, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial