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New shot could tame lupus skin flares

NCT ID NCT06980805

Disease control Sponsor: Immunovant Sciences GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study tests an experimental drug called IMVT-1402 in people with lupus-related skin rashes (subacute or chronic cutaneous lupus) that haven't gotten better with standard treatments. About 56 participants will receive either the drug or a placebo for 12 weeks, then all get the drug for another 14 weeks, followed by a longer extension period. The main goal is to see if the drug reduces skin inflammation and is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IMVT-1402 (an experimental drug given as an injection under the skin)
What this could lead to
If it works, this could point toward a new treatment option for people with lupus-related skin rashes that don't improve with standard therapies.
What could go wrong
This is a small, early-phase trial (Phase 2b) with only 56 participants, so results may not apply to everyone. The drug may not prove more effective than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with or without systemic LE manifestations. * Have a total CLASI-A score of ≥10 at Screening and Day 1. Participants with a CLASI-A score of ≥8 and \<10 are eligible if the score does not include alopecia and/or mucous membrane lesions. * Have active CLE despite an adequate trial of conventional therapies. * Are positive for at least one autoantibody at Screening. Exclusion Criteria: * Have known or suspected drug-induced CLE anti-phospholipid disease, or neuropsychiatric SLE. * Have rapidly progressive nephritis. * Have current inflammatory skin disease other than SCLE/CCLE that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments. Note: Other protocol defined Inclusion/Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

chronic cutaneous lupus erythematosus cutaneous lupus erythematosus discoid lupus erythematosus subacute cutaneous lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic cutaneous lupus erythematosus Subacute cutaneous lupus erythematosus

Contacts and locations

Locations

  • Site Number - 1000

    Aurora, Colorado, 80045-2541, United States

  • Site Number - 1002

    Hershey, Pennsylvania, 17033, United States

  • Site Number - 1003

    Saint Clair Shores, Michigan, 48081-1274, United States

  • Site Number - 1004

    Saint Joseph, Missouri, 64506-2459, United States

  • Site Number - 1005

    Fremont, California, 94538, United States

  • Site Number - 1006

    Smithfield, North Carolina, 27577-4664, United States

  • Site Number - 1007

    Charlotte, North Carolina, 28211-1064, United States

  • Site Number - 1008

    Durham, North Carolina, 27713-8505, United States

  • Site Number - 1009

    Buford, Georgia, 30518-8721, United States

  • Site Number - 1010

    Anniston, Alabama, 36207-4780, United States

  • Site Number - 1011

    Miami Lakes, Florida, 33014-5602, United States

  • Site Number - 1012

    Irving, Texas, 75061, United States

  • Site Number - 1013

    Troy, Michigan, 48084 3536, United States

  • Site Number - 1014

    Hialeah, Florida, 33012, United States

  • Site Number - 1015

    Philadelphia, Pennsylvania, 19103-4708, United States

  • Site Number - 1017

    Jacksonville, Florida, 32256, United States

  • Site Number - 1018

    Chula Vista, California, 91910, United States

  • Site Number - 1019

    Auburn Hills, Michigan, 48326-3396, United States

  • Site Number - 1020

    Birmingham, Alabama, 35203-4050, United States

  • Site Number - 1021

    Farmington, Connecticut, 06030-2840, United States

  • Site Number - 1022

    Beverly Hills, California, 90211, United States

  • Site Number - 1023

    Los Angeles, California, 90045, United States

  • Site Number - 1024

    Miami, Florida, 33133, United States

  • Site Number - 1025

    Orlando, Florida, 32819, United States

  • Site Number - 1026

    St Louis, Missouri, 63104, United States

  • Site Number - 1027

    Miami, Florida, 33136, United States

  • Site Number - 1028

    Miami, Florida, 33122, United States

  • Site Number - 1030

    Brighton, Massachusetts, 02135, United States

  • Site Number - 1033

    Castle Rock, Colorado, 80109-8034, United States

  • Site Number - 1034

    Scottsdale, Arizona, 85260, United States

  • Site Number - 1035

    Houston, Texas, 77030, United States

  • Site Number - 1036

    San Juan, 918, Puerto Rico

  • Site Number - 1037

    Ponce, 00716-0377, Puerto Rico

  • Site Number - 1038

    Phoenix, Arizona, 85037, United States

  • Site Number - 1039

    Corona, California, 92882, United States

  • Site Number - 2000

    Calgary, Alberta, T2W 4X9, Canada

  • Site Number - 2002

    Vancouver, British Columbia, V5Z 4E8, Canada

  • Site Number - 2003

    Sarnia, Ontario, N7T 5W4, Canada

  • Site Number - 3000

    Warsaw, Masovian Voivodeship, 00-716, Poland

  • Site Number - 3001

    Warsaw, Masovian Voivodeship, 00-874, Poland

  • Site Number - 3002

    Rzeszów, Podkarpackie Voivodeship, 35-309, Poland

  • Site Number - 3003

    Lodz, 90-436, Poland

  • Site Number - 3004

    Poznan, Greater Poland Voivodeship, 60-702, Poland

  • Site Number - 3005

    Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland

  • Site Number - 3006

    Rzeszów, Pakistan, 35-055, Poland

  • Site Number - 3900

    Attiki, 12462, Greece

  • Site Number - 3901

    Athens, Attica, 16121, Greece

  • Site Number - 3902

    Attiki, Athens, 104 31, Greece

  • Site Number - 3903

    Thessaloniki, Central Macedonia, 56403, Greece

  • Site Number - 3904

    Larissa, 411 10, Greece

  • Site Number - 3905

    Thessaloniki, Central Macedonia, 56403, Greece

  • Site Number - 3906

    Heraklion, Crete, 71110, Greece

  • Site Number - 5000

    CABA, C1023AAB, Argentina

  • Site Number - 5001

    CABA, C1425DND, Argentina

  • Site Number - 5002

    San Miguel de Tucumán, T4000AXL, Argentina

  • Site Number - 5003

    San Miguel de Tucumán, T4000IHE, Argentina

  • Site Number - 5600

    Sofia, 1606, Bulgaria

  • Site Number - 5601

    Sofia, 1257, Bulgaria

  • Site Number - 5603

    Sofia, 1431, Bulgaria

  • Site Number - 5605

    Sofia, 1618, Bulgaria

  • Site Number - 5606

    Sofia, 1680, Bulgaria

  • Site Number - 5700

    Victoria, 4720638, Chile

  • Site Number - 5701

    Temuco, 4810345, Chile

  • Site Number - 5702

    Independencia, 8380000, Chile

  • Site Number - 5703

    Santiago, 8320000, Chile

  • Site Number - 5704

    Santiago, 7640881, Chile

  • Site Number - 6500

    Erlangen, Bavaria, 91054, Germany

  • Site Number - 6501

    Oldenburg, Lower Saxony, 26133, Germany

  • Site Number - 6502

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Site Number - 6503

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Site Number - 7000

    Manchester, M15 6SE, United Kingdom

  • Site Number - 7002

    Leeds, West Yorkshire, LS7 4SA, United Kingdom

  • Site Number - 7003

    London, SE1 9RT, United Kingdom

  • Site Number - 7100

    Madrid, 28003, Spain

  • Site Number - 7101

    Burjassot, Valencia, 46100, Spain

  • Site Number - 7102

    Madrid, 28041, Spain

  • Site Number - 7103

    Málaga, 29016, Spain

  • Site Number - 7104

    Badalona, Catalonia, 8916, Spain

  • Site Number - 7105

    Pamplona, Navarre, 31008, Spain

  • Site Number - 8000

    Tbilisi, 0160, Georgia

  • Site Number - 8002

    Tbilisi, 0112, Georgia

  • Site Number - 9000

    Belgrade, 11000, Serbia

  • Site Number - 9001

    Belgrade, 11000, Serbia

  • Site Number - 9003

    Novi Sad, 21000, Serbia

  • Site Number -5004

    CABA, 1406, Argentina

  • Site Number-1029

    Caguas, 00725-2443, Puerto Rico

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