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New drug could tame lupus skin flares

NCT ID NCT04857034

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Updated 1 time

Summary

This phase 2 trial tests deucravacitinib, an anti-inflammatory pill, against a placebo in 74 adults with active discoid or subacute cutaneous lupus — skin rashes caused by lupus. The main goal is to see if the drug reduces rash severity after 16 weeks. Participants must already be on standard lupus treatments.

What this could mean

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

Active substance
deucravacitinib (a pill that targets inflammation)
What this could lead to
If it works, this could offer 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 (74 people) comparing the drug to a placebo. It may not show enough benefit, or side effects could limit its use.

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

74 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Feb 2028

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 to 75 years

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: * Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit * Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol * Currently receiving treatment for DLE/SCLE with a stable regimen of at least one of the following medications: oral corticosteroid, and/or antimalarial, and/or immunosuppressant * Participant could be with or without concurrent systemic lupus erythematosus (SLE) * If participant receives nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics treatment then the participant must be on a stable dose 2 weeks prior to screening Exclusion Criteria: * Women who are pregnant, lactating, breastfeeding or planning pregnancy during the study period * Any of the following specific CLE subtypes in isolation: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains * Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE) * Antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit * History of 3 or more unexplained consecutive pregnancy losses * Active severe or unstable neuropsychiatric SLE * Other autoimmune diseases or non-SLE driven inflammatory joint or skin disease or overlap syndromes as primary disease that in the opinion of the investigator will significantly impact the assessment of CLE/SLE disease manifestations and activity Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Local Institution

    Guadalajara, Jalisco, 45030, Mexico

  • Local Institution - 0001

    Kogarah, New South Wales, 2217, Australia

  • Local Institution - 0002

    Camberwell, Victoria, 3124, Australia

  • Local Institution - 0003

    Botany, New South Wales, 2019, Australia

  • Local Institution - 0005

    Rzeszów, 35-055, Poland

  • Local Institution - 0006

    Hamburg, 22391, Germany

  • Local Institution - 0007

    Clayton, Victoria, 0, Australia

  • Local Institution - 0008

    Lodz, Łódź Voivodeship, 94-046, Poland

  • Local Institution - 0009

    Wroclaw, 50-566, Poland

  • Local Institution - 0010

    Paris, 75970, France

  • Local Institution - 0013

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Local Institution - 0014

    Erlangen, 91054, Germany

  • Local Institution - 0018

    Capital Federal, Buenos Aires, 1023, Argentina

  • Local Institution - 0019

    Buenos Aires, 1431, Argentina

  • Local Institution - 0021

    Taichung, 404, Taiwan

  • Local Institution - 0022

    Taipei, 10051, Taiwan

  • Local Institution - 0023

    Taichung, 402, Taiwan

  • Local Institution - 0026

    Oklahoma City, Oklahoma, 73104, United States

  • Local Institution - 0027

    Créteil, 94000, France

  • Local Institution - 0028

    Guadalajara, 0, Mexico

  • Local Institution - 0029

    Aguascalientes, 20130, Mexico

  • Local Institution - 0031

    Kaohsiung City, 833, Taiwan

  • Local Institution - 0035

    Berlin, 10117, Germany

  • Local Institution - 0036

    Monterrey, Nuevo León, 64718, Mexico

  • Local Institution - 0037

    New York, New York, 10029, United States

  • Local Institution - 0038

    Bordeaux, 33075, France

  • Local Institution - 0046

    Los Angeles, California, 90045, United States

  • Local Institution - 0054

    Charleston, South Carolina, 29407, United States

  • Local Institution - 0058

    Zapopan, Jalisco, 45070, Mexico

  • Local Institution - 0059

    St Louis, Missouri, 63108, United States

  • Local Institution - 0060

    Ann Arbor, Michigan, 48109, United States

  • Local Institution - 0065

    Durham, North Carolina, 27713, United States

  • Local Institution - 0067

    Columbus, Ohio, 43215, United States

  • Local Institution - 0071

    Mexico City, 14080, Mexico

  • Local Institution - 0072

    Dresden, Saxony, 01307, Germany

  • Local Institution - 0073

    Farmington, Connecticut, 06030, United States

  • Local Institution - 0076

    Irvine, California, 92697, United States

  • Local Institution - 0077

    Scottsdale, Arizona, 85259, United States

  • Local Institution - 0078

    Melbourne, Victoria, 3004, Australia

  • Local Institution - 0082

    Orlando, Florida, 32827, United States

  • Local Institution - 0087

    Victoria Park, Western Australia, 6100, Australia