Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study of daxdilimab injection for adults with moderate to severe discoid lupus erythematosus

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on evaluating a new treatment for Primary Discoid Lupus Erythematosus (DLE), a skin condition that causes disc-shaped patches on the skin. The study will test a medication called daxdilimab, which is given as an injection under the skin, compared to placebo in people with moderate to severe forms of the disease.

The purpose of this study is to determine if daxdilimab can reduce disease activity in adults with DLE after 24 weeks of treatment. During the study, participants will receive either daxdilimab or placebo through subcutaneous injections. Some participants may continue their current medications such as antimalarials, methotrexate, mycophenolate, azathioprine, or low-dose corticosteroids if they were already taking them before the study.

The study will monitor changes in the skin lesions and overall disease activity throughout the treatment period. The medication dose will not exceed 300 milligrams. The researchers will also check how the body processes the medication and watch for any side effects that may occur during the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and medication start

    You will receive either daxdilimab (study medication) or placebo (salt solution) as an injection under the skin.

    The initial visit includes examination of your skin condition and assessment of your discoid lupus lesions.

    Digital photographs of your skin will be taken to document your condition.

  2. Step 2

    Ongoing treatment phase

    You will continue receiving injections under the skin throughout the 24-week study period.

    If you are currently taking other medications for your condition (such as antimalarials, methotrexate, or others), you will continue them at the same dose.

    Regular skin examinations will be performed to monitor your progress.

  3. Step 3

    Monitoring visits

    Your skin condition will be regularly assessed using a special scoring system called CLASI-A.

    Blood samples will be taken to measure the levels of the study medication in your body.

    You will be monitored for any side effects or reactions to the treatment.

  4. Step 4

    Final evaluation

    At week 24, a final assessment of your skin condition will be performed.

    The effectiveness of the treatment will be measured by comparing your skin condition to how it was at the start of the study.

    Your safety and any side effects experienced during the study will be evaluated.

Who can join the trial?

9 criteria

  • Age between 18 and 75 years old
  • Must have had Discoid Lupus Erythematosus (DLE) for at least 6 months before screening, confirmed by either: - A skin biopsy, or - A clinical score of 7 or higher on the DLE Classification scale
  • Must have active disease with: - Confirmed active discoid lesions through photography - A score of 8 or higher on the CLASI-A scale (measure of disease activity)
  • Must have disease that did not respond to previous treatments or could not tolerate standard medications like antimalarials
  • If currently on medications, doses must be stable for: - 8 weeks for antimalarial drugs - 4 weeks for methotrexate, mycophenolate, azathioprine, or oral steroids - 1 week for topical treatments
  • Vaccinations must be up to date according to local guidelines
  • For women who can become pregnant: - Must have negative pregnancy tests - Must use highly effective birth control during the study and for 6 months after - Must not be pregnant or breastfeeding
  • For men: - Must use contraception during the study and for 3 months after - Must agree not to donate sperm during this period
  • Must be willing to: - Sign informed consent - Follow study procedures - Attend all required study visits

Who cannot join the trial?

13 criteria

  • Age below 18 years or above 75 years
  • Pregnant or breastfeeding women
  • History of systemic lupus erythematosus (SLE) - a condition affecting multiple organs in the body
  • Current or recent treatment with immunosuppressive medications - drugs that lower the body's immune response
  • Active or chronic infections, including tuberculosis, hepatitis B, hepatitis C, or HIV
  • History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Severe kidney or liver disease
  • Uncontrolled high blood pressure
  • History of severe allergic reactions to medications
  • Participation in other clinical trials within the past 30 days
  • Mental conditions that could interfere with study compliance
  • Substance abuse within the past year
  • Any condition that, in the investigator's opinion, could compromise patient safety during the study
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Daxdilimab is an investigational medication given by injection under the skin (subcutaneous injection). It is being studied for treating moderate to severe discoid lupus erythematosus (DLE), which is a form of lupus that primarily affects the skin. The medication works by targeting the immune system to reduce inflammation and disease activity in people with DLE. This is a new treatment approach that aims to help control the symptoms and skin lesions associated with this condition.

What is already known about the treatment

Daxdilimab - A novel investigational medication administered through subcutaneous injection, currently being studied in Phase 2 clinical trials for the treatment of primary discoid lupus erythematosus (DLE). This drug belongs to the class of targeted immunotherapy agents and is designed to reduce disease activity in patients with moderate to severe DLE by modulating the immune system response. The medication is being evaluated for its efficacy and safety compared to placebo, with the primary goal of decreasing active disease manifestations over a 24-week treatment period, potentially offering a new therapeutic option for patients with this challenging autoimmune skin condition.

Investigated diseases

Primary Discoid Lupus Erythematosus – A chronic autoimmune skin condition that causes coin-shaped (discoid) lesions on sun-exposed areas of the body, particularly the face, ears, and scalp. The lesions typically appear as red, inflamed patches that become thick and scaly, and may cause scarring and permanent hair loss in affected areas. The condition primarily affects the skin and doesn't usually involve internal organs. Over time, the lesions can leave behind depressed areas of permanent scarring and skin color changes, with the center of older lesions often becoming lighter in color while the borders remain darker. The condition tends to worsen with sun exposure and may show periods of improvement and flare-ups.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509746-35-00Protocol codeHZNP-DAX-202Estimated enrolment72 patientsSponsorHorizon Therapeutics Ireland Designated Activity Company

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.