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

1

What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Sanatorium profesora Arenbergera Prague Czechia
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Bispebjerg Hospital Copenhagen Denmark
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Klinikum Oldenburg AöR Oldenburg In Holstein Germany
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Diagnostics And Consultancy Center Sveti Georgi EOOD Haskovo Bulgaria
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o. Malbork Poland
Clinical Research Group Sp. z o.o. Warsaw Poland
Evangelismos S.A. Athens Greece
General University Hospital Of Larissa Larissa Greece
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Odense University Hospital Odense Denmark
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Lyon Sud Pierre Benite France
Region Sjaelland Holbæk Denmark
ASMC – IPSMC – Skin And Venereal Diseases Sofia Bulgaria
Medical Center Evrohealth EOOD Sofia Bulgaria
Lhbyz Ckxosg Sdqf du Twukfm Kenengycdyn dc Ahglses Ksxtrqje Szczecin Poland
Uhmfzoydyu Gfyvqwx Hqxsxgkl Argnynq Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
01.05.2023
Czechia Czechia
Not recruiting
01.05.2023
Denmark Denmark
Not recruiting
01.05.2023
France France
Not recruiting
01.05.2023
Germany Germany
Not recruiting
01.05.2023
Greece Greece
Not recruiting
01.05.2023
Poland Poland
Not recruiting
01.05.2023

Trial locations

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.

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 ID:
2023-509746-35-00
Protocol code:
HZNP-DAX-202
NCT ID:
NCT05591222
Trial Phase:
Therapeutic exploratory (Phase II)

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