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Safety and Tolerability of Lebrikizumab in Adults with Newly Diagnosed Bullous Pemphigoid

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on Bullous pemphigoid, a rare condition that causes painful blisters and red, inflamed skin. The medication being tested is a laboratory‑made protein called Lebrikizumab that blocks a substance in the body known as IL-13, which is thought to play a role in the development of the blisters.

The purpose of the research is to see whether the drug can be given safely and is well tolerated by people who have just been diagnosed with the disease. Participants will receive a subcutaneous injection of the medication using a pre‑filled syringe at regular intervals over a period of about one year, with clinic visits scheduled to monitor health and collect information.

During the study, doctors will track changes in a score called the BPDAI, which measures the number and size of blisters and the amount of skin affected. They will also ask participants to rate their itch on a simple 0‑10 scale, evaluate the impact on daily life and mood, and record any use of other skin‑care treatments. These assessments help determine how the drug affects the skin condition and overall well‑being.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After joining the study, you will attend a baseline visit at the clinic. during this visit, the research team will confirm your diagnosis of bullous pemphigoid and collect initial information about your skin condition.

    You will complete questionnaires that measure disease severity (bpdaI score), itch intensity (itch nrs), skin involvement (absis), quality of life (dlqi), psychological well‑being (who‑5), and cognitive status (cog‑log).

    Blood samples will be taken to measure antibodies (bp180 and bp230), and a small skin biopsy may be performed to examine the dermal‑epidermal junction.

  2. Step 2

    First lebrikizumab injection

    You will receive the study medication, lebrikizumab, as a subcutaneous injection (injection under the skin) using a pre‑filled syringe.

    The dose is 500 mg per injection. the injection is given at the clinic by trained staff.

  3. Step 3

    Regular clinic visits and follow‑up assessments

    Throughout the 48‑week study period, you will return to the clinic at scheduled intervals. at each visit you will:

    - receive another 500 mg dose of lebrikizumab by subcutaneous injection,

    - complete the same set of questionnaires to track changes in disease severity, itch, skin involvement, quality of life, well‑being, and cognition,

    - provide blood samples for antibody testing at the times specified by the study protocol,

    - possibly undergo additional skin biopsies if required by the protocol,

    - record any use of topical corticosteroids (tcs) so the study can calculate total tcs use and tcs‑free days.

  4. Step 4

    Mid‑study evaluation at week 24

    At week 24, you will have a comprehensive evaluation that includes the same questionnaires and blood tests performed at baseline.

    The results will be used to assess intermediate changes in disease activity, itch, skin scores, quality of life, psychological well‑being, cognitive status, and antibody levels.

  5. Step 5

    Final evaluation at week 48

    At week 48, the study concludes with a final assessment. you will repeat all questionnaires, blood tests, and any required skin biopsies.

    The primary goal is to compare the bpdaI score from baseline to week 48 to determine safety and tolerability of the medication.

    Secondary outcomes include changes in itch, skin scores, quality of life, well‑being, cognition, antibody levels, and total use of topical corticosteroids.

Who can join the trial?

9 criteria

  • You must be 18 years old or older.
  • You can be a man or a woman.
  • You need to be able to understand the study information and sign a written consent form.
  • You must have had a skin biopsy examined with direct immunofluorescence (DIF) that shows results typical for bullous pemphigoid.
  • If blood tests for BP180 and BP230 autoantibodies were done, the results must be on file (these tests look for specific immune proteins related to the disease).
  • Your disease must be moderate to severe, measured by a score of 24 or higher on the BPDAI and an itch rating of 4 or more on the Itch NRS scale (0‑10).
  • You must not have improved enough with prescription skin creams called topical corticosteroids (TCS) – either no response (group 2) or only a small improvement (group 3).
  • Your doctor must think you are a good candidate for biologic treatment (a medicine made from living cells).
  • If you are a woman who could become pregnant, a blood pregnancy test (serum hCG) must be negative at the screening visit (women of childbearing potential (WOCBP)).

Who cannot join the trial?

22 criteria

  • Age: You must be older than 18 years; anyone 18 years old or younger cannot join.
  • Allergic reaction (hypersensitivity) to any part of the study drug or its container means you cannot take part.
  • Having had, or planning, a major surgery within the 8 weeks before the first study visit or during the study will exclude you.
  • If you have ever had a strong allergy to lidocaine or other local anesthetic medicines used to numb the skin, you cannot join.
  • A serious mental health problem (for example, thoughts of harming yourself) or ongoing alcohol or drug abuse that might prevent you from following the study rules will keep you out.
  • Having a current infection that needs treatment with medicines such as antibiotics (for bacteria), antivirals (for viruses), antiparasitics (for parasites), or antifungals (for fungi) within 2 weeks before the start, or a skin infection within 1 week, means you cannot participate until the infection is cleared.
  • A history of a weak immune system (immunosuppression) or past serious infections that take advantage of a weak immune system—such as tuberculosis, fungal infections like histoplasmosis or aspergillosis, or other rare infections—will exclude you.
  • Any past or present infection with HIV (the virus that causes AIDS) will prevent participation.
  • Testing positive for hepatitis B or hepatitis C infections (specific blood markers) at screening means you cannot join.
  • If the doctor finds any important abnormal results in your blood, urine, or chemistry tests during screening, you will be excluded.
  • Having other skin conditions that could interfere with the study’s skin assessments will keep you out.
  • Having a different type of pemphigoid disease that is not caused by the specific antibodies the study is focused on will exclude you.
  • A diagnosis of cancer within the past 2 years, except for fully treated early‑stage cervical cancer or non‑metastatic skin cancers that have been completely removed, will prevent enrollment.
  • If you are unable to understand the study information and sign the consent form because of mental incapacity, you cannot participate.
  • Being pregnant or breastfeeding will exclude you from the trial.
  • Testing positive for antibodies called anti‑desmoglein that suggest a different blistering disease (pemphigus) will keep you out.
  • Having previously taken medicines that target the immune proteins IL‑4 or IL‑13, such as dupilumab, will exclude you.
  • Using topical corticosteroid creams (TCS) within 7 days before the first study visit will prevent participation.
  • Taking oral steroids (systemic corticoids) within 2 weeks before the first study visit will exclude you.
  • Using strong immune‑suppressing drugs (such as azathioprine, methotrexate, mycophenolate mofetil, or cyclosporine) within 2 weeks before the first study visit will keep you out.
  • Having ever received rituximab or other biologic therapies, including intravenous immunoglobulin (IVIG), will exclude you.
  • Any other health problem or situation that the doctor believes could interfere with the study procedures or increase your risk will prevent you from joining.
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Investigated drugs

lebrikizumab is a medication being tested in this study. It is given as a liquid that is injected under the skin using a pre‑filled syringe. The drug works by blocking a protein called IL‑13, which is involved in the inflammation that causes bullous pemphigoid, a skin disease that leads to blisters. In this trial, researchers are looking to see if lebrikizumab is safe and well‑tolerated by people who have just been diagnosed with this condition.

What is already known about the treatment

Lebrikizumab - It is given as a 250 mg solution for injection in a pre‑filled syringe that is placed under the skin (subcutaneous injection). The drug is a humanized monoclonal antibody that has been studied in asthma and eczema and is now being tested for the skin disease bullous pemphigoid. It works by attaching to the protein IL‑13, stopping this molecule from causing inflammation in the skin. Lebrikizumab belongs to the class of immunomodulating antibodies that target cytokines.

Investigated diseases

Bullous pemphigoid - Bullous pemphigoid is an autoimmune skin condition that causes large, fluid‑filled blisters to develop on the skin’s surface. It usually begins with itchy red patches that later form tense blisters, most often on the arms, abdomen, and groin. Over time, new blisters may appear as older ones heal, leading to widespread involvement of the skin.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525685-22-00Estimated enrolment25 patientsSponsorRegion Midtjylland

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