AuthorisedTherapeutic exploratory (Phase II)Interventional

Targeting IL-13 in Bullous Pemphigoid: An Investigator-Initiated, Prospective, Multicenter, Proof-of-Concept, Open-Label Pilot Study of Lebrikizumab

Bullous pemphigoid is an autoimmune skin condition that causes intense itching and large, fluid-filled blisters. It is usually treated with steroids, but these can cause long-term side effects. This study is testing an injection called lebrikizumab (brand name Ebglyss). Lebrikizumab targets a protein in the immune system called IL-13, which is thought to play a major role in skin inflammation and itch. Because this is an 'open-label' study, all participants will receive the active study medicine; no one will be given a dummy drug (placebo). Researchers will track participants for 48 weeks to see if the treatment clears their skin blisters, stops their itching, and improves their day-to-day well-being. They will also measure whether it allows patients to use fewer steroid creams. The trial is open to adults aged 18 and over with bullous pemphigoid.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Region Midtjylland, Region Sjaelland

Enrolment target

Start

31 Aug 2026

Bullous pemphigoid

What is this study about?

Bullous pemphigoid is a painful and uncomfortable autoimmune condition where the body's immune system accidentally attacks the skin. This leads to intense itching, red patches, and large, fluid-filled blisters that break easily. Standard treatments rely heavily on steroids, either as creams or tablets. While steroids help control the skin, using them for a long time can lead to significant side effects, especially in older adults.

Researchers want to find gentler, more targeted treatments. In this trial, doctors are studying a medicine called lebrikizumab (also known as Ebglyss). Lebrikizumab works by blocking a specific messenger protein in the body called interleukin-13 (IL-13). This protein causes swelling, rash, and intense itching in various skin conditions. By blocking IL-13, researchers hope to calm the immune response and give the skin a chance to heal.

This is an early-stage 'proof-of-concept' study. It aims to see if targeting IL-13 actually makes a real difference to people living with bullous pemphigoid. Because this is an open-label trial, every person who joins will receive the actual study medicine, rather than a dummy injection. If successful, this research could open up a new, steroid-sparing treatment path for patients.

Key takeaways

Testing a targeted injection (lebrikizumab) for adults with bullous pemphigoid.
Aims to heal blisters, stop itch, and cut down the need for steroid creams.
All participants receive the active medicine; there is no placebo.
The study lasts for 48 weeks and involves regular hospital check-ups and skin assessments.
Taking part is voluntary, and you can withdraw at any point.

Who may be eligible?

This trial is designed for adults aged 18 and over who have been diagnosed with bullous pemphigoid. It is open to people of all genders.

To join, participants must have active symptoms, such as blisters or persistent itching, that can be measured by the study team. Doctors will also check your overall medical history and current medications to make sure the treatment is safe for you.

Certain people may not be able to participate. For example, if you have other serious medical conditions, active severe infections, or are taking medications that interfere with the study drug, you may not be eligible. The study doctor will review all your details before you decide to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been diagnosed with bullous pemphigoid.
I currently have active blisters, rash, or skin itch.
I am able and willing to attend regular hospital appointments for 48 weeks.
I am comfortable receiving injections under the skin.

Answer every question to see your result.

What does participation involve?

If you take part, your involvement will last for around 48 weeks. You will receive lebrikizumab as an injection just under the skin (subcutaneous injection) using a pre-filled syringe. You will visit the clinic regularly so the medical team can examine your skin and monitor your health.

At these visits, doctors will measure the number and severity of blisters using standard skin scoring charts. You will also be asked to rate your itching and complete short questionnaires about your mood, quality of life, and daily routine. The team will take regular blood samples, track how often you need to use steroid creams, and may take small skin samples (biopsies) to see how your skin is healing under a microscope.

Potential risks and benefits

The main hope of this study is that lebrikizumab will reduce your blisters, soothe your itching, and lower your need for steroid creams, though these benefits cannot be guaranteed. Like all medicines, lebrikizumab can cause side effects. Common reactions can include redness, swelling, or pain where the injection is given, as well as allergic reactions or mild eye irritation. You will be closely looked after by a specialist team throughout the study. Taking part is completely voluntary, and you are free to leave the trial at any time without your regular NHS care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Denmark

Common questions

What is bullous pemphigoid?

It is a rare autoimmune condition where the body's immune system attacks the layer between the outer and inner skin, causing itchy rashes and large, tense blisters.

Will I receive a dummy treatment (placebo)?

No. This is an open-label study, which means every person who participates will receive the active study medicine, lebrikizumab.

How is the study medicine given?

Lebrikizumab is given as an injection just under the skin using a pre-filled syringe, similar to how insulin is administered.

How long will I be in the study?

Your participation will last for approximately 48 weeks, during which you will have scheduled check-ups with the study team.

Can I carry on using my normal steroid creams?

The study team will give you clear guidance on this. The goal is to see if the new medicine allows you to safely reduce or stop your use of steroid creams over time.