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A study to evaluate the effectiveness and safety of LAD328 in adults with moderate to severe hidradenitis suppurativa

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What is this trial about?

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

This study focuses on adults living with Hidradenitis Suppurativa, a long-term skin condition that causes painful bumps, inflammation, and potentially deep tunnels or sores under the skin. The research aims to evaluate the efficacy and safety of a new medication called LAD328, which is a human IgG1 monoclonal antibody against interleukin 21. This type of medicine is a lab-made protein designed to target a specific part of the immune system to help control inflammation. The study will compare the effects of this treatment against a placebo consisting of sodium chloride.

Participants in the study will receive their assigned treatment through an intravenous infusion, which means the medicine is delivered directly into the bloodstream through a needle in a vein. During the course of the study, the safety and how well the medication works will be closely monitored. This includes observing how the body reacts to the treatment and checking general health indicators such as heart rhythm and blood tests.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study participation
The study begins with the administration of either the test medication or a placebo.
The test medication, known as lad328, is a solution for injection containing a human igg1 monoclonal antibody against interleukin 21, which is delivered through an intravenous infusion (a liquid passed directly into a vein).
The placebo, which is sodium chloride (a salt solution), is also delivered through an intravenous infusion.
Step 2
Monitoring and evaluation
During the trial, safety is monitored by checking vital signs, ecg (a test that records the electrical activity of the heart), and clinical laboratory parameters (blood or urine tests).
The effectiveness of the treatment is evaluated by measuring the reduction in symptoms of hidradenitis suppurativa, a skin condition involving painful lumps under the skin.
Any adverse events, which are unexpected medical occurrences, are recorded to ensure the safety and tolerability of the medication.

Who can join the trial?

11 criteria

You must be a male or female between the ages of 18 and 65.
Your Body Mass Index (BMI), which is a measure of your body weight relative to your height, must be 40 or less, and you must weigh at least 45 kilograms.
You must be able to understand the study requirements and be willing to follow them.
You must provide written informed consent, which is a formal document where you agree to participate after being told all the details.
You must have been diagnosed with moderate-to-severe hidradenitis suppurativa (HS), a skin condition that causes painful lumps under the skin, for at least 6 months.
Your condition must involve at least 5 inflammatory lesions, which are painful bumps or pockets of infection, during both the initial check and the start of the study.
The skin lumps must be in at least 2 different body areas, such as both armpits.
At least one of these areas must be at a Hurley Stage II or III, which are levels used to describe the severity of the skin condition.
You must have a history of not responding well to systemic antibiotics, which are medicines taken by mouth or through a vein to treat infections, or you must be unable to take them due to side effects.
You must agree to use over-the-counter topical antiseptics, which are germ-killing liquids or creams applied directly to the skin, at least 3 days per week.
Women who may become pregnant and men must agree to follow specific rules to avoid pregnancy and prevent a partner from being exposed to the study medicine.

Who cannot join the trial?

22 criteria

Having syndromic HS, which means the skin condition is linked to genetic issues, problems with how hair follicles are formed, or an overactive immune system.
A history of a significant allergic reaction or body-wide reaction to a previous biologic therapy, which is a type of medicine made from living cells to target specific parts of the immune system.
Any physical or mental health condition that, in the doctor's opinion, would make it difficult for you to follow all the rules and steps of the study.
Having an active infection (either long-term or sudden) that requires medicine like antibiotics (for bacteria), antivirals (for viruses), antiparasitics (for parasites), or antifungals (for fungus) within two weeks before the study starts, or having a fever higher than 38°C within one week before the study starts.
Testing positive for Hepatitis B, Hepatitis C, or HIV (a virus that affects the immune system).
A history of alcohol or drug abuse within the last year.
Having had major surgery, such as open-heart surgery or an organ transplant, in the three months before the study starts, or planning to have such surgery during the study.
Having used the study medication, LAD328, before.
Receiving live vaccines (vaccines that use a weakened form of a germ) within four weeks before the study starts or planning to get one during the study.
Planning to use any other medicines or treatments that are not allowed by the study rules, or not waiting long enough for a forbidden medicine to leave your system, a process known as a wash-out period.
Not getting enough improvement from two or more different types of biologics for your skin condition that work in different ways.
Having tuberculosis (an active infection or a past infection that is currently dormant), or testing positive for it.
Being pregnant, breastfeeding, or planning to become pregnant during the study or shortly after finishing the medicine.
Being living in an institution due to a legal or government order.
Being an employee or a close relative of the people or companies running the study.
A history of malignancy, which is a term for cancer, within the last five years, except for certain types of skin cancer that were successfully treated.
A history of liver disease or having abnormal results in blood tests that check how well your liver is working.
Having more than 20 draining tunnels (small passages under the skin that leak fluid) in your skin.
Having other skin conditions, such as severe acne or skin infections, that might make it hard for doctors to measure the study results.
Having surgery to treat your skin condition within three months before the study starts.
Having ongoing health conditions, such as inflammatory bowel disease or rheumatoid arthritis, that require medicines that suppress or change your immune system.
A known or suspected allergy to the study medicine or any of its excipients, which are the inactive ingredients used to make the medicine.

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Verified sites

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

Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Verified
Mainz, Germany
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Responsive
Sosnowiec, Poland
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

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Investigated drugs

LAD328 is an experimental treatment given through an IV infusion. It is designed to target and block a specific protein in the body called interleukin 21, which may help manage the inflammation associated with the condition being studied.

Sodium Chloride

What is already known about the treatment

LAD328
This medication is an experimental protein delivered through an intravenous infusion as a liquid injection. It is currently being studied in clinical trials and is not yet available for general medical use. It works by specifically targeting and blocking a certain signal in the immune system called interleukin 21 to reduce excessive inflammation. This type of drug is classified as a monoclonal antibody and is being tested to treat people with moderate to severe hidradenitis suppurativa.
Sodium chloride
This substance is administered as an intravenous infusion and is used in this study as a placebo. It is a common salt solution that is widely used in medicine to maintain fluid balance and is already well-established in medical practice. It does not have a specific therapeutic effect on the disease being studied, as it serves as an inactive control to compare against the test medication. In pharmacological terms, it is classified as a saline solution.

Investigated diseases

Hidradenitis suppurativa - This is a chronic skin condition that primarily affects areas where skin rubs together, such as the armpits and groin. It begins with the formation of painful lumps under the skin. Over time, these lumps can rupture and release fluid or pus. As the condition progresses, it can lead to the development of tunnels or tracts under the skin. These tracts may eventually connect, creating complex networks of inflammation and scarring.