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A Study of LAD191 Compared to Placebo and Adalimumab 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 is looking at hidradenitis suppurativa, a long-term skin condition that causes painful lumps and abscesses to form under the skin, usually in areas where skin rubs together such as the armpits, groin, buttocks, and under the breasts. The study will test a new medication called LAD191, which is also known by the code name ISB 880. This medication is given as an injection under the skin. Some participants will receive LAD191, some will receive placebo, some will receive sodium chloride solution, and some will receive adalimumab, which is an approved medication already used to treat this condition. The purpose of the study is to see how well different doses of LAD191 work in treating moderate-to-severe hidradenitis suppurativa and to check how safe it is for patients to use.

The study is designed in multiple stages and will compare different treatment groups to understand which approach works best. Participants will receive their assigned treatment through injections under the skin over a period of time. Throughout the study, doctors will count and examine the skin lesions to see if they improve with treatment. They will look specifically at whether the number of abscesses and inflamed bumps decreases by at least half, which is one way to measure if the treatment is working. The study will also monitor participants for any side effects or unwanted reactions to the medication.

During the study, participants will need to continue using over-the-counter antiseptic products on their skin lesions regularly, as they should have been doing before joining the study. The study will track various safety measures including blood tests, heart activity recordings, vital signs like blood pressure and heart rate, and any problems or discomfort at the injection sites. Doctors will carefully watch for any adverse events, serious health problems, or reasons why someone might need to stop treatment early. The study requires that participants have tried antibiotic treatment before without success or were unable to tolerate it, and they must have lesions in at least two different body areas.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment period begins
Upon joining the study, you will be randomly assigned to one of several treatment groups. This means that a computer program will decide which treatment you receive, similar to flipping a coin.
You may receive LAD191 (the medication being tested), adalimumab (an approved medication for comparison), or placebo (an inactive substance that looks like the medication but contains no active ingredients).
Neither you nor your doctor will know which treatment you are receiving during the study. This is called a double-blind design and helps ensure accurate results.
Step 2
Medication administration method
The study medication will be administered as an injection under the skin, which is called subcutaneous injection.
The injection will be given in the fatty tissue just beneath the skin surface.
The study products include LAD191 solution for injection, adalimumab for injection, or placebo.
Step 3
Use of antiseptics during the study
Throughout the entire study, you will be required to regularly use over-the-counter topical antiseptics on your hidradenitis suppurativa lesions.
These are cleaning products that help reduce bacteria on the skin and can be purchased without a prescription.
You should apply these antiseptics preferably daily, but at least 3 days per week for the duration of the study.
Step 4
Regular monitoring visits
You will attend scheduled visits at the study site throughout the treatment period.
During these visits, the study team will examine your hidradenitis suppurativa lesions, counting abscesses (pockets of pus under the skin) and inflammatory nodules (painful lumps under the skin).
Your vital signs, such as blood pressure, heart rate, and temperature, will be measured.
Electrocardiograms (ECGs), which are tests that measure the electrical activity of your heart, will be performed.
Blood and other laboratory samples will be collected to monitor your health and check for any side effects.
Step 5
Assessment of treatment response
The study team will regularly assess whether your condition is improving using a measurement called HiSCR 50.
This measurement evaluates whether there has been at least a 50% reduction in the number of abscesses and inflammatory nodules, with no increase in the number of abscesses or draining tunnels under the skin.
This assessment helps determine if the treatment is working for your hidradenitis suppurativa.
Step 6
Safety monitoring throughout the study
Throughout the study, you will be monitored for any adverse events, which are any unwanted or harmful effects that occur during treatment.
The study team will check for reactions at the injection site, such as redness, swelling, or pain.
Any side effects you experience, whether mild or serious, will be recorded and evaluated.
If you experience any serious adverse events or side effects that are difficult to tolerate, your treatment may be stopped.
Step 7
Continuation of treatment
The study uses an adaptive design, which means that decisions about treatment doses and duration may be adjusted based on results observed during the study.
You will continue receiving your assigned treatment according to the schedule determined for your treatment group.
The exact duration of treatment will depend on the specific dosing regimen you are assigned to.
Step 8
Pregnancy prevention requirements
If you are a woman who can become pregnant or a male participant, you must follow specific requirements to prevent pregnancy during the study.
These measures are necessary to avoid potential exposure of an unborn child to the study medication.
You will need to agree to use appropriate contraceptive methods as specified in the study requirements.
Step 9
Study completion
The study is expected to continue until approximately July 2027.
You will be informed about the specific duration of your participation based on your treatment group.
Final assessments will be conducted to evaluate the overall effect of the treatment on your hidradenitis suppurativa and your general health.

Who can join the trial?

8 criteria

You must be able to understand the purpose and risks of the trial, be willing and able to follow the study rules, and provide written permission to participate
You must be between 18 and 65 years old
Your BMI (body mass index, a measure of body weight in relation to height) must be 40 or less
You must have a diagnosis of moderate-to-severe hidradenitis suppurativa (a skin condition causing painful lumps under the skin), with at least 5 inflammatory lesions (swollen bumps including abscesses, which are pus-filled lumps, and inflammatory nodules, which are painful bumps) at both the screening visit and the first day of the study, and you must have had signs and symptoms of this condition for at least 6 months
You must have skin lesions (affected areas) in at least 2 different body areas (for example, left and right armpit), and at least one of these areas must be classified as Hurley Stage II or Hurley Stage III (stages that indicate more severe disease with deeper lumps and scarring) at both the screening visit and the first day of the study
You must have a history of not responding well to, not tolerating, or having a medical reason to avoid systemic antibiotics (antibiotics taken by mouth or injection that work throughout the body) for treating your condition, including if you initially responded to antibiotics but the condition came back after stopping them
You must have been regularly using over-the-counter topical antiseptics (cleaning products applied directly to the skin that you can buy without a prescription) on your affected skin areas for at least 2 weeks before the first day of the study, and you must agree to continue using them regularly, preferably daily but at least 3 days per week, throughout the entire study
If you are a woman who can become pregnant or a man, you must agree to specific requirements to prevent pregnancy and avoid exposing your partner to the study medication during the trial

Who cannot join the trial?

4 criteria

The study did not provide specific exclusion criteria, which are reasons why a patient cannot participate in the trial
To find out if you can join this study, you will need to discuss your individual situation with the study team
General factors that often prevent participation in clinical trials may include having other serious health conditions, taking certain medications, or being pregnant or breastfeeding
Your doctor will review your complete medical history to determine if this study is appropriate for you

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Verified sites

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Verified
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Verified
Azienda USL Toscana Centro
Prato, Italy
Responsive
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Sosnowiec, Poland

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Investigated drugs

LAD191 is an investigational medication being studied for the treatment of hidradenitis suppurativa, a chronic skin condition that causes painful lumps under the skin. This medication is being tested at different dose levels to see how well it works and how safe it is for patients with moderate-to-severe forms of this condition.

Placebo is an inactive substance that looks like the real medication but contains no active ingredients. It is used in this study to compare against the actual medication to determine if the treatment is truly effective.

An active control medication is also being used in this study. This is an existing approved treatment for hidradenitis suppurativa that will be compared to the investigational medication to help researchers understand how well the new treatment works.

What is already known about the treatment

LAD191 – LAD191 is an investigational medication currently being studied in clinical trials for the treatment of moderate-to-severe hidradenitis suppurativa, a chronic skin condition that causes painful lumps under the skin. The drug is being tested in different dosing schedules to determine how well it works compared to placebo and to evaluate its safety in patients with this condition. The specific form of administration, exact mechanism of action at the molecular level, and pharmacological classification have not been publicly disclosed in the available trial information, as this medication is still in the early phases of clinical development and research.

Investigated diseases

Hidradenitis Suppurativa – Hidradenitis suppurativa is a chronic skin condition that affects areas of the body where skin rubs together, such as the armpits, groin, buttocks, and under the breasts. The disease begins with painful lumps under the skin that can break open and drain fluid with an unpleasant odor. Over time, these lumps may recur in the same areas and can lead to the formation of tunnels under the skin connecting different lumps. The condition often starts after puberty and can cause significant discomfort and pain. As the disease progresses, it may result in scarring and limited movement in affected areas. The severity can range from occasional single lumps to widespread areas with multiple interconnected lesions.