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Study on the Effectiveness and Safety of Brensocatib for 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 clinical trial is focused on studying the effects of a medication called Brensocatib on adults with a skin condition known as Hidradenitis Suppurativa. Hidradenitis Suppurativa is a chronic skin disease that causes small, painful lumps to form under the skin, often in areas where skin rubs together. The study aims to evaluate how effective and safe Brensocatib is in treating this condition.

Participants in the study will receive either Brensocatib or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for up to 52 weeks, during which participants will take the medication in the form of a film-coated tablet. The main goal is to observe changes in the number of painful lumps and abscesses over time, particularly at the 16-week mark.

The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving Brensocatib and who is receiving the placebo. This helps ensure that the results are unbiased. The trial will take place at multiple centers, allowing for a diverse group of participants to be involved. The findings from this study could provide valuable insights into the treatment of Hidradenitis Suppurativa with Brensocatib.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of hidradenitis suppurativa (HS), and the presence of moderate to severe symptoms.
Eligibility criteria require a history of HS symptoms for at least six months and lesions in at least two distinct areas of the body.
Step 2
Baseline visit
A baseline visit is scheduled to document the current state of HS, including the count of inflammatory nodules and abscesses.
This visit establishes a reference point for evaluating changes during the study.
Step 3
Medication administration
Participants receive either brensocatib or a placebo. Both are provided as film-coated tablets for oral use.
The dosage and frequency of administration are determined by the study protocol and are consistent throughout the trial.
Step 4
Ongoing monitoring
Regular monitoring occurs to assess the efficacy and safety of the treatment. This includes tracking changes in the number of abscesses and nodules.
Participants are evaluated for any side effects or adverse reactions to the medication.
Step 5
Evaluation at week 16
At week 16, a primary evaluation is conducted to measure the percent change in the total count of abscesses and inflammatory nodules.
Secondary evaluations include assessing responder status for achieving specific improvement criteria.
Step 6
Completion of study
The study is estimated to conclude by March 2027. Participants complete their involvement after the final assessments are conducted.
The results contribute to understanding the efficacy and safety of brensocatib in treating moderate to severe HS.

Who can join the trial?

8 criteria

Participants must be **adults** between the ages of 18 and 80 at the time they sign the consent form.
Participants must have a **diagnosis** of Hidradenitis Suppurativa (**HS**), confirmed by a skin doctor, with symptoms for at least 6 months before the study starts.
Participants must have **moderate or severe HS**, which means having at least 6 inflamed lumps or abscesses for at least 8 weeks before the study begins.
Participants must have HS lumps in at least 2 different body areas, with at least one area being at a more advanced stage (Hurley Stage II or III) at both the start and during the study.
Both male and female participants must use **birth control** methods that follow local rules for clinical studies. This includes:
**Male participants**: Must use effective birth control and avoid donating sperm from the start of the study to at least 90 days after the last dose of the study drug.
**Female participants**: Must be postmenopausal, surgically sterile, or use highly effective birth control methods from the start of the study to at least 90 days after the last dose of the study drug.
Participants must be able to give **informed consent**, which means they understand and agree to follow the study's rules and requirements.

Who cannot join the trial?

10 criteria

Patients who are currently participating in another clinical trial.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Patients with a medical condition that the study doctors believe could interfere with the study results.
Patients who are pregnant or breastfeeding.
Patients who have used certain medications recently that might affect the study.
Patients with a history of drug or alcohol abuse that could affect their ability to follow the study procedures.
Patients who have had a major surgery recently or are planning to have surgery during the study period.
Patients with certain infections that could interfere with the study.
Patients who have a condition that affects their immune system, which is the body's defense against infections.
Patients who have a history of cancer, except for some types of skin cancer that have been treated successfully.

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Verified sites

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Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Katholisches Klinikum Bochum gGmbH
Bochum, Germany
Responsive
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Rzeszow, Poland

Trial locations

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Investigated drugs

Brensocatib is a medication being studied for its potential to help adults with moderate to severe hidradenitis suppurativa, a skin condition that causes painful lumps under the skin. The trial aims to see how effective and safe this medication is for treating the condition.

BRENSOCATIB

What is already known about the treatment

Brensocatib – Brensocatib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness and safety in treating moderate to severe Hidradenitis Suppurativa, a chronic skin condition. The medication works by inhibiting an enzyme that contributes to inflammation, thereby reducing symptoms associated with the condition. Brensocatib is classified as an anti-inflammatory agent, and its development is ongoing, with research focusing on its potential benefits for patients with inflammatory skin diseases.

Investigated diseases

Hidradenitis Suppurativa – This is a chronic skin condition characterized by the formation of painful lumps under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can become inflamed and may rupture, leading to the formation of abscesses and tunnels under the skin. Over time, the condition can cause scarring and the development of sinus tracts, which are channels that connect the lumps under the skin. The disease often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause is not well understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors.