Study on the Effectiveness and Safety of Brensocatib for Adults with Moderate to Severe Hidradenitis Suppurativa

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France
Royalderm Agnieszka Nawrocka	Warsaw	Poland

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Umbal – Prof. D-R Stoyan Kirkovich AD	Stara Zagora	Bulgaria
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Wromedica I Bielicka A Strzalkowska s.c.	Wroclaw	Poland
Klinikum Darmstadt GmbH	Darmstadt	Germany
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens	Greece
Pratia S.A.	Skorzewo	Poland
Hopital Prive D Antony	Antony	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Dhmmdlnyhd Awn Cavyqdxjdj Cskdvl Xskytfqtsiji Ezen	Sofia	Bulgaria
Dkntrsatr Sqy z ogsn	Wroclaw	Poland
Ekvyvex Ujdqmppmjiin Mugmvni Cszgrba Rqmcqkqnf (uvjnawv Mjj	Rotterdam	The Netherlands
Ppiriyimk Imsqtnsj Mgqbtoky Mlsekidxbyye Sfxpk Wxiahaqgofww I Aytwugnlgqsry	Warsaw	Poland
Hgyyljzk Ugxlaoysqgiab Hyqagkkc Tocmo y Pomydi Ihllxjvc Cuzgdv dzhjnytermyosmaus (crih	Badalona	Spain
Meieuwl Cnfhsd Mgptyekuoq Pybwwz Oam	Pleven	Bulgaria
Ujtbcjyzfh Gpjutlm Hitfheut Arlmvfm	Athens	Greece

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	01.03.2025
France	Not recruiting	01.03.2025
Germany	Not recruiting	01.03.2025
Greece	Not recruiting	01.03.2025
Poland	Not recruiting	01.03.2025
Spain	Not recruiting	01.03.2025
The Netherlands	Not recruiting	01.03.2025

Trial locations

Investigated drugs:

BRENSOCATIB

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.

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.

Trial ID:

2024-515959-38-00

Protocol code:

INS1007-231

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Brensocatib for Adults with Moderate to Severe Hidradenitis Suppurativa

What is this study about?

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Who Cannot Join the Study?