A study to evaluate the effectiveness and safety of zasocitinib in patients with moderate to severe hidradenitis suppurativa

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What is this study about?

This study is designed to evaluate the efficacy and safety of zasocitinib in people living with Hidradenitis Suppurativa. Hidradenitis Suppurativa is a long-term skin condition that causes painful lumps, abscesses (pus-filled bumps), and inflammatory nodules (red, swollen lumps under the skin) to form, typically in areas where skin rubs together. The study focuses on individuals experiencing moderate to severe symptoms of this condition.

Participants in this trial will be assigned to receive either the study drug, zasocitinib, which is taken in the form of an oral capsule, or a placebo. This is a double-blind study, meaning that neither the participants nor the researchers will know which treatment is being administered until the study is completed. This method is used to ensure that the results are not influenced by expectations or biases.

During the course of the study, the progress of the condition will be monitored over several weeks. The main goal is to see how well the medication reduces the number of painful lumps and skin lesions compared to the placebo. The study will also track any adverse events, which are unintended medical problems or side effects that may occur during the treatment period.

Who Can Join the Study?

You must have had signs and symptoms of hidradenitis suppurativa (a skin condition that causes painful lumps under the skin) for at least 6 months before the study starts.
A dermatologist (a doctor who specializes in skin, hair, and nails) must confirm your diagnosis during your first visit.
Your skin symptoms must have remained stable for at least 2 months before the study begins.
You must have skin lesions (areas of skin that are damaged or abnormal, such as bumps or sores) in at least 2 different parts of your body.
At least one of those body areas must show signs of Hurley Stage II or III, which refers to more advanced stages of the disease involving deeper tunnels or more frequent scarring under the skin.
You must have at least 5 inflammatory lesions (painful, swollen bumps such as abscesses, which are collections of pus, or nodules, which are hard lumps) at the start of the study.
You must have a history of not responding well to oral antibiotics (pills used to fight bacterial infections) or have experienced the disease returning, side effects, or being unable to take the medicine.
You must be at least 18 years old.
If you are able to become pregnant, you must either have had a surgery to prevent pregnancy, be in postmenopausal status (the stage of life after a woman’s monthly periods have permanently stopped), or agree to use a highly effective method of contraception (methods used to prevent pregnancy).
You must be willing and able to follow all study rules, including using digital tools and phone applications.
You must provide written informed consent (a signed document showing you understand and agree to participate) and privacy authorization before any study activities begin.

Who Cannot Join the Study?

You have more than 20 draining tunnels, which are narrow pathways under the skin that leak fluid, at the start of the study.
Your ECG, which is a test that records the electrical activity of your heart, shows abnormalities that could make participating unsafe.
Your kidney, liver, or pancreas (an organ that helps with digestion) are not working correctly based on blood tests.
Your blood tests show low levels of hemoglobin (a protein in red blood cells that carries oxygen), white blood cells (cells that fight infection), neutrophils (a type of white blood cell), lymphocytes (another type of white blood cell), or platelets (cells that help blood clot).
Your thyroid levels, which are hormones that control how your body uses energy, are outside the normal range.
Your triglyceride levels (a type of fat in your blood) are too high.
Your CPK levels, which is an enzyme found in muscles, are too high.
You have difficulty having blood drawn through a vein, known as venipuncture.
You have a history of severe allergic reactions, such as anaphylaxis (a life-threatening allergic reaction), or you are allergic to the study medicine.
You are pregnant, breastfeeding, or planning to become pregnant or donate eggs or sperm during the study.
You have used drugs or substances excessively within the last 12 months.
You have donated a large amount of blood or plasma (the liquid part of blood) recently or plan to do so during the study.
You are currently in a hospital or institution against your will due to mental or physical health reasons.
You are an employee of the study site or a close family member of someone working on the study.
You have another skin condition, such as a bacterial infection or fungus, that might make it hard to judge your progress with the main disease.
You have had cancer in the last 5 years, unless it was a specific, successfully treated type of skin cancer.
You have a history of heavy smoking or excessive alcohol use.
You have been diagnosed with sarcoidosis (an inflammatory disease), lupus (an immune system disease), or inflammatory bowel disease (a condition affecting the intestines).
You have other inflammatory conditions like psoriasis or rheumatoid arthritis (conditions where the immune system attacks joints).
You have tuberculosis (a serious bacterial infection), or you have a history of it or a test showing you might have a hidden infection.
You have an active herpes infection or a history of severe herpes infections.
You have Hepatitis B, Hepatitis C, or HIV (viral infections that affect the immune system).
You have had a recent serious infection that required hospitalization or strong medicine.
You have a history of chronic infections, such as long-term lung or skin infections.
You have an infected joint prosthesis (an artificial joint) that has not been replaced.
You have any other medical condition that makes your health unstable or puts you at risk during the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
St. Josef-Hospital	Bochum	Germany
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.	Malbork	Poland
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Tzhpqbdsyvy uav Siauaysbeyo Bezihuxi Ggdl	Bad Bentheim	Germany
Ebalnuk Ugnzeuvwuder Msxvywp Copgzhe Ryywajusl (bzzxmbx Mlp	Rotterdam	The Netherlands
Pmforeddd Iockmsku Mhelrmwk Mrwwvltrzjst Sylcc Wwpmzrdbewhp I Aniduqshqhzeu	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.04.2026
Germany	Not yet recruiting	01.04.2026
Poland	Not yet recruiting	01.04.2026
The Netherlands	Not yet recruiting	01.04.2026

Trial locations

Investigated drugs:

Zasocitinib

Zasocitinib is an oral capsule being tested to see if it can help treat people with moderate to severe hidradenitis suppurativa, a condition that causes painful lumps and inflammation on the skin.

Hidradenitis suppurativa – This is a chronic skin condition that causes painful lumps to form under the skin. These lumps typically appear in areas where skin rubs together, such as the armpits or groin. Over time, these bumps can develop into larger, inflamed nodules or abscesses. As the condition progresses, these lesions may rupture and create tunnels under the skin. These tunnels can connect different areas and lead to more frequent drainage.

Trial ID:

2025-522831-33-00

Protocol code:

TAK-279-HS-2001

Trial Phase:

Therapeutic exploratory (Phase II)

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A study to evaluate the effectiveness and safety of zasocitinib in patients with moderate to severe hidradenitis suppurativa

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?