Study of Tibulizumab to Treat Adults with Hidradenitis Suppurativa

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What is this study about?

This clinical trial focuses on studying hidradenitis suppurativa, a chronic skin condition that causes painful bumps and abscesses in areas where skin rubs together. The study will test a medication called tibulizumab, which will be given as a solution for injection under the skin, compared to a placebo. The purpose is to evaluate how well tibulizumab works in treating the lesions associated with hidradenitis suppurativa.

The study consists of two parts: first, participants will be randomly assigned to receive either tibulizumab or placebo. After this initial period, all participants will have the opportunity to receive tibulizumab in what is called an open-label extension period. The total treatment duration for each participant will be 28 weeks.

During the study, researchers will monitor changes in the number of abscesses and inflammatory nodules (painful bumps under the skin). They will also track improvements in participants’ quality of life, their assessment of the condition’s severity, and any skin pain they experience. Throughout the study, participants’ health will be closely monitored to ensure their safety and to observe how well they tolerate the treatment.

1 Initial treatment period start

You will enter a randomized period where you will receive either tibulizumab or a placebo through subcutaneous injection (injection under the skin)

The treatment will focus on your hidradenitis suppurativa (a chronic skin condition that causes painful lumps under the skin)

2 Treatment monitoring – Week 1-16

Your skin condition will be regularly monitored, particularly the number of abscesses and inflammatory nodules

Medical staff will track changes in your skin condition using several measures:

– Changes in the number of painful lumps and abscesses

– Quality of life assessment using a special questionnaire

– Your own assessment of the condition severity

– Level of skin pain using a numerical scale

3 Safety monitoring throughout the study

Regular health checks will include:

– Vital signs measurements

– Heart activity monitoring (ECG)

– Blood tests

Any side effects that occur during the treatment will be recorded

4 Extended treatment period

After the initial 16-week period, the study continues with an open-label extension phase

During this phase, all participants will receive the active medication

The study is expected to continue until February 2027

5 Important requirements throughout the study

If you can become pregnant, you must use effective birth control from 4 weeks before starting until 12 weeks after the last treatment

If you are male and sexually active, you must use effective birth control from day 1 until 12 weeks after the last treatment

You cannot donate reproductive cells (sperm or eggs) during the study and for 12 weeks after the last treatment

Who Can Join the Study?

Age between 18 and 70 years old at the time of giving consent
Must have at least 5 active nodules (inflamed bumps under the skin) during screening and first day of study
Must have skin lesions in at least 2 different body areas, with one area showing moderate to severe disease severity
For women who can become pregnant: must use effective birth control starting 4 weeks before study and continue until 12 weeks after last treatment. Must have negative pregnancy tests
For men who can father children: must use effective birth control from first day of study until 12 weeks after last treatment
Women must agree not to donate eggs or undergo fertility treatments during the study and for 12 weeks after last treatment
Men must agree not to donate sperm during the study and for 12 weeks after last treatment
Must provide written informed consent
Must be willing to follow all study procedures and attend all visits
Must have been diagnosed with condition for at least 6 months before screening
Must have either:
- Not responded well to oral antibiotics, or
- Cannot tolerate oral antibiotics, or
- Have medical reasons preventing antibiotic use, or
- Had condition return after stopping antibiotics

Who Cannot Join the Study?

People below 18 years of age
History of serious allergic reactions to similar medications
Active or chronic infections, including tuberculosis or hepatitis
Current diagnosis of cancer or history of cancer in the past 5 years
Severe liver disease or abnormal liver function tests
Severe kidney disease or significantly reduced kidney function
Uncontrolled high blood pressure
Severe heart conditions or heart failure
Pregnant women or women planning to become pregnant
Breastfeeding women
Use of other biological treatments (specialized medications that affect the immune system) within the past 3 months
Major surgery planned during the study period
Participation in other clinical trials within the past 30 days
Substance abuse or alcohol dependency within the past 6 months
Mental health conditions that could interfere with study participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Technische Universitaet Dresden	Dresden	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
St. Josef-Hospital	Bochum	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.	Malbork	Poland
Solumed Sp. z o.o. sp.k.	Poznan	Poland
Renew Clinic Sp. z o.o.	Bialystok	Poland
Klinikum Darmstadt GmbH	Darmstadt	Germany
University Of Debrecen	Debrecen	Hungary
Semmelweis University	Budapest	Hungary
University Of Szeged	Szeged	Hungary
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Krolicki	Szczecin	Poland
Upsvwwqtug Mgoauro Cnfrqe Hllevmwxewxivodef	Hamburg	Germany
Mehdhprgqye Ucnkd Suu z ouxd	Warsaw	Poland
Pefvjbb Puaxhispuhj Sof z oraa	Warsaw	Poland
Ulhmakyiobtpfvcfufhyl Mfkvzmcb Avr	Munster	Germany
Ksysksdu doz Udgbvckmamvv Mvkzhygf Apt	Munich	Germany
Pcrhzkf Stt z ofwn	Katowice	Poland
Fghdpimfg Phlj Lx Ibejdfwzlpljg Bmkckbass Dzk Hvpklqxs Ubelrplwzmevz Lm Ptb	Madrid	Spain
Togcvvvrkbk usn Sewkytwpmfe Brmoiznd Gwtb	Bad Bentheim	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	30.09.2025
Hungary	Not recruiting	30.09.2025
Poland	Not recruiting	30.09.2025
Spain	Not recruiting	30.09.2025

Trial locations

Tibulizumab is an investigational medication being studied for the treatment of hidradenitis suppurativa (HS), a chronic inflammatory skin condition. This medication belongs to a class of drugs that target specific components of the immune system. It is designed to reduce inflammation and help manage the painful lesions and abscesses that occur in people with HS. The medication is being tested to determine how well it works and how safe it is for patients with this condition.

Hidradenitis Suppurativa – A chronic skin condition that causes small, painful lumps to form under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. The condition begins with tender areas that may look like pimples or boils, which can progress to form tunnels under the skin connecting the lumps. These areas can become inflamed, break open, and release fluid or pus. The condition tends to start after puberty and can persist for many years, with periods of flare-ups and remission. Hidradenitis Suppurativa affects the areas of skin that contain sweat glands and hair follicles, leading to recurring episodes of painful swelling.

Trial ID:

2024-519736-17-00

Protocol code:

ZB-106-HS-202

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Tibulizumab to Treat Adults with Hidradenitis Suppurativa

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