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Study of Tibulizumab to Treat Adults with 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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

14 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

Tibulizumab - A novel investigational biologic medication administered through subcutaneous injection, currently being studied in Phase 2 clinical trials for the treatment of Hidradenitis Suppurativa (HS), a chronic inflammatory skin condition. This drug belongs to the class of monoclonal antibodies, designed to target specific inflammatory pathways involved in HS pathogenesis, though its exact molecular mechanism of action is still being investigated through clinical research. The medication aims to reduce the formation of painful inflammatory lesions and nodules characteristic of HS, potentially offering a new therapeutic option for patients with this challenging skin condition.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519736-17-00Protocol codeZB-106-HS-202Estimated enrolment225 patientsSponsorZura Bio Inc.

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