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Clinical study on Hidradenitis Suppurativa
(Acne Inversa)

Do you suffer from recurring, painful inflammation in the armpits, groin, breasts or genital area? We are looking for patients to take part in a clinical study on chronic inflammatory and recurrent Hidradenitis Suppurativa, also known as Acne Inversa.

Potential participants must fulfil certain requirements in order to take part in the study.

Participating study sites

Study information

Phase 2a

18+ years

Injection

Possible symptoms and consequences
of Hidradenitis Suppurativa

Symptoms

  • Nodules and inflammation: painful, reddened skin nodules that often spread under the skin
  • Abscesses: purulent inflammations that burst open and secrete foul-smelling secretions
  • Fistula ducts: connecting ducts under the skin that link different centres of inflammation
  • Itching, pain and a feeling of pressure

Consequences

  • Chronic pain
  • Restricted movement, especially in affected areas of the body near joints
  • Scarring: repeated inflammation often results in hard, bulging scars
  • Scar strands and skin distortions after years of progression
  • Lymphatic drainage disorders when lymph nodes are affected
  • Social isolation due to shame about the symptoms (e.g. odour, wounds)
  • Depression and anxiety disorders
  • Impairment of sexuality and partnership
  • Incapacity for work in severe cases

Why the study is being conducted?

We are looking for participants for our study who suffer from the symptoms listed. The aim of the study is to evaluate the effect of the investigational drug to be tested on recurrent Hidradenitis Suppurativa and the change in quality of life for you as a patient. During the course of the study, you will receive comprehensive, no-cost and study-related treatment from our medical specialists.

Important information

Study treatment and time required

The patients are randomly divided into three groups. There are two different dosage forms. Group 1 receives dosage form 1, group 2 receives dosage form 2 and there is also a placebo group. The active substance is administered by injection under the skin. The study will be conducted in three phases:

  • Preliminary examination: up to 6 weeks before the start of treatment (1 visit to the study site)
  • Treatment phase: 12 weeks (9 visits, 6 injections)
  • Follow-up care: 4 weeks (2 visits)

The total duration of the study is approximately 22 weeks and includes 12 visits to the study site. All participants are monitored by medical professionals throughout the course of the study and are examined at regular intervals.

What is Hidradenitis Suppurativa?

Hidradenitis Suppurativa (HS) is a chronic inflammatory skin disease that repeatedly causes painful inflammation in certain areas of the skin - especially where skin rubs against skin or where there are many sweat glands, e.g. in the armpits, groin area, under the breast or on the buttocks. The disease usually begins after puberty and progresses in episodes. Hidradenitis Suppurativa is not contagious.

Requirements for participation

You are suitable if you:

  • are at least 18 years old
  • have had moderate or severe Hidradenitis Suppurativa in at least two different parts of the body for at least 6 months
  • have at least five abscesses or inflammatory nodules
  • have had an inadequate response to oral antibiotics OR have developed a recurrence after stopping antibiotics OR have an intolerance OR have a contraindication to oral antibiotics for the treatment of your HS

Excluded from participation are persons who:

  • have another skin disease in the treatment area
  • are infected with hepatitis B, hepatitis C or the human immunodeficiency virus
  • are currently pregnant, breastfeeding or planning to become pregnant in the near future
  • have a history of severe allergies, non-allergic drug reactions or multiple drug allergies
  • have recently participated in another clinical study

Participate in the study

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FAQ on clinical studies –
Frequently asked questions

What are clinical studies for?
Clinical studies are used for scientific research into new drugs, therapies or medical procedures. The aim is to test the effectiveness and safety of these measures before they are made available to the general public. They are an indispensable part of medical development and help to improve existing treatments or make new ones possible.

What are the advantages of a clinical study?
  • Access to new therapies: Participants get early access to innovative treatments that are not yet widely available.
  • Close monitoring: Participants receive intensive medical care during the study.
  • Contribution to research: Participation helps to improve medical care for future patients.
  • Possible alleviation of personal complaints: Depending on the study, the new therapy may also result in personal health benefits.

Can anyone take part in a study?
No, not every person can participate. Every clinical study has so-called inclusion and exclusion criteria, for example:
  • Age, gender or health condition
  • Existing medical conditions or medication
  • Severity of the disease
These criteria serve to ensure the safety of the participants and the scientific validity of the study.

How does a clinical study work?
The procedure may vary depending on the study, but typically follows these steps:
  • Preliminary examination: Medical examination to determine whether you are suitable for the study.
  • Information session and consent: You will be informed in detail and give your written consent.
  • Participation phase: Depending on the study, you will receive treatment, medication or an examination. Your state of health will be monitored regularly.
  • Completion and follow-up: After the end of treatment, follow-up examinations may follow to observe long-term effects.

Is participation voluntary?
Yes, your participation is voluntary. You can decide not to participate or withdraw your consent at any time during the study - without giving reasons and without any disadvantages for your further medical care.

What benefit do I have?
  • Personal benefit: Possible improvement in your state of health through new treatment approaches.
  • Social benefit: You help to develop medicine for other patients.
  • Medical care: Close medical supervision by the study team.

Are there any costs for me?
No, there are no costs for you. In addition, your travelling expenses will be reimbursed, medication will be provided free of charge, and examinations and treatments will be covered as part of the study.

What are the risks?
Every medical treatment can have risks and side effects. These are monitored particularly closely in clinical studies. You will be informed in detail about possible risks in advance. Your safety always comes first.

Who will look after me during the study?
You will be supervised by a qualified study team consisting of doctors, study coordinators and specialised medical staff who will accompany you throughout the study and monitor your health.

What happens to my data?
Your personal data will be treated as strictly confidential and anonymised or pseudonymised in accordance with the applicable data protection laws. Only authorised persons have access to your data.

Can I continue my regular treatment?
This depends on the study. In many cases, the new treatment will be tested in addition to or compared with the regular therapy. Your treating doctor will work with the study team to ensure optimal care.