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Study on the Effectiveness of IC0624 for Patients with Mild to Moderate Hidradenitis Suppurativa

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a skin condition called Hidradenitis Suppurativa (HS), which is characterized by painful lumps under the skin, often in areas like the armpits, groin, and buttocks. The study is testing a treatment called IC0624, which is being evaluated as a first-line therapy for people with mild to moderate forms of this condition. The treatment is administered in the form of gastro-resistant tablets, which means they are designed to pass through the stomach without dissolving until they reach the intestines.

The purpose of the study is to assess the effectiveness of taking IC0624 over a period of six weeks. Participants will be randomly assigned to receive either the active treatment or a placebo, which looks like the treatment but does not contain the active substance. The study is conducted in a double-blind manner, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will have regular check-ups to monitor their condition and any changes in their symptoms. The main goal is to see if the treatment can reduce the number of lumps and improve the overall condition of the skin. Additional assessments will include checking for any side effects and evaluating the participants' quality of life during the treatment period. The study aims to provide valuable information on the potential benefits of IC0624 for people living with Hidradenitis Suppurativa.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants must provide written informed consent. This is a document that confirms understanding and agreement to participate in the study.

    Participants must be between 18 and 65 years old and have a confirmed diagnosis of mild to moderate Hidradenitis Suppurativa (HS).

  2. Step 2

    Medication administration

    Participants will receive either the active medication, ICHTHRALETTEN® 200 mg, or a placebo. Both are in the form of gastro-resistant tablets.

    The medication is taken orally. The exact dosage and frequency will be provided by the study team.

  3. Step 3

    Treatment duration

    The treatment period lasts for six weeks. During this time, participants will take the medication as instructed.

  4. Step 4

    Monitoring and assessments

    Participants will be monitored for changes in their condition. The primary measure of success is the HiSCR50 at week 6, which assesses improvement in skin lesions.

    Secondary assessments include HiSCR50 at weeks 2 and 4, HiSCR75 at weeks 2, 4, and 6, and counts of abscesses and inflammatory nodules at weeks 2, 4, and 6.

  5. Step 5

    Safety and tolerability checks

    Safety and tolerability will be evaluated through laboratory tests at week 6, comparing results to baseline measurements taken at the start of the study.

    Tests will include liver function, kidney function, cholesterol levels, and blood counts.

  6. Step 6

    Quality of life assessments

    Participants will complete quality of life assessments at week 6, comparing their condition to the start of the study.

    These assessments will include the DLQI and WHO-5 questionnaires, which evaluate the impact of the condition on daily life and overall well-being.

  7. Step 7

    Study completion

    At the end of the six-week period, participants will have a final evaluation to assess the overall effectiveness and safety of the treatment.

Who can join the trial?

7 criteria

  • Provide written informed consent before any study-related activities. This means you agree to participate after understanding the study details.
  • Be a male, female, or diverse individual aged between 18 and 65 years.
  • Have a skin type classified as Fitzpatrick I-VI, which refers to different skin tones and their reaction to sun exposure.
  • Have a clinically confirmed diagnosis of mild to moderate Hidradenitis Suppurativa (HS), a skin condition.
  • Have an IHS4 score of at least 1, which means having at least one skin nodule, and no more than 10, with these mainly located in the groin, armpits, and buttocks.
  • Be in Hurley Stage I to II, which are stages used to describe the severity of Hidradenitis Suppurativa.
  • Be expected to follow the study medication and instructions well, including keeping a diary as part of the study.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with Hidradenitis Suppurativa, a skin condition that causes small, painful lumps under the skin.
  • Patients who are younger than 18 years old.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.
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Investigated drugs

IC0624 is being studied as a first-line treatment for patients with active mild to moderate Hidradenitis Suppurativa (HS). This medication is being tested to see how effective it is in reducing the symptoms of HS over a period of six weeks. The trial is designed to compare the effects of IC0624 with a placebo to determine its potential benefits for patients suffering from this skin condition.

What is already known about the treatment

IC0624 – This medication is administered orally and is currently being studied in a Phase 2 clinical trial for its effectiveness in treating Hidradenitis Suppurativa, a chronic skin condition. The trial aims to assess the clinical efficacy of a 6-week treatment period. IC0624 is being investigated as a first-line therapy for patients with active mild to moderate forms of this condition. The exact mechanism of action at the molecular level is not detailed in the available data, but it is being explored for its potential benefits in reducing symptoms associated with Hidradenitis Suppurativa.

Investigated diseases

Hidradenitis Suppurativa – This is a chronic skin condition characterized by the presence of painful lumps under the skin, often 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 lead to scarring and the development of sinus tracts. The disease often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause is not fully understood, but it is believed to involve a combination of genetic, hormonal, and environmental factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518180-35-00Protocol codeFD-069-169Estimated enrolment186 patientsSponsorIchthyol-Gesellschaft Cordes Hermanni & Co. GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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