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

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What is this study about?

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.

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 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 treatment duration

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

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hautzentrum Weißensee, Studienzentrum KorSearch	Berlin	Germany
MVZ Dr. Kasche und Kollegen GmbH	Hamburg	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Harzklinikum Dorothea Christiane Erxleben GmbH	Quedlinburg	Germany
Hms GmbH	Merzig	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Mcchygkop Disdtjhpkeqd	Remscheid	Germany
Hkjg Hknpv uba Lcwcafwjgqrb Plzuxyn	Potsdam	Germany
Upahgpoqsebmiflehasmz Mmzjzkui Alr	Munster	Germany
Gxohum Ujqskoduau Fxssvkabs	Frankfurt	Germany
Txfqxhmzpna uvd Sdtczrzezhg Bfyuhvjd Gfiq	Bad Bentheim	Germany
Glqvcuctnqpowmqbyjh Wpfoqcxhlqmny	Augsburg	Germany
Hppmz utw Lvmecrfzydmb Herqaxjax Dojvnkvlcgigogeq Spmfjghkbpzdgq	Simmern	Germany
Dnuungkyvvri Qagkm	Mainz	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.02.2025

Trial locations

Investigated drugs:

SODIUM BITUMINOSULFONATE DRY SUBSTANCE

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.

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 ID:

2024-518180-35-00

Protocol code:

FD-069-169

Trial Phase:

Therapeutic exploratory (Phase II)

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

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