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SODIUM BITUMINOSULFONATE DRY SUBSTANCE

SODIUM BITUMINOSULFONATE DRY SUBSTANCE is being studied in clinical trials for people with active mild to moderate hidradenitis suppurativa. These trials look at whether it can help improve disease signs and how well it works compared with placebo. The main focus is on efficacy and trial outcomes in adult patients.

Table of contents

Trial overview

The available trial studied SODIUM BITUMINOSULFONATE DRY SUBSTANCE in people with active mild to moderate hidradenitis suppurativa.[1]

This was a completed Phase 2 study, which means it was designed to look at early signs of benefit in a patient group while still checking how the treatment performs in a controlled setting.[1]

The study title described it as a randomized, double-blind, placebo-controlled trial of IC0624 as first-line therapy.[1]

Study design and treatment groups

The trial was interventional, meaning researchers assigned a treatment rather than only observing patients.[1]

It was randomized, so participants were placed into study groups by chance.[1]

It was also double-blind, which means neither the participants nor the study team knew who received the active treatment or the placebo during the study.[1]

The comparison group received a placebo, which is an inactive treatment used to help show whether the study drug has an effect beyond expectation alone.[1]

The brief study summary said the goal was to evaluate the clinical efficacy of a 6-week intake of IC0624.[1]

Who could participate

The study focused on patients with active mild to moderate hidradenitis suppurativa.[1]

This means the trial was not for people with quiet disease; it was for those who still had active symptoms at the time of enrollment.[1]

The study was described as first-line therapy, so it was aimed at people who might be using this treatment as an early treatment option for their condition.[1]

A total of 186 participants were enrolled.[1]

What the study measured

The main outcome, or primary endpoint, was HiSCR50 at week 6.[1]

HiSCR50 is a study measure used in hidradenitis suppurativa to show whether there was at least a 50% improvement in disease signs.[1]

Week 6 means the outcome was checked after six weeks of treatment.[1]

The study summary also stated that the trial was designed to evaluate the clinical efficacy of a 6-week intake of IC0624.[1]

What the trial means for patients

For patients, this trial shows that SODIUM BITUMINOSULFONATE DRY SUBSTANCE was tested in a controlled study for a painful chronic skin condition, not just in routine care.[1]

The use of placebo and blinding makes the study more reliable because it helps reduce bias, which is when results are influenced by expectations rather than the treatment itself.[1]

The main question was simple: can a 6-week course improve the signs of hidradenitis suppurativa in people with active mild to moderate disease?[1]

Because the trial is completed, the key design details are known, but the provided source does not include full outcome results beyond the planned primary endpoint.[1]

Trial ID Phase Condition studied Status Enrollment
2024-518180-35-00 Phase 2 Hidradenitis Suppurativa Completed 186

FAQ

  • What condition is being studied with SODIUM BITUMINOSULFONATE DRY SUBSTANCE? The trial is studying hidradenitis suppurativa, a long-term skin disease that causes painful lumps and inflammation. It includes people with active mild to moderate disease.
  • What phase is the trial of SODIUM BITUMINOSULFONATE DRY SUBSTANCE? The study is a Phase 2 trial. Phase 2 trials usually look at early signs of benefit and continue to check safety and how well the treatment works.
  • Who could take part in the study? The target group was patients with active mild to moderate hidradenitis suppurativa. The trial studied adults in a first-line treatment setting.
  • What is the main outcome being measured? The main outcome is HiSCR50 at week 6. This means the study checks whether there is at least a 50% improvement in hidradenitis suppurativa signs by week 6.
  • Was the trial comparing SODIUM BITUMINOSULFONATE DRY SUBSTANCE with anything else? Yes. It was randomized, double-blind, and placebo-controlled, so some people received SODIUM BITUMINOSULFONATE DRY SUBSTANCE and others received placebo. Placebo means an inactive treatment used for comparison.

Ongoing Clinical Trials on SODIUM BITUMINOSULFONATE DRY SUBSTANCE

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

    Not recruiting

    1 1
    Investigated drugs:
    Germany

Glossary

  • Hidradenitis suppurativa: A long-term inflammatory skin condition that can cause painful lumps, swelling, and draining areas, often in skin folds.
  • Active disease: A condition that is currently causing signs and symptoms, not in a quiet or inactive phase.
  • Mild to moderate: A level of disease that is not the most severe. It means the symptoms are present, but not at the highest intensity.
  • Phase 2: A clinical trial stage that looks more closely at whether a treatment works and continues to assess safety.
  • Randomized: People are assigned by chance to different treatment groups, so the groups are more balanced.
  • Double-blind: Neither the participants nor the study team know who is getting the real treatment or the placebo during the trial.
  • Placebo: A treatment that looks like the study drug but does not contain the active substance. It is used for comparison.
  • First-line therapy: The first treatment approach used for a condition before trying other options.
  • Primary endpoint: The main result the study is designed to measure.
  • HiSCR50: A study measure in hidradenitis suppurativa showing at least a 50% improvement in key disease signs.
  • Week 6: The time point six weeks after the start of treatment, when the main outcome was checked.

References

  1. https://clinicaltrials.gov/study/2024-518180-35-00