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Study on the Effectiveness of Ianalumab for Treating Moderate to Severe Hidradenitis Suppurativa in Patients

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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, which is characterized by painful lumps under the skin, often in areas like the armpits or groin. The study is looking at patients with moderate to severe forms of this condition. The main goal is to evaluate the effectiveness and safety of different investigational drugs compared to a placebo. One of the investigational drugs being tested is called VAY736, which is also known by its active substance name, ianalumab. This drug is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.

Participants in the study will receive either the investigational drug or a placebo. The study is designed to be "blinded," meaning neither the participants nor the researchers know who is receiving the actual drug and who is receiving the placebo. This helps ensure that the results are not influenced by expectations. The study will last for a period of 16 weeks, during which the participants' response to the treatment will be closely monitored. The primary focus is to see how many patients show a clinical response, which means an improvement in their condition, after the treatment period.

Throughout the study, the safety of the participants will be a top priority. This includes monitoring for any side effects or adverse events, as well as conducting regular physical examinations and checking vital signs. The study aims to provide valuable information on the potential benefits and risks of using VAY736 for treating moderate to severe hidradenitis suppurativa, which could lead to new treatment options for patients with this challenging condition.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, such as age between 18 and 65 years and a clinical diagnosis of hidradenitis suppurativa (HS) for at least 12 months.

    The study involves different cohorts, each with specific requirements regarding the number of inflammatory lesions.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to receive either an investigational drug or a placebo.

    The investigational drugs include VAY736, administered as a solution for infusion.

  3. Step 3

    Treatment administration

    The treatment is administered through subcutaneous use.

    The duration of the treatment phase is 16 weeks.

  4. Step 4

    Monitoring and assessments

    Throughout the study, regular monitoring occurs to assess the treatment's effectiveness and safety.

    Assessments include physical examinations, vital signs, laboratory tests, and ECGs.

  5. Step 5

    Evaluation of clinical response

    The primary goal is to evaluate the proportion of patients achieving a clinical response using the simplified Hidradenitis Suppurativa Clinical Response (HiSCR) after 16 weeks.

    Secondary evaluations focus on the number and severity of any adverse events experienced.

Who can join the trial?

6 criteria

  • Both male and female patients can participate.
  • Participants must be between 18 to 65 years old, including those ages.
  • Participants must have been clinically diagnosed with hidradenitis suppurativa (HS) for at least 12 months before the screening.
  • For Cohort A, C, and E: Participants need to have at least 5 inflammatory lesions, which are areas of swelling or lumps that may include abscesses or nodules.
  • For Cohort B and D: Participants need to have at least 3 inflammatory lesions, which are areas of swelling or lumps that may include abscesses or nodules.
  • For all groups: Participants should have no more than 15 fistulae (abnormal connections between organs or vessels) and must have HS lesions in at least two different body areas.

Who cannot join the trial?

8 criteria

  • Patients who have a different condition than moderate to severe hidradenitis suppurativa cannot participate. This is a skin condition that causes small, painful lumps under the skin.
  • Patients who are not within the specified age range for the study cannot participate. The study is for certain age groups only.
  • Patients who are not willing to follow the study procedures or take the study medication as directed cannot participate.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate cannot join.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have participated in another clinical trial recently may not be eligible to join this study.
  • Patients who have allergies or reactions to the study medication or similar medications cannot participate.
  • Patients who are unable to give informed consent, which means they cannot understand the study and agree to participate, cannot join.
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Investigated drugs

  • Investigational Drug A

    is being tested to see if it can help reduce the symptoms of moderate to severe hidradenitis suppurativa, a skin condition that causes painful lumps under the skin. This drug is being compared to a placebo to determine its effectiveness and safety.

  • Investigational Drug B

    is another treatment being studied for its potential to improve the condition of patients with moderate to severe hidradenitis suppurativa. Researchers are evaluating how well it works and whether it is safe for patients to use.

  • Investigational Drug C

    is included in the trial to explore its ability to alleviate the symptoms of hidradenitis suppurativa. The study aims to find out if this drug can provide relief for patients suffering from this chronic skin condition.

What is already known about the treatment

Adalimumab – Adalimumab is administered via subcutaneous injection and is currently well-established in medical literature as a treatment for various inflammatory conditions. It is primarily indicated for moderate to severe hidradenitis suppurativa, among other autoimmune diseases. The medication works by inhibiting tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. Adalimumab is classified as a biologic disease-modifying antirheumatic drug (DMARD).

Investigated diseases

Hidradenitis Suppurativa – Hidradenitis Suppurativa is a chronic skin condition characterized by small, painful lumps under the skin. These lumps can break open and cause tunnels under the skin, leading to scarring. The condition typically affects areas where skin rubs together, such as the armpits, groin, and under the breasts. It often starts after puberty and can persist for many years, with periods of flare-ups and remission. The severity of the condition can vary, with some individuals experiencing mild symptoms and others having more severe and widespread lesions. The exact cause is not fully understood, but it is believed to involve hair follicles becoming blocked and inflamed.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509296-16-00Protocol codeCCFZ533H12201BCEstimated enrolment343 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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