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Long-term Safety and Efficacy of Remibrutinib in Adults with Moderate to Severe Hidradenitis Suppurativa

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study is being done in adults with hidradenitis suppurativa, a long-lasting skin disease that can cause painful lumps, swelling, and drainage under the skin. The study uses remibrutinib, also known by the code name LOU064, taken as a tablet by mouth. Some participants will receive different doses of remibrutinib, and some will receive placebo. The purpose of the study is to assess the long-term safety of remibrutinib in this condition.

The study is a follow-up, or extension, of earlier research and is designed to continue for a long period. During the study, participants will take the study tablets and return for regular checkups so the study team can watch for any health problems and see how the treatment is being tolerated over time. The study compares the two remibrutinib doses with placebo in a blinded way, which means the treatment given is not revealed to the participants or the study team during the study.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of the extension study

    You enter a phase 3 extension study for adults with moderate to severe hidradenitis suppurativa (HS, a long-term skin condition that causes painful lumps and swelling). The study is described as double-blind and double-dummy. Double-blind means that the treatment assignment is not known to you or the study staff. Double-dummy means that different study tablets are used so that the treatment groups look the same.

    You remain in the study for long-term treatment and monitoring. The study is designed to evaluate the safety of remibrutinib over time.

  2. Step 2

    Study treatment period

    You take one of the study treatments by mouth as a film-coated tablet. The study uses remibrutinib or a placebo. A placebo is a tablet that looks like the study medicine but does not contain the active medicine.

    Two doses of remibrutinib are studied. The source data lists the dose as 00 mg for both remibrutinib products, but no readable dose amount is provided beyond that. The medicine is taken orally, which means by mouth.

    The treatment is given for a long-term period. The exact duration of dosing is not stated in the source data.

  3. Step 3

    Ongoing study checks during treatment

    During the study, your condition is checked for treatment-emergent adverse events (TEAEs, meaning unwanted medical problems that start or become worse after treatment begins). This is the main safety measure in the study.

    Your skin condition is also assessed using study measures that track improvement. These include AN50/75/90, IHS4, HiSCR50/75/90, and NRS30 for participants who had a baseline NRS of 3 or more in the main studies. IHS4 is a scoring system used to measure HS severity. HiSCR is a measure of response in HS. NRS means numerical rating scale, a number-based symptom rating.

    The study records the percentage change from baseline, which means the change compared with the starting point of the study.

  4. Step 4

    End of study participation

    Your participation continues until the study ends. The estimated study period runs from 2026-09-30 to 2032-10-25.

    At the end of the study, your treatment period and study assessments stop.

Who can join the trial?

6 criteria

  • The participant must have signed informed consent before any study checks are done. This means the person agrees in writing to take part after being told about the study.
  • The participant must be able to communicate effectively with the study doctor or investigator, which means they can understand questions and give clear answers.
  • The participant must be willing and able to follow all study requirements, including visits, instructions, and treatment rules.
  • The participant must have completed the full treatment period in the earlier core study, which lasted 68 weeks. A treatment period is the planned time a person receives the study treatment.
  • The participant must have taken part in one of the core studies: CLOU064J12301 or CLOU064J12302.
  • The participant must not meet any treatment stopping criteria at Week 68 in the core study. Treatment stopping criteria are the rules that would require the study treatment to be stopped.

Who cannot join the trial?

7 criteria

  • Ongoing or planned use of prohibited treatments for hidradenitis suppurativa or for other conditions. “Prohibited” means treatments that are not allowed during the study.
  • Being judged by the study doctor as unlikely to benefit from the extension study, or as having an unacceptable safety risk if taking part.
  • Having a severe, worsening, or uncontrolled illness right now, if the study doctor decides this makes the person unsuitable for the study. “Uncontrolled” means not kept stable or not well managed.
  • Being pregnant.
  • Being breastfeeding or lactating. “Lactating” means producing breast milk.
  • Planning to become pregnant during the study or within 4 weeks after the last dose of the study treatment.
  • Being a woman who can become pregnant and not using a highly effective birth control method while taking the study treatment and for 7 days after stopping it. “Highly effective” means a method with less than 1% chance of failure per year.
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Investigated drugs

Remibrutinib is the study medicine being tested in this trial. It is taken by mouth as a film-coated tablet and is being studied to see how safe it is and how well it works over a long period of time in adults with moderate to severe hidradenitis suppurativa. Some participants receive one of two study doses, but the main purpose is to find out whether remibrutinib can help control the disease and whether it is safe for long-term use.

What is already known about the treatment

Remibrutinib - Remibrutinib is taken by mouth as a film-coated tablet, which is swallowed whole. It is still an investigational medicine in clinical research and is not yet a standard treatment in routine medical practice for hidradenitis suppurativa. It is being studied for moderate to severe hidradenitis suppurativa, a long-lasting skin condition that causes painful lumps and inflammation, and it belongs to a group of medicines called Bruton’s tyrosine kinase inhibitors. At the molecular level, it works by blocking a protein called BTK inside immune cells, which helps reduce the signals that drive inflammation.

Investigated diseases

Hidradenitis suppurativa - Hidradenitis suppurativa is a long-term skin disease that causes painful, swollen lumps in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can break open and drain fluid or pus, and they may come back again and again. Over time, repeated inflammation can lead to tunnels under the skin and scarring.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523259-72-00Protocol codeCLOU064J12303BEstimated enrolment877 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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