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Efficacy and safety of remibrutinib (LOU064) in adult patients with papulopustular rosacea: a randomized, double‑blind, placebo‑controlled Phase 2 trial

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What is this trial about?

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

A clinical trial is being conducted in adults who have Papulopustular Rosacea, a skin condition that causes red bumps, pimples and sometimes small lumps on the face. The study will compare an oral tablet containing the experimental drug remibrutinib with a matching placebo tablet. The purpose of the study is to assess the efficacy of remibrutinib compared to placebo at Week 16.

Participants will be randomly assigned to receive either the active medication or the placebo, and neither the participants nor the study staff will know which treatment is being given (double‑blind). This is a phase 2 trial, meaning it is an early test of how well the drug works and how safe it is. After taking the tablets daily, subjects will attend a few clinic visits over about four months, during which doctors will count the facial lesions and evaluate overall skin appearance using a simple grading system. Any side effects that arise will be recorded throughout the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    You will attend a first visit after joining the study. during this visit a healthcare professional will examine your face, count the number of papules, pustules and nodules, and may take photographs. you will also answer questions about your medical history and current symptoms.

  2. Step 2

    Randomization

    Based on the information collected at the baseline visit, you will be randomly assigned to receive either remibrutinib (the test medication) or a placebo (an inactive tablet). the study is double‑blind, which means neither you nor the study staff will know which medication you receive.

  3. Step 3

    Receive study medication

    You will be given a supply of film‑coated tablets to take by mouth. each tablet contains 00 mg of the assigned medication. you will be instructed to take one tablet each day for a total period of 16 weeks.

  4. Step 4

    Daily medication intake

    Each day you will swallow one tablet with water, preferably at the same time each day. keep the tablets in a safe place and do not share them with anyone.

  5. Step 5

    Follow‑up visits

    You will return to the study site at approximately week 4, week 8, week 12 and week 16. at each visit the investigator will count facial lesions again, check for any side effects (also called treatment‑emergent adverse events), and ask about any new symptoms. these visits help determine how well the medication works and whether it is safe.

  6. Step 6

    Final assessment at week 16

    At the week 16 visit a comprehensive evaluation will be performed. the primary goal is to measure the absolute change in the number of facial inflammatory lesions compared with the baseline count. secondary goals include assessing overall improvement using the investigator’s global assessment and recording any side effects that occurred during the study.

Who can join the trial?

6 criteria

  • Signed informed consent (you agree in writing to join the study) must be obtained before you start.
  • You must be an adult aged 18 years or older and have a doctor‑confirmed diagnosis of Papulopustular Rosacea (PPR).
  • Your condition must be moderate to severe, which means a score of 3 or 4 on a special rating called the Investigator’s Global Assessment (IGA) that doctors use to measure rosacea severity.
  • You need to have between 15 and 60 red or pus‑filled spots (called papules or pustules) on your face at the screening visit, and at least 15 of those spots must still be present on the first day of treatment.
  • You must have stopped taking any systemic (body‑wide) antibiotics or other prohibited medicines for at least 30 days before randomization – this break is called a washout period.
  • You must agree not to start any new treatments or procedures that could affect your rosacea during the double‑blind part of the study, and you can only use the products that the study allows.

Who cannot join the trial?

8 criteria

  • Having more than two small, raised, inflamed bumps on the face, known as nodular inflammatory lesions.
  • Having any active skin condition on the face that could interfere with seeing the rosacea signs, such as oily, flaky skin (seborrheic dermatitis), a rash around the mouth (perioral dermatitis), regular acne, acne‑like rashes caused by other medicines, or a steroid‑induced rash that looks like rosacea or acne.
  • Having a known allergic reaction (hypersensitivity) to any of the study medicines, their inactive ingredients, or to medicines that are chemically similar.
  • Having used medicines made from living cells (biologics) within the time it takes for the drug to drop to half its level in the body (five half‑lives) before screening, or until its effect on the body has completely gone away.
  • Having taken other non‑steroid immune‑changing medicines (immunosuppressants) or small‑molecule drugs within five half‑lives or within 30 days before screening, whichever is longer.
  • Having used any whole‑body steroid medicines (systemic corticosteroids), whole‑body antibiotics (systemic antibiotics), or skin‑applied medicines (including steroids, antibiotics, ivermectin, azelaic acid, or metronidazole) within 30 days before being randomly assigned to treatment, or planning to use them during the study.
  • Having received a weakened‑virus vaccine (live attenuated vaccine) within 6 weeks before randomization, or needing such a vaccine while taking the study drug.
  • Not following the required waiting periods (washout periods) for prohibited medicines, especially if you have taken the study drug remibrutinib or another similar drug called a BTK‑inhibitor within the past 4 months.
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Investigated drugs

remibrutinib (LOU064) is an experimental oral tablet being studied as the active treatment in this trial. It is taken by mouth and is designed to target the underlying inflammation that causes papulopustular rosacea, a skin condition with redness, bumps, and pustules. In the study, participants receive this medication to see if it can improve their skin symptoms compared with a placebo, while researchers also monitor its safety and how well patients tolerate it.

What is already known about the treatment

  • Placebo to remibrutinib (LOU064) 00 mg film-coated tablet

    This is an oral film‑coated tablet that contains no active drug and is used only as a control in the study. It is not a marketed medicine and has no therapeutic use on its own. Because it has no active ingredient, it does not have a mechanism of action or a pharmacological class. It serves to help compare the effects of the test drug against a neutral baseline.

  • LOU064

    This is an oral film‑coated tablet that delivers the active substance remibrutinib. The drug is still in clinical testing (Phase 2) and is not yet approved for general medical use. It is being studied for treating papulopustular rosacea, a skin condition that causes red bumps and pustules. Remibrutinib works by blocking a protein called Bruton’s tyrosine kinase, which reduces the inflammatory signals that cause the skin lesions. It belongs to the class of BTK inhibitors, a type of small‑molecule drug.

Investigated diseases

Papulopustular rosacea - It is a long‑lasting skin disorder that mainly affects the central face. The condition starts with frequent flushing and then develops small red bumps and pus‑filled pimples. Over time the lesions can become more numerous and may merge into larger nodules. The redness and bumps often worsen with heat, spicy foods, alcohol, or stress. If not controlled, the skin may become thicker and the appearance more persistent.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524496-23-00Protocol codeCLOU064Q12201Estimated enrolment100 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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