ClinicalTrials.gov record NCT07681271

A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 25, 2026

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old and older
SexAll
LocationCanada, China, Singapore, South Korea, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, double-blind Phase 2 trial tests remibrutinib (LOU064) against matching placebo in adults with moderate-to-severe papulopustular rosacea. Treatment is oral and given for a 16-week double-blind period, with a safety follow-up about 30 days after the final dose. The study evaluates effects on facial inflammatory lesion counts and records safety and tolerability.

What it is studying. The study is testing whether inhibition of Bruton's tyrosine kinase with remibrutinib produces a measurable change in inflammatory facial lesion counts in adults with moderate-to-severe papulopustular rosacea, and it also assesses the drug's safety and tolerability in this setting.

What the researchers hope to learn. To evaluate efficacy by change in facial inflammatory lesion count at Week 16, to assess Investigator's Global Assessment responses, and to collect safety and tolerability data for remibrutinib in papulopustular rosacea.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This Phase 2 study aims to evaluate whether Bruton's tyrosine kinase (BTK) inhibition with remibrutinib can produce a clinically meaningful reduction in inflammatory lesions in adults with moderate-to-severe papulopustular rosacea, while also assessing safety and tolerability of remibrutinib in this indication.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • LOU064
  • Placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Signed informed consent must be obtained prior to participation in the study.
  • Adult ≥18 years with a clinical diagnosis of PPR.
  • Moderate-to-severe disease defined by a modified Investigator's Global Assessment (IGA) score of 3 or 4
  • The presence of 15 - 60 inflammatory (papular/pustular, max. 2 nodular) facial lesions at screening, with at least 15 lesions present at Day 1 (Baseline).
  • Completed requisite washout of systemic antibiotics (30 days) and other prohibited systemic therapies before randomization.
  • Willingness to refrain from initiating treatments or undergoing procedures that target or impact PPR during the double-blind period, and to use only protocol-allowed products.
  • Key

Exclusion criteria

  • Presence of more than 2 nodular inflammatory lesions
  • Any active facial dermatoses or skin disease or condition that may interfere with assessment of PPR (e.g., seborrheic dermatitis, perioral dermatitis, acne, acneiform eruptions from biologic medications, steroid-induced dermatitis resembling rosacea or acne).
  • History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
  • Use of biologics within five half-lives prior to screening or until the expected pharmacodynamic (PD) effect has returned to baseline, whichever is longer; or longer if required by local regulations
  • Use of small molecules and/or immunosuppressants that are not corticosteroids within 5 half-lives or within 30 days prior to screening, whichever is longer; or longer if required by local regulations
  • Any use of systemic corticosteroids, systemic antibiotics, or topical treatments (including corticosteroids, antibiotics, ivermectin, azelaic acid, or metronidazole) within 30 days prior to randomization, or any planned use of these agents during the study treatment period.
  • History of live attenuated vaccine within 6 weeks prior to randomization or requirement to receive these vaccinations at any time while on study treatment.
  • Use, planned use, or failure to meet the protocol-defined washout periods for prohibited therapies. In particular, patients with pretreatment with remibrutinib or another BTK-inhibitor within 4 months prior to randomization.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is a multicenter, randomized, participant and Investigator-blinded, placebo-controlled, parallel-group Phase 2 study designed to evaluate the efficacy, safety, and tolerability of remibrutinib in adults with moderate-to-severe PPR. Following a screening period of up to 30 days, which can be extended by a further 2 weeks only to allow washout from rosacea treatments and other systemic therapies as specified in the prohibited medication section, eligible participants will be randomized at baseline to receive either remibrutinib or matching placebo for a 16-week double-blind treatment phase. A safety follow up visit will occur approximately 30 days after the final dose.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After screening (up to 30 days; may be extended by up to 2 weeks to allow required washouts) participants are randomized to receive oral remibrutinib (LOU064) or matching placebo for a 16-week double-blind treatment period. Study visits include clinical skin assessments such as facial inflammatory lesion counts and Investigator's Global Assessment at baseline and Week 16, regular safety assessments during treatment, and a safety follow-up visit about 30 days after the final dose. Participants must complete required medication washouts before baseline and avoid other rosacea treatments while on study. The study team will monitor safety throughout; additional protocol-defined assessments may occur per study procedures.

How the study is structured. Participants are randomly assigned, and both participants and investigators are blinded, to one of two parallel groups: oral remibrutinib or matching placebo. There is a screening period (up to 30 days, with a possible 2-week extension for treatment washout), a 16-week double-blind treatment phase, and a safety follow-up visit about 30 days after the last dose.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Papulopustular Rosacea. Does it apply to my diagnosis?
  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The listed sites are in Canada, China, Singapore, South Korea, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Jul 30, 2026
Primary completion
Dec 7, 2027 (estimated)
Study completion
Dec 7, 2027 (estimated)
Target enrollment
100 participants (estimated)
Last updated on registry
Sep 28, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Novartis Pharmaceuticals

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (7)

  • Three A ResearchRecruiting

    El Paso, Texas, 79902 · United States

  • Novartis Investigative SiteRecruiting

    London, Ontario, N6H 5L5 · Canada

  • Novartis Investigative SiteRecruiting

    Markham, Ontario, L3P 1X3 · Canada

  • Novartis Investigative SiteRecruiting

    Shanghai, 200040 · China

  • Novartis Investigative SiteRecruiting

    Singapore, 308205 · Singapore

  • Novartis Investigative SiteRecruiting

    Dongjak Gu, Seoul, 07061 · South Korea

  • Novartis Investigative SiteRecruiting

    Icheon, 21431 · South Korea

Terms used on this page · explanations by MedicalUpdates.ai

informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
washout
A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
randomization
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
double-blind
Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
five half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
pharmacodynamic
What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.
immunosuppressants
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
corticosteroids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Key Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
blinded
Who does not know which intervention a participant is receiving. It can apply to participants, the people giving the treatment, those assessing results, or those analysing the data.
placebo-controlled
A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
parallel-group
Participants are divided into two or more groups, and each group receives a different intervention at the same time, so the groups can be compared.
prohibited medication
A medicine that participants may not use during the study, usually because it could interfere with the study treatment or its measurement.
matching placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
follow up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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