Remibrutinib for Papulopustular Rosacea

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

Recruiting Phase 2 Interventional Study
Papulopustular Rosacea
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for

This trial is looking for adults with moderate-to-severe papulopustular rosacea. Participants will receive treatment with remibrutinib and will be monitored for its effects and safety.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am an adult aged 18 or older.
  • I have been diagnosed with papulopustular rosacea.
  • I have moderate-to-severe disease based on a specific score.
  • I have 15 to 60 inflammatory facial lesions.
  • I stopped using certain antibiotics and therapies before starting.
  • I agree not to use other treatments for my condition during the study.

You may not be able to join if

  • I have more than 2 nodular inflammatory lesions.
  • I have active skin conditions that might affect my rosacea assessment.
  • I am allergic to any of the study treatments or similar drugs.
  • I have used biologics recently.
  • I have taken certain medications before the study that are not allowed.
  • I have used corticosteroids, antibiotics, or specific topical treatments recently.
  • I have received a live vaccine recently.
  • I have used remibrutinib or another BTK-inhibitor in the last 4 months.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Key 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 inflammator…
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Novartis Pharmaceuticals

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