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Phase 2 Study of Remibrutinib for Papulopustular Rosacea

This Phase 2 study is looking at an oral medication called remibrutinib (LOU064) for adults with moderate-to-severe papulopustular rosacea (PPR). PPR is a skin condition that causes red bumps and pus-filled pimples on the face. Researchers want to see if remibrutinib can reduce these inflammatory lesions and if it is safe and well-tolerated. The study will compare remibrutinib to a placebo (an inactive substance that looks like the study drug). About 80 people are expected to join. To be eligible, you must be at least 18 years old and have a clinical diagnosis of moderate-to-severe PPR, with 15 to 60 inflammatory lesions.

Study design
This is a randomized, participant and investigator-blinded, placebo-controlled Phase 2 study involving about 80 participants. Participants will receive either remibrutinib or a matching placebo.
What's involved
After a screening period of up to 30 days (which can be extended), eligible participants will take either remibrutinib or placebo for 16 weeks.
Compensation
Not stated in the trial record.
Follow-up
A safety follow-up visit will occur approximately 30 days after your final dose of the study medication.

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NCT07681271

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~80 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:LOU064Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Absolute change from baseline in facial inflammatory lesion count
Measured over Baseline, Week 16

Conditions

Papulopustular Rosacea

Explore related trials

Papulopustular Rosacea

Where it's being run

1 sites across 1 states
Texas1

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Absolute change from baseline in facial inflammatory lesion countBaseline, Week 16

    The facial inflammatory lesion count is defined as the sum of papules, pustules, and nodules present on the face. Lesions are visually counted across the full facial area (forehead, cheeks, nose, chin). A negative value indicates a reduction in lesions (clinical improvement), as lower counts reflect less inflammatory activity.