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

Part of paid clinical trials in El Paso, Texas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07681271
Phase
PHASE2
Status
Recruiting
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Conditions

  • Papulopustular Rosacea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LOU064 — DRUG
    LOU064 administered by oral route
  • Placebo — DRUG
    Matching placebo

Study Details

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.

Key Dates

First listed
Jul 2, 2026
Start date
Jul 29, 2026
Status verified
Jul 2026
Primary completion
Dec 7, 2027
Completion
Dec 7, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LOU064
    LOU064 administered by oral route
  • Placebo Comparator: Placebo
    Matching placebo

Primary Outcome Measure

Absolute change from baseline in facial inflammatory lesion count [ Time Frame: Baseline, Week 16 ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (1)

FacilityCityStateZIPSite coordinators
Three A ResearchEl PasoTexas79902
Genesis Jaramillo
[email protected]
Brenda Simpson (PRINCIPAL_INVESTIGATOR)

Find similar trials in El Paso, TX

By research site
Three A Research· El Paso, TX

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