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

NCT07681271 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: CLOU064Q122012025-524496-23-00
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Papulopustular Rosacea

Keywords

Papulopustular Rosacea; PPR; Ph2; efficacy; safety; tolerability

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in facial inflammatory lesion count

  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.

  Baseline, Week 16

Secondary Outcomes (2)

• Proportion of participants with Investigator's Global Assessment (IGA,modified scale without erythema) grade 0 or 1, with at least 2 grade reduction from baseline

  Baseline, Week 16

• Percentage change from baseline in facial inflammatory lesion count

  Baseline, Week 16

Study Arms (2)

LOU064

EXPERIMENTAL

LOU064 administered by oral route

Drug: LOU064

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

LOU064 DRUG

LOU064 administered by oral route

Also known as: Remibrutinib

LOU064

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Three A Research

El Paso, Texas, 79902, United States

RECRUITING

MeSH Terms

Conditions

Rosacea; Primary hyperoxaluria type 2

Interventions

remibrutinib

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): December 7, 2027
• Study Completion (Estimated): December 7, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)