Recruiting
Phase 2

Remibrutinib

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07681271

Conditions

Papulopustular Rosacea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LOU064

Placebo

Study Details

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

Study ID

NCT07681271

Start date

Jul 30, 2026

Status verified date

Sep, 2026

Completion date

Dec 7, 2027

Anticipated

Primary completion date

Dec 7, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LOU064

LOU064 administered by oral route

placebo comparator: Placebo

Matching placebo

Interventions

LOU064

LOU064 administered by oral route

Placebo

Matching placebo

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

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

Novartis Pharmaceuticals

+41613241111

Locations

Three A Research

Recruiting

El Paso, Texas, United States, 79902

Contacts

Genesis Jaramillo

genesis@3aresearch.com

Principal Investigator:

Brenda Simpson

Novartis Investigative Site

Recruiting

London, Ontario, Canada, N6H 5L5

Novartis Investigative Site

Recruiting

Markham, Ontario, Canada, L3P 1X3

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • Papulopustular Rosacea
  • PPR
  • Ph2
  • efficacy
  • safety
  • tolerability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-09-14.