^
    2ms
    An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib (clinicaltrials.gov)
    P3, N=696, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=1021 --> 696 | Trial completion date: Aug 2027 --> Feb 2027 | Trial primary completion date: Jul 2027 --> Feb 2027
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    remibrutinib (LOU064)
    3ms
    Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov)
    P2, N=248, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    remibrutinib (LOU064) • ianalumab (VAY736)
    6ms
    A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks. (clinicaltrials.gov)
    P3, N=144, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion
    |
    remibrutinib (LOU064)
    6ms
    Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts (clinicaltrials.gov)
    P2, N=72, Recruiting, Novartis Pharmaceuticals | N=110 --> 72 | Trial completion date: Apr 2026 --> Feb 2025
    Enrollment change • Trial completion date
    |
    remibrutinib (LOU064)
    7ms
    Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov)
    P2, N=245, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Oct 2026 --> Nov 2024
    Trial primary completion date
    |
    remibrutinib (LOU064) • ianalumab (VAY736)
    7ms
    A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients. (clinicaltrials.gov)
    P3, N=468, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2026 --> Mar 2027
    Trial completion date
    |
    remibrutinib (LOU064)
    9ms
    A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks. (clinicaltrials.gov)
    P3, N=144, Active, not recruiting, Novartis Pharmaceuticals | Initiation date: Jan 2023 --> Oct 2022
    Trial initiation date
    |
    remibrutinib (LOU064)
    11ms
    A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines (clinicaltrials.gov)
    P3, N=348, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Pan tumor
    |
    remibrutinib (LOU064)
    almost1year
    A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients. (clinicaltrials.gov)
    P3, N=468, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting | Phase classification: P3b --> P3
    Enrollment open • Phase classification
    |
    remibrutinib (LOU064)
    1year
    A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Hepatic Impairment Compared With Matched Healthy Participants (clinicaltrials.gov)
    P1, N=48, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2023 --> Dec 2023
    Trial completion date • Trial primary completion date
    |
    remibrutinib (LOU064)
    1year
    Remibrutinib (LOU064) inhibits neuroinflammation driven by B cells and myeloid cells in preclinical models of multiple sclerosis. (PubMed, J Neuroinflammation)
    Remibrutinib inhibited EAE models by a two-pronged mechanism based on inhibition of pathogenic B cell autoreactivity, as well as direct anti-inflammatory effects in microglia. Remibrutinib showed efficacy in both models in absence of direct B cell depletion, broad T cell inhibition or reduction of total Ig levels. These findings support the view that remibrutinib may represent a novel treatment option for patients with MS.
    Preclinical • Journal
    |
    remibrutinib (LOU064)
    over1year
    Remibrutinib Inhibits Neuroinflammation Driven by B Cells and Myeloid Cells in Preclinical Models of Multiple Sclerosis (AAN 2023)
    Potential for efficacy and anti-inflammatory effects on myeloid cells and microglia was observed. Remibrutinib may represent a novel treatment option for patients with MS.
    Preclinical
    |
    NEFL (Neurofilament Light Chain)
    |
    remibrutinib (LOU064)
    2years
    Remibrutinib inhibits neuroinflammation driven by B cells and myeloid cells in preclinical models of multiple sclerosis (ECTRIMS 2022)
    Remibrutinib exhibited dose-dependent efficacy in a B cell-driven EAE model. In addition, it revealed efficacy on clinical scores and anti-inflammatory effects by acting on myeloid cells and microglia. These findings support the view that remibrutinib may represent a novel treatment option for patients with MS.
    Preclinical
    |
    NEFL (Neurofilament Light Chain)
    |
    remibrutinib (LOU064)
    over2years
    Novel Bruton's tyrosine kinase inhibitor remibrutinib: Assessment of drug-drug interaction potential as a perpetrator of cytochrome P450 enzymes and drug transporters and the impact of covalent binding on possible drug interactions. (PubMed, Eur J Pharm Sci)
    Observed inhibition of metabolic enzymes indicated that remibrutinib is a weak inhibitor of CYP3A4 and CYP2C9 and is not a clinically relevant inhibitor of uptake and efflux transporters, except for intestinal P-glycoprotein and breast cancer resistance protein inhibition. OC may be safely administered and are effective when given with pharmacologically relevant doses of remibrutinib.
    Journal
    |
    CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    remibrutinib (LOU064)