A 12-week Randomized, Participant and Investigator-blinded, Placebo-controlled, Exploratory Study in Adult Participants With Chronic Urticaria to Assess the Efficacy and Safety and Explore the Mechanism of Action of Remibrutinib (LOU064)

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants with Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CINDU).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Signed informed consent must be obtained prior to participation in the study.

• Male and female participants ≥ 18 years of age at the time of signing of the informed consent forms.

• CINDU patients: Confirmed diagnosis of CINDU with a duration of ≥ 4 months (defined as onset of CINDU with supporting documentation (e.g. medical record, clinical history, photographs) and inadequate control with H1-AH at local label approved doses at the time of randomization. The response to the provocation test for each CINDU subtype is required before randomization (either during screening or prior to randomization on Day 1):

• CINDU patients: Patients should be symptomatic for their most bothersome symptom as assessed with the USDD during baseline with a NRS score of 3 or more

• CSU patients: Diagnosis of CSU (acc. to Zuberbier et al 2022c) not adequately controlled with H1-AH at approved doses alone for at least 4 weeks prior to randomization, as defined by all of the following:

‣ UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during 7 days prior to randomization

⁃ CSU for ≥ 6 months

• Participants must be willing and able to attend the protocol defined test procedure throughout the study.

Locations
United States
Florida
Ziaderm Research LLC
RECRUITING
North Miami Beach
Illinois
Endeavor Health
RECRUITING
Glenview
Other Locations
France
Novartis Investigative Site
RECRUITING
Grenoble
Novartis Investigative Site
RECRUITING
Montpellier
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Pierre-bénite
Germany
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Dresden
Novartis Investigative Site
RECRUITING
Mainz
Novartis Investigative Site
RECRUITING
Tübingen
Poland
Novartis Investigative Site
RECRUITING
Poznan
Novartis Investigative Site
RECRUITING
Rzeszów
Novartis Investigative Site
RECRUITING
Warsaw
Spain
Novartis Investigative Site
RECRUITING
Alicante
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Pamplona
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2027-10-07
Participants
Target number of participants: 44
Treatments
Experimental: LOU064-CINDU
Diagnosis of Chronic Inducible Urticaria (CINDU), symptoms of symptomatic dermographism urticaria, cold urticaria, cholinergic urticaria, heat urticaria, solar urticaria, urticaria as diagnosed by pressure, evidence of urticaria after exposure to water, evidence of urticaria following contact to identified material causing urticaria symptoms.
Experimental: LOU064-CSU
Diagnosis of Chronic Spontaneous Urticaria (CSU) not adequately controlled
Placebo_comparator: Placebo-CINDU
Diagnosis of Chronic Inducible Urticaria (CINDU), symptoms of symptomatic dermographism urticaria, cold urticaria, cholinergic urticaria, heat urticaria, solar urticaria, urticaria as diagnosed by pressure, evidence of urticaria after exposure to water, evidence of urticaria following contact to identified material causing urticaria symptoms.
Placebo_comparator: Placebo-CSU
Diagnosis of Chronic Spontaneous Urticaria (CSU) not adequately controlled
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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