Resumen

The purpose of this study was to assess the effect of remibrutinib 25 mg twice a day (b.i.d.) open-label on Systolic Blood Pressure (SBP) measured as a change in 24-hour weighted average SBP from baseline to Week 4 assessed by Ambulator Blood Pressure Monitoring (ABPM); and to assess overall safety and efficacy over 12 weeks in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled with second generation H1 antihistamines (H1-AH) treatment. ABPM was chosen for the blood pressure assessment in this trial as recommended by the FDA for drugs intended for chronic use (Assessment of Pressor Effects of Drugs Guidance for Industry (FDA 2022)).

Descripción detallada

This study consisted of a screening period of up to 4 weeks, a 12-week open-label treatment period and a treatment-free follow-up period of 4 weeks, with a total study duration of up to 20 weeks. At the end of the treatment phase, participants had the option to continue in an extension study (CLOU064A2303B (NCT05513001)) if approved in the country and at the site.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

Signed informed consent obtained prior to participation in the study
Male and female adult participants \>= 18 years of age
CSU duration for \>= 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation).
Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of baseline (Day 1)
Documentation of hives within three months before baseline (either at screening and/or at baseline (Day 1); or documented in the participants' medical history).
Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the protocol
Participants had no more than 2 missing UPDD entries (either morning or evening) in the 7 days prior to baseline (Day 1).

Criterios de exclusión

Participants unable to tolerate 24-hour ambulatory blood pressure measurement using automatic ABPM device
Ongoing or past history of hypertension and/or SBP \>= 140 or =\< 90 OR DBP \>= 90 or =\< 60 mmHg at screening
Participants working night shifts
Participants taking/requiring medications prohibited by the protocol (including those known to interfere with blood pressure assessments in the study)
Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the Investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.

Intervenciones

drug

LOU064

One film-coated tablet (25 mg) was to be taken in the morning and evening, respectively, with a 12-hour interval at approximately the same time everyday.

Ubicaciones

Novartis Investigative Site

Nueve de Julio, Buenos Aires, Argentina

Novartis Investigative Site

Sourigues, Buenos Aires, Argentina

Novartis Investigative Site

Santa Fe, Rosario, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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.

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

LOU064

Ubicaciones

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Patrocinadores