Clinical trial NCT05795153: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Spontaneous Urticaria
Keywords: Chronic Spontaneous Urticaria (CSU)
remibrutinib
Systolic Blood Pressure (SBP)
Diastolic Blood Pressure (DBP)
Ambulator Blood Pressure Monitoring (ABPM)
H1 antihistamines (H1-AH) treatment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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)).

Detailed description: 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.

Eligibility criteria: Key Inclusion Criteria:

* 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).

Key Exclusion Criteria:

* 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.

Primary outcomes:
measure: Estimated Mean Change From Baseline at Week 4 in 24-hour Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Observed Mean Change From Baseline to Week 4 in 24-hour Weighted Average Systolic Blood Pressure (SBP) Measured by ABPM
timeFrame: Baseline, Week 4
measure: Estimated Mean Change From Baseline at Week 4 in 24-hour Diastolic Blood Pressure (DBP) Measured by ABPM
timeFrame: Baseline, Week 4
measure: Estimated Mean Change From Baseline at Week 4 in Daytime and Nighttime Average SBP Measured by ABPM
timeFrame: Baseline, Week 4
measure: Estimated Mean Change From Baseline at Week 4 in Daytime and Nighttime Average DBP Measured by ABPM
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Acuro Research Inc
state: Arkansas
city: Aventura
country: United States
facility: Florida Ctr Allergy Asthma Research
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research
state: Florida
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Glenview
country: United States
facility: Endeavor Health
state: Illinois
city: Owensboro
country: United States
facility: Allergy and Asthma Specialist P S C
state: Kentucky
city: Oklahoma City
country: United States
facility: Allergy Asthma and Clinical Research
state: Oklahoma
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Greenfield
country: United States
facility: Allergy Asthma and amp Sinus Ctr S C
state: Wisconsin
city: Nueve de Julio
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Sourigues
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Santa Fe
country: Argentina
facility: Novartis Investigative Site
state: Rosario
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Angers Cedex 9
country: France
facility: Novartis Investigative Site
city: Antony
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Saint Mande
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Bramsche
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Goettingen
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Halle Saale
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Dalseo Gu
city: Suwon si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Komarno
country: Slovakia
facility: Novartis Investigative Site
city: Levice
country: Slovakia
facility: Novartis Investigative Site
city: Nove Zamky
country: Slovakia
facility: Novartis Investigative Site
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kayseri
country: Turkey
facility: Novartis Investigative Site
city: Samsun
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: