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.

Last updated: October 8, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Hives (Urticaria)

Urticaria

Treatment

LOU064

Clinical Study ID

NCT05795153
CLOU064A2305
2022-002838-13
  • Ages 18-99
  • All Genders

Study 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)).

Eligibility Criteria

Inclusion

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 CSUdetermined by the Investigator based on all available supporting documentation).

  • Diagnosis of CSU inadequately controlled by second generation H1-AH at the time ofbaseline (Day 1)

  • Documentation of hives within three months before baseline (either at screeningand/or at baseline (Day 1); or documented in the participants' medical history).

  • Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for theduration of the study and adhere to the protocol

  • Participants had no more than 2 missing UPDD entries (either morning or evening) inthe 7 days prior to baseline (Day 1).

Exclusion

Key Exclusion Criteria:

  • Participants unable to tolerate 24-hour ambulatory blood pressure measurement usingautomatic 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 (includingthose 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 ofthe study results or otherwise preclude participation or protocol adherence of theparticipant.

Study Design

Total Participants: 144
Treatment Group(s): 1
Primary Treatment: LOU064
Phase: 3
Study Start date:
April 05, 2023
Estimated Completion Date:
April 25, 2024

Study 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.

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  • Novartis Investigative Site

    Nueve de Julio, Buenos Aires B6500BWQ
    Argentina

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    Ranelagh Partido De Berazate, Buenos Aires 1884
    Argentina

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    Ranelagh, Partido De Berazate, Buenos Aires 1884
    Argentina

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    Nueve de Julio 3842881, Buenos Aires 3435907 B6500BWQ
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    Sourigues, Buenos Aires 3435907 B1837
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    Buenos Aires, Nueve De Julio B6500BWQ
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    Santa Fe, Rosario S2000DBS
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    Santa Fe 3836277, Rosario S2000DBS
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    Rosario, Santa Fe S2000JKR
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    Rosario 3838583, Santa Fe Province 3836276 S2000JKR
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    Calgary, Alberta T2M 1A6
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    Calgary 5913490, Alberta 5883102 T2M 1A6
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    Antony, 92160
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    Glenview, Illinois 60077
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    Glenview, Illinois 60077
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    Skokie, Illinois 60077
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    Greenfield 5255068, Wisconsin 5279468 53228
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