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.

NCT05795153 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CLOU064A23052022-002838-13
• Study Type: interventional
• Target: 144
• Locations: 10 countries
• Sites: 44

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)).

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

Outcome Measures

Primary Outcomes (1)

• Estimated Mean Change From Baseline at Week 4 in 24-hour Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM)

  A linear regression with SBP as a covariate was employed. The change in SBP from baseline to Week 4 was predicted at the median baseline level. The change from baseline in the 24-hour weighted average SBP was calculated using the time weighted average of the area under the curve (AUC) of SBP obtained over a 24-hour period as measured by ABPM. That is, the time weighted average of AUC of 24-hour SBP obtained at baseline was subtracted from corresponding time weighted average of AUC of SBP at Week 4. In the analysis, if participants took prohibited antihypertensive treatment before Week 4, their subsequent measurements were excluded. In such cases, the excluded measurements were imputed by increasing the 24-hour SBP by 3 mmHg from the baseline value at Week 4. Moreover, participants who discontinued of study treatment due to any reason prior to the Week 4 were excluded from the analysis. The Mixed Models for Repeated Measures (MMRM) approach was used.

  Baseline, Week 4

Secondary Outcomes (4)

• Observed Mean Change From Baseline to Week 4 in 24-hour Weighted Average Systolic Blood Pressure (SBP) Measured by ABPM

  Baseline, Week 4

• Estimated Mean Change From Baseline at Week 4 in 24-hour Diastolic Blood Pressure (DBP) Measured by ABPM

  Baseline, Week 4

• Estimated Mean Change From Baseline at Week 4 in Daytime and Nighttime Average SBP Measured by ABPM

  Baseline, Week 4

• Estimated Mean Change From Baseline at Week 4 in Daytime and Nighttime Average DBP Measured by ABPM

  Baseline, Week 4

Study Arms (1)

LOU064 (remibrutinib)

EXPERIMENTAL

All participants were assigned to remibrutinib 25 mg b.i.d. for 12 weeks.

Drug: LOU064

Interventions

LOU064 DRUG

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.

Also known as: remibrutinib

LOU064 (remibrutinib)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (44)

Acuro Research Inc

Little Rock, Arkansas, 72205, United States

Location

Florida Ctr Allergy Asthma Research

Aventura, Florida, 33180, United States

Location

Finlay Medical Research

Greenacres City, Florida, 33467, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Endeavor Health

Glenview, Illinois, 60077, United States

Location

Allergy and Asthma Specialist P S C

Owensboro, Kentucky, 42301, United States

Location

Allergy Asthma and Clinical Research

Oklahoma City, Oklahoma, 73120, United States

Location

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241, United States

Location

Western Sky Medical Research

El Paso, Texas, 79924, United States

Location

Allergy Asthma and amp Sinus Ctr S C

Greenfield, Wisconsin, 53228, United States

Location

Novartis Investigative Site

Nueve de Julio, Buenos Aires, B6500BWQ, Argentina

Location

Novartis Investigative Site

Sourigues, Buenos Aires, B1837, Argentina

Location

Novartis Investigative Site

Santa Fe, Rosario, S2000DBS, Argentina

Location

Novartis Investigative Site

Rosario, Santa Fe Province, S2000JKR, Argentina

Location

Novartis Investigative Site

Calgary, Alberta, T2M 1A6, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H2V 2K1, Canada

Location

Novartis Investigative Site

Angers, 49933, France

Location

Novartis Investigative Site

Antony, 92160, France

Location

Novartis Investigative Site

Brest, 29609, France

Location

Novartis Investigative Site

Montpellier, 34295, France

Location

Novartis Investigative Site

Paris, 75970, France

Location

Novartis Investigative Site

Reims, 51100, France

Location

Novartis Investigative Site

Saint-Mandé, 94160, France

Location

Novartis Investigative Site

Toulouse, 31400, France

Location

Novartis Investigative Site

Bramsche, Lower Saxony, 49565, Germany

Location

Novartis Investigative Site

Göttingen, Lower Saxony, 37075, Germany

Location

Novartis Investigative Site

Halle, Saxony-Anhalt, 06108, Germany

Location

Novartis Investigative Site

Erlangen, 91054, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Marburg, 35039, Germany

Location

Novartis Investigative Site

Singapore, 308205, Singapore

Location

Novartis Investigative Site

Komárno, 945 01, Slovakia

Location

Novartis Investigative Site

Levice, 934 01, Slovakia

Location

Novartis Investigative Site

Nové Zámky, 940 34, Slovakia

Location

Novartis Investigative Site

Daegu, Dalseo Gu, 41931, South Korea

Location

Novartis Investigative Site

Suwon, Gyeonggi-do, 16499, South Korea

Location

Novartis Investigative Site

Seoul, 03080, South Korea

Location

Novartis Investigative Site

Alicante, Valencia, 03010, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46014, Spain

Location

Novartis Investigative Site

Madrid, 28006, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Izmir, 35140, Turkey (Türkiye)

Location

Novartis Investigative Site

Kayseri, 38070, Turkey (Türkiye)

Location

Novartis Investigative Site

Samsun, 55139, Turkey (Türkiye)

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Chronic Urticaria

Interventions

remibrutinib

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: April 5, 2023
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: October 16, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (2); FR (8); KR (3); US (10); TU (3); DE (6); SG (1); AR (4); ES (4); SL (3)