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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.

Primary Purpose

Chronic Spontaneous Urticaria

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LOU064
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring CSU, remibrutinib

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study. Male and female adult participants ≥18 years of age at the time of screening. 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) defined as: The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of second generation H1-AH during this time period. UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0-21) ≥ 6 during the 7 days prior to 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 study protocol. Participants must not have had more than two missing UPDD entry (either morning or evening) in the 7 days prior to baseline (Day 1). Exclusion Criteria: Use of other investigational drugs within 5 half-lives or within 30 days (for small molecules) prior to Screening or until the expected pharmacodynamic (PD) effect has returned to baseline (for biologics), whichever is longer; or longer if required by local regulations. Previous use of remibrutinib or other BTK inhibitors. History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes. Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria. Ongoing or past history of hypertension and/or SBP ≥140 or ≤90 and/or DBP ≥90 or ≤60 mmHg at screening. Participants unable to tolerate 24-hour ambulatory blood pressure measurement prior to baseline. Participants with an arm circumference greater than 50cm.

Sites / Locations

  • Novartis Investigative SiteRecruiting
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LOU064 (remibrutinib)

Arm Description

Open label single arm trial.

Outcomes

Primary Outcome Measures

Ambulatory blood pressure monitoring (ABPM) measurement
The change in the Ambulatory blood pressure monitoring (ABPM)-measured 24-hour weighted average systolic blood pressure (SBP) at Week 4 compared to baseline

Secondary Outcome Measures

Full Information

First Posted
March 21, 2023
Last Updated
October 12, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05795153
Brief 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.
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
July 19, 2024 (Anticipated)
Study Completion Date
August 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the study is to rule out an increase of >3mmHg in 24-hour average Systolic Blood Pressure at steady state (Week 4) compared to baseline. 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
The primary objective of the study is to rule out an increase of >3mmHg in 24-hour average Systolic Blood Pressure at steady state (Week 4) compared to baseline. 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)). It allows the observation over a 24-hour period and the measure of an individual's blood pressure throughout an entire day. This ABPM study will be performed in a patient population similar to the ongoing Phase 3 studies. The study duration will be up to 20 weeks. The treatment duration will be up to 12 weeks and the visit frequency will be once every 4 weeks with additional 2 visits for application of the ABPM device before baseline and Week 4 visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria
Keywords
CSU, remibrutinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LOU064 (remibrutinib)
Arm Type
Experimental
Arm Description
Open label single arm trial.
Intervention Type
Drug
Intervention Name(s)
LOU064
Other Intervention Name(s)
remibrutinib
Intervention Description
LOU064 (Open-Label) taken orally for 12 weeks
Primary Outcome Measure Information:
Title
Ambulatory blood pressure monitoring (ABPM) measurement
Description
The change in the Ambulatory blood pressure monitoring (ABPM)-measured 24-hour weighted average systolic blood pressure (SBP) at Week 4 compared to baseline
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent must be obtained prior to participation in the study. Male and female adult participants ≥18 years of age at the time of screening. 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) defined as: The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of second generation H1-AH during this time period. UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0-21) ≥ 6 during the 7 days prior to 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 study protocol. Participants must not have had more than two missing UPDD entry (either morning or evening) in the 7 days prior to baseline (Day 1). Exclusion Criteria: Use of other investigational drugs within 5 half-lives or within 30 days (for small molecules) prior to Screening or until the expected pharmacodynamic (PD) effect has returned to baseline (for biologics), whichever is longer; or longer if required by local regulations. Previous use of remibrutinib or other BTK inhibitors. History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes. Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria. Ongoing or past history of hypertension and/or SBP ≥140 or ≤90 and/or DBP ≥90 or ≤60 mmHg at screening. Participants unable to tolerate 24-hour ambulatory blood pressure measurement prior to baseline. Participants with an arm circumference greater than 50cm.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79912
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ranelagh, Partido De Berazate
State/Province
Buenos Aires
ZIP/Postal Code
1884
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Buenos Aires
State/Province
Nueve De Julio
ZIP/Postal Code
B6500BWQ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santa Fe
State/Province
Rosario
ZIP/Postal Code
S2000DBS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000JKR
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2M 1A6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2V 2K1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Angers 09
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Antony
ZIP/Postal Code
92160
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75970
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Reims
ZIP/Postal Code
51100
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Saint Mande
ZIP/Postal Code
94160
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toulouse
ZIP/Postal Code
31400
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bramsche
ZIP/Postal Code
49565
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Halle (Saale)
ZIP/Postal Code
06108
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Langenau
ZIP/Postal Code
89129
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Daegu
State/Province
Dalseo Gu
ZIP/Postal Code
42602
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Suwon si
State/Province
Gyeonggi Do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
308205
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Komarno
ZIP/Postal Code
945 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Levice
ZIP/Postal Code
934 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nove Zamky
ZIP/Postal Code
940 34
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Alicante
State/Province
Comunidad Valenciana
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35140
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kayseri
ZIP/Postal Code
38070
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

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.

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