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.

Chronic Spontaneous Urticaria Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05795153
• Other study ID #: CLOU064A2305
• Secondary ID: 2022-002838-13
• Status: Completed
• Phase: Phase 3
• Start date: April 5, 2023
• Est. completion date: April 25, 2024

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: April 25, 2024
• Est. primary completion date: April 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study.

2. Male and female adult participants =18 years of age at the time of screening.

3. CSU duration for = 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation).

4. 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).

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

6. Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol.

7. 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:

1. 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.

2. Previous use of remibrutinib or other BTK inhibitors.

3. History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.

4. 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.

5. Ongoing or past history of hypertension and/or SBP =140 or =90 and/or DBP =90 or =60 mmHg at screening.

6. Participants unable to tolerate 24-hour ambulatory blood pressure measurement prior to baseline.

7. Participants with an arm circumference greater than 50cm.

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

Intervention

Drug:
• LOU064
LOU064 (Open-Label) taken orally for 12 weeks

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires	Nueve De Julio
Argentina	Novartis Investigative Site	Ranelagh Partido De Berazate	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Santa Fe	Rosario
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Montreal	Quebec
France	Novartis Investigative Site	Angers 09
France	Novartis Investigative Site	Antony
France	Novartis Investigative Site	Brest
France	Novartis Investigative Site	Montpellier cedex 5
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Reims
France	Novartis Investigative Site	Saint Mande
France	Novartis Investigative Site	Toulouse
Germany	Novartis Investigative Site	Bramsche
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Gottingen
Germany	Novartis Investigative Site	Halle (Saale)
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Marburg
Korea, Republic of	Novartis Investigative Site	Daegu	Dalseo Gu
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Suwon si	Gyeonggi Do
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Komarno
Slovakia	Novartis Investigative Site	Levice
Slovakia	Novartis Investigative Site	Nove Zamky
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Kayseri
Turkey	Novartis Investigative Site	Samsun
United States	Florida Ctr Allergy Asthma Research .	Aventura	Florida
United States	Florida Ctr Allergy Asthma Research Suite 408	Aventura	Florida
United States	Treasure Valley Medical Research	Boise	Idaho
United States	Western Sky Medical Research	El Paso	Texas
United States	Northshore University Health System .	Glenview	Illinois
United States	Finlay Medical Research	Greenacres City	Florida
United States	Allergy Asthma and amp Sinus Center S C	Greenfield	Wisconsin
United States	Little Rock Allergy and Asthma Clnc	Little Rock	Arkansas
United States	Allergy Asthma and Clinical Research	Oklahoma City	Oklahoma
United States	Allergy and Asthma Specialist P S C Main Center	Owensboro	Kentucky
United States	Allergy and Clinical Immunology Ass	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  France,  Germany,  Korea, Republic of,  Singapore,  Slovakia,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 4