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.
Completed · Phase 3
Conditions studied: Chronic Spontaneous Urticaria
In brief
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)).
Key facts
- Study ID
- NCT05795153
- Run by
- Novartis Pharmaceuticals
- People needed
- 144
- Starts
- 2023-04-05
- Expected to finish
- 2024-04-25
- Last updated by the study team
- 2025-10-16
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Acuro Research Inc — Little Rock, Arkansas, United States
- Florida Ctr Allergy Asthma Research — Aventura, Florida, United States
- Finlay Medical Research — Greenacres City, Florida, United States
- Treasure Valley Medical Research — Boise, Idaho, United States
- Endeavor Health — Glenview, Illinois, United States
- Allergy and Asthma Specialist P S C — Owensboro, Kentucky, United States
- Allergy Asthma and Clinical Research — Oklahoma City, Oklahoma, United States
- Allergy and Clinical Immunology Associates — Pittsburgh, Pennsylvania, United States
- Western Sky Medical Research — El Paso, Texas, United States
- Allergy Asthma and amp Sinus Ctr S C — Greenfield, Wisconsin, United States
- Novartis Investigative Site — Nueve de Julio, Buenos Aires, Argentina
- Novartis Investigative Site — Sourigues, Buenos Aires, Argentina
- Novartis Investigative Site — Santa Fe, Rosario, Argentina
- Novartis Investigative Site — Rosario, Santa Fe Province, Argentina
- Novartis Investigative Site — Calgary, Alberta, Canada
- Novartis Investigative Site — Montreal, Quebec, Canada
- Novartis Investigative Site — Angers, France
- Novartis Investigative Site — Antony, France
- Novartis Investigative Site — Brest, France
- Novartis Investigative Site — Montpellier, France
- Novartis Investigative Site — Paris, France
- Novartis Investigative Site — Reims, France
- Novartis Investigative Site — Saint-Mandé, France
- Novartis Investigative Site — Toulouse, France
- Novartis Investigative Site — Bramsche, Lower Saxony, Germany
Full record on ClinicalTrials.gov
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