Study Description
The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 studies.
This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.
This is a global, multicenter, randomized, double-blind, placebo-controlled, randomized withdrawal Phase 3b extension study, followed by long-term open label treatment cycles to assess the efficacy, safety and tolerability of remibrutinib in adult participants with CSU inadequately controlled by H1-AH. The study comprises 2 Epochs. Epoch 1 is the initial study period for participants who completed preceding remibrutinib Phase 3 studies. Epoch 1 comprises of a 24-week randomized withdrawal period with remibrutinib or placebo for patients with UAS7<16 OR a 24 week Open-label treatment period with remibrutinib for patients with UAS7≥16.
Participants will be randomized in a 1:1 ratio to enter the double-blind placebo-controlled 24-week withdrawal phase. In case of relapse (UAS7≥16) in the blinded group, participants enter the (Re-)treatment period Epoch 1 and receive 24 weeks of Open-label treatment with remibrutinib. At the end of the (Re-)treatment period Epoch 1, participants will move to Epoch 2.
Epoch 2 is the second subsequent study period and consists of 24-week cycles that could either encompass treatment-free Observation and/or Open-label (Re-)treatment periods with remibrutinib, with or without background H1-AH.
In case of relapse (UAS7≥16) during an Observation period, participants enter the next (Re-)treatment period and receive 24 weeks of treatment with remibrutinib. Participants completing an Observation period 2/3/4/5 with a UAS7≤6 will complete the study. Participants with a UAS7 >6 -<16 can enter the next (Re-)treatment period if continuous treatment is considered necessary and beneficial for the individual participant. For participants with a UAS7<16 that enter the next (Re-)treatment period, remibrutinib monotherapy treatment (without background H1-AH) is required.
Interventions
LOU064 (blinded)
LOU064 (open label)
Placebo
Eligibility Criteria
Inclusion Criteria:
Written informed consent must be obtained before any assessment is performed.
Male and female, adult participants ≥18 years of age.
Participants who successfully completed the preceding core studies CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304 or CLOU064A2305 according to the respective protocols.
Willing and able to adhere to the study protocol and visit schedule.
Exclusion Criteria:
Significant bleeding risk or coagulation disorders.
History of gastrointestinal bleeding.
Requirement for anti-platelet medication.
Requirement for anticoagulant medication.
History or current hepatic disease.
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.
Study Location
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Ranelagh, Partido De Berazate,Buenos Aires,1884,Argentina
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Santa Fe,S3000FIL,Argentina
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Buenos Aires,Nueve De Julio,B6500BWQ,Argentina
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Rosario,Santa Fe,S2000JKR,Argentina
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Caba,Buenos Aires,C1414AIF,Argentina
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Capital Federal,C1023AAB,Argentina
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Santo Andre,SP,09060 650,Brazil
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Ottawa,Ontario,K1G 6C6,Canada
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Verdun,Quebec,H4G 3E7,Canada
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Calgary,Alberta,T2M 1A6,Canada
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Edmonton,Alberta,T6G 1C3,Canada
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Shanghai,200443,China
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Hangzhou,Zhejiang,310003,China
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Guangdong,Guangzhou,510091,China
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Hangzhou,Zhejiang,310016,China
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Guangzhou,Guangdong,510515,China
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Guangzhou,Guangdong,510630,China
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Wuxi,Jiangsu,214002,China
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Shanghai,200040,China
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Barranquilla,080020,Colombia
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Bogota,110221,Colombia
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Medellin,Antioquia,050010,Colombia
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Barranquilla,Atlantico,080002,Colombia
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Praha 5,150 06,Czech Republic
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Olomouc,779 00,Czech Republic
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Copenhagen NV,2400,Denmark
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Hellerup,2900,Denmark
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Brest,29609,France
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Paris,75970,France
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Montpellier cedex 5,34295,France
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Reims,51100,France
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Angers 09,49933,France
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Pierre Benite,69495,France
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Antony,92160,France
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Toulouse,31400,France
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Rouen,76031,France
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Nice,06000,France
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Saint Mande,94160,France
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Bordeaux Cedex,33075,France
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Halle,06097,Germany
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Gottingen,37075,Germany
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Berlin,13187,Germany
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Luebeck,23538,Germany
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Berlin,13353,Germany
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Muenchen,80377,Germany
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Mainz,55131,Germany
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Muenchen,81377,Germany
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Marburg,35039,Germany
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Dresden,01307,Germany
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Bad Bentheim,48455,Germany
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Merzig,66663,Germany
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Halle (Saale),06108,Germany
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Leipzig,04103,Germany
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Bramsche,49565,Germany
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Debrecen,Hajdu Bihar,4026,Hungary
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Debrecen,4032,Hungary
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Milano,MI,20162,Italy
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Fukuoka,819 0167,Japan
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Seoul,03080,Korea, Republic of
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Seoul,03722,Korea, Republic of
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Gwangju,61469,Korea, Republic of
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Seoul,07061,Korea, Republic of
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Incheon,405 760,Korea, Republic of
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Lodz,90-265,Poland
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Poznan,60-693,Poland
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Bialystok,15 276,Poland
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Poznan,60-823,Poland
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Warszawa,02-507,Poland
Alma Cruz-Santana Private Practice
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Carolina,Sandra Ortiz (+1 787 769 1954) email: [email protected] -- Alma Cruz,00985,Puerto Rico
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Cape Town,Western Province,7700,South Africa
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Pretoria,Gauteng,0009,South Africa
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Istanbul,34662,Turkey
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Samsun,55139,Turkey
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Izmir,35040,Turkey
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Talas / Kayseri,38039,Turkey
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Izmir,35140,Turkey
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Izmir,35380,Turkey
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Aydin,09100,Turkey
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Izmir,35620,Turkey
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Kayseri,38070,Turkey
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Sakarya,54290,Turkey
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Cardiff,CF14 4XW,United Kingdom
UCONN Health Dermatology
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Farmington,Margaret Toro (860-679-4600) email: [email protected] -- Jun Lu,06030-2840 - Connecticut,United States
Florida Ctr Allergy Asthma Research .
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Aventura,Aixa Valdes (305-273-2988) email: [email protected] -- Ileana Rodicio,33180 - Florida,United States
Antelope Valley Clinical Trials
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Lancaster,Rose Warner-Castellanos (661-429-0100) email: [email protected] -- Ricardo Tan,93534 - California,United States
Oakview Dermatology
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Athens,Leslie Lucas (740-566-4621) email: [email protected] -- Dawn Merritt,45701 - Ohio,United States
Northshore University Health System
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Glenview,Madeline Snedden (847-663-6814) email: [email protected] -- Giselle Mosnaim,60077 - Illinois,United States
Allergy and Asthma Diagnostic Treatment Center
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Tallahassee,(850-386-8034) -- Ronald H Saff,32308 - Florida,United States
Western Sky Medical Research
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El Paso,Catherine Posey-Sarinana (915-544-2557) email: [email protected] -- Todd Funkhouser,79924 - Texas,United States
Arkansas Research Trials
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North Little Rock,Hannah Anderson (+1 501 621 1100) email: [email protected] -- Scott Michael Dinehart,72117 - Arkansas,United States
Optimed Research LLC
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Columbus,(614-430-8022) -- Donald Mcneil,43235 - Ohio,United States
Allergy and Asthma Specialist P S C
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Owensboro,Andrea Arthur (270-684-6144) email: [email protected] -- Lee Clore,42301 - Kentucky,United States
Institute for Asthma and Allergy PC
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Chevy Chase,Amie Koroma (301-962-5800) email: [email protected] -- Mark Scarupa,20815 - Maryland,United States
Asthma and Allergy Associates P C
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Colorado Springs,Fellicia Grimes (719-473-8330) email: [email protected] -- Daniel Soteres,80907 - Colorado,United States
Orion Clinical Research .
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Austin,(512-492-3797) -- William Howland III,78759 - Texas,United States
Allergy Associates of Utah
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Murray,Maria Alcala (801-263-8700) email: [email protected] -- Andrew Smith,84107 - Utah,United States
John Hopkins University
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Baltimore,Kelly Devine (410-938-3000) email: [email protected] -- Sarbjit S Saini,21204 - Maryland,United States
Bellingham Asthma Allergy and Immunology
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Bellingham,(360-733-5733) -- David Elkayam,98225 - Washington,United States
RFSA Dermatology
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San Antonio,Lindsey Finklea,78213 - Texas,United States
Allergy Asthma Assoc Monmouth
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Little Silver,Laura Marini (732-741-8222) email: [email protected] -- Tina Zecca,07739 - New Jersey,United States
Kern Research
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Bakersfield,Wandy Noriega (661-864-7710) email: [email protected] -- Eric Boren,93301 - California,United States
Toledo Institute of Clinical Research
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Toledo,Faheem Husain (419-843-8815) email: [email protected] -- Syed Rehman,43617 - Ohio,United States
Deaconess Clin Allerg Res Inst
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Evansville,Jessica Welchance (812-463-4793) email: [email protected] -- Anne Mclaughlin,47715 - Indiana,United States
Allervie Clinical Research
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Birmingham,Justin Hall (205-209-4101) email: [email protected] -- John Anderson,35209 - Alabama,United States
Miami Dade Medical Research
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Miami,Estela Neira (305-722-7210) email: [email protected] -- Vicente Chavarria,33176 - Florida,United States
AeroAllergy Research Laboratories of Savannah, Inc.
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Savannah,Servon Jackson (912-356-3619) email: [email protected] -- Bruce Finkel,31406 - Georgia,United States
Treasure Valley Medical Research
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Boise,Stacy Gonzales email: [email protected] -- Neetu Talreja,83706 - Idaho,United States
Finlay Medical Research
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Greenacres City,Danelis Sanchez Perez (561-766-2181) email: [email protected] -- Jorge Calle Medina,33467 - Florida,United States
National Allergy and Asthma Research LLS
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North Charleston,Vera Markovic (843-820-1036) email: [email protected] -- Patricia Gerber,29420 - South Carolina,United States
Allergy and Asthma Consultants
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Redwood City,Sherry Lipson email: [email protected] -- Brian Lipson,94063 - California,United States
Worldwide Contacts
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