Phase
Condition
Hives (Urticaria)
Urticaria
Treatment
LOU064
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
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 CSUdetermined by the Investigator based on all available supporting documentation).
Diagnosis of CSU inadequately controlled by second generation H1-AH at the time ofbaseline (Day 1)
Documentation of hives within three months before baseline (either at screeningand/or at baseline (Day 1); or documented in the participants' medical history).
Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for theduration of the study and adhere to the protocol
Participants had no more than 2 missing UPDD entries (either morning or evening) inthe 7 days prior to baseline (Day 1).
Exclusion
Key Exclusion Criteria:
Participants unable to tolerate 24-hour ambulatory blood pressure measurement usingautomatic 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 (includingthose 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 ofthe study results or otherwise preclude participation or protocol adherence of theparticipant.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Nueve de Julio, Buenos Aires B6500BWQ
ArgentinaSite Not Available
Novartis Investigative Site
Ranelagh Partido De Berazate, Buenos Aires 1884
ArgentinaSite Not Available
Novartis Investigative Site
Ranelagh, Partido De Berazate, Buenos Aires 1884
ArgentinaSite Not Available
Novartis Investigative Site
Nueve de Julio 3842881, Buenos Aires 3435907 B6500BWQ
ArgentinaSite Not Available
Novartis Investigative Site
Sourigues, Buenos Aires 3435907 B1837
ArgentinaSite Not Available
Novartis Investigative Site
Buenos Aires, Nueve De Julio B6500BWQ
ArgentinaSite Not Available
Novartis Investigative Site
Santa Fe, Rosario S2000DBS
ArgentinaSite Not Available
Novartis Investigative Site
Santa Fe 3836277, Rosario S2000DBS
ArgentinaSite Not Available
Novartis Investigative Site
Rosario, Santa Fe S2000JKR
ArgentinaSite Not Available
Novartis Investigative Site
Rosario 3838583, Santa Fe Province 3836276 S2000JKR
ArgentinaSite Not Available
Novartis Investigative Site
Calgary, Alberta T2M 1A6
CanadaSite Not Available
Novartis Investigative Site
Calgary 5913490, Alberta 5883102 T2M 1A6
CanadaSite Not Available
Novartis Investigative Site
Montreal, Quebec H2V 2K1
CanadaSite Not Available
Novartis Investigative Site
Montreal 6077243, Quebec 6115047 H2V 2K1
CanadaSite Not Available
Novartis Investigative Site
Angers 3037656, 49933
FranceSite Not Available
Novartis Investigative Site
Angers 09, 49933
FranceSite Not Available
Novartis Investigative Site
Angers Cedex 9, 49933
FranceSite Not Available
Novartis Investigative Site
Angers cedex 09, 49933
FranceSite Not Available
Novartis Investigative Site
Antony, 92160
FranceSite Not Available
Novartis Investigative Site
Antony 3037423, 92160
FranceSite Not Available
Novartis Investigative Site
Brest, 29609
FranceSite Not Available
Novartis Investigative Site
Brest 3030300, 29609
FranceSite Not Available
Novartis Investigative Site
Montpellier, 34295
FranceSite Not Available
Novartis Investigative Site
Montpellier 2992166, 34295
FranceSite Not Available
Novartis Investigative Site
Montpellier cedex 5, 34295
FranceSite Not Available
Novartis Investigative Site
Paris, 75970
FranceSite Not Available
Novartis Investigative Site
Paris 2988507, 75970
FranceSite Not Available
Novartis Investigative Site
Reims, 51100
FranceSite Not Available
Novartis Investigative Site
Reims 2984114, 51100
FranceSite Not Available
Novartis Investigative Site
Saint Mande, 94160
FranceSite Not Available
Novartis Investigative Site
Saint-Mandé 2978621, 94160
FranceSite Not Available
Novartis Investigative Site
Toulouse, 31400
FranceSite Not Available
Novartis Investigative Site
Toulouse 2972315, 31400
FranceSite Not Available
Novartis Investigative Site
Bramsche 2945474, Lower Saxony 2862926 49565
GermanySite Not Available
Novartis Investigative Site
Göttingen 2918632, Lower Saxony 2862926 37075
GermanySite Not Available
Novartis Investigative Site
Bramsche, Niedersachsen 49565
GermanySite Not Available
Novartis Investigative Site
Goettingen, Niedersachsen 37075
GermanySite Not Available
Novartis Investigative Site
Halle Saale, Sachsen-Anhalt 06108
GermanySite Not Available
Novartis Investigative Site
Halle 2911522, Saxony-Anhalt 2842565 06108
GermanySite Not Available
Novartis Investigative Site
Erlangen, 91054
GermanySite Not Available
Novartis Investigative Site
Erlangen 2929567, 91054
GermanySite Not Available
Novartis Investigative Site
Gottingen, 37075
GermanySite Not Available
Novartis Investigative Site
Halle (Saale), 06108
GermanySite Not Available
Novartis Investigative Site
Hannover, 30625
GermanySite Not Available
Novartis Investigative Site
Hanover 2910831, 30625
GermanySite Not Available
Novartis Investigative Site
Langenau, 89129
GermanySite Not Available
Novartis Investigative Site
Marburg, 35039
GermanySite Not Available
Novartis Investigative Site
Marburg 2873759, 35039
GermanySite Not Available
Novartis Investigative Site
Daegu, Dalseo Gu 41931
Korea, Republic ofSite Not Available
Novartis Investigative Site
Suwon si, Gyeonggi Do 16499
Korea, Republic ofSite Not Available
Novartis Investigative Site
Seoul, 03080
Korea, Republic ofSite Not Available
Novartis Investigative Site
Singapore, 308205
SingaporeSite Not Available
Novartis Investigative Site
Singapore 1880252, 308205
SingaporeSite Not Available
Novartis Investigative Site
Komarno, 945 01
SlovakiaSite Not Available
Novartis Investigative Site
Komárno 3059435, 945 01
SlovakiaSite Not Available
Novartis Investigative Site
Levice, 934 01
SlovakiaSite Not Available
Novartis Investigative Site
Levice 3059101, 934 01
SlovakiaSite Not Available
Novartis Investigative Site
Nove Zamky, 940 34
SlovakiaSite Not Available
Novartis Investigative Site
Nové Zámky 3058472, 940 34
SlovakiaSite Not Available
Novartis Investigative Site
Daegu 1835329, Dalseo Gu 41931
South KoreaSite Not Available
Novartis Investigative Site
Suwon 1835553, Gyeonggi-do 1841610 16499
South KoreaSite Not Available
Novartis Investigative Site
Seoul 1835848, 03080
South KoreaSite Not Available
Novartis Investigative Site
Malaga, Andalucia 29009
SpainSite Not Available
Novartis Investigative Site
Alicante, Comunidad Valenciana 03010
SpainSite Not Available
Novartis Investigative Site
Valencia, Comunidad Valenciana 46014
SpainSite Not Available
Novartis Investigative Site
Alicante 2521978, Valencia 2593113 03010
SpainSite Not Available
Novartis Investigative Site
Valencia 2509954, Valencia 2593113 46014
SpainSite Not Available
Novartis Investigative Site
Madrid, 28006
SpainSite Not Available
Novartis Investigative Site
Madrid 3117735, 28006
SpainSite Not Available
Novartis Investigative Site
Izmir, 35140
TurkeySite Not Available
Novartis Investigative Site
Kayseri, 38070
TurkeySite Not Available
Novartis Investigative Site
Samsun, 55139
TurkeySite Not Available
Novartis Investigative Site
Izmir 311046, 35140
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Kayseri 308464, 38070
Turkey (Türkiye)Site Not Available
Novartis Investigative Site
Samsun 740264, 55139
Turkey (Türkiye)Site Not Available
Acuro Research Inc
Little Rock, Arkansas 72205
United StatesSite Not Available
Little Rock Allergy and Asthma Clnc
Little Rock, Arkansas 72205
United StatesSite Not Available
Little Rock Allergy nd Asthma Clnc
Little Rock, Arkansas 72205
United StatesSite Not Available
Novartis Investigative Site
Little Rock, Arkansas 72205
United StatesActive - Recruiting
Acuro Research Inc
Little Rock 4119403, Arkansas 4099753 72205
United StatesSite Not Available
Florida Ctr Allergy Asthma Research
Aventura, Florida 33180
United StatesSite Not Available
Florida Ctr Allergy Asthma Research .
Aventura, Florida 33180
United StatesSite Not Available
Florida Ctr Allergy Asthma Research Suite 408
Aventura, Florida 33180
United StatesSite Not Available
Novartis Investigative Site
Aventura, Florida 33180
United StatesActive - Recruiting
Finlay Medical Research
Greenacres City, Florida 33467
United StatesSite Not Available
Novartis Investigative Site
Greenacres City, Florida 33467
United StatesActive - Recruiting
Florida Ctr Allergy Asthma Research
Aventura 4146429, Florida 4155751 33180
United StatesSite Not Available
Finlay Medical Research
Greenacres City 4157467, Florida 4155751 33467
United StatesSite Not Available
Novartis Investigative Site
Boise, Idaho 83706
United StatesActive - Recruiting
Treasure Valley Medical Research
Boise, Idaho 83706
United StatesSite Not Available
Treasure Valley Medical Research
Boise 5586437, Idaho 5596512 83706
United StatesSite Not Available
Endeavor Health
Glenview, Illinois 60077
United StatesSite Not Available
Northshore University Health System .
Glenview, Illinois 60077
United StatesSite Not Available
NorthShore University Health System .
Skokie, Illinois 60077
United StatesSite Not Available
Novartis Investigative Site
Skokie, Illinois 60077
United StatesActive - Recruiting
Endeavor Health
Glenview 4893886, Illinois 4896861 60077
United StatesSite Not Available
Allergy and Asthma Specialist P S C
Owensboro, Kentucky 42301
United StatesSite Not Available
Allergy and Asthma Specialist P S C Main Center
Owensboro, Kentucky 42301
United StatesSite Not Available
Allergy and Asthma Specialist, P.S.C. Main Center
Owensboro, Kentucky 42301
United StatesSite Not Available
Novartis Investigative Site
Owensboro, Kentucky 42301
United StatesActive - Recruiting
Allergy and Asthma Specialist P S C
Owensboro 4303436, Kentucky 6254925 42301
United StatesSite Not Available
Novartis Investigative Site
Lincoln, Nebraska 68510
United StatesSite Not Available
Allergy Asthma and Clinical Research
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
Novartis Investigative Site
Oklahoma City, Oklahoma 73120
United StatesActive - Recruiting
Allergy Asthma and Clinical Research
Oklahoma City 4544349, Oklahoma 4544379 73120
United StatesSite Not Available
Allergy and Clinical Immunology Ass
Pittsburgh, Pennsylvania 15241
United StatesSite Not Available
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania 15241
United StatesSite Not Available
Novartis Investigative Site
Pittsburgh, Pennsylvania 15241
United StatesActive - Recruiting
Allergy and Clinical Immunology Associates
Pittsburgh 5206379, Pennsylvania 6254927 15241
United StatesSite Not Available
Novartis Investigative Site
El Paso, Texas 79912
United StatesActive - Recruiting
Western Sky Medical Research
El Paso, Texas 79924
United StatesSite Not Available
Western Sky Medical Research
El Paso 5520993, Texas 4736286 79924
United StatesSite Not Available
Allergy Asthma and amp Sinus Center S C
Greenfield, Wisconsin 53228
United StatesSite Not Available
Allergy Asthma and amp Sinus Ctr S C
Greenfield, Wisconsin 53228
United StatesSite Not Available
Novartis Investigative Site
Greenfield, Wisconsin 53228
United StatesActive - Recruiting
Allergy Asthma and amp Sinus Ctr S C
Greenfield 5255068, Wisconsin 5279468 53228
United StatesSite Not Available

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