A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

ClinicalTrials.gov Identifier: NCT05030311

Novartis Reference Number: CLOU064A2301

Last Update: Sep 09, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.

Condition 
Chronic Spontaneous Urticaria
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Nov 30, 2021
Completion date 
Mar 01, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
LOU064 (blinded)
LOU064 (blinded) active treatment
Drug
Placebo
Placebo
Drug
LOU064 (open-label)
LOU064 (open-label) active treatment

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.
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 antihistamines at the time of randomization defined as:
The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of second generation H1-antihistamines 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 randomization (Day 1)
Documentation of hives within three months before randomization (either at screening and/or at randomization; 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 one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1).

Exclusion Criteria:

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
Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or drug-induced urticaria
Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results, e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis
Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York heart association (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), 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
Significant bleeding risk or coagulation disorders
History of gastrointestinal bleeding, e.g. in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g. requiring hospitalization or blood transfusion)
Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel. The use of dual anti-platelet therapy (e.g. acetylsalicylic acid + clopidogrel) is prohibited.
Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOAC))
History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening

Study Locations

United States
Novartis Investigative Site
Recruiting
Birmingham, 35205
Alabama
United States
Novartis Investigative Site
Recruiting
Birmingham, 35209
Alabama
United States
Novartis Investigative Site
Recruiting
Gilbert, 85234
Arizona
United States
Novartis Investigative Site
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North Little Rock, 72117
Arkansas
United States
Novartis Investigative Site
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Bakersfield, 93301
California
United States
Novartis Investigative Site
Recruiting
Lancaster, 93534
California
United States
Novartis Investigative Site
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Los Angeles, 90025
California
United States
Novartis Investigative Site
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Redwood City, 94063
California
United States
Novartis Investigative Site
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Denver, 80230
Colorado
United States
Novartis Investigative Site
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Greenacres City, 33467
Florida
United States
Novartis Investigative Site
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Miami, 33176
Florida
United States
Novartis Investigative Site
Recruiting
Sarasota, 34233
Florida
United States
Novartis Investigative Site
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Tallahassee, 32308
Florida
United States
Novartis Investigative Site
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Albany, 31707
Georgia
United States
Novartis Investigative Site
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Sandy Springs, 30328
Georgia
United States
Novartis Investigative Site
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Woodstock, 30188
Georgia
United States
Novartis Investigative Site
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Evansville, 47715
Indiana
United States
Novartis Investigative Site
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Lexington, 40509
Kentucky
United States
Novartis Investigative Site
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Wheaton, 20902
Maryland
United States
Novartis Investigative Site
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Rochester, 55905
Minnesota
United States
Novartis Investigative Site
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Rolla, 65401
Missouri
United States
Novartis Investigative Site
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Saint Louis, 63141
Missouri
United States
Novartis Investigative Site
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Lincoln, 68510
Nebraska
United States
Novartis Investigative Site
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Athens, 45701
Ohio
United States
Novartis Investigative Site
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Beachwood, 44122
Ohio
United States
Novartis Investigative Site
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Columbus, 43235
Ohio
United States
Novartis Investigative Site
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Toledo, 43617
Ohio
United States
Novartis Investigative Site
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Tulsa, 74136
Oklahoma
United States
Novartis Investigative Site
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Medford, 97504
Oregon
United States
Novartis Investigative Site
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Austin, 78759
Texas
United States
Novartis Investigative Site
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El Paso, 79903
Texas
United States
Novartis Investigative Site
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San Antonio, 78213
Texas
United States
Novartis Investigative Site
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Waco, 76712
Texas
United States
Novartis Investigative Site
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Murray, 84107
Utah
United States
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Bellingham, 98225
Washington
United States
Argentina
Novartis Investigative Site
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Caba, C1181ACH
Buenos Aires
Argentina
Novartis Investigative Site
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Caba, C1414AIF
Buenos Aires
Argentina
Novartis Investigative Site
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La Plata, B1902COS
Buenos Aires
Argentina
Novartis Investigative Site
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Buenos Aires, B6500BWQ
Nueve De Julio
Argentina
Novartis Investigative Site
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Santa Fe, S2000DBS
Rosario
Argentina
Novartis Investigative Site
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Rosario, S2000JKR
Santa Fe
Argentina
Novartis Investigative Site
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Bahia Blanca, B8000JRB
-
Argentina
Novartis Investigative Site
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Buenos Aires, C1125ABE
-
Argentina
Novartis Investigative Site
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Capital Federal, C1023AAB
-
Argentina
Novartis Investigative Site
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Santa Fe, S3000FIL
-
Argentina
Australia
Novartis Investigative Site
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Phillip, 2606
Australian Capital Territory
Australia
Novartis Investigative Site
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Sydney, 2010
New South Wales
Australia
Novartis Investigative Site
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East Melbourne, 3002
Victoria
Australia
Novartis Investigative Site
Recruiting
Parkville, 3002
Victoria
Australia
Bulgaria
Novartis Investigative Site
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Pleven, 5800
-
Bulgaria
Novartis Investigative Site
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Sofia, 1407
-
Bulgaria
Novartis Investigative Site
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Sofia, 1431
-
Bulgaria
Colombia
Novartis Investigative Site
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Barranquilla, 080002
Atlantico
Colombia
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Barranquilla, 080020
-
Colombia
Novartis Investigative Site
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Bogota, 110221
-
Colombia
Czech Republic
Novartis Investigative Site
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Brno, 656 91
Czech Republic
Czech Republic
Novartis Investigative Site
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Olomouc, 775 20
-
Czech Republic
Novartis Investigative Site
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Plzen, 305 99
-
Czech Republic
Novartis Investigative Site
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Praha 5, 150 06
-
Czech Republic
France
Novartis Investigative Site
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Antony, 92160
-
France
Novartis Investigative Site
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Bordeaux Cedex, 33075
-
France
Novartis Investigative Site
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Nice, 06000
-
France
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Pierre Benite Cedex, 69495
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France
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Reims, 51100
-
France
Novartis Investigative Site
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Rouen, 76031
-
France
Hungary
Novartis Investigative Site
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Szeged, 6720
Csongrad
Hungary
Novartis Investigative Site
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Debrecen, 4026
Hajdu Bihar
Hungary
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Debrecen, 4032
-
Hungary
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Szeged, 6720
-
Hungary
India
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New Delhi, 110 060
Delhi
India
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Nagpur, 440012
Maharashtra
India
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Nagpur, 440015
Maharashtra
India
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Nashik, 422005
Maharashtra
India
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Hyderabad, 500004
Telangana
India
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Varanasi, 221005
Uttar Pradesh
India
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Kolkata, 700054
West Bengal
India
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Chandigarh, 160012
-
India
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Pune, 411019
-
India
Italy
Novartis Investigative Site
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Ancona, 60126
AN
Italy
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Milano, 20162
MI
Italy
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Pisa, 56126
PI
Italy
Novartis Investigative Site
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Torino, 10128
TO
Italy
Japan
Novartis Investigative Site
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Hiroshima City, 734-8551
Hiroshima
Japan
Novartis Investigative Site
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Obihiro, 080 0013
Hokkaido
Japan
Novartis Investigative Site
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Yokohama, 220-6208
Kanagawa
Japan
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Kamimashi-gun, 861-3106
Kumamoto
Japan
Novartis Investigative Site
Recruiting
Takatsuki-city, 569-8686
Osaka
Japan
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Koto, 136-0074
Tokyo
Japan
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Fukuoka, 819 0167
-
Japan
Korea, Republic of
Novartis Investigative Site
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Daegu, 42602
Dalseo Gu
Korea, Republic of
Novartis Investigative Site
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Hwaseong si, 18450
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
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Suwon si, 16499
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
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Seoul, 06591
Seocho Gu
Korea, Republic of
Novartis Investigative Site
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Gwangju, 61469
-
Korea, Republic of
Novartis Investigative Site
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Incheon, 405 760
-
Korea, Republic of
Novartis Investigative Site
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Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
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Seoul, 03722
-
Korea, Republic of
Novartis Investigative Site
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Seoul, 05505
-
Korea, Republic of
Novartis Investigative Site
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Seoul, 07061
-
Korea, Republic of
Novartis Investigative Site
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Seoul, 07441
-
Korea, Republic of
Puerto Rico
Novartis Investigative Site
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Carolina, 00985
-
Puerto Rico
Novartis Investigative Site
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San Juan, 00927
-
Puerto Rico
Russian Federation
Novartis Investigative Site
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Chelyabinsk, 454048
-
Russian Federation
Novartis Investigative Site
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Moscow, 115478
-
Russian Federation
Novartis Investigative Site
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Saratov, 410012
-
Russian Federation
Spain
Hospital Universitario Reina Sofía
Recruiting
Av.menendez Pidal S/N, Cordoba, 14004 - Andalucia
Contact: Juan Ruano (+34 957 011 227) - [email protected] -
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08003 - Catalunya
Contact: Ana M Gimenez Arnau ('+34932483000) - [email protected] -
Spain
Hospital Universitari Vall d'Hebron
Recruiting
Passeig Vall d'Hebron, Num 119-129, Barcelona, 08035 - Catalunya
Contact: Paula Galván Blasco - [email protected] -
Spain
Hospital General Universitario de Alicante, Edifico Consultas Externas
Recruiting
Alicante, 6ª Planta, EECC Dermatología, C/Pintor Baeza 12, 03010 - Comunidad Valenciana
Contact: Mireia Llorca (+34965913723) - [email protected] -
Spain
Hospital Arnau de Vilanova de Valencia
Recruiting
San Clemente 12, Valencia, 46015 - Comunidad Valenciana
Contact: Francisco Javier Miquel Miquel - [email protected] -
Spain
Novartis Investigative Site
Recruiting
Pamplona, 31008
Navarra
Spain
Clinica Universitaria de Navarra
Recruiting
C/Marquesado De Santa Marta, Madrid, 28027
Contact: Marta Ferrer Puga (+34948255400) - [email protected] -
Spain
Novartis Investigative Site
Recruiting
Las Palmas de Gran Canaria, 35010
-
Spain
Novartis Investigative Site
Recruiting
Valencia, 46026
Contact: Veronica Masso (+34961244183) - [email protected] -
Spain
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 11217
-
Taiwan
Turkey
Novartis Investigative Site
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Aydin, 09100
-
Turkey
Novartis Investigative Site
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Istanbul, 34662
-
Turkey
Novartis Investigative Site
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Izmir, 35040
-
Turkey
Novartis Investigative Site
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Izmir, 35380
-
Turkey
Novartis Investigative Site
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Kayseri, 38070
-
Turkey
Novartis Investigative Site
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Okmeydani, 34370
-
Turkey
Novartis Investigative Site
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Sakarya, 54290
-
Turkey
Novartis Investigative Site
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Samsun, 55139
-
Turkey
Novartis Investigative Site
Recruiting
Talas / Kayseri, 38039
-
Turkey

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