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: Feb 16, 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
Little Rock, 72117
Arkansas
United States
Novartis Investigative Site
Recruiting
Bakersfield, 93301
California
United States
Novartis Investigative Site
Recruiting
Lancaster, 93534
California
United States
Novartis Investigative Site
Recruiting
Redwood City, 94063
California
United States
Novartis Investigative Site
Recruiting
Denver, 80230
Colorado
United States
Novartis Investigative Site
Recruiting
Miami, 33176
Florida
United States
Novartis Investigative Site
Recruiting
Sarasota, 34233
Florida
United States
Novartis Investigative Site
Recruiting
Wheaton, 20902
Maryland
United States
Novartis Investigative Site
Recruiting
Rolla, 65401
Missouri
United States
Novartis Investigative Site
Recruiting
Saint Louis, 63141
Missouri
United States
Novartis Investigative Site
Recruiting
Lincoln, 68510
Nebraska
United States
Novartis Investigative Site
Recruiting
Athens, 45701
Ohio
United States
Novartis Investigative Site
Recruiting
Columbus, 43235
Ohio
United States
Novartis Investigative Site
Recruiting
Austin, 78759
Texas
United States
Novartis Investigative Site
Recruiting
El Paso, 79903
Texas
United States
Novartis Investigative Site
Recruiting
Murray, 84107
Utah
United States
Novartis Investigative Site
Recruiting
Bellingham, 98225
Washington
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1414AIF
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Santa Fe, S3000FIL
-
Argentina
Australia
Novartis Investigative Site
Recruiting
Sydney, 2010
New South Wales
Australia
Novartis Investigative Site
Recruiting
East Melbourne, 3002
Victoria
Australia
Novartis Investigative Site
Recruiting
Parkville, 3002
Victoria
Australia
Czech Republic
Novartis Investigative Site
Recruiting
Plzen, 305 99
-
Czech Republic
Novartis Investigative Site
Recruiting
Praha 5, 150 06
-
Czech Republic
France
Novartis Investigative Site
Recruiting
Antony, 92160
-
France
Novartis Investigative Site
Recruiting
Nice, 06000
-
France
Novartis Investigative Site
Recruiting
Pierre Benite Cedex, 69495
-
France
Novartis Investigative Site
Recruiting
Reims, 51100
-
France
Novartis Investigative Site
Recruiting
Rouen, 76031
-
France
Hungary
Novartis Investigative Site
Recruiting
Debrecen, 4026
Hajdu Bihar
Hungary
Novartis Investigative Site
Recruiting
Szeged, 6720
-
Hungary
Japan
Novartis Investigative Site
Recruiting
Obihiro, 080 0013
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Yokohama, 220-6208
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Kamimashi-gun, 861-3106
Kumamoto
Japan
Novartis Investigative Site
Recruiting
Fukuoka, 819 0167
-
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Hwaseong si, 18450
Gyeonggi Do
Korea, Republic of
Russian Federation
Novartis Investigative Site
Recruiting
Chelyabinsk, 454092
-
Russian Federation
Novartis Investigative Site
Recruiting
Izhevsk, 426061
-
Russian Federation
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08003
Catalunya
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Pamplona, 31008
Navarra
Spain
Novartis Investigative Site
Recruiting
Las Palmas de Gran Canaria, 35010
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 11217
-
Taiwan
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 348999
Pendik
Turkey
Novartis Investigative Site
Recruiting
Aydin, 09100
-
Turkey
Novartis Investigative Site
Recruiting
Sakarya, 54290
-
Turkey
Novartis Investigative Site
Recruiting
Samsun, 55139
-
Turkey
Novartis Investigative Site
Recruiting
Talas / Kayseri, 38039
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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