Back to resultsA Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines (REMIX-1)
Primary Purpose
Chronic Spontaneous Urticaria
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LOU064 (blinded)
Placebo
LOU064 (open-label)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring BTK inhibitor, Chronic spontaneous urticaria, Urticaria activity score, Hives severity score, Itch severity score, CSU
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
Sites / Locations
- Novartis Investigative Site
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- Hospital Universitario Reina SofíaRecruiting
- Novartis Investigative Site
- Hospital Universitari Vall d'HebronRecruiting
- Hospital General Universitario de Alicante, Edifico Consultas ExternasRecruiting
- Hospital Arnau de Vilanova de ValenciaRecruiting
- Novartis Investigative Site
- Hospital Universitario Gran Canaria Doctor NegrinRecruiting
- Novartis Investigative SiteRecruiting
- Clinica Universitaria de NavarraRecruiting
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1: LOU064 (blinded)
Arm 2: LOU064 placebo (blinded)
Arm Description
LOU064 (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2).
LOU064 placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2).
Outcomes
Primary Outcome Measures
Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy endpoint)
To demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in UAS7 at Week 12 by assessing absolute change from baseline in weekly Urticaria Activity Score (UAS7) at week 12.
The UAS7 is a scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
Absolute change in ISS7 and absolute change in HSS7 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)
To demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in ISS7 and HSS7 at Week 12 by assessing absolute change from baseline in weekly Itch Severity Score (ISS7) and weekly Hive Severity Score (HSS7) at week 12.
The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The HSS7 score is the wheal/hives severity score for 7 days and the ISS7 is the itch severity score for 7 days, both these scores range from 0 to 21.
Secondary Outcome Measures
Change from baseline in UAS7 (only in scenario 2)
To demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in UAS7 at Week 12 by assessing absolute change from baseline in UAS7 at week 12.
Sustained disease activity control (UAS7 ≤6)
To demonstrate that remibrutinib treated participants maintain disease activity control (defined as UAS7≤6) for more weeks compared to placebo treated participants over 12 weeks by assessing cumulative number of weeks with an UAS7 ≤ 6 response between baseline and Week 12.
Complete absence of hives and itch (UAS7 = 0)
To demonstrate that a greater proportion of participants achieve complete absence of hives and itch (UAS7 = 0) at Week 12 who are treated with remibrutinib compared to placebo-treated participants by assessing achievement of UAS7 at week 12.
Reduction of weekly ISS score (only in scenario 1)
To demonstrate the superiority of remibrutinib treated participants with respect to a reduction from baseline in the weekly itch severity score at Week 12 compared to placebo-treated participants by assessing absolute change from baseline in ISS7 score.
Reduction of weekly HSS score (only in scenario 1)
To demonstrate the superiority of remibrutinib treated participants with respect to a reduction from baseline in the weekly hive severity score at Week 12 compared to placebo-treated participants by assessing absolute change from baseline in HSS7 score.
Early onset of disease control (UAS7 ≤ 6 at week 2)
To demonstrate that a greater proportion of participants achieve UAS7 ≤ 6 at Week 2 who are treated with remibrutinib compared to placebo-treated participants by assessing achievement of UAS ≤ 6 at week 2.
Disease activity control (UAS7 ≤ 6)
To demonstrate that a greater proportion of participants achieve disease activity control (UAS7 ≤ 6) at Week 12 who are treated with remibrutinib compared to placebo-treated participants by assessing achievement of UA7 ≤ 6 at week 12.
Achievement of DLQI = 0 - 1
To demonstrate that a greater proportion of participants who are treated with remibrutinib achieve DLQI = 0-1 at Week 12 compared to placebo-treated participants by assessing achievement of DLQI = 0 - 1 at week 12.
Number of weeks without angioedema (AAS = 0)
To demonstrate that remibrutinib treated participants have more angioedema occurrence-free weeks over 12 weeks compared with placebo-treated participants by assessing the cumulative number of weeks with an AAS = 0 response between baseline and week 12.
Number of participants with Adverse Events
To demonstrate the safety and tolerability of remibrutinib by assessing the occurrence of treatment emergent adverse events and serious adverse events during the study.
Full Information
NCT ID
NCT05030311
First Posted
August 19, 2021
Last Updated
October 18, 2023
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05030311
Brief Title
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines
Acronym
REMIX-1
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
January 19, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
This is a global, multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase 3 study investigating the safety, tolerability, and efficacy of remibrutinib in adult participants with CSU inadequately controlled by second generation H1-antihistamines.
Inadequate control of CSU by H1-antihistamines is 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).
The study consists of four periods, the total study duration is up to 60 weeks. Screening period of up to 4 weeks, double-blind treatment period of 24 weeks, open-label treatment period of 28 weeks and 4 weeks of treatment-free follow up.
Eligible participants will be randomly assigned to the treatment arms in a 2:1 ratio. The study population will consist of approximately 450 female and male adult participants (300 in the active arm and 150 in the placebo arm) with CSU inadequately controlled by second generation H1-antihistamines at least at locally label approved dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria
Keywords
BTK inhibitor, Chronic spontaneous urticaria, Urticaria activity score, Hives severity score, Itch severity score, CSU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: LOU064 (blinded)
Arm Type
Experimental
Arm Description
LOU064 (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2).
Arm Title
Arm 2: LOU064 placebo (blinded)
Arm Type
Placebo Comparator
Arm Description
LOU064 placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2).
Intervention Type
Drug
Intervention Name(s)
LOU064 (blinded)
Other Intervention Name(s)
remibrutinib
Intervention Description
LOU064 (blinded) active treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
LOU064 (open-label)
Other Intervention Name(s)
remibrutinib
Intervention Description
LOU064 (open-label) active treatment
Primary Outcome Measure Information:
Title
Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy endpoint)
Description
To demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in UAS7 at Week 12 by assessing absolute change from baseline in weekly Urticaria Activity Score (UAS7) at week 12.
The UAS7 is a scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
Time Frame
12 weeks
Title
Absolute change in ISS7 and absolute change in HSS7 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)
Description
To demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in ISS7 and HSS7 at Week 12 by assessing absolute change from baseline in weekly Itch Severity Score (ISS7) and weekly Hive Severity Score (HSS7) at week 12.
The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The HSS7 score is the wheal/hives severity score for 7 days and the ISS7 is the itch severity score for 7 days, both these scores range from 0 to 21.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in UAS7 (only in scenario 2)
Description
To demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in UAS7 at Week 12 by assessing absolute change from baseline in UAS7 at week 12.
Time Frame
12 weeks
Title
Sustained disease activity control (UAS7 ≤6)
Description
To demonstrate that remibrutinib treated participants maintain disease activity control (defined as UAS7≤6) for more weeks compared to placebo treated participants over 12 weeks by assessing cumulative number of weeks with an UAS7 ≤ 6 response between baseline and Week 12.
Time Frame
12 weeks
Title
Complete absence of hives and itch (UAS7 = 0)
Description
To demonstrate that a greater proportion of participants achieve complete absence of hives and itch (UAS7 = 0) at Week 12 who are treated with remibrutinib compared to placebo-treated participants by assessing achievement of UAS7 at week 12.
Time Frame
12 weeks
Title
Reduction of weekly ISS score (only in scenario 1)
Description
To demonstrate the superiority of remibrutinib treated participants with respect to a reduction from baseline in the weekly itch severity score at Week 12 compared to placebo-treated participants by assessing absolute change from baseline in ISS7 score.
Time Frame
12 weeks
Title
Reduction of weekly HSS score (only in scenario 1)
Description
To demonstrate the superiority of remibrutinib treated participants with respect to a reduction from baseline in the weekly hive severity score at Week 12 compared to placebo-treated participants by assessing absolute change from baseline in HSS7 score.
Time Frame
12 weeks
Title
Early onset of disease control (UAS7 ≤ 6 at week 2)
Description
To demonstrate that a greater proportion of participants achieve UAS7 ≤ 6 at Week 2 who are treated with remibrutinib compared to placebo-treated participants by assessing achievement of UAS ≤ 6 at week 2.
Time Frame
2 weeks
Title
Disease activity control (UAS7 ≤ 6)
Description
To demonstrate that a greater proportion of participants achieve disease activity control (UAS7 ≤ 6) at Week 12 who are treated with remibrutinib compared to placebo-treated participants by assessing achievement of UA7 ≤ 6 at week 12.
Time Frame
12 weeks
Title
Achievement of DLQI = 0 - 1
Description
To demonstrate that a greater proportion of participants who are treated with remibrutinib achieve DLQI = 0-1 at Week 12 compared to placebo-treated participants by assessing achievement of DLQI = 0 - 1 at week 12.
Time Frame
12 weeks
Title
Number of weeks without angioedema (AAS = 0)
Description
To demonstrate that remibrutinib treated participants have more angioedema occurrence-free weeks over 12 weeks compared with placebo-treated participants by assessing the cumulative number of weeks with an AAS = 0 response between baseline and week 12.
Time Frame
12 weeks
Title
Number of participants with Adverse Events
Description
To demonstrate the safety and tolerability of remibrutinib by assessing the occurrence of treatment emergent adverse events and serious adverse events during the study.
Time Frame
56 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Facility Information:
Facility Name
Novartis Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30188
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79912
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1902COS
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Buenos Aires
State/Province
Nueve De Julio
ZIP/Postal Code
B6500BWQ
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Santa Fe
State/Province
Rosario
ZIP/Postal Code
S2000DBS
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000JKR
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Bahia Blanca
ZIP/Postal Code
B8000JRB
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1125ABE
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Capital Federal
ZIP/Postal Code
C1023AAB
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Santa Fe
ZIP/Postal Code
S3000FIL
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Phillip
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
0050010
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080002
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Brno
State/Province
Czech Republic
ZIP/Postal Code
656 91
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Antony
ZIP/Postal Code
92160
Country
France
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Bordeaux Cedex
ZIP/Postal Code
33075
Country
France
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Reims
ZIP/Postal Code
51100
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Debrecen
State/Province
Hajdu Bihar
ZIP/Postal Code
4026
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 060
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Belagavi
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440015
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500004
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221005
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Pune
ZIP/Postal Code
411019
Country
India
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Ancona
State/Province
AN
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Messina
State/Province
ME
ZIP/Postal Code
98125
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Parma
State/Province
PR
ZIP/Postal Code
43100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Torino
State/Province
TO
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080 0013
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
220-6208
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Kamimashi-gun
State/Province
Kumamoto
ZIP/Postal Code
861-3106
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Takatsuki-city
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Koto
State/Province
Tokyo
ZIP/Postal Code
136-0074
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
819 0167
Country
Japan
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Daegu
State/Province
Dalseo Gu
ZIP/Postal Code
42602
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Hwaseong si
State/Province
Gyeonggi Do
ZIP/Postal Code
18450
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Suwon si
State/Province
Gyeonggi Do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Seocho Gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Incheon
ZIP/Postal Code
405 760
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Villahermosa
State/Province
Tabasco
ZIP/Postal Code
86035
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Carolina
ZIP/Postal Code
00985
Country
Puerto Rico
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Izhevsk
ZIP/Postal Code
426061
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Penza
ZIP/Postal Code
440067
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
308205
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Reina Sofía
City
Av.menendez Pidal S/N, Cordoba
State/Province
Andalucia
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Ruano
Phone
+34 957 011 227
Email
EECCDERMATOLOGIA@OUTLOOK.ES
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Passeig Vall d'Hebron, Num 119-129, Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Galván Blasco
Email
paulagb2@blanquerna.url.edu
Facility Name
Hospital General Universitario de Alicante, Edifico Consultas Externas
City
Alicante, 6ª Planta, EECC Dermatología, C/Pintor Baeza 12
State/Province
Comunidad Valenciana
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireia Llorca
Phone
+34965913723
Email
mllorca.hgua@gmail.com
Facility Name
Hospital Arnau de Vilanova de Valencia
City
San Clemente 12, Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Javier Miquel Miquel
Email
fjmiquel0406@gmail.com
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Gran Canaria Doctor Negrin
City
Barranco De La Ballena S/N, Las Palmas De Gran Canaria
State/Province
Las Palmas De Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregorio Carretero
Email
investigacionderma.negrin@gmail.com
Facility Name
Novartis Investigative Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universitaria de Navarra
City
C/Marquesado De Santa Marta, Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Ferrer Puga
Phone
+34948255400
Email
ctlalerg@unav.es
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Istanbul
State/Province
Pendik
ZIP/Postal Code
348999
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35380
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35620
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Kayseri
ZIP/Postal Code
38070
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Okmeydani
ZIP/Postal Code
34370
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Sakarya
ZIP/Postal Code
54290
Country
Turkey
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Talas / Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Learn more about this trial
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines
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