Back to resultsA Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
Primary Purpose
Chronic Spontaneous Urticaria
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ligelizumab
Omalizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring Anti-IgE, CSU (Chronic Spontaneous Urticaria), hives severity score, itch severity score, urticaria activity score
Eligibility Criteria
Key Inclusion Criteria:
- Signed informed consent must be obtained prior to participation in the study. The subject's', parent'ssubject's, parent's or legal guardian's signed written informed consent and child's assent, if appropriate, must be obtained before any assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
- Male and female subjects ≥ 12 years of age at the time of screening.
- CSU diagnosis for ≥ 6 months.
- Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:
- The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-AH
- UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during the 7 days prior to randomization (Visit 110, Day 1)
- Subjects must be on H1-AH at only approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)
- Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
Key Exclusion Criteria:
- History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).
- Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic- or contact-urticaria.
- Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
- Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.
- Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
- Prior exposure to ligelizumab or omalizumab.
- Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1 antihistamines use at greater than approved doses after Visit 1.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Ligelizumab Dose A
Ligelizumab Dose B
Omalizumab 300 mg
Placebo
Arm Description
Ligelizumab Dose A q4w
Ligelizumab Dose B q4w
Omalizumab 300 mg q4w
Placebo q4w from randomization to week 20. Ligelizumab Dose B from week 24 to week 48.
Outcomes
Primary Outcome Measures
Absolute change from baseline in UAS7 at Week 12
The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS).
The HSS has a scale of 0 (none) to 3 (intense/severe). A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days.
The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days.
The UAS7 is the sum of the HSS7 score and the ISS7 score, and has a possible range in score of 0-42.
Complete hives response is defined as HSS7 (average daily HSS over the preceding 7 days) = 0.
Complete itch response is defined as ISS7 (average daily ISS over the preceding 7 days) = 0.
Complete UAS7 response is defined as UAS7=0.
Secondary Outcome Measures
Complete absence of hives and itch at Week 12
Assessed as percentage of subjects achieving UAS7 = 0
Improvement of severity of itch
Assessed as absolute change from baseline in ISS7 score at Week 12
No impact on subject's quality of life at Week 12
Assessed as percentage of subjects achieving DLQI = 0-1
Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12
To assess the cumulative period of time that treated subjects are angioedema occurrence-free
Occurrence of treatment emergent adverse events and serious adverse events during the study
Treatment emergent adverse events and serious adverse events are those which occur at any time only after treatment has started
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03580356
Brief Title
A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
Official Title
A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2018 (Actual)
Primary Completion Date
June 22, 2021 (Actual)
Study Completion Date
June 14, 2022 (Actual)
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 was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.
The study population consisted of 1,079 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines.
This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria
Keywords
Anti-IgE, CSU (Chronic Spontaneous Urticaria), hives severity score, itch severity score, urticaria activity score
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a Phase III multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There is a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Patients, investigator staff and personnel performing the study assessments will remain blinded to the identity of the treatment from the time of randomization until final database lock. The study drug must be prepared by an independent unblinded pharmacist (or authorized delegate) and administered by an independent unblinded study drug administrator. Neither the unblinded pharmacist nor the unblinded study drug administrator will be involved in any assessments.
Allocation
Randomized
Enrollment
1079 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ligelizumab Dose A
Arm Type
Experimental
Arm Description
Ligelizumab Dose A q4w
Arm Title
Ligelizumab Dose B
Arm Type
Experimental
Arm Description
Ligelizumab Dose B q4w
Arm Title
Omalizumab 300 mg
Arm Type
Active Comparator
Arm Description
Omalizumab 300 mg q4w
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo q4w from randomization to week 20. Ligelizumab Dose B from week 24 to week 48.
Intervention Type
Biological
Intervention Name(s)
Ligelizumab
Intervention Description
Liquid in vial
Intervention Type
Biological
Intervention Name(s)
Omalizumab
Intervention Description
Lyophilized powder for solution in vial
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Liquid in vial
Primary Outcome Measure Information:
Title
Absolute change from baseline in UAS7 at Week 12
Description
The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS).
The HSS has a scale of 0 (none) to 3 (intense/severe). A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days.
The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days.
The UAS7 is the sum of the HSS7 score and the ISS7 score, and has a possible range in score of 0-42.
Complete hives response is defined as HSS7 (average daily HSS over the preceding 7 days) = 0.
Complete itch response is defined as ISS7 (average daily ISS over the preceding 7 days) = 0.
Complete UAS7 response is defined as UAS7=0.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Complete absence of hives and itch at Week 12
Description
Assessed as percentage of subjects achieving UAS7 = 0
Time Frame
Week 12
Title
Improvement of severity of itch
Description
Assessed as absolute change from baseline in ISS7 score at Week 12
Time Frame
Week 12
Title
No impact on subject's quality of life at Week 12
Description
Assessed as percentage of subjects achieving DLQI = 0-1
Time Frame
Week 12
Title
Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12
Description
To assess the cumulative period of time that treated subjects are angioedema occurrence-free
Time Frame
Weekly to Week 12
Title
Occurrence of treatment emergent adverse events and serious adverse events during the study
Description
Treatment emergent adverse events and serious adverse events are those which occur at any time only after treatment has started
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Signed informed consent must be obtained prior to participation in the study. The subject's', parent'ssubject's, parent's or legal guardian's signed written informed consent and child's assent, if appropriate, must be obtained before any assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
Male and female subjects ≥ 12 years of age at the time of screening.
CSU diagnosis for ≥ 6 months.
Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:
The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-AH
UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during the 7 days prior to randomization (Visit 110, Day 1)
Subjects must be on H1-AH at only approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)
Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
Key Exclusion Criteria:
History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).
Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic- or contact-urticaria.
Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.
Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
Prior exposure to ligelizumab or omalizumab.
Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1 antihistamines use at greater than approved doses after Visit 1.
Facility Information:
Facility Name
Novartis Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Novartis Investigative Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Novartis Investigative Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72209
Country
United States
Facility Name
Novartis Investigative Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Novartis Investigative Site
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Novartis Investigative Site
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Novartis Investigative Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Novartis Investigative Site
City
Eagle
State/Province
Idaho
ZIP/Postal Code
83616
Country
United States
Facility Name
Novartis Investigative Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Novartis Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Novartis Investigative Site
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Novartis Investigative Site
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Novartis Investigative Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Novartis Investigative Site
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Novartis Investigative Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Novartis Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Novartis Investigative Site
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Novartis Investigative Site
City
Blue Bell
State/Province
Pennsylvania
ZIP/Postal Code
19422
Country
United States
Facility Name
Novartis Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Novartis Investigative Site
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
Novartis Investigative Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Novartis Investigative Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Novartis Investigative Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Novartis Investigative Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Novartis Investigative Site
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Novartis Investigative Site
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Facility Name
Novartis Investigative Site
City
Ciudad de Mendoza
State/Province
Mendoza
ZIP/Postal Code
M5500AWD
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
State/Province
Rosario
ZIP/Postal Code
S2000DBS
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000BRH
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000JKR
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1425DKG
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
ZIP/Postal Code
1035
Country
Argentina
Facility Name
Novartis Investigative Site
City
Salta
ZIP/Postal Code
4400
Country
Argentina
Facility Name
Novartis Investigative Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Novartis Investigative Site
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Novartis Investigative Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Novartis Investigative Site
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Loverval
ZIP/Postal Code
6280
Country
Belgium
Facility Name
Novartis Investigative Site
City
Salvador
State/Province
BA
ZIP/Postal Code
40110-060
Country
Brazil
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Novartis Investigative Site
City
Alphaville Barueri
State/Province
Sao Paulo
ZIP/Postal Code
06454010
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090 000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05437 010
Country
Brazil
Facility Name
Novartis Investigative Site
City
Vitacura
State/Province
Santiago
ZIP/Postal Code
7640881
Country
Chile
Facility Name
Novartis Investigative Site
City
Osorno
Country
Chile
Facility Name
Novartis Investigative Site
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Novartis Investigative Site
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Name
Novartis Investigative Site
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Novartis Investigative Site
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Novartis Investigative Site
City
Nice Cedex
ZIP/Postal Code
06202
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Novartis Investigative Site
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Novartis Investigative Site
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novartis Investigative Site
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Novartis Investigative Site
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Novartis Investigative Site
City
Halle
ZIP/Postal Code
06097
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22303
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
80377
Country
Germany
Facility Name
Novartis Investigative Site
City
Osnabrueck
ZIP/Postal Code
49074
Country
Germany
Facility Name
Novartis Investigative Site
City
Quedlinburg
ZIP/Postal Code
06484
Country
Germany
Facility Name
Novartis Investigative Site
City
Simmern
ZIP/Postal Code
55469
Country
Germany
Facility Name
Novartis Investigative Site
City
Stade
ZIP/Postal Code
21682
Country
Germany
Facility Name
Novartis Investigative Site
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
Facility Name
Novartis Investigative Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Novartis Investigative Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 060
Country
India
Facility Name
Novartis Investigative Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560004
Country
India
Facility Name
Novartis Investigative Site
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575002
Country
India
Facility Name
Novartis Investigative Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422 101
Country
India
Facility Name
Novartis Investigative Site
City
Bikaner
State/Province
Rajasthan
ZIP/Postal Code
334001
Country
India
Facility Name
Novartis Investigative Site
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Novartis Investigative Site
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Novartis Investigative Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novartis Investigative Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Novartis Investigative Site
City
Cagliari
State/Province
CA
ZIP/Postal Code
09042
Country
Italy
Facility Name
Novartis Investigative Site
City
Catania
State/Province
CT
ZIP/Postal Code
95125
Country
Italy
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
FI
ZIP/Postal Code
50122
Country
Italy
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Facility Name
Novartis Investigative Site
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
State/Province
MO
ZIP/Postal Code
41100
Country
Italy
Facility Name
Novartis Investigative Site
City
Siena
State/Province
SI
ZIP/Postal Code
53100
Country
Italy
Facility Name
Novartis Investigative Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
454-0012
Country
Japan
Facility Name
Novartis Investigative Site
City
Chikushino
State/Province
Fukuoka
ZIP/Postal Code
818 0083
Country
Japan
Facility Name
Novartis Investigative Site
City
Hiroshima City
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Novartis Investigative Site
City
Amagasaki city
State/Province
Hyogo
ZIP/Postal Code
660 8550
Country
Japan
Facility Name
Novartis Investigative Site
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Novartis Investigative Site
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
211-0063
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
220-6208
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
221-0825
Country
Japan
Facility Name
Novartis Investigative Site
City
Kamimashi-gun
State/Province
Kumamoto
ZIP/Postal Code
861-3106
Country
Japan
Facility Name
Novartis Investigative Site
City
Sakai
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Novartis Investigative Site
City
Izumo-city
State/Province
Shimane
ZIP/Postal Code
693 8501
Country
Japan
Facility Name
Novartis Investigative Site
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Novartis Investigative Site
City
Machida-city
State/Province
Tokyo
ZIP/Postal Code
194-0013
Country
Japan
Facility Name
Novartis Investigative Site
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
158-0097
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinagawa ku
State/Province
Tokyo
ZIP/Postal Code
141 8625
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
ZIP/Postal Code
819 0167
Country
Japan
Facility Name
Novartis Investigative Site
City
Ashrafieh
ZIP/Postal Code
166830
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Beirut
ZIP/Postal Code
166378
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Saida
ZIP/Postal Code
652
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Novartis Investigative Site
City
Villahermosa
State/Province
Tabasco
ZIP/Postal Code
86035
Country
Mexico
Facility Name
Novartis Investigative Site
City
Breda
State/Province
CK
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Bergen op Zoom
ZIP/Postal Code
4624 VT
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Lipa City
State/Province
Batangas
ZIP/Postal Code
4217
Country
Philippines
Facility Name
Novartis Investigative Site
City
Taguig City
State/Province
Metro Manila
ZIP/Postal Code
1634
Country
Philippines
Facility Name
Novartis Investigative Site
City
Makati City
ZIP/Postal Code
1220
Country
Philippines
Facility Name
Novartis Investigative Site
City
Pasig City
ZIP/Postal Code
1605
Country
Philippines
Facility Name
Novartis Investigative Site
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Novartis Investigative Site
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Novartis Investigative Site
City
Gdansk
ZIP/Postal Code
80-402
Country
Poland
Facility Name
Novartis Investigative Site
City
Krosno
ZIP/Postal Code
38-400
Country
Poland
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Novartis Investigative Site
City
Lodz
ZIP/Postal Code
90-436
Country
Poland
Facility Name
Novartis Investigative Site
City
Ossy
ZIP/Postal Code
42 624
Country
Poland
Facility Name
Novartis Investigative Site
City
Sopot
ZIP/Postal Code
81 756
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 2
ZIP/Postal Code
020762
Country
Romania
Facility Name
Novartis Investigative Site
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Novartis Investigative Site
City
Cluj Napoca
ZIP/Postal Code
400162
Country
Romania
Facility Name
Novartis Investigative Site
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Novartis Investigative Site
City
Iasi
ZIP/Postal Code
700381
Country
Romania
Facility Name
Novartis Investigative Site
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
191123
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
194223
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St.-Petersburg
ZIP/Postal Code
195112
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Stavropol
ZIP/Postal Code
355000
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Levice
State/Province
Slovak Republic
ZIP/Postal Code
934 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kezmarok
ZIP/Postal Code
060 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Komarno
ZIP/Postal Code
945 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Nove Zamky
ZIP/Postal Code
940 34
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Povazska Bystrica
ZIP/Postal Code
017 26
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Svidnik
ZIP/Postal Code
08901
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Topolcany
ZIP/Postal Code
95501
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Zilina
ZIP/Postal Code
010 01
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Cordoba
State/Province
Andalucia
ZIP/Postal Code
14004
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46014
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46015
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novartis Investigative Site
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Novartis Investigative Site
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Novartis Investigative Site
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Novartis Investigative Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Novartis Investigative Site
City
La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Novartis Investigative Site
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novartis Investigative Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Tao Yuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Sfax
State/Province
Tunusia
ZIP/Postal Code
3029
Country
Tunisia
Facility Name
Novartis Investigative Site
City
Sousse
ZIP/Postal Code
4000
Country
Tunisia
Facility Name
Novartis Investigative Site
City
Tunis
ZIP/Postal Code
1007
Country
Tunisia
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Novartis Investigative Site
City
Ho Chi Minh
ZIP/Postal Code
7000
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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 III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
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