A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

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

ClinicalTrials.gov Identifier: NCT03580369

Novartis Reference Number: CQGE031C2302

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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 efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab.

The study population will consist of approximately 1050 male and female subjects aged ≥ 12 years who have been diagnosed with CSU and who remain symptomatic despite the use of H1-antihistamines. Of these, approximately 1000 adults and 50 adolescents are planned for inclusion in the study.

This is a 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.

Condition 
Chronic Spontaneous Urticaria
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
1050 participants
Start date 
Oct 17, 2018
Completion date 
Jan 26, 2022
Gender 
All
Age(s)
12 Years and older (Child, Adult, Older Adult)

Interventions

Biological
Ligelizumab
Liquid in vial
Biological
Omalizumab
Lyophilized powder for solution in vial
Other
Placebo
Liquid in vial

Eligibility Criteria

Key Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study. The subject'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-antihistamine
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-antihistamine 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.

Study Locations

United States
Novartis Investigative Site
Recruiting
Gilbert, 85234
Arizona
United States
Novartis Investigative Site
Recruiting
Litchfield Park, 85340
Arizona
United States
Novartis Investigative Site
Recruiting
Scottsdale, 85258
Arizona
United States
Novartis Investigative Site
Recruiting
Little Rock, 72205
Arkansas
United States
Novartis Investigative Site
Recruiting
Bakersfield, 93301
California
United States
Novartis Investigative Site
Recruiting
Beverly Hills, 90211
California
United States
Novartis Investigative Site
Recruiting
Huntington Beach, 92647
California
United States
Novartis Investigative Site
Recruiting
Long Beach, 90808
California
United States
Novartis Investigative Site
Withdrawn
Los Angeles, 90064
California
United States
Novartis Investigative Site
Recruiting
Colorado Springs, 80907
Colorado
United States
Novartis Investigative Site
Recruiting
Denver, 80230
Colorado
United States
Novartis Investigative Site
Recruiting
Lake Worth, 33467
Florida
United States
Novartis Investigative Site
Recruiting
Miami, 33155
Florida
United States
Novartis Investigative Site
Recruiting
Tallahassee, 32308
Florida
United States
Novartis Investigative Site
Recruiting
Tampa, 33613
Florida
United States
Novartis Investigative Site
Recruiting
Marietta, 30060
Georgia
United States
Novartis Investigative Site
Withdrawn
Savannah, 31406
Georgia
United States
Novartis Investigative Site
Recruiting
Boise, 83706
Idaho
United States
Novartis Investigative Site
Recruiting
Evansville, 47713
Indiana
United States
Novartis Investigative Site
Recruiting
Indianapolis, 46256
Indiana
United States
Novartis Investigative Site
Recruiting
Overland Park, 66211
Kansas
United States
Novartis Investigative Site
Withdrawn
Florence, 41042
Kentucky
United States
Novartis Investigative Site
Recruiting
Bangor, 04401
Maine
United States
Novartis Investigative Site
Recruiting
Waldorf, 20602
Maryland
United States
Novartis Investigative Site
Recruiting
Clarkston, 48346
Michigan
United States
Novartis Investigative Site
Recruiting
Ypsilanti, 48197
Michigan
United States
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Recruiting
Plymouth, 55441
Minnesota
United States
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Recruiting
Columbia, 65201
Missouri
United States
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Recruiting
Bronx, 10461
New York
United States
Novartis Investigative Site
Recruiting
Asheville, 28801
North Carolina
United States
Novartis Investigative Site
Recruiting
Gastonia, 28054
North Carolina
United States
Novartis Investigative Site
Recruiting
Cincinnati, 45231
Ohio
United States
Novartis Investigative Site
Recruiting
Mayfield Heights, 44124
Ohio
United States
Novartis Investigative Site
Recruiting
Tulsa, 74136
Oklahoma
United States
Novartis Investigative Site
Recruiting
Medford, 97504
Oregon
United States
Novartis Investigative Site
Recruiting
Plymouth Meeting, 19462
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Goodlettsville, 37072-2301
Tennessee
United States
Novartis Investigative Site
Recruiting
Dallas, 75230
Texas
United States
Novartis Investigative Site
Withdrawn
Dallas, 75230
Texas
United States
Novartis Investigative Site
Recruiting
Dallas, 75231
Texas
United States
Novartis Investigative Site
Completed
Pflugerville, 78660
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78251
Texas
United States
Novartis Investigative Site
Withdrawn
Temple, 76508
Texas
United States
Novartis Investigative Site
Completed
South Burlington, 05403
Vermont
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1056ABJ
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Caba, C1414AIF
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Ciudad Autonoma de Bs As, C1425BEA
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
La Plata, B1902COS
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, B6500BWQ
Nueve De Julio
Argentina
Novartis Investigative Site
Recruiting
Bahia Blanca, B8000JRB
-
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, C1125ABE
-
Argentina
Novartis Investigative Site
Recruiting
Capital Federal, C1023AAB
-
Argentina
Austria
Novartis Investigative Site
Recruiting
Innsbruck, 6020
-
Austria
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Recruiting
Linz, A 4020
-
Austria
Novartis Investigative Site
Recruiting
Wien, A 1090
-
Austria
Brazil
Novartis Investigative Site
Recruiting
Vitoria, 29025 023
ES
Brazil
Novartis Investigative Site
Recruiting
Alphaville Barueri, 06454010
Sao Paulo
Brazil
Novartis Investigative Site
Recruiting
Santo Andre, 09060 650
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 05403 000
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 05437 010
SP
Brazil
Bulgaria
Novartis Investigative Site
Active, not recruiting
Pleven, 5800
-
Bulgaria
Novartis Investigative Site
Withdrawn
Sofia, 1407
-
Bulgaria
Novartis Investigative Site
Active, not recruiting
Sofia, 1407
-
Bulgaria
Novartis Investigative Site
Active, not recruiting
Sofia, 1431
-
Bulgaria
Novartis Investigative Site
Active, not recruiting
Sofia, 1606
-
Bulgaria
Novartis Investigative Site
Active, not recruiting
Varna, 9000
-
Bulgaria
Canada
Novartis Investigative Site
Active, not recruiting
Hamilton, L8N 3Z5
Ontario
Canada
Novartis Investigative Site
Recruiting
Kingston, K7L 2V7
Ontario
Canada
Novartis Investigative Site
Recruiting
Mississauga, L5A 3V4
Ontario
Canada
Novartis Investigative Site
Recruiting
Toronto, M4V 1R2
Ontario
Canada
Novartis Investigative Site
Recruiting
Waterloo, N2J 1C4
Ontario
Canada
Novartis Investigative Site
Active, not recruiting
Montreal, H3G 1L5
Quebec
Canada
Novartis Investigative Site
Recruiting
Quebec, G1V 4W2
-
Canada
Colombia
Novartis Investigative Site
Recruiting
Medellin, 0050010
Antioquia
Colombia
Novartis Investigative Site
Recruiting
Bogota, 110221
-
Colombia
Croatia
Novartis Investigative Site
Recruiting
Zagreb, 10000
-
Croatia
Czechia
Novartis Investigative Site
Withdrawn
Usti nad Labem, 400 11
Czech Republic
Czechia
Novartis Investigative Site
Recruiting
Teplice, 415 01
CZE
Czechia
Novartis Investigative Site
Recruiting
Prague, 11000
Prague 1
Czechia
Novartis Investigative Site
Recruiting
Olomouc, 775 20
-
Czechia
Novartis Investigative Site
Recruiting
Plzen, 305 99
-
Czechia
Denmark
Novartis Investigative Site
Active, not recruiting
Copenhagen NV, 2400
-
Denmark
Novartis Investigative Site
Withdrawn
Hellerup, 2900
-
Denmark
Novartis Investigative Site
Active, not recruiting
Herlev, 2730
-
Denmark
France
Novartis Investigative Site
Completed
Bordeaux Cedex, 33075
-
France
Novartis Investigative Site
Completed
Montpellier cedex 5, 34295
-
France
Novartis Investigative Site
Active, not recruiting
Pierre Benite Cedex, 69495
-
France
Novartis Investigative Site
Active, not recruiting
Toulouse Cedex, 31400
-
France
Novartis Investigative Site
Active, not recruiting
Trevenans, 90400
-
France
Germany
Novartis Investigative Site
Recruiting
Regensburg, 93053
Bavaria
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Bielefeld, 33647
-
Germany
Novartis Investigative Site
Recruiting
Bochum, 44791
-
Germany
Novartis Investigative Site
Recruiting
Bochum, 44793
-
Germany
Novartis Investigative Site
Recruiting
Erlangen, 91054
-
Germany
Novartis Investigative Site
Recruiting
Essen, 45147
-
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Recruiting
Jena, 07740
-
Germany
Novartis Investigative Site
Recruiting
Langenau, 89129
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Novartis Investigative Site
Recruiting
Marburg, 35039
-
Germany
Novartis Investigative Site
Recruiting
Memmingen, 87700
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81377
-
Germany
Novartis Investigative Site
Recruiting
Oldenburg, 26133
-
Germany
Novartis Investigative Site
Withdrawn
Wiesbaden, 65199
-
Germany
Greece
Novartis Investigative Site
Recruiting
Athens, 115 27
GR
Greece
Novartis Investigative Site
Recruiting
Athens, 115 27
-
Greece
Novartis Investigative Site
Recruiting
Athens, 12462
-
Greece
Novartis Investigative Site
Recruiting
Athens, 161 21
-
Greece
Guatemala
Novartis Investigative Site
Withdrawn
Guatemala city, 01010
-
Guatemala
Novartis Investigative Site
Recruiting
Guatemala City, 01010
-
Guatemala
Novartis Investigative Site
Recruiting
Guatemala City, 01015
-
Guatemala
Novartis Investigative Site
Recruiting
Guatemala, 01015
-
Guatemala
Hungary
Novartis Investigative Site
Recruiting
Kecskemet, 6000
Bacs Kiskun
Hungary
Novartis Investigative Site
Recruiting
Szeged, 6720
Csongrad
Hungary
Novartis Investigative Site
Recruiting
Debrecen, 4032
-
Hungary
Novartis Investigative Site
Recruiting
Pecs, 7632
-
Hungary
India
Novartis Investigative Site
Recruiting
Bangalore, 560054
Karnataka
India
Novartis Investigative Site
Recruiting
Belagavi, 590010
Karnataka
India
Novartis Investigative Site
Recruiting
Nashik, 422 101
Maharashtra
India
Novartis Investigative Site
Recruiting
Nashik, 422005
Maharashtra
India
Novartis Investigative Site
Recruiting
Navi Mumbai, 400 706
Maharashtra
India
Novartis Investigative Site
Recruiting
New Delhi, 110029
-
India
Novartis Investigative Site
Recruiting
Vijayawada, 520002
-
India
Korea, Republic of
Novartis Investigative Site
Recruiting
Daegu, 42602
Dalseo Gu
Korea, Republic of
Novartis Investigative Site
Recruiting
Wonju, 26426
Gangwon-Do
Korea, Republic of
Novartis Investigative Site
Recruiting
Bundang Gu, 13620
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
Recruiting
Hwaseong si, 18450
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
Active, not recruiting
Suwon si, 16499
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
Active, not recruiting
Seoul, 08308
Korea
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 06591
Seocho Gu
Korea, Republic of
Novartis Investigative Site
Recruiting
Gwangju, 61469
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Incheon, 405 760
-
Korea, Republic of
Novartis Investigative Site
Active, not recruiting
Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03722
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 05505
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 06973
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 07061
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 150-950
-
Korea, Republic of
Malaysia
Novartis Investigative Site
Recruiting
Ipoh, 30450
Perak
Malaysia
Novartis Investigative Site
Recruiting
Kuala Lumpur, 50586
Wilayah Persekutuan
Malaysia
Novartis Investigative Site
Recruiting
Penang, 10990
-
Malaysia
Oman
Novartis Investigative Site
Recruiting
Muscat, 123
-
Oman
Peru
Novartis Investigative Site
Active, not recruiting
Miraflores, 15074
Lima
Peru
Novartis Investigative Site
Active, not recruiting
San Borja, 41
Lima
Peru
Poland
Novartis Investigative Site
Recruiting
Ksawerow, 95-054
POL
Poland
Novartis Investigative Site
Recruiting
Katowice, 40-648
-
Poland
Novartis Investigative Site
Recruiting
Kielce, 25-155
-
Poland
Novartis Investigative Site
Recruiting
Krakow, 31-530
-
Poland
Novartis Investigative Site
Recruiting
Lublin, 20-080
-
Poland
Novartis Investigative Site
Recruiting
Rzeszow, 35 055
-
Poland
Novartis Investigative Site
Recruiting
Wroclaw, 50 566
-
Poland
Puerto Rico
Novartis Investigative Site
Recruiting
San Juan, 00909
-
Puerto Rico
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 123182
-
Russian Federation
Novartis Investigative Site
Recruiting
Rostov on Don, 344022
-
Russian Federation
Novartis Investigative Site
Completed
Ryazan, 390046
-
Russian Federation
Novartis Investigative Site
Recruiting
Saratov, 410012
-
Russian Federation
Novartis Investigative Site
Recruiting
Smolensk, 214019
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
St Petersburg, 194325
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
St. Petersburg, 193231
-
Russian Federation
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119074
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169608
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 229899
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 308205
-
Singapore
South Africa
Novartis Investigative Site
Recruiting
Cape Town, 7700
Western Province
South Africa
Novartis Investigative Site
Recruiting
Cape Town, 7700
-
South Africa
Novartis Investigative Site
Recruiting
Durban, 3630
-
South Africa
Spain
Novartis Investigative Site
Recruiting
Malaga, 29009
Andalucia
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41009
Andalucia
Spain
Novartis Investigative Site
Recruiting
Hospitalet de Llobregat, 08907
Barcelona
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08003
Cataluna
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Cataluna
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Alicante, 03010
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
La Coruna, 15006
Galicia
Spain
Novartis Investigative Site
Recruiting
Bilbao, 48013
Pais Vasco
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08041
-
Spain
Sweden
Novartis Investigative Site
Completed
Malmo, SE-205 02
-
Sweden
Novartis Investigative Site
Withdrawn
Stockholm, 17176
-
Sweden
Thailand
Novartis Investigative Site
Recruiting
Bangkoknoi, 10700
Bangkok
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10400
Phayathai
Thailand
Novartis Investigative Site
Recruiting
Bangkok, 10400
-
Thailand
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34098
TUR
Turkey
Novartis Investigative Site
Recruiting
Aydin, 09100
-
Turkey
Novartis Investigative Site
Recruiting
Denizli, 20070
-
Turkey
Novartis Investigative Site
Recruiting
Gaziantep, 27310
-
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 348999
-
Turkey
Novartis Investigative Site
Recruiting
Izmir, 35040
-
Turkey
Novartis Investigative Site
Recruiting
Izmir, 35380
-
Turkey
Novartis Investigative Site
Withdrawn
Izmir,
-
Turkey
Novartis Investigative Site
Recruiting
Okmeydani, 34370
-
Turkey
Novartis Investigative Site
Recruiting
Samsun, 55139
-
Turkey
Novartis Investigative Site
Recruiting
Talas / Kayseri, 38039
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]