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: NCT03580356

Novartis Reference Number: CQGE031C2303

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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 20, 2018
Completion date 
Apr 08, 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'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.

Study Locations

United States
Novartis Investigative Site
Recruiting
Birmingham, 35209
Alabama
United States
Novartis Investigative Site
Recruiting
Scottsdale, 85251
Arizona
United States
Novartis Investigative Site
Recruiting
Little Rock, 72209
Arkansas
United States
Novartis Investigative Site
Recruiting
Fresno, 93720
California
United States
Novartis Investigative Site
Recruiting
Los Angeles, 90025
California
United States
Novartis Investigative Site
Recruiting
Orange, 92868
California
United States
Novartis Investigative Site
Recruiting
Redwood City, 94063
California
United States
Novartis Investigative Site
Recruiting
Rolling Hills Estates, 90274
California
United States
Novartis Investigative Site
Recruiting
San Jose, 95117
California
United States
Novartis Investigative Site
Recruiting
North Miami Beach, 33162
Florida
United States
Novartis Investigative Site
Recruiting
Sarasota, 34233
Florida
United States
Novartis Investigative Site
Recruiting
Tampa, 33609
Florida
United States
Novartis Investigative Site
Recruiting
Columbus, 31904
Georgia
United States
Novartis Investigative Site
Recruiting
Eagle, 83616
Idaho
United States
Novartis Investigative Site
Completed
Normal, 61761
Illinois
United States
Novartis Investigative Site
Recruiting
Baltimore, 21204
Maryland
United States
Novartis Investigative Site
Recruiting
Wheaton, 20902
Maryland
United States
Novartis Investigative Site
Recruiting
White Marsh, 21162
Maryland
United States
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Recruiting
Brighton, 02135
Massachusetts
United States
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Recruiting
Rochester, 55905
Minnesota
United States
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Recruiting
Saint Louis, 63141
Missouri
United States
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Recruiting
Missoula, 59808
Montana
United States
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Recruiting
Papillion, 68046
Nebraska
United States
Novartis Investigative Site
Recruiting
Brick, 08724
New Jersey
United States
Novartis Investigative Site
Recruiting
New York, 10029
New York
United States
Novartis Investigative Site
Recruiting
Columbus, 43210
Ohio
United States
Novartis Investigative Site
Recruiting
Toledo, 43617
Ohio
United States
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Recruiting
Oklahoma City, 73120
Oklahoma
United States
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Recruiting
Clackamas, 97015
Oregon
United States
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Recruiting
Blue Bell, 19422
Pennsylvania
United States
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Recruiting
Pittsburgh, 15241
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Sugarloaf, 18249
Pennsylvania
United States
Novartis Investigative Site
Recruiting
North Charleston, 29420
South Carolina
United States
Novartis Investigative Site
Recruiting
Bellaire, 77401
Texas
United States
Novartis Investigative Site
Recruiting
El Paso, 79903
Texas
United States
Novartis Investigative Site
Completed
Fort Worth, 76132
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77030
Texas
United States
Novartis Investigative Site
Completed
San Antonio, 78229
Texas
United States
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Recruiting
San Antonio, 78230
Texas
United States
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Recruiting
Waco, 76712
Texas
United States
Novartis Investigative Site
Recruiting
Murray, 84107
Utah
United States
Novartis Investigative Site
Recruiting
Salt Lake City, 84102
Utah
United States
Novartis Investigative Site
Recruiting
Bellingham, 98225
Washington
United States
Novartis Investigative Site
Recruiting
Everett, 98201
Washington
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1181ACH
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Caba, C1414AIF
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Ciudad de Mendoza, M5500AWD
Mendoza
Argentina
Novartis Investigative Site
Recruiting
Santa Fe, S2000DBS
Rosario
Argentina
Novartis Investigative Site
Recruiting
Rosario, S2000BRH
Santa Fe
Argentina
Novartis Investigative Site
Recruiting
Rosario, S2000JKR
Santa Fe
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, C1425DKG
-
Argentina
Novartis Investigative Site
Recruiting
Caba, 1035
-
Argentina
Novartis Investigative Site
Recruiting
Salta, 4400
-
Argentina
Australia
Novartis Investigative Site
Recruiting
Darlinghurst, 2010
New South Wales
Australia
Novartis Investigative Site
Recruiting
Adelaide, 5000
South Australia
Australia
Novartis Investigative Site
Recruiting
East Melbourne, 3002
Victoria
Australia
Novartis Investigative Site
Recruiting
Parkville, 3002
Victoria
Australia
Belgium
Novartis Investigative Site
Recruiting
Jette, 1090
Brussel
Belgium
Novartis Investigative Site
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Bruxelles, 1070
-
Belgium
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Bruxelles, 1200
-
Belgium
Novartis Investigative Site
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Gent, 9000
-
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Novartis Investigative Site
Withdrawn
Liege, 4000
-
Belgium
Novartis Investigative Site
Recruiting
Loverval, 6280
-
Belgium
Brazil
Novartis Investigative Site
Recruiting
Salvador, 40110-060
BA
Brazil
Novartis Investigative Site
Recruiting
Rio de Janeiro, 21941-913
RJ
Brazil
Novartis Investigative Site
Recruiting
Alphaville Barueri, 06454010
Sao Paulo
Brazil
Novartis Investigative Site
Recruiting
Sao Jose do Rio Preto, 15090 000
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 05437 010
SP
Brazil
Chile
Novartis Investigative Site
Recruiting
Vitacura, 7640881
Santiago
Chile
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Osorno,
-
Chile
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Santiago, 8420383
-
Chile
Estonia
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Tallinn, 10138
-
Estonia
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Tartu, 51014
-
Estonia
Finland
Novartis Investigative Site
Recruiting
Helsinki, 00180
-
Finland
France
Novartis Investigative Site
Active, not recruiting
Clermont Ferrand cedex 1, 63003
-
France
Novartis Investigative Site
Active, not recruiting
La Tronche, 38700
-
France
Novartis Investigative Site
Recruiting
Nice, 06202
-
France
Novartis Investigative Site
Active, not recruiting
Paris, 75970
-
France
Novartis Investigative Site
Active, not recruiting
Rouen, 76031
-
France
Germany
Novartis Investigative Site
Withdrawn
Mannheim, 68305
Baden-Wuerttemberg
Germany
Novartis Investigative Site
Recruiting
Bad Bentheim, 48455
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
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Recruiting
Duesseldorf, 40225
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60590
-
Germany
Novartis Investigative Site
Withdrawn
Friedrichshafen, 88045
-
Germany
Novartis Investigative Site
Recruiting
Gera, 07548
-
Germany
Novartis Investigative Site
Recruiting
Gottingen, 37075
-
Germany
Novartis Investigative Site
Recruiting
Halle, 06097
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22303
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 22391
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30625
-
Germany
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Recruiting
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81675
-
Germany
Novartis Investigative Site
Recruiting
Osnabrueck, 49074
-
Germany
Novartis Investigative Site
Recruiting
Quedlinburg, 06484
-
Germany
Novartis Investigative Site
Recruiting
Simmern, 55469
-
Germany
Novartis Investigative Site
Recruiting
Stade, 21682
-
Germany
Novartis Investigative Site
Recruiting
Stuttgart, 70178
-
Germany
Novartis Investigative Site
Recruiting
Tübingen, 72076
-
Germany
India
Novartis Investigative Site
Recruiting
New Delhi, 110 060
Delhi
India
Novartis Investigative Site
Recruiting
Bangalore, 560004
Karnataka
India
Novartis Investigative Site
Recruiting
Mangalore, 575002
Karnataka
India
Novartis Investigative Site
Recruiting
Nashik, 422 101
Maharashtra
India
Novartis Investigative Site
Recruiting
Bikaner, 334001
Rajasthan
India
Novartis Investigative Site
Recruiting
Hyderabad, 500096
Telangana
India
Israel
Novartis Investigative Site
Recruiting
Afula, 1834111
-
Israel
Novartis Investigative Site
Recruiting
Haifa, 3339419
-
Israel
Novartis Investigative Site
Recruiting
Jerusalem, 91120
-
Israel
Novartis Investigative Site
Recruiting
Kfar Saba, 4428164
-
Israel
Novartis Investigative Site
Recruiting
Ramat Gan, 52621
-
Israel
Novartis Investigative Site
Recruiting
Rehovot, 76100
-
Israel
Italy
Novartis Investigative Site
Withdrawn
Ancona, 60126
AN
Italy
Novartis Investigative Site
Recruiting
Catania, 95125
CT
Italy
Novartis Investigative Site
Recruiting
Modena, 41100
Emila-Romagna
Italy
Novartis Investigative Site
Recruiting
Firenze, 50122
FI
Italy
Novartis Investigative Site
Recruiting
Firenze, 50134
FI
Italy
Novartis Investigative Site
Recruiting
Rozzano, 20089
MI
Italy
Novartis Investigative Site
Withdrawn
Pisa, 56124
PI
Italy
Novartis Investigative Site
Recruiting
Cagliari, 09042
Sicilia
Italy
Novartis Investigative Site
Recruiting
Siena, 53100
SI
Italy
Japan
Novartis Investigative Site
Recruiting
Nagoya, 454-0012
Aichi
Japan
Novartis Investigative Site
Recruiting
Chikushino, 818 0083
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Amagasaki city, 660 8550
Hyogo
Japan
Novartis Investigative Site
Recruiting
Kobe-shi, 650-0017
Hyogo
Japan
Novartis Investigative Site
Recruiting
Kawasaki, 211-0063
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Yokohama, 220-6208
Kanagawa
Japan
Novartis Investigative Site
Completed
Yokohama, 221-0825
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Kamimashi-gun, 861-3101
Kumamoto
Japan
Novartis Investigative Site
Recruiting
Sakai, 593-8324
Osaka
Japan
Novartis Investigative Site
Recruiting
Izumo-city, 693 8501
Shimane
Japan
Novartis Investigative Site
Recruiting
Itabashi-ku, 173-8610
Tokyo
Japan
Novartis Investigative Site
Recruiting
Machida-city, 194-0013
Tokyo
Japan
Novartis Investigative Site
Recruiting
Setagaya-ku, 158-0097
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinagawa ku, 141 8625
Tokyo
Japan
Novartis Investigative Site
Recruiting
Fukuoka, 819 0167
-
Japan
Novartis Investigative Site
Recruiting
Hiroshima, 734-8551
-
Japan
Lebanon
Novartis Investigative Site
Recruiting
Ashrafieh, 166830
-
Lebanon
Novartis Investigative Site
Recruiting
Beirut, 166378
-
Lebanon
Novartis Investigative Site
Recruiting
Saida, 652
-
Lebanon
Mexico
Novartis Investigative Site
Recruiting
Guadalajara, 44130
Jalisco
Mexico
Novartis Investigative Site
Recruiting
Guadalajara, 44657
Jalisco
Mexico
Novartis Investigative Site
Recruiting
Villahermosa, 86035
Tabasco
Mexico
Netherlands
Novartis Investigative Site
Recruiting
Breda, 4818
CK
Netherlands
Novartis Investigative Site
Recruiting
Bergen op Zoom, 4624 VT
-
Netherlands
Novartis Investigative Site
Recruiting
Rotterdam, 3015 CE
-
Netherlands
Novartis Investigative Site
Recruiting
Utrecht, 3508 GA
-
Netherlands
Philippines
Novartis Investigative Site
Recruiting
Lipa City, 4217
Batangas
Philippines
Novartis Investigative Site
Recruiting
Taguig City, 1634
Metro Manila
Philippines
Novartis Investigative Site
Recruiting
Las Pinas, 1740
-
Philippines
Novartis Investigative Site
Recruiting
Makati City, 1220
-
Philippines
Novartis Investigative Site
Recruiting
Pasig City, 1605
-
Philippines
Novartis Investigative Site
Recruiting
Quezon City, 1102
-
Philippines
Poland
Novartis Investigative Site
Recruiting
Warszawa, 02 495
Mazowian
Poland
Novartis Investigative Site
Recruiting
Bydgoszcz, 85-094
-
Poland
Novartis Investigative Site
Recruiting
Gdansk, 80-402
-
Poland
Novartis Investigative Site
Recruiting
Krosno, 38-400
-
Poland
Novartis Investigative Site
Recruiting
Lodz, 90-153
-
Poland
Novartis Investigative Site
Recruiting
Lodz, 90-436
-
Poland
Novartis Investigative Site
Recruiting
Ossy, 42 624
-
Poland
Novartis Investigative Site
Recruiting
Sopot, 81 756
-
Poland
Novartis Investigative Site
Recruiting
Warszawa, 02-507
-
Poland
Romania
Novartis Investigative Site
Recruiting
Bucharest, 020762
District 2
Romania
Novartis Investigative Site
Recruiting
Timisoara, 300566
Timis
Romania
Novartis Investigative Site
Recruiting
Brasov, 500283
-
Romania
Novartis Investigative Site
Recruiting
Cluj Napoca, 400162
-
Romania
Novartis Investigative Site
Recruiting
Craiova, 200642
-
Romania
Novartis Investigative Site
Recruiting
Iasi, 700381
-
Romania
Russian Federation
Novartis Investigative Site
Recruiting
Chelyabinsk, 454092
-
Russian Federation
Novartis Investigative Site
Withdrawn
Kazan, 420012
-
Russian Federation
Novartis Investigative Site
Recruiting
Kazan, 420012
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 115478
-
Russian Federation
Novartis Investigative Site
Recruiting
Saint Petersburg, 191123
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 194223
-
Russian Federation
Novartis Investigative Site
Recruiting
St.-Petersburg, 195112
-
Russian Federation
Novartis Investigative Site
Recruiting
Stavropol, 355000
-
Russian Federation
Slovakia
Novartis Investigative Site
Recruiting
Levice, 934 01
Slovak Republic
Slovakia
Novartis Investigative Site
Recruiting
Kezmarok, 060 01
-
Slovakia
Novartis Investigative Site
Recruiting
Komarno, 945 01
-
Slovakia
Novartis Investigative Site
Recruiting
Nove Zamky, 940 34
-
Slovakia
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Recruiting
Povazska Bystrica, 017 26
-
Slovakia
Novartis Investigative Site
Recruiting
Svidnik, 08901
-
Slovakia
Novartis Investigative Site
Recruiting
Topolcany, 95501
-
Slovakia
Novartis Investigative Site
Recruiting
Zilina, 010 01
-
Slovakia
Spain
Novartis Investigative Site
Recruiting
Cordoba, 14004
Andalucia
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Valencia, 46014
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
Valencia, 46015
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
Valencia, 46026
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
Alcorcon, 28922
Madrid
Spain
Novartis Investigative Site
Recruiting
Fuenlabrada, 28942
Madrid
Spain
Novartis Investigative Site
Recruiting
Pozuelo de Alarcon, 28223
Madrid
Spain
Novartis Investigative Site
Recruiting
Pamplona, 31008
Navarra
Spain
Novartis Investigative Site
Recruiting
La Laguna, 38320
Santa Cruz De Tenerife
Spain
Novartis Investigative Site
Recruiting
Granada, 18012
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28041
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Taichung, 40705
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan
Novartis Investigative Site
Recruiting
Tao Yuan, 333
-
Taiwan
Tunisia
Novartis Investigative Site
Recruiting
Sfax, 3029
Tunusia
Tunisia
Novartis Investigative Site
Recruiting
Sousse, 4000
-
Tunisia
Novartis Investigative Site
Recruiting
Tunis, 1007
-
Tunisia
United Kingdom
Novartis Investigative Site
Recruiting
Westbruy On Trym, BS10 5NB
Bristol
United Kingdom
Novartis Investigative Site
Recruiting
Salford, M6 8HD
Manchester
United Kingdom
Novartis Investigative Site
Recruiting
Cardiff, CF14 4XW
-
United Kingdom
Novartis Investigative Site
Recruiting
Glasgow, G51 4TF
-
United Kingdom
Novartis Investigative Site
Recruiting
Leeds, LS9 7TF
-
United Kingdom
Novartis Investigative Site
Recruiting
London, E1 1BB
-
United Kingdom
Novartis Investigative Site
Recruiting
London, SE1 7EH
-
United Kingdom
Vietnam
Novartis Investigative Site
Recruiting
Hanoi, 100000
-
Vietnam
Novartis Investigative Site
Recruiting
Ho Chi Minh, 7000
-
Vietnam

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]