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

Last Update: Mar 16, 2021

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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 and over placebo.

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 
Jun 16, 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
Recruiting
Saint Louis, 63141
Missouri
United States
Novartis Investigative Site
Recruiting
Missoula, 59808
Montana
United States
Novartis Investigative Site
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
Toledo, 43617
Ohio
United States
Novartis Investigative Site
Recruiting
Oklahoma City, 73120
Oklahoma
United States
Novartis Investigative Site
Recruiting
Clackamas, 97015
Oregon
United States
Novartis Investigative Site
Recruiting
Blue Bell, 19422
Pennsylvania
United States
Novartis Investigative Site
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
Recruiting
Houston, 77030
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78230
Texas
United States
Novartis Investigative Site
Recruiting
Waco, 76712
Texas
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
Santa Fe, S2000DBS
Rosario
Argentina
Novartis Investigative Site
Recruiting
Buenos Aires, C1425DKG
-
Argentina
Chile
Novartis Investigative Site
Recruiting
Vitacura, 7640881
Santiago
Chile
Novartis Investigative Site
Recruiting
Osorno,
-
Chile
Novartis Investigative Site
Recruiting
Santiago, 8420383
-
Chile
Germany
Novartis Investigative Site
Recruiting
Bad Bentheim, 48455
-
Germany
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
Yokohama, 220-6208
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Kamimashi-gun, 861-3101
Kumamoto
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
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
Netherlands
Novartis Investigative Site
Recruiting
Utrecht, 3508 GA
-
Netherlands
Poland
Novartis Investigative Site
Recruiting
Gdansk, 80-402
-
Poland
Romania
Novartis Investigative Site
Recruiting
Timisoara, 300566
Timis
Romania
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 115478
-
Russian Federation
Novartis Investigative Site
Recruiting
Saint Petersburg, 191123
-
Russian Federation
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
Salford, M6 8HD
Manchester
United Kingdom
Novartis Investigative Site
Recruiting
Cardiff, CF14 4XW
-
United Kingdom
Novartis Investigative Site
Recruiting
Leeds, LS9 7TF
-
United Kingdom
Novartis Investigative Site
Recruiting
London, E1 1BB
-
United Kingdom
Vietnam
Novartis Investigative Site
Recruiting
Hanoi, 100000
-
Vietnam
Novartis Investigative Site
Recruiting
Ho Chi Minh, 7000
-
Vietnam

Contacts

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

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