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

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 17, 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'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
Recruiting
Denver, 80230
Colorado
United States
Novartis Investigative Site
Recruiting
Greenacres City, 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
Recruiting
Boise, 83706
Idaho
United States
Novartis Investigative Site
Recruiting
Overland Park, 66211
Kansas
United States
Novartis Investigative Site
Recruiting
Clarkston, 48346
Michigan
United States
Novartis Investigative Site
Recruiting
Ypsilanti, 48197
Michigan
United States
Novartis Investigative Site
Recruiting
Plymouth, 55441
Minnesota
United States
Novartis Investigative Site
Recruiting
Columbia, 65201
Missouri
United States
Novartis Investigative Site
Recruiting
Mayfield Heights, 44124
Ohio
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
Recruiting
Dallas, 75231
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78251
Texas
United States
Argentina
Novartis Investigative Site
Recruiting
Caba, C1414AIF
Buenos Aires
Argentina
Novartis Investigative Site
Recruiting
Bahia Blanca, B8000JRB
-
Argentina
Austria
Novartis Investigative Site
Recruiting
Linz, A 4020
-
Austria
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, 05437 010
SP
Brazil
Korea, Republic of
Novartis Investigative Site
Recruiting
Gwangju, 61469
-
Korea, Republic of
Puerto Rico
Novartis Investigative Site
Recruiting
San Juan, 00909
-
Puerto Rico
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
Alicante, 03010
Comunidad Valenciana
Spain
Novartis Investigative Site
Recruiting
La Coruna, 15006
Galicia
Spain
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, 348999
Pendik
Turkey
Novartis Investigative Site
Recruiting
Aydin, 09100
-
Turkey
Novartis Investigative Site
Recruiting
Izmir, 35380
-
Turkey
Novartis Investigative Site
Recruiting
Samsun, 55139
-
Turkey
Novartis Investigative Site
Recruiting
Talas / Kayseri, 38039
-
Turkey

Contacts

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

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