Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03580356




Registration number
NCT03580356
Ethics application status
Date submitted
26/06/2018
Date registered
9/07/2018
Date last updated
25/03/2024

Titles & IDs
Public title
A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
Scientific 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
Secondary ID [1] 0 0
2018-000840-24
Secondary ID [2] 0 0
CQGE031C2303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Spontaneous Urticaria 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Ligelizumab
Treatment: Other - Omalizumab
Other interventions - Placebo

Experimental: Ligelizumab 120 mg - Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Experimental: Ligelizumab 72 mg - Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w

Active comparator: Omalizumab 300 mg - Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w

Placebo comparator: Placebo - Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48


Treatment: Other: Ligelizumab
Liquid in vial

Treatment: Other: Omalizumab
Lyophilized powder for solution in vial

Other interventions: Placebo
Liquid in vial
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects
Timepoint [1] 0 0
Baseline, Week 12
Primary outcome [2] 0 0
Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Number and Percentage of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)
Timepoint [6] 0 0
Baseline, Week 12

Eligibility
Key inclusion criteria
Key

* 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 locally label 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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.
* H1-AH used as background medication at greater than locally label-approved doses after visit 1

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/06/2022
Sample size
Target
Accrual to date
Final
1078
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [2] 0 0
Novartis Investigative Site - East Melbourne
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3002 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Montana
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Mendoza
Country [24] 0 0
Argentina
State/province [24] 0 0
Rosario
Country [25] 0 0
Argentina
State/province [25] 0 0
Santa Fe
Country [26] 0 0
Argentina
State/province [26] 0 0
Caba
Country [27] 0 0
Argentina
State/province [27] 0 0
Salta
Country [28] 0 0
Belgium
State/province [28] 0 0
Brussel
Country [29] 0 0
Belgium
State/province [29] 0 0
Bruxelles
Country [30] 0 0
Belgium
State/province [30] 0 0
Gent
Country [31] 0 0
Belgium
State/province [31] 0 0
Leuven
Country [32] 0 0
Belgium
State/province [32] 0 0
Loverval
Country [33] 0 0
Brazil
State/province [33] 0 0
BA
Country [34] 0 0
Brazil
State/province [34] 0 0
RJ
Country [35] 0 0
Brazil
State/province [35] 0 0
Sao Paulo
Country [36] 0 0
Brazil
State/province [36] 0 0
SP
Country [37] 0 0
Chile
State/province [37] 0 0
Santiago
Country [38] 0 0
Chile
State/province [38] 0 0
Osorno
Country [39] 0 0
Estonia
State/province [39] 0 0
Tallinn
Country [40] 0 0
Estonia
State/province [40] 0 0
Tartu
Country [41] 0 0
Finland
State/province [41] 0 0
Helsinki
Country [42] 0 0
France
State/province [42] 0 0
Clermont Ferrand
Country [43] 0 0
France
State/province [43] 0 0
La Tronche
Country [44] 0 0
France
State/province [44] 0 0
Nice
Country [45] 0 0
France
State/province [45] 0 0
Paris
Country [46] 0 0
France
State/province [46] 0 0
Rouen
Country [47] 0 0
Germany
State/province [47] 0 0
Bad Bentheim
Country [48] 0 0
Germany
State/province [48] 0 0
Dresden
Country [49] 0 0
Germany
State/province [49] 0 0
Duesseldorf
Country [50] 0 0
Germany
State/province [50] 0 0
Frankfurt
Country [51] 0 0
Germany
State/province [51] 0 0
Gera
Country [52] 0 0
Germany
State/province [52] 0 0
Gottingen
Country [53] 0 0
Germany
State/province [53] 0 0
Halle
Country [54] 0 0
Germany
State/province [54] 0 0
Hamburg
Country [55] 0 0
Germany
State/province [55] 0 0
Hannover
Country [56] 0 0
Germany
State/province [56] 0 0
Heidelberg
Country [57] 0 0
Germany
State/province [57] 0 0
Leipzig
Country [58] 0 0
Germany
State/province [58] 0 0
Muenchen
Country [59] 0 0
Germany
State/province [59] 0 0
Osnabrueck
Country [60] 0 0
Germany
State/province [60] 0 0
Quedlinburg
Country [61] 0 0
Germany
State/province [61] 0 0
Simmern
Country [62] 0 0
Germany
State/province [62] 0 0
Stade
Country [63] 0 0
Germany
State/province [63] 0 0
Stuttgart
Country [64] 0 0
Germany
State/province [64] 0 0
Tuebingen
Country [65] 0 0
India
State/province [65] 0 0
Delhi
Country [66] 0 0
India
State/province [66] 0 0
Karnataka
Country [67] 0 0
India
State/province [67] 0 0
Maharashtra
Country [68] 0 0
India
State/province [68] 0 0
Rajasthan
Country [69] 0 0
Israel
State/province [69] 0 0
Afula
Country [70] 0 0
Israel
State/province [70] 0 0
Haifa
Country [71] 0 0
Israel
State/province [71] 0 0
Jerusalem
Country [72] 0 0
Israel
State/province [72] 0 0
Kfar Saba
Country [73] 0 0
Israel
State/province [73] 0 0
Ramat Gan
Country [74] 0 0
Israel
State/province [74] 0 0
Rehovot
Country [75] 0 0
Italy
State/province [75] 0 0
CA
Country [76] 0 0
Italy
State/province [76] 0 0
CT
Country [77] 0 0
Italy
State/province [77] 0 0
FI
Country [78] 0 0
Italy
State/province [78] 0 0
MI
Country [79] 0 0
Italy
State/province [79] 0 0
MO
Country [80] 0 0
Italy
State/province [80] 0 0
SI
Country [81] 0 0
Japan
State/province [81] 0 0
Aichi
Country [82] 0 0
Japan
State/province [82] 0 0
Fukuoka
Country [83] 0 0
Japan
State/province [83] 0 0
Hyogo
Country [84] 0 0
Japan
State/province [84] 0 0
Kanagawa
Country [85] 0 0
Japan
State/province [85] 0 0
Kumamoto
Country [86] 0 0
Japan
State/province [86] 0 0
Osaka
Country [87] 0 0
Japan
State/province [87] 0 0
Shimane
Country [88] 0 0
Japan
State/province [88] 0 0
Tokyo
Country [89] 0 0
Japan
State/province [89] 0 0
Hiroshima
Country [90] 0 0
Lebanon
State/province [90] 0 0
Ashrafieh
Country [91] 0 0
Lebanon
State/province [91] 0 0
Beirut
Country [92] 0 0
Lebanon
State/province [92] 0 0
Saida
Country [93] 0 0
Mexico
State/province [93] 0 0
Jalisco
Country [94] 0 0
Mexico
State/province [94] 0 0
Tabasco
Country [95] 0 0
Netherlands
State/province [95] 0 0
CK
Country [96] 0 0
Netherlands
State/province [96] 0 0
Bergen op Zoom
Country [97] 0 0
Netherlands
State/province [97] 0 0
Rotterdam
Country [98] 0 0
Netherlands
State/province [98] 0 0
Utrecht
Country [99] 0 0
Philippines
State/province [99] 0 0
Batangas
Country [100] 0 0
Philippines
State/province [100] 0 0
Metro Manila
Country [101] 0 0
Philippines
State/province [101] 0 0
Makati City
Country [102] 0 0
Philippines
State/province [102] 0 0
Pasig City
Country [103] 0 0
Philippines
State/province [103] 0 0
Quezon
Country [104] 0 0
Poland
State/province [104] 0 0
Bydgoszcz
Country [105] 0 0
Poland
State/province [105] 0 0
Gdansk
Country [106] 0 0
Poland
State/province [106] 0 0
Krosno
Country [107] 0 0
Poland
State/province [107] 0 0
Lodz
Country [108] 0 0
Poland
State/province [108] 0 0
Ossy
Country [109] 0 0
Poland
State/province [109] 0 0
Sopot
Country [110] 0 0
Poland
State/province [110] 0 0
Warszawa
Country [111] 0 0
Romania
State/province [111] 0 0
District 2
Country [112] 0 0
Romania
State/province [112] 0 0
Brasov
Country [113] 0 0
Romania
State/province [113] 0 0
Cluj Napoca
Country [114] 0 0
Romania
State/province [114] 0 0
Craiova
Country [115] 0 0
Romania
State/province [115] 0 0
Iasi
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Chelyabinsk
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Kazan
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Moscow
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Saint Petersburg
Country [120] 0 0
Russian Federation
State/province [120] 0 0
St Petersburg
Country [121] 0 0
Russian Federation
State/province [121] 0 0
St.-Petersburg
Country [122] 0 0
Russian Federation
State/province [122] 0 0
Stavropol
Country [123] 0 0
Slovakia
State/province [123] 0 0
Slovak Republic
Country [124] 0 0
Slovakia
State/province [124] 0 0
Kezmarok
Country [125] 0 0
Slovakia
State/province [125] 0 0
Komarno
Country [126] 0 0
Slovakia
State/province [126] 0 0
Nove Zamky
Country [127] 0 0
Slovakia
State/province [127] 0 0
Povazska Bystrica
Country [128] 0 0
Slovakia
State/province [128] 0 0
Svidnik
Country [129] 0 0
Slovakia
State/province [129] 0 0
Topolcany
Country [130] 0 0
Slovakia
State/province [130] 0 0
Zilina
Country [131] 0 0
Spain
State/province [131] 0 0
Andalucia
Country [132] 0 0
Spain
State/province [132] 0 0
Catalunya
Country [133] 0 0
Spain
State/province [133] 0 0
Comunidad Valenciana
Country [134] 0 0
Spain
State/province [134] 0 0
Madrid
Country [135] 0 0
Spain
State/province [135] 0 0
Navarra
Country [136] 0 0
Spain
State/province [136] 0 0
Santa Cruz De Tenerife
Country [137] 0 0
Spain
State/province [137] 0 0
Granada
Country [138] 0 0
Taiwan
State/province [138] 0 0
Taichung
Country [139] 0 0
Taiwan
State/province [139] 0 0
Taipei
Country [140] 0 0
Taiwan
State/province [140] 0 0
Tao Yuan
Country [141] 0 0
Tunisia
State/province [141] 0 0
Tunusia
Country [142] 0 0
Tunisia
State/province [142] 0 0
Sousse
Country [143] 0 0
Tunisia
State/province [143] 0 0
Tunis
Country [144] 0 0
United Kingdom
State/province [144] 0 0
London
Country [145] 0 0
Vietnam
State/province [145] 0 0
Hanoi
Country [146] 0 0
Vietnam
State/province [146] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03580356
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03580356