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Trial details
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
Current status:
Approved
|
Date registered:
15/04/2020
Trial version(s)
History: 08/02/2019
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History: 08/02/2019
Current: 08/02/2019
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Main Information
Primary registry identifying number
LBCTR2019020192
Protocol number
CQGE031C2303
MOH registration number
37979/2018
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
LCTR was recently initiated, original file was previously submitted by Paper
Date of registration in national regulatory agency
13/09/2018
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public 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
Acronym
Pearl 2
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
Acronym
Brief summary of the study: English
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 Chronic Spontaneous Urticaria 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.
Brief summary of the study: Arabic
دراسة متعددة المراكز وعشوائيّة التوزيع ومزدوجة التعمية ونشطة قائمة على مقارنة تأثير الدواء بدواء وهميّ لدراسة فعاليّة وسلامة دواء ليجيليزوماب (QGE031 ) في علاج الشرى التلقائي المزمن غير المسيطر عليه بشكل كافٍ بمضادات الهستامين- H1لدى المراهقين والبالغين
Health conditions/problem studied: Specify
Patients with chronic spontaneous urticaria
Interventions: Specify
IMP: Ligelizumab Comparators: Omalizumab and Placebo
Key inclusion and exclusion criteria: 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 inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
12
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: 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.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Other
Trial scope: Specify scope
Efficacy and safety
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Active
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
Ligelizumab
Type of IMP
Immunological
Pharmaceutical class
Humanized monoclonal antibody of the subtype IgG1/ (anti-IgE)
Therapeutic indication
Patients with chronic spontaneous urticaria inadequately controlled with H1-antihistamines
Therapeutic benefit
Absolute change from baseline in UAS7 at Week 12
Biospecimen retention
Samples without DNA
Biospecimen description
Central lab name, address and contact details: Q² Solutions The Alba Campus Rosebank Livingston EH54 7EG United Kingdom Lab tests to be preformed: Hematology, Clinical chemistry , Coagulation PK/PD:ligelizumab/total IgE Anti-Drug(ligelizumab) antibodies (ADA) Chronic urticaria (CU) index panel (CU index, thyroid peroxidase IgG,thyroglobulin IgG) IgE-autoantibodies,Total tryptase Urine dipstick, Urine Pregnancy Test .
Target sample size
22
Actual enrollment target size
13
Date of first enrollment: Type
Actual
Date of first enrollment: Date
19/02/2019
Date of study closure: Type
Actual
Date of study closure: Date
30/07/2021
Recruitment status
Recruiting
Date of completion
28/02/2020
IPD sharing statement plan
No
IPD sharing statement description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT03580356?term=CQGE031C2303&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
National Institute of Health (clinicaltrials.gov)
NCT03580369
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Hadi
Hamam
Saida
Lebanon
961 3 795 246
hadihamam@hotmail.com
Hammoud Hospital
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Carla
Irani
Beirut
Lebanon
961 3 495 496
iranica@yahoo.com
Hotel Dieu De France
Public
Alfred
Ammoury
Beirut
Lebanon
961 78 820 821
docalf@yahoo.com
Saint George Hospital University Medical Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hammoud Hospital University Medical Center
Dr Hadi Hamam
Dermatology
Approved
Hotel Dieu De France
Dr Carla Irani
Immunologist and Allergist
Approved
Saint Georges Hospital UMC
Dr Alfred Ammoury
Dermatology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
31/07/2018
Nancy Alam
nancy.alam@usj.edu.lb
961 1421000 ext 2335
Saint George Hospital University Medical Center
23/10/2018
Michel Daher
mndaher@stgeorgehospital.org
01/441733
Hammoud Hospital University Medical Center
16/07/2018
Ahmad Zaatari
zaatari@hammoudhospital.com
961 (0) 7 723111 ext 1160
Countries of Recruitment
Name
Australia
Belgium
Japan
Germany
Norway
Russian Federation
Spain
United States of America
Italy
France
Tunisia
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
chronic spontaneous urticaria
Urticaria, unspecified (L50.9)
chronic spontaneous urticaria
Interventions
Intervention
Description
Keyword
Informed consent, questionnaires, Lab tests, drug administration
Informed consent, questionnaires, Lab tests, drug administration
ICF, Lab, ECG, IMP
Primary Outcomes
Name
Time points
Measure
Absolute change from baseline in UAS7
Week 12
Week 12
Complete itch response is defined as ISS7 :average daily ISS
ISS over the preceding 7 days = 0
ISS over the preceding 7 days = 0
Key Secondary Outcomes
Name
Time points
Measure
Complete absence of hives and itch
week 12
Week 12
Improvement of severity of itch
week 12
week12
No impact on subjects quality of life
week 12
week 12
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
New Import License submission
14/04/2020
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