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Trial details
CQGE031C2302E1 Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
Current status:
Approved
|
Date registered:
19/10/2020
Trial version(s)
History: 01/09/2020
History: 01/09/2020
History: 01/09/2020
History: 01/09/2020
History: 01/09/2020
History: 01/09/2020
History: 01/09/2020
History: 01/09/2020
History: 01/09/2020
History: 01/09/2020
History: 01/09/2020
History: 01/09/2020
History: 01/09/2020
Current: 01/09/2020
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Main Information
Primary registry identifying number
LBCTR2020094573
Protocol number
CQGE031C2302E1
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharmaceuticals
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
CQGE031C2302E1 Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
Acronym
Scientific title
A Multi-center, Double-blinded and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment, Self-administered Therapy and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301
Acronym
Brief summary of the study: English
The purpose of this extension study is to establish efficacy and safety of ligelizumab. This will be assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who have completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. In a subset of subjects, the safety and efficacy of ligelizumab monotherapy will be assessed. This study will also fulfill the Novartis commitment to provide post-trial access to patients who have completed studies CQGE031C2302, CGQE031C2303, CQGE031C2202 or CQGE031C1301
Brief summary of the study: Arabic
دراسة تمديد متعدّدة المراكز ومزدوجة التعمية ومفتوحة اللصاقة لتقييم فعاليّة وسلامة ليجيليزوماب كإعادة معالجة وعلاج يُعطى ذاتيًا ومعالجة أحاديّة لدى مرضى الشرى التلقائي المزمن الذين أنجزوا دراسات CQGE031C2302، CQGE031C2303، CQGE031C2202 أو CQGE031C1301
Health conditions/problem studied: Specify
Chronic Spontaneous Urticaria
Interventions: Specify
Drug: Ligelizumab liquid in vial 120 mg/mL Prefilled Syringe 120 mg/mL Other Name: QGE031
Key inclusion and exclusion criteria: Inclusion criteria
Key Inclusion Criteria: •Written informed consent •Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301 •Male and female, adult and adolescent subjects ≥12 years of age •Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule
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
Key Exclusion Criteria: •Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment •Use of omalizumab within 16 weeks of Screening •History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes •New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302, CQGE031C2303 or CQGE031C2202. •Diseases with possible symptoms of urticaria or angioedema •Subjects with evidence of helminthic parasitic infection •Documented history of anaphylaxis •Pregnant or nursing (lactating) women
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Non-randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
N/A
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
Ligelizumab is a high-affinity anti-human-IgE
Therapeutic indication
Patients with: Chronic Spontaneous Urticaria
Therapeutic benefit
improvement of CSU symptoms including itch, hives, angioedema
Biospecimen retention
Samples without DNA
Biospecimen description
Samples will be sent to Q2 central Lab for analysis
Target sample size
10
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
30/09/2020
Date of study closure: Type
Anticipated
Date of study closure: Date
16/12/2026
Recruitment status
Pending
Date of completion
20/04/2022
IPD sharing statement plan
No
IPD sharing statement description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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/NCT04210843?cond=ligelizumab&draw=3
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinical trials.gov
NCT04210843
Sources of Monetary or Material Support
Name
Novartis Pharma services
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@hot mail.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
Ashrafieh
Lebanon
9613495496
iranica@yahoo.com
Hotel Dieu De France
Public
Alfred
Ammoury
Ashrafieh
Lebanon
96178820821
docalf@yahoo.com
St. Georges 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
Hadi Hamam
Dermatology
Approved
Hotel Dieu De France
Carla Irani
Allergy and Immunology
Approved
St Georges Hospital University Medical Center
Alfred Ammoury
Dermatology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hammoud Hospital University Medical Center
28/05/2020
Ahmad Zaatari
zaatari@hammoudhospital.com
961 (0) 7 723111 ext 1160
Hotel Dieu de France
05/05/2020
Nancy Alam
nancy.alam@usj.edu.lb
961 (0) 1 421000 ext 2335
Saint George Hospital University Medical Center
24/09/2020
Michel Daher
mndaher@stgeorgehospital.org
9611581714
Countries of Recruitment
Name
Australia
Austria
Belgium
Canada
Czech Republic
France
Germany
Greece
Hungary
Japan
Republic of Korea
Slovakia
Spain
Thailand
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
proportion of subjects with well-controlled disease USA7
Week 12
Week 12
Reduction in number of hives and itch
week 12
week 12
Improvement of severity of itch
week 12
week 12
Key Secondary Outcomes
Name
Time points
Measure
Complete control of chronic spontaneous urticaria (CSU)
week 12
week 12
Reduction from extension baseline in weekly itch severity score (ISS7)
ISS over the preceding 7 days
ISS over the preceding 7 days
Reduction from extension baseline in weekly Urticaria Activity Score (UAS7)
week 12
week 12
Reduction from extension baseline in weekly hives severity score HSS7
week 12
week 12
Achieving a weekly angioedema-free period (AAS7) = 0
week 12
week 12
Percentage of subjects achieving Dermatology Life Quality Index (DLQI) = 0-1
week 12
week 12
Efficacy of ligelizumab in the treatment of CSU after self administration
week 12
week 12
Safety and tolerability of ligelizumab 120 mg q4w after self administration
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
Adding new site SGHUMC
18/10/2020
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