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Trial details
Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
Current status:
Approved
|
Date registered:
27/02/2023
Trial version(s)
History: 09/11/2021
History: 09/11/2021
Current: 09/11/2021
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Main Information
Primary registry identifying number
LBCTR2022014919
Protocol number
CQGE031E12301
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
Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines
Acronym
PEARL-PROVOKE
Scientific title
A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Acronym
Brief summary of the study: English
This is a placebo controlled, phase 3 study designed to evaluate the efficacy and safety of ligelizumab in participants with chronic inducible urticaria who are inadequately controlled with H1-antihistamines
Brief summary of the study: Arabic
دراسة متعددة المراكز، عشوائيّة التوزيع، مزدوجة التعمية، مرتكزة على المقارنة بدواء وهمي للبحث في فعاليّة وسلامة ليجليزوماب(QGE031) في علاج الشّرى المزمن المحرَّض لدى مراهقين وبالغين حالتهم غير مضبوطة بشكل كافٍ بواسطة مضادات الهيستامين H1
Health conditions/problem studied: Specify
Chronic Inducible Urticaria
Interventions: Specify
Drug: Ligelizumab - Ligelizumab treated groups and arms - Other Name: QGE031 Other: Placebo - Placebo treated groups and arms
Key inclusion and exclusion criteria: Inclusion criteria
Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months. Diagnosis of CINDU (symptomatic dermographism, cold urticaria or cholinergic urticaria) inadequately controlled with H1-AH at local label approved doses at the time of randomization, as defined by all of the following: Positive response (i.e development of symptoms) to triggers despite treatment with H1-AH Positive response (i.e. development of symptoms) to provocation test on day of randomization Participants must be able to physically perform the protocol defined provocation test specific to the participant's CINDU. Cholinergic urticaria participants must show sweating in performing the pulse-controlled ergometry test on day of randomization. Participants with anhidrosis must not be included. Willing and able to complete a daily symptom eDiary as per protocol requirement 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 its components or to drugs of similar chemical classes or to the provocation test or items used in provocation tests Participants who have concomitant CSU at screening Participants who have a familial form of the target CINDU that is being considered for the participant's inclusion in this study Participants having a more defined other form of inducible urticaria than the target CINDU that is being considered for the participant's inclusion in this study Diseases, other than chronic inducible 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). Any other skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.) or skin diseases associated with only wheals and no itch e.g asymptomatic dermographism Prior exposure to ligelizumab, omalizumab and or other anti-IgE therapies
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
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
Anti-IgE
Therapeutic indication
Patients with Chronic Inducible Urticaria
Therapeutic benefit
There are currently no approved therapies for patients with CINDU who remain symptomatic despite treatment with H1-antihistamines. The purpose of this study is to establish efficacy and safety of ligelizumab (QGE031) over placebo in participants with chronic inducible urticaria (CINDU) who remain symptomatic despite treatment with H1 antihistamine.
Biospecimen retention
Samples without DNA
Biospecimen description
hematology, chemistry, PK/PD/ADA will be sent to Q2 lab
Target sample size
8
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
10/04/2022
Date of study closure: Type
Anticipated
Date of study closure: Date
21/06/2022
Recruitment status
Suspended
Date of completion
06/04/2022
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.
Additional data URL
https://clinicaltrials.gov/ct2/show/NCT05024058?term=CQGE031E12301&draw=2&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
ClinicalTrials.gov
NCT05024058
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 795246
hadihamam@hotmail.com
Hammoud Hospital
Scientific
Hind
Khairallah
Beirut
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 495496
iranica@yahoo.com
Hotel Dieu De France Hospital
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 Hospital
Carla Irani
Dermatology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hammoud Hospital University Medical Center
01/12/2021
Ibrahim Omeis
iomeis@hammoudhospital.org
+961 7 721021 ext 1160
Hotel Dieu de France
31/01/2022
Nancy Alam
nancy.alam@usj.edu.lb
+961 (0) 1 421000 ext 2335
Countries of Recruitment
Name
Hungary
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Chronic Inducible Urticaria
Urticaria (L50)
CINDU
Interventions
Intervention
Description
Keyword
- IMP Administration - Informed consent procedure - Visit Schedule and Assessments
- IMP Administration - Informed consent procedure - Visit Schedule and Assessments
ICF-IMP
Primary Outcomes
Name
Time points
Measure
Change from baseline in Total Fric Score in participants with symptomatic dermographism
Week 12
Total Fric score (a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1)
Change from baseline in critical temperature threshold in participants with cold urticaria
Week 12
The Temptest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the Temptest, determines the highest temperature sufficient for inducing symptoms.
Change from baseline in itch numerical rating scale in participants with cholinergic urticaria
Week 12
Itch numerical rating scale, a scale from 0 to 10
Key Secondary Outcomes
Name
Time points
Measure
Proportion of participants with symptomatic dermographism with Total Fric score = 0
Week 12
Total Fric score, a scale from 0-4 where a positive response with all of the four pins is TFS = 4, while a positive response with only one pin - the largest pin is TFS = 1
Change from baseline in itch numerical rating scale in participants with symptomatic dermographism
Week 12
Itch numerical rating scale, a scale from 0-10
Proportion of participants with cold urticaria with complete response (no itch or hives) to the TempTest
Week 12
The Temptest is used to induce itch and hives in participants with cold urticaria
Change from baseline in itch numerical rating scale in participants with cold urticaria
Week 12
Itch numerical rating scale, a scale from 0-10
Proportion of participants with cholinergic urticaria with itch numerical rating scale =0
Week 12
Itch numerical rating scale, a scale from 0-10
Proportion of participants with cholinergic urticaria with physician global assessment of severity of hives (PGA - hive score) =0
Week 12
Physician global assessment of severity of hives
Occurrence of treatment emergent adverse events and serious adverse events during the study
Week 24
Treatment emergent adverse events and serious adverse events are those which occur at any time only after treatment has started
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
Annual Review
20/12/2022
QGE031 SUSARs 01OCT2021 31MAR2022
20/12/2022
QGE031 IB Edition 18
20/12/2022
Investigator Letter
20/12/2022
Warehouse Reconciliation Log QGE031
20/12/2022
Warehouse reconciliation Log Zyrtec
20/12/2022
CSR Synopsis
20/12/2022
Download as PDF
Save a PDF copy of the summary of the trial