Clinical Trials List
Protocol NumberCQGE031C2302E1
NCT Number(ClinicalTrials.gov Identfier)NCT04210843
2020-05-01 - 2023-05-31
Phase III
Not yet recruiting1
Recruiting2
ICD-10L50.6
Contact urticaria
ICD-10L50.8
Other urticaria
ICD-9708.8
Other specified urticaria
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
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 卓雍哲 無
- WEI-HSIN WU 無
- 沈宜萱 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic Spontaneous Urticaria
Objectives
Primary objective(s)
To evaluate the efficacy of retreatment with ligelizumab 72 mg or 120 mg q4w in subjects previously treated in the core studies
(CQGE031C2302/CQGE031C2303)
To evaluate the efficacy of retreatment with ligelizumab in the subgroup of these subjects who achieved a weekly urticaria
activity score (UAS7) ≤ 6 after 12 weeks of treatment in these core studies
Secondary objective(s)
For retreatment efficacy evaluation:
To describe the efficacy of ligelizumab 72 mg
or 120 mg q4w in achieving complete control
of chronic spontaneous urticaria (CSU) at
Week 12 when used as retreatment for
subjects previously treated in the core studies
(CQGE031C2302/CQGE031C2303)
To describe the efficacy of ligelizumab with
respect to a reduction from extension study
baseline in the UAS7 and its components
(weekly itch severity score (ISS7) and weekly
hives severity score (HSS7) at Week 12 in all
subjects receiving the same dose regimen as
in the core studies, i.e. 72 mg or 120 mg q4w
To describe the efficacy of ligelizumab in
achieving an angioedema-free period at Week
12 in all subjects receiving the same dose
regimen as in the core studies, i.e. 72 mg or
120 mg q4w
To describe the efficacy of ligelizumab in
achieving Dermatology Life Quality Index
(DLQI) = 0-1 at Week 12 when used as retreatment for all subjects receiving the same
dose regimen as in the core studies, i.e. 72 mg
or 120 mg q4w
Test Drug
QGE031
Active Ingredient
Ligelizumab
Dosage Form
Liquid in vial, Solution for injection in pre-filled syringe
Dosage
120
Endpoints
Primary Outcome Measures :
The proportion of subjects with well-controlled disease (UAS7 ≤ 6) at Week 12 [ Time Frame: Week 12 ]
The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS).
The HSS, defined by number of hives (wheals), will be recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 preceding days. The possible range of the weekly score is therefore 0 - 21.
The severity of the itch will be recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly score (ISS7) is derived by adding up the average daily scores of the 7 preceding days. The possible range of the weekly score is therefore 0-21 (maximum itch).
The UAS7 is the sum of the HSS7 score and the ISS7 score. The possible range of the weekly UAS7 score is 0 - 42 (highest activity).
Secondary Outcome Measures :
Complete control of chronic spontaneous urticaria (CSU) at Week 12 [ Time Frame: Week 12 ]
Assessed as the proportion of subjects with completely controlled disease (UAS7 =0) at Week 12
A reduction from extension study baseline in the UAS7 at Week 12 [ Time Frame: Week 12 ]
Assessed as absolute change from extension study baseline in the UAS7 at Week 12
A reduction from extension study baseline in the ISS7 at Week 12 [ Time Frame: Week 12 ]
Assessed as absolute change from extension study baseline in the ISS7 (weekly itch severity score) at Week 12
A reduction from extension study baseline in the HSS7 at Week 12 [ Time Frame: Week 12 ]
Assessed as absolute change from extension study baseline in the HSS7 (weekly hives severity score) at Week 12
Achieving an angioedema-free period at Week 12 [ Time Frame: Week 12 ]
Assessed as cumulative number of weeks that subjects achieve weekly angioedema activity score (AAS7) = 0 between extension study baseline and Week 12
Achieving Dermatology Life Quality Index (DLQI) = 0-1 at Week 12 [ Time Frame: Week 12 ]
Assessed as percentage of subjects achieving DLQI = 0-1 at Week 12
Efficacy of ligelizumab in the treatment of CSU, 12 weeks after starting self-administration [ Time Frame: Week 12 ]
Assessed as the proportion of subjects with well-controlled disease (UAS7 ≤ 6), 12 weeks after starting self-administration
Safety and tolerability of ligelizumab 120 mg q4w in all subjects who self-administer [ Time Frame: from Week 24 to Week 104 ]
Occurence of Adverse Events for patients who self-administer
The proportion of subjects with well-controlled disease (UAS7 ≤ 6) at Week 12 [ Time Frame: Week 12 ]
The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS).
The HSS, defined by number of hives (wheals), will be recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 preceding days. The possible range of the weekly score is therefore 0 - 21.
The severity of the itch will be recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly score (ISS7) is derived by adding up the average daily scores of the 7 preceding days. The possible range of the weekly score is therefore 0-21 (maximum itch).
The UAS7 is the sum of the HSS7 score and the ISS7 score. The possible range of the weekly UAS7 score is 0 - 42 (highest activity).
Secondary Outcome Measures :
Complete control of chronic spontaneous urticaria (CSU) at Week 12 [ Time Frame: Week 12 ]
Assessed as the proportion of subjects with completely controlled disease (UAS7 =0) at Week 12
A reduction from extension study baseline in the UAS7 at Week 12 [ Time Frame: Week 12 ]
Assessed as absolute change from extension study baseline in the UAS7 at Week 12
A reduction from extension study baseline in the ISS7 at Week 12 [ Time Frame: Week 12 ]
Assessed as absolute change from extension study baseline in the ISS7 (weekly itch severity score) at Week 12
A reduction from extension study baseline in the HSS7 at Week 12 [ Time Frame: Week 12 ]
Assessed as absolute change from extension study baseline in the HSS7 (weekly hives severity score) at Week 12
Achieving an angioedema-free period at Week 12 [ Time Frame: Week 12 ]
Assessed as cumulative number of weeks that subjects achieve weekly angioedema activity score (AAS7) = 0 between extension study baseline and Week 12
Achieving Dermatology Life Quality Index (DLQI) = 0-1 at Week 12 [ Time Frame: Week 12 ]
Assessed as percentage of subjects achieving DLQI = 0-1 at Week 12
Efficacy of ligelizumab in the treatment of CSU, 12 weeks after starting self-administration [ Time Frame: Week 12 ]
Assessed as the proportion of subjects with well-controlled disease (UAS7 ≤ 6), 12 weeks after starting self-administration
Safety and tolerability of ligelizumab 120 mg q4w in all subjects who self-administer [ Time Frame: from Week 24 to Week 104 ]
Occurence of Adverse Events for patients who self-administer
Inclution 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
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
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
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
The Estimated Number of Participants
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Taiwan
50 participants
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Global
2213 participants
