Clinical Trials List
Protocol NumberCQGE031C2201E1
NCT Number(ClinicalTrials.gov Identfier)NCT02649218
2016-06-01 - 2019-08-31
Phase II
Terminated3
ICD-10L50
Urticaria
An open label, multicenter, extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria patients who completed study CQGE031C2201
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
-
Sponsor
Novartis Pharmaceuticals
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- WEN-NAN HUANG Division of Dermatology
- 林靖才 Division of Dermatology
- 洪維廷 Division of Dermatology
- 譚國棟 Division of Dermatology
- 周吟怡 Division of Dermatology
- Yi-Ming Chen Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Terminated
Linkou Chang Gung Medical Foundation
Taiwan National PI
鐘文宏
Co-Principal Investigator
- Chung-Yao Hsu Division of Dermatology
- Chin-Yi Yang Division of Dermatology
- 林怡廷 Division of Dermatology
- Yu-Huei Huang Division of Dermatology
The Actual Total Number of Participants Enrolled
6 Terminated
Audit
None
Co-Principal Investigator
- Chih-Chieh Chan Division of Dermatology
- 卓雍哲 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Chronic Spontaneous Urticaria
Objectives
Primary
The primary objective of this study is to assess the long-term safety of QGE031 in adult CSU
patients who completed the core study CQGE031C2201 using the following evaluations:
Incidence and severity of non-serious and serious adverse events including any events of
special interest
Changes in vital signs, laboratory assessments, and ECGs
Test Drug
QGE031
Active Ingredient
Ligelizumab
Dosage Form
concentrate for solution for infusion/injection
Dosage
120
Endpoints
Efficacy assessment:
Hives Severity Score (HSS7)
Itch Severity Score (ISS7)
Urticaria Activity Score (UAS7)
Safety assessment:
Incidence and severity of adverse events including serious adverse events, adverse events
leading to study treatment discontinuation and any events of special interest
Changes in vital signs, laboratory assessments, and ECGs
Other assessment:
Concentrations of drug and total IgE (sum of drug bound and free IgE),
Hives Severity Score (HSS7)
Itch Severity Score (ISS7)
Urticaria Activity Score (UAS7)
Safety assessment:
Incidence and severity of adverse events including serious adverse events, adverse events
leading to study treatment discontinuation and any events of special interest
Changes in vital signs, laboratory assessments, and ECGs
Other assessment:
Concentrations of drug and total IgE (sum of drug bound and free IgE),
Inclution Criteria
Main inclusion criteria:
1. Written informed consent must be obtained before any assessment is performed.
2. Patients who complete the treatment epoch in study CQGE031C2201 and complete at least
Visit 203 (Week 32 of the follow-up epoch, ≥16 weeks after last injection) and present active
disease as defined by UAS7 ≥12.
3. Patients must not have any missing eDiary entries in the 7 days prior to Visit 301 (patients are
allowed to repeat until this criterion is met).
4. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere
to the study visit schedules.
1. Written informed consent must be obtained before any assessment is performed.
2. Patients who complete the treatment epoch in study CQGE031C2201 and complete at least
Visit 203 (Week 32 of the follow-up epoch, ≥16 weeks after last injection) and present active
disease as defined by UAS7 ≥12.
3. Patients must not have any missing eDiary entries in the 7 days prior to Visit 301 (patients are
allowed to repeat until this criterion is met).
4. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere
to the study visit schedules.
Exclusion Criteria
Main exclusion criteria:
1. Use of other investigational drugs at the time of enrollment into the extension study or within
30 days or 5-half-lives prior to visit 206, whichever is longer.
2. Patients with a stool examination positive for ova and parasites (stool sample taken at visit
206).
3. New onset or signs and symptoms of any form of chronic urticaria other than CSU during
the follow-up epoch of study CQGE031C2201. This includes the following:
Inducible urticaria: urticaria factitia, cold, heat, solar, pressure, delayed pressure,
aquagenic, cholinergic, or contact urticarial per investigator’s evaluation
Diseases with possible symptoms of urticaria or angioedema such as urticarial
vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and
hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
4. Any other skin disease associated with chronic itching that might confound the study
evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis
herpetiformis, senile pruritus etc.)
5. Onset or ongoing alcohol or drug abuse, within the last 6 months
6. Unable to comply with study and follow-up procedures during the entire treatment and
follow-up period
7. Use of prohibited treatment as detailed in protocol
8. Hypersensitivity to any of the study drugs i.e. QGE031, fexofenadine, loratidine, cetirizine,
or epinephrine or any of the ingredients or its components, or to drugs of similar chemical
classes (i.e. to murine, chimeric, or human antibodies)
9. History of anaphylactic shock
10. Onset of malignancy of any organ system within the past 1 year (except for basal cell
carcinoma or actinic keratoses or Bowen disease (carcinoma in situ) that have been treated
with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or
non-invasive malignant colon polyps that have been removed)
11. Onset of clinically significant cardiovascular (such as but not limited to myocardial
infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure
arrhythmia, uncontrolled hypertension within 12 months prior to visit 206), neurological,
psychiatric, metabolic, or other pathological conditions such as but not limited to
cerebrovascular disease, neurodegenerative diseases, or other neurological disease,
uncontrolled hypo- and hyperthyroidism and other autoimmune diseases, hypokalemia,
hyperadrenergic state, or ophthalmologic disorder that could interfere with the
compromise the safety of the patients, interfere with evaluation or interpretation of the
study results, or preclude completion of the study
12. Medical examination or laboratory findings that suggest the possibility of decompensation
of co-existing conditions for the duration of this study. Any items that are cause for
uncertainty will be reviewed with the investigator
13. History or current treatment for hepatic disease including but not limited to acute or
chronic hepatitis, cirrhosis or hepatic failure or AST/ALT levels or INR of more than 1.5x
upper limit of normal (ULN)
14. History of renal disease or creatinine level above 1.5x ULN at visit 206
15. Platelets < 100,000/μL at visit 206
16. Long QT syndrome or whose QTcF (Fridericia) measured at end of core study visit (Visit
206) is prolonged (> 450 ms for males or > 460 ms for females) and confirmed by a
central assessor (ECG measurement should not be repeated in these patients to confirm
eligibility)
17. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
after conception and until the termination of gestation, confirmed by a positive hCG
laboratory test
18. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using effective methods of contraception during
dosing of study treatment. Effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the
subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
methods) and withdrawal are not acceptable methods of contraception
Female sterilization (have had surgical bilateral oophorectomy with or without
hysterectomy) or tubal ligation at least six weeks before taking study treatment. In
case of oophorectomy alone, only when the reproductive status of the woman has
been confirmed by follow up hormone level assessment
Male sterilization (at least 6 m prior to screening in core study). For female subjects
on the study, the vasectomized male partner should be the sole partner for that subject
Barrier methods of contraception:
o Male or female condom with or without spermicide
o Cap, diaphragm, or sponge with spermicide
Use of oral, injected or implanted hormonal methods of contraception or other forms
of hormonal contraception that have comparable efficacy (failure rate <1%), for
example hormone vaginal ring or transdermal hormone contraception
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
In case of use of oral contraception women should have been stable on the same pill
for a minimum of 3 months before taking study treatment.
1. Use of other investigational drugs at the time of enrollment into the extension study or within
30 days or 5-half-lives prior to visit 206, whichever is longer.
2. Patients with a stool examination positive for ova and parasites (stool sample taken at visit
206).
3. New onset or signs and symptoms of any form of chronic urticaria other than CSU during
the follow-up epoch of study CQGE031C2201. This includes the following:
Inducible urticaria: urticaria factitia, cold, heat, solar, pressure, delayed pressure,
aquagenic, cholinergic, or contact urticarial per investigator’s evaluation
Diseases with possible symptoms of urticaria or angioedema such as urticarial
vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and
hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
4. Any other skin disease associated with chronic itching that might confound the study
evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis
herpetiformis, senile pruritus etc.)
5. Onset or ongoing alcohol or drug abuse, within the last 6 months
6. Unable to comply with study and follow-up procedures during the entire treatment and
follow-up period
7. Use of prohibited treatment as detailed in protocol
8. Hypersensitivity to any of the study drugs i.e. QGE031, fexofenadine, loratidine, cetirizine,
or epinephrine or any of the ingredients or its components, or to drugs of similar chemical
classes (i.e. to murine, chimeric, or human antibodies)
9. History of anaphylactic shock
10. Onset of malignancy of any organ system within the past 1 year (except for basal cell
carcinoma or actinic keratoses or Bowen disease (carcinoma in situ) that have been treated
with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or
non-invasive malignant colon polyps that have been removed)
11. Onset of clinically significant cardiovascular (such as but not limited to myocardial
infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure
arrhythmia, uncontrolled hypertension within 12 months prior to visit 206), neurological,
psychiatric, metabolic, or other pathological conditions such as but not limited to
cerebrovascular disease, neurodegenerative diseases, or other neurological disease,
uncontrolled hypo- and hyperthyroidism and other autoimmune diseases, hypokalemia,
hyperadrenergic state, or ophthalmologic disorder that could interfere with the
compromise the safety of the patients, interfere with evaluation or interpretation of the
study results, or preclude completion of the study
12. Medical examination or laboratory findings that suggest the possibility of decompensation
of co-existing conditions for the duration of this study. Any items that are cause for
uncertainty will be reviewed with the investigator
13. History or current treatment for hepatic disease including but not limited to acute or
chronic hepatitis, cirrhosis or hepatic failure or AST/ALT levels or INR of more than 1.5x
upper limit of normal (ULN)
14. History of renal disease or creatinine level above 1.5x ULN at visit 206
15. Platelets < 100,000/μL at visit 206
16. Long QT syndrome or whose QTcF (Fridericia) measured at end of core study visit (Visit
206) is prolonged (> 450 ms for males or > 460 ms for females) and confirmed by a
central assessor (ECG measurement should not be repeated in these patients to confirm
eligibility)
17. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
after conception and until the termination of gestation, confirmed by a positive hCG
laboratory test
18. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using effective methods of contraception during
dosing of study treatment. Effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the
subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
methods) and withdrawal are not acceptable methods of contraception
Female sterilization (have had surgical bilateral oophorectomy with or without
hysterectomy) or tubal ligation at least six weeks before taking study treatment. In
case of oophorectomy alone, only when the reproductive status of the woman has
been confirmed by follow up hormone level assessment
Male sterilization (at least 6 m prior to screening in core study). For female subjects
on the study, the vasectomized male partner should be the sole partner for that subject
Barrier methods of contraception:
o Male or female condom with or without spermicide
o Cap, diaphragm, or sponge with spermicide
Use of oral, injected or implanted hormonal methods of contraception or other forms
of hormonal contraception that have comparable efficacy (failure rate <1%), for
example hormone vaginal ring or transdermal hormone contraception
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
In case of use of oral contraception women should have been stable on the same pill
for a minimum of 3 months before taking study treatment.
The Estimated Number of Participants
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Taiwan
24 participants
-
Global
240 participants
