Clinical Trials List
Protocol NumberCQGE031C2201
NCT Number(ClinicalTrials.gov Identfier)NCT02477332
2015-08-14 - 2017-12-31
Phase II
Terminated3
ICD-10L50.1
Idiopathic urticaria
A multicenter, randomized, double-blind, placebo and active controlled Phase 2b dose-finding study of QGE031 as add-on therapy to investigate the efficacy and safety in patients with Chronic Spontaneous Urticaria (CSU)
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
-
Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 譚國棟 Division of Rheumatology
- 林靖才 Division of Rheumatology
- Chen Der-Yuan Division of Rheumatology
- 洪維廷 Division of Rheumatology
- 蔡肇基 Division of Rheumatology
- 周吟怡 Division of Rheumatology
- WEN-NAN HUANG Division of Rheumatology
- Yi-Ming Chen Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Chung-Yao Hsu Division of Dermatology
- 楊志勛 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
0 Completed
Co-Principal Investigator
- 卓雍哲 Division of Dermatology
- Chih-Chieh Chan Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Condition/Disease
Chronic Spontaneous Urticaria (CSU)
Objectives
Primary
To establish the dose-response relationship of QGE031 with respect to achievement of complete
hives response at Week 12 in patients with CSU when added to standard of care treatment
Test Drug
QGE031
Active Ingredient
ligelizumab
Dosage Form
S.C. Injection
Dosage
120
Endpoints
Primary endpoint(s):
Dose-response relationship of QGE031 with respect to achievement of complete hives response
at Week 12
Dose-response relationship of QGE031 with respect to achievement of complete hives response
at Week 12
Inclution Criteria
Main inclusion criteria:
1. Signed written informed consent before any assessment is performed.
2. Male and female adult patients aged ≥ 18 to ≤ 75 years. In Taiwan, ≥ 20 year old male or
female patients are eligible.
3. Diagnosis of CSU (with or without urticarial dermographism when testing for
dermographism) refractory to H1-AH at approved or increased doses alone, or in
combination with H2-AH and/or leukotriene receptor antagonist (LTRA) 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 enrollment
despite current use of H1-AH (up to four times the approved dosage), or in combination
with H2-AH and/or LTRA treatment during this time period
UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during 7 days prior to
randomization (Day 1)
In-clinic UAS ≥ 4 on at least one of the screening visit days (Day -14, Day -7, or Day 1)
Patients must have been on H1-AH at approved or increased doses (up to fourfold) alone
or in combination with H2-AH and/or a LTRA for treatment of CSU for at least the 3
consecutive days immediately prior to the Day -14 screening visit and must have
documented current use on the day of the initial screening visit
CSU diagnosis for ≥ 6 months
4. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere
to the study visit schedules.
5. Patients must not have had any missing eDiary entries in the 7 days prior to randomization.
Re-screening may be considered.
1. Signed written informed consent before any assessment is performed.
2. Male and female adult patients aged ≥ 18 to ≤ 75 years. In Taiwan, ≥ 20 year old male or
female patients are eligible.
3. Diagnosis of CSU (with or without urticarial dermographism when testing for
dermographism) refractory to H1-AH at approved or increased doses alone, or in
combination with H2-AH and/or leukotriene receptor antagonist (LTRA) 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 enrollment
despite current use of H1-AH (up to four times the approved dosage), or in combination
with H2-AH and/or LTRA treatment during this time period
UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during 7 days prior to
randomization (Day 1)
In-clinic UAS ≥ 4 on at least one of the screening visit days (Day -14, Day -7, or Day 1)
Patients must have been on H1-AH at approved or increased doses (up to fourfold) alone
or in combination with H2-AH and/or a LTRA for treatment of CSU for at least the 3
consecutive days immediately prior to the Day -14 screening visit and must have
documented current use on the day of the initial screening visit
CSU diagnosis for ≥ 6 months
4. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere
to the study visit schedules.
5. Patients must not have had any missing eDiary entries in the 7 days prior to randomization.
Re-screening may be considered.
Exclusion Criteria
Main exclusion criteria:
1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lifes
prior to Visit 1, whichever is longer.
2. History of hypersensitivity to any of the study drugs or its components, or to drugs of
similar chemical classes (i.e. to murine, chimeric, or human antibodies).
3. Clearly defined underlying etiology for chronic urticarias other than CSU. This includes the
following:
Inducible urticaria: urticaria factitia, cold-, heat-, solar-, pressure-, delayed pressure-,
aquagenic-, cholinergic-, or contact-urticaria
Diseases with possible symptoms of urticaria or angioedema such as urticarial
vasculitis, erythema multiforme, cutaneous mastocytosis (urticarial pigmentosa), and
hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
4. Patients with a stool examination positive for ova or parasites (at screening); re-screening
may be considered if a repeat stool examination is negative following treatment.
5. 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.)
6. Previous exposure to omalizumab or QGE031
7. History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to
randomization
8. Inability to comply with study and follow-up procedures
9. Use of prohibited treatment detailed in protocol
10. Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or
epinephrine or any of the ingredients
11. History of anaphylactic shock
12. History of malignancy of any organ system within the past 5 years (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 noninvasive malignant colon polyps that have been removed)
13. Presence of clinically significant cardiovascular (such as myocardial infarction within 12
months prior to Visit 1), neurological, psychiatric, metabolic, or other pathological
conditions that could interfere with the interpretation of the study results and or compromise
the safety of the patients
14. Medical examination or laboratory findings that suggest the possibility of decompensation
of co-existing conditions for the duration of the study. Any items that are cause for
uncertainty will be reviewed with the investigator
15. 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) at Visit 1
16. History of renal disease or creatinine level above 1.5x ULN at Visit 1
17. Platelets < 100,000/μL at Visit 1
18. History of long QT syndrome or whose QTcF (Fridericia) measured at Visit 1 is prolonged
(> 450 ms for males or > 460 ms for females) and confirmed by a central assessor (these
patients should not be re-screened).
19. Patients who, either in the judgment of the investigator have a clinically significant
condition such as (but not limited to) unstable ischemic heart disease, NYHA Class III/IV
left ventricular failure arrhythmia, uncontrolled hypertension, cerebrovascular disease,
neurodegenerative diseases, or other neurological disease, uncontrolled hypo- and
hyperthyroidism and other autoimmune diseases, hypokalemia, hyperadrenergic state, or
ophthalmologic disorder or patients with a medical condition that might compromise patient
safety, interfere with evaluation, or preclude completion of the study
20. 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
21. 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 medication. Effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the patient.
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). For female patients on the study, the
vasectomized male partner should be the sole partner for that patient
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, or within 30 days or 5 half-lifes
prior to Visit 1, whichever is longer.
2. History of hypersensitivity to any of the study drugs or its components, or to drugs of
similar chemical classes (i.e. to murine, chimeric, or human antibodies).
3. Clearly defined underlying etiology for chronic urticarias other than CSU. This includes the
following:
Inducible urticaria: urticaria factitia, cold-, heat-, solar-, pressure-, delayed pressure-,
aquagenic-, cholinergic-, or contact-urticaria
Diseases with possible symptoms of urticaria or angioedema such as urticarial
vasculitis, erythema multiforme, cutaneous mastocytosis (urticarial pigmentosa), and
hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency)
4. Patients with a stool examination positive for ova or parasites (at screening); re-screening
may be considered if a repeat stool examination is negative following treatment.
5. 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.)
6. Previous exposure to omalizumab or QGE031
7. History or evidence of ongoing alcohol or drug abuse, within the last 6 months prior to
randomization
8. Inability to comply with study and follow-up procedures
9. Use of prohibited treatment detailed in protocol
10. Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or
epinephrine or any of the ingredients
11. History of anaphylactic shock
12. History of malignancy of any organ system within the past 5 years (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 noninvasive malignant colon polyps that have been removed)
13. Presence of clinically significant cardiovascular (such as myocardial infarction within 12
months prior to Visit 1), neurological, psychiatric, metabolic, or other pathological
conditions that could interfere with the interpretation of the study results and or compromise
the safety of the patients
14. Medical examination or laboratory findings that suggest the possibility of decompensation
of co-existing conditions for the duration of the study. Any items that are cause for
uncertainty will be reviewed with the investigator
15. 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) at Visit 1
16. History of renal disease or creatinine level above 1.5x ULN at Visit 1
17. Platelets < 100,000/μL at Visit 1
18. History of long QT syndrome or whose QTcF (Fridericia) measured at Visit 1 is prolonged
(> 450 ms for males or > 460 ms for females) and confirmed by a central assessor (these
patients should not be re-screened).
19. Patients who, either in the judgment of the investigator have a clinically significant
condition such as (but not limited to) unstable ischemic heart disease, NYHA Class III/IV
left ventricular failure arrhythmia, uncontrolled hypertension, cerebrovascular disease,
neurodegenerative diseases, or other neurological disease, uncontrolled hypo- and
hyperthyroidism and other autoimmune diseases, hypokalemia, hyperadrenergic state, or
ophthalmologic disorder or patients with a medical condition that might compromise patient
safety, interfere with evaluation, or preclude completion of the study
20. 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
21. 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 medication. Effective contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the patient.
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). For female patients on the study, the
vasectomized male partner should be the sole partner for that patient
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
-
Taiwan
35 participants
-
Global
515 participants
