Clinical Trials List
Protocol NumberCQGE031B2204
NCT Number(ClinicalTrials.gov Identfier)NCT02336425
2015-09-30 - 2018-09-30
Phase II
Terminated3
ICD-9493.90
Asthma, unspecified, without mention of status asthmaticus
A multi-center, randomized, double-blind, placebo controlled study to investigate the efficacy and safety of 52 weeks treatment with QGE031 s.c. in asthma patients not adequately controlled by medium- or high-dose ICS plus LABA with or without OCS
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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
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 張晟瑜 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Asthma
Objectives
This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset.
Test Drug
QGE031
Active Ingredient
ligelizumab
Dosage Form
S.C. Injection
Dosage
120
Endpoints
1. Primary:
To evaluate the efficacy of QGE031(24 mg, 72 mg, 240 mg s.c. q4w) compared to
placebo on top of SoC in atopic patients with asthma who are not adequately
controlled by medium- or high-dose ICS plus LABA with or without OCS on the
reduction in rate of severe asthma exacerbations during 52 weeks of treatment.
2. Secondary:
To evaluate the efficacy of QGE031 (24 mg, 72 mg, 240 mg s.c. q4w) compared to
placebo on top of SoC in all asthma patients (atopic and nonatopic) who are not
adequately controlled by medium- or high-dose ICS plus LABA with or without
OCS on the reduction in rate of severe asthma exacerbations during 52 weeks of
treatment.
To evaluate the efficacy of QGE031 (24 mg, 72 mg, 240 mg s.c. q4w) compared to
placebo on top of SoC in non-atopic patients with asthma who are not adequately
controlled by medium- or high-dose ICS plus LABA with or without OCS on the
reduction in rate of severe asthma exacerbations during 52 weeks of treatment.
Other secondary objectives:
- Exacerbation (except listed above)
- ACQ5, 6, 7 scores
- ACD scores
- FEV1, FVC, FEV1/FVC
- PEF in the morning and evening
- Daily rescue medication use as assessed by SABA use
- Total daily symptom score
- Safety and tolerability
- The heterogeneity of response to QGE031 between atopic asthma and nonatopic
asthma.
To evaluate the efficacy of QGE031(24 mg, 72 mg, 240 mg s.c. q4w) compared to
placebo on top of SoC in atopic patients with asthma who are not adequately
controlled by medium- or high-dose ICS plus LABA with or without OCS on the
reduction in rate of severe asthma exacerbations during 52 weeks of treatment.
2. Secondary:
To evaluate the efficacy of QGE031 (24 mg, 72 mg, 240 mg s.c. q4w) compared to
placebo on top of SoC in all asthma patients (atopic and nonatopic) who are not
adequately controlled by medium- or high-dose ICS plus LABA with or without
OCS on the reduction in rate of severe asthma exacerbations during 52 weeks of
treatment.
To evaluate the efficacy of QGE031 (24 mg, 72 mg, 240 mg s.c. q4w) compared to
placebo on top of SoC in non-atopic patients with asthma who are not adequately
controlled by medium- or high-dose ICS plus LABA with or without OCS on the
reduction in rate of severe asthma exacerbations during 52 weeks of treatment.
Other secondary objectives:
- Exacerbation (except listed above)
- ACQ5, 6, 7 scores
- ACD scores
- FEV1, FVC, FEV1/FVC
- PEF in the morning and evening
- Daily rescue medication use as assessed by SABA use
- Total daily symptom score
- Safety and tolerability
- The heterogeneity of response to QGE031 between atopic asthma and nonatopic
asthma.
Inclution Criteria
1. Main inclusion criteria:
Male and female adult patients aged ≥ 18 to ≤ 75 years. In Taiwan, 20-75 year old
male or female patients are eligible
Daily treatment with medium- or high-dose ICS plus a LABA for ≥ 3 months
prior to Visit 1 (stable regimen at least 4 weeks prior to Visit 1). If the patients are
treated with OCS (≤10 mg/day of prednisone or equivalent), the regimen of OCS
should be stable at least 4 weeks prior to Visit 1.
FEV1 of ≥ 40% and ≤ 80% of the predicted normal value at Visit 101
ACQ5 score of ≥1.5 at Visit 101 and Visit 102
Positive reversibility (an increase in FEV1 of ≥ 12% and 200 mL) or
bronchoprovocation (airway hyper-reactivity)
A documented history of at least 2 asthma exacerbations in the 12 months.
BMI must be within the range of ≥ 18 and ≤ 45 kg/m2.
The atopic status will be assessed at Visit 1 by using “Skin Prick Test (SPT)”and
blood multi-allergen testing (ImmunoCAP Phadiatop, Phadia AB)”. The definition
is:
Atopic: Either test (SPT or Phadiatop) is positive.
Non-atopic: Both tests (SPT & Phadiatop) are negative.
Male and female adult patients aged ≥ 18 to ≤ 75 years. In Taiwan, 20-75 year old
male or female patients are eligible
Daily treatment with medium- or high-dose ICS plus a LABA for ≥ 3 months
prior to Visit 1 (stable regimen at least 4 weeks prior to Visit 1). If the patients are
treated with OCS (≤10 mg/day of prednisone or equivalent), the regimen of OCS
should be stable at least 4 weeks prior to Visit 1.
FEV1 of ≥ 40% and ≤ 80% of the predicted normal value at Visit 101
ACQ5 score of ≥1.5 at Visit 101 and Visit 102
Positive reversibility (an increase in FEV1 of ≥ 12% and 200 mL) or
bronchoprovocation (airway hyper-reactivity)
A documented history of at least 2 asthma exacerbations in the 12 months.
BMI must be within the range of ≥ 18 and ≤ 45 kg/m2.
The atopic status will be assessed at Visit 1 by using “Skin Prick Test (SPT)”and
blood multi-allergen testing (ImmunoCAP Phadiatop, Phadia AB)”. The definition
is:
Atopic: Either test (SPT or Phadiatop) is positive.
Non-atopic: Both tests (SPT & Phadiatop) are negative.
Exclusion Criteria
2. Main exclusion criteria:
History of malignancy of any organ system (other than localized basal cell
carcinoma of the skin or in-situ cervical cancer) within the past 5 years
Patients who have smoked or inhaled tobacco products within 6 month period prior
to Visit 1, or who have a smoking history of greater than 10 pack years.
Patients who have had an asthma attack/exacerbation requiring a short burst of SCSs
for at least 3 continuous days within 6 weeks prior to Visit 1
Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
History of life-threatening asthma in the previous ten years
History or active of chronic lung diseases other than asthma
Pregnant or nursing (lactating) women
Women of child-bearing potential without effective contraception methods
History of malignancy of any organ system (other than localized basal cell
carcinoma of the skin or in-situ cervical cancer) within the past 5 years
Patients who have smoked or inhaled tobacco products within 6 month period prior
to Visit 1, or who have a smoking history of greater than 10 pack years.
Patients who have had an asthma attack/exacerbation requiring a short burst of SCSs
for at least 3 continuous days within 6 weeks prior to Visit 1
Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
History of life-threatening asthma in the previous ten years
History or active of chronic lung diseases other than asthma
Pregnant or nursing (lactating) women
Women of child-bearing potential without effective contraception methods
The Estimated Number of Participants
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Taiwan
12 participants
-
Global
440 participants
