Efficacy and Safety of QGE031 Compared With Placebo in Pa... | NCT02336425

NCT02336425

ID	Type	Description	Link
2014-003155-57	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QGE031 240 mg	Experimental	QGE031 240 mg subcutaneous injection every 4 weeks	Drug: QGE031
QGE031 72 mg	Experimental	QGE031 72 mg subcutaneous injection every 4 weeks	Drug: QGE031
QGE031 24 mg	Experimental	QGE031 24 mg subcutaneous injection every 4 weeks	Drug: QGE031
Placebo to QGE031	Placebo Comparator	Placebo subcutaneous injection every 4 weeks	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
QGE031	Drug	QGE031 120 mg per 1 mL liquid in vial	QGE031 24 mg QGE031 240 mg QGE031 72 mg

Outcomes Module

Measure	Description	Time Frame
QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations		Week 52

Secondary Outcomes

Measure	Description	Time Frame
QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations		Week 52
QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations		Week 52

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Birmingham	Alabama	35209	United States
Novartis Investigative Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks
FG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks
BG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks
BG002	QGE031 24 mg	QGE031 24 mg subcutaneous injection every 4 weeks
BG003	Placebo to QGE031	Placebo subcutaneous injection every 4 weeks
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations

Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.

Posted

Week 52

ID	Title	Description
OG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks
OG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks
OG002	QGE031 24 mg	QGE031 24 mg subcutaneous injection every 4 weeks
OG003	Placebo to QGE031	Placebo subcutaneous injection every 4 weeks

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations

Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.

Posted

Week 52

ID	Title	Description
OG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks
OG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks
OG002	QGE031 24 mg	QGE031 24 mg subcutaneous injection every 4 weeks
OG003	Placebo to QGE031	Placebo subcutaneous injection every 4 weeks

Units	Counts
Participants

Secondary

QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations

Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.

Posted

Week 52

ID	Title	Description
OG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks
OG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks
OG002	QGE031 24 mg	QGE031 24 mg subcutaneous injection every 4 weeks
OG003	Placebo to QGE031	Placebo subcutaneous injection every 4 weeks

Units	Counts
Participants

Secondary

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity)

Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.

Posted

Week 52

ID	Title	Description
OG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks
OG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks
OG002	QGE031 24 mg	QGE031 24 mg subcutaneous injection every 4 weeks
OG003	Placebo to QGE031	Placebo subcutaneous injection every 4 weeks

Units	Counts
Participants

Secondary

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Time to First Asthma Exacerbations (by Severity)

Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.

Posted

Week 52

ID	Title	Description
OG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks
OG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks
OG002	QGE031 24 mg	QGE031 24 mg subcutaneous injection every 4 weeks
OG003	Placebo to QGE031	Placebo subcutaneous injection every 4 weeks

Units	Counts
Participants

Secondary

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ)

Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.

Posted

Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)

ID	Title	Description
OG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks
OG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks
OG002	QGE031 24 mg	QGE031 24 mg subcutaneous injection every 4 weeks
OG003	Placebo to QGE031	Placebo subcutaneous injection every 4 weeks

Units	Counts

Secondary

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Diary (ACD)

Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.

Posted

Over 52 weeks (Treatment) and 20 weeks (follow-up)

ID	Title	Description
OG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks
OG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks
OG002	QGE031 24 mg	QGE031 24 mg subcutaneous injection every 4 weeks
OG003	Placebo to QGE031	Placebo subcutaneous injection every 4 weeks

Units	Counts

Secondary

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Forced Expiratory Volume in 1 Second (FEV1)

Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.

Posted

Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)

ID	Title	Description
OG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks
OG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks
OG002	QGE031 24 mg	QGE031 24 mg subcutaneous injection every 4 weeks
OG003	Placebo to QGE031	Placebo subcutaneous injection every 4 weeks

Units	Counts

Secondary

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Peak Expiratory Flow (PEF) in the Morning and Evening

Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.

Posted

Over 52 weeks (Treatment) and 20 weeks (follow-up)

ID	Title	Description
OG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks
OG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks
OG002	QGE031 24 mg	QGE031 24 mg subcutaneous injection every 4 weeks
OG003	Placebo to QGE031	Placebo subcutaneous injection every 4 weeks

Units	Counts

Secondary

QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Total Daily Symptom Score

Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.

Posted

Over 52 weeks (Treatment) and 20 weeks (follow-up)

ID	Title	Description
OG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks
OG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks
OG002	QGE031 24 mg	QGE031 24 mg subcutaneous injection every 4 weeks
OG003	Placebo to QGE031	Placebo subcutaneous injection every 4 weeks

Units	Counts

Secondary

Response to QGE031 Between Atopic Asthma and Non-atopic Asthma

Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.

Posted

Over 52 weeks (treatment) and 20 weeks (follow up)

ID	Title	Description
OG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks
OG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks
OG002	QGE031 24 mg	QGE031 24 mg subcutaneous injection every 4 weeks
OG003	Placebo to QGE031	Placebo subcutaneous injection every 4 weeks

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	QGE031 240 mg	QGE031 240 mg subcutaneous injection every 4 weeks	2	1	2
EG001	QGE031 72 mg	QGE031 72 mg subcutaneous injection every 4 weeks	2	2	2
EG002	QGE031 24 mg	QGE031 24 mg subcutaneous injection every 4 weeks	3	1	3
EG003	Placebo to QGE031	Placebo subcutaneous injection every 4 weeks	3	2	3

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA18.1	Systematic Assessment	EG0001 events1 affected2 at risk EG0010 events0 affected2 at risk EG0020 events0 affected3 at risk EG0030 events0 affected3 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected2 at risk EG0012 events1 affected2 at risk EG0020 events0 affected3 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected2 at risk EG0011 events1 affected2 at risk EG0020 events0 affected3 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected2 at risk EG0022 events1 affected3 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected2 at risk EG0021 events1 affected3 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected2 at risk EG0020 events0 affected3 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected2 at risk EG0010 events0 affected2 at risk EG0021 events1 affected3 at risk EG003

Study was terminated due to the efficacy results from the Phase II study CQGE031B2201 (NCT01716754). Data analyses were not performed due to the very limited dataset (only 10 participants received study medication of the 440 participants planned).

Certain Agreements

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
C000598891	ligelizumab