Trial Outcomes & Findings for Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma (NCT NCT02336425)

NCT ID: NCT02336425

Last Updated: 2017-08-11

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: Week 52
• Results posted on: 2017-08-11

Participant Flow

Participants were randomized to one of the four treatment arms.

Participant milestones

Measure	QGE031 240 mg QGE031 240 mg subcutaneous injection every 4 weeks	QGE031 72 mg QGE031 72 mg subcutaneous injection every 4 weeks	QGE031 24 mg QGE031 24 mg subcutaneous injection every 4 weeks	Placebo to QGE031 Placebo subcutaneous injection every 4 weeks
Overall Study STARTED	2	2	3	3
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	2	2	3	3

Reasons for withdrawal

Measure	QGE031 240 mg QGE031 240 mg subcutaneous injection every 4 weeks	QGE031 72 mg QGE031 72 mg subcutaneous injection every 4 weeks	QGE031 24 mg QGE031 24 mg subcutaneous injection every 4 weeks	Placebo to QGE031 Placebo subcutaneous injection every 4 weeks
Overall Study Study terminated.	2	2	3	3

Baseline Characteristics

Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma

Baseline characteristics by cohort

Measure	QGE031 240 mg n=2 Participants QGE031 240 mg subcutaneous injection every 4 weeks	QGE031 72 mg n=2 Participants QGE031 72 mg subcutaneous injection every 4 weeks	QGE031 24 mg n=3 Participants QGE031 24 mg subcutaneous injection every 4 weeks	Placebo to QGE031 n=3 Participants Placebo subcutaneous injection every 4 weeks	Total n=10 Participants Total of all reporting groups
Age, Continuous	46.5 Years STANDARD_DEVIATION 16.26 • n=5 Participants	47.0 Years STANDARD_DEVIATION 1.41 • n=7 Participants	53.7 Years STANDARD_DEVIATION 11.59 • n=5 Participants	47.7 Years STANDARD_DEVIATION 2.89 • n=4 Participants	49.1 Years STANDARD_DEVIATION 8.45 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 52

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 52

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 52

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 52

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 52

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: 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.

Outcome measures

Outcome data not reported

Adverse Events

QGE031 240 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

QGE031 72 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

QGE031 24 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo to QGE031

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	QGE031 240 mg n=2 participants at risk QGE031 240 mg subcutaneous injection every 4 weeks	QGE031 72 mg n=2 participants at risk QGE031 72 mg subcutaneous injection every 4 weeks	QGE031 24 mg n=3 participants at risk QGE031 24 mg subcutaneous injection every 4 weeks	Placebo to QGE031 n=3 participants at risk Placebo subcutaneous injection every 4 weeks
Respiratory, thoracic and mediastinal disorders Productive cough	50.0% 1/2 • Number of events 1	0.00% 0/2	0.00% 0/3	0.00% 0/3
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/2	50.0% 1/2 • Number of events 2	0.00% 0/3	33.3% 1/3 • Number of events 2
Injury, poisoning and procedural complications Contusion	0.00% 0/2	50.0% 1/2 • Number of events 1	0.00% 0/3	0.00% 0/3
Hepatobiliary disorders Biliary colic	0.00% 0/2	0.00% 0/2	33.3% 1/3 • Number of events 2	0.00% 0/3
Infections and infestations Conjunctivitis	0.00% 0/2	0.00% 0/2	33.3% 1/3 • Number of events 1	0.00% 0/3
Infections and infestations Respiratory tract infection	0.00% 0/2	0.00% 0/2	0.00% 0/3	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Dysphagia	0.00% 0/2	0.00% 0/2	33.3% 1/3 • Number of events 1	0.00% 0/3

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
• Publication restrictions are in place

Restriction type: OTHER