Trial Outcomes & Findings for Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201 (NCT NCT02075008)
NCT ID: NCT02075008
Last Updated: 2017-08-11
Results Overview
Safety was monitored throughout the study.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
270 participants
Primary outcome timeframe
52 weeks
Results posted on
2017-08-11
Participant Flow
This was an open-label, single arm study for participants who completed the core study CQGE031B2201 (NCT01716754).
Participant milestones
| Measure |
QGE031 Every 4 Weeks (q4w)
QGE031 240 mg subcutaneously q4w
|
|---|---|
|
Overall Study
STARTED
|
270
|
|
Overall Study
COMPLETED
|
94
|
|
Overall Study
NOT COMPLETED
|
176
|
Reasons for withdrawal
| Measure |
QGE031 Every 4 Weeks (q4w)
QGE031 240 mg subcutaneously q4w
|
|---|---|
|
Overall Study
Technical problems
|
1
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Study terminated by Sponsor
|
159
|
Baseline Characteristics
Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201
Baseline characteristics by cohort
| Measure |
QGE031 Every 4 Weeks (q4w)
n=270 Participants
QGE031 240 mg subcutaneously q4w
|
|---|---|
|
Age, Continuous
|
48.2 Years
STANDARD_DEVIATION 13.17 • n=99 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: The safety set, which included all participants, was analyzed.
Safety was monitored throughout the study.
Outcome measures
| Measure |
QGE031 Every 4 Weeks (q4w)
n=270 Participants
QGE031 240 mg subcutaneously q4w
|
|---|---|
|
Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability
Non-serious AEs
|
176 Participants
|
|
Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability
Serious AEs
|
19 Participants
|
|
Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability
Deaths
|
1 Participants
|
Adverse Events
QGE031 Every 4 Weeks (q4w)
Serious events: 19 serious events
Other events: 130 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QGE031 Every 4 Weeks (q4w)
n=270 participants at risk
QGE031 240 mg subcutaneously q4w
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.37%
1/270
|
|
Ear and labyrinth disorders
Vertigo
|
0.37%
1/270
|
|
Endocrine disorders
Goitre
|
0.37%
1/270
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.37%
1/270
|
|
Immune system disorders
Anaphylactic reaction
|
0.37%
1/270
|
|
Immune system disorders
Drug hypersensitivity
|
0.37%
1/270
|
|
Infections and infestations
Diverticulitis
|
0.37%
1/270
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.37%
1/270
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.37%
1/270
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.37%
1/270
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.37%
1/270
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.37%
1/270
|
|
Nervous system disorders
Cerebrovascular accident
|
0.74%
2/270
|
|
Nervous system disorders
Vertebral artery thrombosis
|
0.37%
1/270
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.9%
5/270
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.37%
1/270
|
|
Vascular disorders
Varicose vein
|
0.37%
1/270
|
Other adverse events
| Measure |
QGE031 Every 4 Weeks (q4w)
n=270 participants at risk
QGE031 240 mg subcutaneously q4w
|
|---|---|
|
General disorders
Injection site reaction
|
16.7%
45/270
|
|
Infections and infestations
Bronchitis
|
7.4%
20/270
|
|
Infections and infestations
Nasopharyngitis
|
12.2%
33/270
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
17/270
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
29.6%
80/270
|
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