Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma (NCT NCT01478360)
NCT ID: NCT01478360
Last Updated: 2015-11-20
Results Overview
The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Baseline and 85 Days
Results posted on
2015-11-20
Participant Flow
Participant milestones
| Measure |
AIN457
AIN457 10 mg/kg
|
Placebo
Placebo intravenous injection
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
15
|
|
Overall Study
PD (Pharmacodynamic) Analysis Set
|
31
|
15
|
|
Overall Study
PK (Pharmacokinetics) Analysis Set
|
31
|
0
|
|
Overall Study
COMPLETED
|
29
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
AIN457
AIN457 10 mg/kg
|
Placebo
Placebo intravenous injection
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Administrative problems
|
1
|
2
|
Baseline Characteristics
Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma
Baseline characteristics by cohort
| Measure |
AIN457
n=31 Participants
AIN457 10 mg/kg
|
Placebo
n=15 Participants
Placebo intravenous injection
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 Years
STANDARD_DEVIATION 11.62 • n=93 Participants
|
46.2 Years
STANDARD_DEVIATION 10.40 • n=4 Participants
|
48.6 Years
STANDARD_DEVIATION 11.25 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 85 DaysPopulation: The Pharmacodynamics (PD) analysis set was used, and subjects were analyzed according to the treatment actually. The number of patients who had evaluable PD data at the particular PD assessment time point received.
The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores.
Outcome measures
| Measure |
AIN457
n=29 Participants
AIN457 10 mg/kg
|
Placebo
n=13 Participants
Placebo intravenous injection
|
|---|---|---|
|
Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score
|
-0.173 Score
Interval -0.425 to 0.079
|
-0.007 Score
Interval -0.38 to 0.365
|
Adverse Events
AIN457 10 mg/kg
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AIN457 10 mg/kg
n=31 participants at risk
AIN457 10 mg/kg
|
Placebo
n=15 participants at risk
Placebo
|
|---|---|---|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
3.2%
1/31
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/31
|
6.7%
1/15
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/31
|
6.7%
1/15
|
Other adverse events
| Measure |
AIN457 10 mg/kg
n=31 participants at risk
AIN457 10 mg/kg
|
Placebo
n=15 participants at risk
Placebo
|
|---|---|---|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/31
|
6.7%
1/15
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/31
|
6.7%
1/15
|
|
Gastrointestinal disorders
ABDOMINAL RIGIDITY
|
0.00%
0/31
|
6.7%
1/15
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/31
|
6.7%
1/15
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/31
|
13.3%
2/15
|
|
Gastrointestinal disorders
NAUSEA
|
6.5%
2/31
|
26.7%
4/15
|
|
Gastrointestinal disorders
VOMITING
|
3.2%
1/31
|
20.0%
3/15
|
|
General disorders
CHILLS
|
3.2%
1/31
|
6.7%
1/15
|
|
General disorders
FATIGUE
|
3.2%
1/31
|
6.7%
1/15
|
|
General disorders
FEELING COLD
|
0.00%
0/31
|
6.7%
1/15
|
|
General disorders
VESSEL PUNCTURE SITE BRUISE
|
0.00%
0/31
|
6.7%
1/15
|
|
Infections and infestations
CYSTITIS
|
6.5%
2/31
|
0.00%
0/15
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
9.7%
3/31
|
13.3%
2/15
|
|
Infections and infestations
NASOPHARYNGITIS
|
35.5%
11/31
|
40.0%
6/15
|
|
Infections and infestations
OTITIS EXTERNA
|
0.00%
0/31
|
6.7%
1/15
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/31
|
6.7%
1/15
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/31
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
CONTUSION
|
3.2%
1/31
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
NAIL INJURY
|
0.00%
0/31
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
PERIORBITAL CONTUSION
|
0.00%
0/31
|
6.7%
1/15
|
|
Investigations
BODY TEMPERATURE INCREASED
|
0.00%
0/31
|
6.7%
1/15
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/31
|
6.7%
1/15
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
0.00%
0/31
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.5%
2/31
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/31
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/31
|
6.7%
1/15
|
|
Nervous system disorders
DIZZINESS
|
3.2%
1/31
|
6.7%
1/15
|
|
Nervous system disorders
HEADACHE
|
9.7%
3/31
|
26.7%
4/15
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
22.6%
7/31
|
13.3%
2/15
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/31
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
9.7%
3/31
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
6.5%
2/31
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
3.2%
1/31
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/31
|
13.3%
2/15
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/31
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
XANTHOMA
|
0.00%
0/31
|
6.7%
1/15
|
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