Phase 2
Completed N=452
A Safety and Efficacy Study of Tralokinumab in Adults With Asthma
Source: ClinicalTrials.gov NCT01402986 ↗Enrolled (actual)
452
Serious AEs
14.2%
Results posted
Mar 2017
Primary outcomePrimary: Annual Asthma Exacerbation Rate (AER) — 0.90; 0.91; 0.97 AER events/person-year — p=0.709
Summary
The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annual Asthma Exacerbation Rate (AER) |
0.90; 0.91; 0.97 | 0.709 |
| SECONDARY Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 |
1.926; 1.922; 1.934; 2.153; 2.094; 2.110 | — |
| SECONDARY Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 |
2.830; 2.809; 2.827; 3.055; 2.981; 2.980 | — |
| SECONDARY Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53 |
3.003; 2.955; 2.993; 3.225; 3.133; 3.125 | — |
| SECONDARY Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53 |
64.508; 65.071; 65.008; 67.152; 66.831; 67.883 | — |
| SECONDARY Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53 |
0.022; 0.023; 0.023; 0.024; 0.024; 0.024 | — |
| SECONDARY Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home |
1.63; 1.61; 1.66; -0.12; 0.01; -0.07 | — |
| SECONDARY Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home |
273.7; 271.0; 281.2; -23.1; -8.0; -24.0 | — |
| SECONDARY Change From Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53 |
2.52; 2.59; 2.54; -0.82; -1.02; -0.93 | — |
| SECONDARY Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53 |
4.05; 3.98; 4.08; 0.85; 1.04; 1.00 | — |
| SECONDARY Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 |
107; 118; 106; 26; 18; 23 | — |
| SECONDARY Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53 |
8.4; 9.3; 7.3 | — |
| SECONDARY Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53 |
1.60; 1.49; 1.56; -0.43; -0.42; -0.49 | — |
| SECONDARY Change From Baseline in Rescue Medication Use at Week 53 |
2.56; 2.77; 2.38; -0.86; -0.77; -1.02 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) |
129; 134; 128; 21; 18; 25 | — |
| SECONDARY Observed Serum Tralokinumab Concentration at Week 53 |
71.3; 25.8 | — |
| SECONDARY Percentage of Participants With Anti-Drug Antibodies (ADA) to Tralokinumab |
1.3; 0.67; 1.3; 3.3; 0.0; 4.0 | — |
| SECONDARY Severe Annual Asthma Exacerbation Rate (AER) |
0.17; 0.11; 0.10 | 0.293 |
| SECONDARY Time to First Exacerbation Through Week 53 |
NA; NA; NA | 0.257 |
| SECONDARY Time to First Severe Exacerbation Through Week 53 |
NA; NA; NA | 0.538 |
| SECONDARY Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin |
1.13; 0.85; 1.27; 0.73; 0.98; 0.63 | 0.190 |
| SECONDARY Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status |
0.96; 0.94; 1.09; 0.90; 0.88; 0.85 | 0.365 |
| SECONDARY Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count |
0.95; 0.84; 0.96; 0.90; 1.09; 0.95 | 0.335 |
| SECONDARY Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility |
0.88; 0.68; 1.08; 0.93; 0.99; 0.90 | 0.245 |
| SECONDARY Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted |
1.05; 0.95; 1.67; 0.93; 0.88; 1.13 | 0.723 |
| SECONDARY Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year |
0.62; 0.61; 0.45; 1.44; 1.42; 1.88 | 0.802 |
| SECONDARY Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin |
0.25; 0.08; 0.12; 0.10; 0.14; 0.08 | 0.046 sig |
| SECONDARY Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility |
0.11; 0.13; 0.13; 0.20; 0.10; 0.09 | 0.975 |
| SECONDARY Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status |
0.12; 0.12; 0.06; 0.21; 0.05; 0.12 | 0.698 |
| SECONDARY Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count |
0.22; 0.16; 0.15; 0.13; 0.08; 0.08 | 0.133 |
| SECONDARY Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups |
4.17; 10.48; 4.36; 1.23; 7.46; 1.30 | 0.057 |
| SECONDARY Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups |
-0.88; -1.18; -0.85; -0.77; -0.81; -1.03 | 0.145 |
| SECONDARY Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups |
0.89; 1.10; 0.95; 0.82; 0.95; 1.07 | 0.211 |
| SECONDARY Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status |
0.85; 0.90; 0.85; 1.05; 0.82; 1.10 | 0.803 |
| SECONDARY Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use |
1.37; 2.04; 2.2; 0.81; 0.68; 0.74 | 0.614 |
| SECONDARY Change From Baseline in Percentage of Nighttime Awakening at Week 53 |
0.44; 0.42; 0.43; -0.22; -0.18; -0.23 | — |
| SECONDARY Change From Baseline in Overall Activity Limitations at Week 53 |
1.71; 1.52; 1.63; -0.45; -0.38; -0.48 | — |
| SECONDARY Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 |
1.926; 1.922; 1.934; 2.153; 2.094; 2.110 | — |
| SECONDARY Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 |
2.830; 2.809; 2.827; 3.055; 2.981; 2.980 | — |
| SECONDARY Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53 |
3.003; 2.955; 2.993; 3.225; 3.133; 3.125 | — |
| SECONDARY Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53 |
0.022; 0.023; 0.023; 0.024; 0.024; 0.024 | — |
| SECONDARY Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home |
-4.96; 1.67; 1.70; -2.83; -2.69; -5.78 | — |
| SECONDARY Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home |
-6.89; -0.64; -2.80; -4.95; -6.62; -11.45 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-75 years
- Body mass index (BMI) between 16-40 kilogram per square meter (kg/m^2) at Visit 1
- Uncontrolled severe asthma
- A chest x-ray with no abnormality
- Females of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective contraception from Day 1
- Non-sterilized males or sterilized males who are less than or equal to (=<) 1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception
Exclusion Criteria
- Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals
- Pregnant or breastfeeding women
- Any other respiratory disease
- Previously taken tralokinumab (the study drug)
- Current smoker or a history of smoking which would be more than 1 pack per day for 10 years
- Known immune deficiency
- History of cancer
- Hepatitis B, C or Human Immuno-deficiency Virus (HIV)
- Any disease which may cause complications whilst taking the study drug.
Data sourced from ClinicalTrials.gov (NCT01402986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.