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A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo Q2W

Tralokinumab 300 mg, Q2W

Placebo, Q2/4W

Tralokinumab 300 mg, Q2/4W

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Tralokinumab, CAT-354

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo, Q2W - Cohort 1

Tralokinumab 300 mg, Q2W - Cohort 1

Placebo, Q2/4W - Cohort 2

Tralokinumab 300 mg, Q2/4W - Cohort 2

Arm Description

Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

Outcomes

Primary Outcome Measures

Annual Asthma Exacerbation Rate (AER)

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. An asthma exacerbation event was considered resolved 7 days after the last dose of oral corticosteroids (OCS) is administered (10 days after administration of an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Secondary Outcome Measures

Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53

Pre- and post-bronchodilator FEV1 at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53

Pre- and post-bronchodilator FEV6 at clinic visits (morning) were measured. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53

Pre- and post-bronchodilator FVC at clinic visits (morning) were measured. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53

Pre- and post-bronchodilator FEV1 and FVC at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Ratio of FEV1/FVC was analysed. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53

Pre- and post-bronchodilator IC at clinic visits (morning) were measured. IC was measured by spirometry. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home

Pre- and post-bronchodilator FEV1 at home (morning and evening) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home

The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Change From Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53

Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53

AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53

The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems) that reflects increasing levels of difficulty. The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53

The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53

There were 3 symptom questions in the ASMA diary: daytime frequency (question 1), daytime severity (question 2) and nighttime severity (question 6). All symptom questions were scored from 0 to 4 averaged, where a higher score indicated greater frequency or severity. Daily Asthma symptom scores were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Change From Baseline in Rescue Medication Use at Week 53

Rescue medication use was collected from 3 questions: daytime use in response to symptoms (question 3), daytime prophylactic use (question 4) and nighttime use (question 7). Rescue medication use questions were first assessed using a dichotomous response option (YES/NO). If the participants reported YES, there was a subsequent question about the number of times rescue medication was used (questions 3a, 4a, and 7a). Daily average scores were summarized each week for all participants with at least 4 non-missing records each week. Days with no reported rescue medication use were represented as 0 and included in the calculation with participants who reported yes and completed questions 3a, 4a and 7a. The baseline scores were calculated from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Week 75 that were absent before treatment or that worsened relative to pre-treatment state. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Observed Serum Tralokinumab Concentration at Week 53

Tralokinumab concentrations that were below limit of quantification (LOQ) of the pharmacokinetic (PK) assay (LOQ = 0.500 microgram per milliliter [mcg/mL]) were replaced by LOQ/2 = 0.250 mcg/mL; results were reported to 3 significant figures level of precision. Observed serum tralokinumab concentration at Week 53 was reported.

Percentage of Participants With Anti-Drug Antibodies (ADA) to Tralokinumab

Immunogenicity assessment included determination of anti-drug (tralokinumab) antibodies in serum samples. ADA positive was defined as a titer greater than or equal to (>=13) at any point in the study. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Severe Annual Asthma Exacerbation Rate (AER)

Severe annualized AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed or administered by the investigator; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. An asthma exacerbation event was considered resolved 7 days after the last dose of oral corticosteroids is administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time to First Exacerbation Through Week 53

Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time to First Severe Exacerbation Through Week 53

Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline serum periostin greater than or equal to (>=) or less than (<) median, >= or < 25th percentile and >= or < 75th percentile. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. AER was evaluated by subgroup Th2 status. Th2-high included those participants who had immunoglobulin E (IgE) >100 international unit per milliliter (IU/mL) and blood eosinophils >= 0.14 * 10 power 9 per Liter. Th2 low would include those participants who do not meet Th2 high status. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroups baseline peripheral blood eosinophil counts. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup baseline FEV1 reversibility >=12% and <12%. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline FEV1% predicaed. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup as asthma exacerbations in the past year. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin

Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER evaluated by subgroup baseline serum periostin. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility

Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup FEV1 reversibility. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status

Severe AER was assessed based on AER data up to Week 53. An asthma exacerbation is a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 days. It was considered resolved 7 days after last dose of OCS administered (10 days after injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup Th2 status. Th2-high include participants who had IgE >100 IU/mL and blood eosinophils >=0.14*10^9/Liter. Th2 low would include participants who do not meet Th2 high status. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count

Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup baseline peripheral blood eosinophil count. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups

Prebronchodilator FEV1 was evaluated by subgroups. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups

Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups

Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status

Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup chronic OCS use. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Change From Baseline in Percentage of Nighttime Awakening at Week 53

Scores for nighttime awakenings were generated based on the single item (question 5) that had a dichotomous response option (YES/NO). Nighttime awakenings were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated with data from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Change From Baseline in Overall Activity Limitations at Week 53

There were 3 activity limitation questions in the ASMA diary. All activity questions were scored from 0 to 4 and averaged, where the higher score indicated greater limitation. Activity limitation scores were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53

Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53

Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53

Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53

Pre- and post-bronchodilator IC at clinic visits (morning) were measured. IC was measured by spirometry. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms. Baseline for IC was measured in liters.

Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home

Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home

Full Information

NCT ID

NCT01402986

First Posted

July 21, 2011

Last Updated

March 3, 2017

Sponsor

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT01402986

Brief Title

A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

Official Title

A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedImmune LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

Interleukin-13 (IL-13) is a key mediator in the pathogenesis of established asthmatic disease. Tralokinumab is a human monoclonal antibody that blocks IL-13, which may result in improved control of asthma. This study will determine whether the addition of tralokinumab to standard asthma medications results in a reduced rate of asthma exacerbations in subjects with severe asthma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Tralokinumab, CAT-354

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

689 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo, Q2W - Cohort 1

Arm Type

Placebo Comparator

Arm Description

Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

Arm Title

Tralokinumab 300 mg, Q2W - Cohort 1

Arm Type

Experimental

Arm Description

Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

Arm Title

Placebo, Q2/4W - Cohort 2

Arm Type

Placebo Comparator

Arm Description

Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

Arm Title

Tralokinumab 300 mg, Q2/4W - Cohort 2

Arm Type

Experimental

Arm Description

Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.

Intervention Type

Other

Intervention Name(s)

Placebo Q2W

Intervention Description

Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.

Intervention Type

Biological

Intervention Name(s)

Tralokinumab 300 mg, Q2W

Other Intervention Name(s)

CAT-354

Intervention Description

Participants received tralokinumab 300 mg subcutaneous injection Q2W for a total of 26 doses up to 50 weeks.

Intervention Type

Other

Intervention Name(s)

Placebo, Q2/4W

Intervention Description

Participants received matching placebo subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.

Intervention Type

Biological

Intervention Name(s)

Tralokinumab 300 mg, Q2/4W

Other Intervention Name(s)

CAT-354

Intervention Description

Participants received tralokinumab 300 mg subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.

Primary Outcome Measure Information:

Title

Annual Asthma Exacerbation Rate (AER)

Description

Time Frame

Week 1 up to Week 53

Secondary Outcome Measure Information:

Title

Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53

Description

Time Frame

Baseline and Week 53

Title

Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53

Description

Time Frame

Baseline and Week 53

Title

Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53

Description

Time Frame

Baseline and Week 53

Title

Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53

Description

Time Frame

Baseline and Week 53

Title

Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53

Description

Pre- and post-bronchodilator IC at clinic visits (morning) were measured. IC was measured by spirometry. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time Frame

Baseline and Week 53

Title

Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home

Description

Time Frame

Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)

Title

Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home

Description

Time Frame

Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)

Title

Change From Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53

Description

Time Frame

Baseline and Week 53

Title

Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53

Description

Time Frame

Baseline and Week 53

Title

Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53

Description

Time Frame

Week 53

Title

Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53

Description

Time Frame

Baseline and Week 53

Title

Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53

Description

Time Frame

Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)

Title

Change From Baseline in Rescue Medication Use at Week 53

Description

Time Frame

Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)

Description

Time Frame

Baseline and Week 75

Title

Observed Serum Tralokinumab Concentration at Week 53

Description

Time Frame

Week 53

Title

Percentage of Participants With Anti-Drug Antibodies (ADA) to Tralokinumab

Description

Time Frame

Baseline and Week 75

Title

Severe Annual Asthma Exacerbation Rate (AER)

Description

Time Frame

Week 1 up to Week 53

Title

Time to First Exacerbation Through Week 53

Description

Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time Frame

Week 1 up to Week 53

Title

Time to First Severe Exacerbation Through Week 53

Description

Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time Frame

Week 1 up to Week 53

Title

Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin

Description

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline serum periostin greater than or equal to (>=) or less than (<) median, >= or < 25th percentile and >= or < 75th percentile. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time Frame

Week 1 up to Week 53

Title

Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status

Description

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. AER was evaluated by subgroup Th2 status. Th2-high included those participants who had immunoglobulin E (IgE) >100 international unit per milliliter (IU/mL) and blood eosinophils >= 0.14 * 10 power 9 per Liter. Th2 low would include those participants who do not meet Th2 high status. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time Frame

Week 1 up to Week 53

Title

Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count

Description

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroups baseline peripheral blood eosinophil counts. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time Frame

Week 1 up to Week 53

Title

Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility

Description

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup baseline FEV1 reversibility >=12% and <12%. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time Frame

Week 1 up to Week 53

Title

Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted

Description

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline FEV1% predicaed. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time Frame

Week 1 up to Week 53

Title

Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year

Description

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup as asthma exacerbations in the past year. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time Frame

Week 1 up to Week 53

Title

Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin

Description

Time Frame

Week 1 up to Week 53

Title

Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility

Description

Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup FEV1 reversibility. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time Frame

Week 1 up to Week 53

Title

Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status

Description

Time Frame

Week 1 up to Week 53

Title

Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count

Description

Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup baseline peripheral blood eosinophil count. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time Frame

Week 1 up to Week 53

Title

Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups

Description

Prebronchodilator FEV1 was evaluated by subgroups. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time Frame

Week 1 up to Week 53

Title

Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups

Description

Time Frame

Week 1 up to Week 53

Title

Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups

Description

Time Frame

Week 1 up to Week 53

Title

Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status

Description

Time Frame

Week 1 up to Week 53

Title

Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use

Description

Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup chronic OCS use. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.

Time Frame

Week 1 up to Week 53

Title

Change From Baseline in Percentage of Nighttime Awakening at Week 53

Description

Time Frame

Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)

Title

Change From Baseline in Overall Activity Limitations at Week 53

Description

Time Frame

Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)

Title

Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53

Description

Time Frame

Baseline and Week 53

Title

Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53

Description

Time Frame

Baseline and Week 53

Title

Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53

Description

Time Frame

Baseline and Week 53

Title

Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53

Description

Time Frame

Baseline and Week 53

Title

Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home

Description

Time Frame

Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)

Title

Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home

Description

Time Frame

Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward Piper, MBBS

Organizational Affiliation

Sponsor GmbH

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Christopher Brightling

Organizational Affiliation

Institute for Lung Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Rancho Mirage

State/Province

California

Country

United States

Facility Name

Research Site

City

Centennial

State/Province

Colorado

Country

United States

Facility Name

Research Site

City

New Haven

State/Province

Connecticut

Country

United States

Facility Name

Research Site

City

Cocoa

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Winter Park

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Albany

State/Province

Georgia

Country

United States

Facility Name

Research Site

City

Fargo

State/Province

North Dakota

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

Research Site

City

Upland

State/Province

Pennsylvania

Country

United States

Facility Name

Research Site

City

Killeen

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Buenos Aires

Country

Argentina

Facility Name

Research Site

City

Ciudad de Buenos Aires

Country

Argentina

Facility Name

Research Site

City

Monte Grande

Country

Argentina

Facility Name

Research Site

City

Ranelagh

Country

Argentina

Facility Name

Research Site

City

Rosario

Country

Argentina

Facility Name

Research Site

City

Calgary

State/Province

Alberta

Country

Canada

Facility Name

Research Site

City

Ottawa

State/Province

Ontario

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

Research Site

City

Quebec

Country

Canada

Facility Name

Research Site

City

Quillota

Country

Chile

Facility Name

Research Site

City

Santiago

Country

Chile

Facility Name

Research Site

City

Valparaiso

Country

Chile

Facility Name

Research Site

City

Viña del Mar

Country

Chile

Facility Name

Research Site

City

Jindrichuv Hradec

Country

Czech Republic

Facility Name

Research Site

City

Plzen

Country

Czech Republic

Facility Name

Research Site

City

Rokycany

Country

Czech Republic

Facility Name

Research Site

City

Marseille Cedex 20

Country

France

Facility Name

Research Site

City

Montpellier

Country

France

Facility Name

Research Site

City

Nantes Cedex 1

Country

France

Facility Name

Research Site

City

Paris Cedex 18

Country

France

Facility Name

Research Site

City

Perpignan

Country

France

Facility Name

Research Site

City

Pessac

Country

France

Facility Name

Research Site

City

Strasbourg Cedex

Country

France

Facility Name

Research Site

City

Berlin

Country

Germany

Facility Name

Research Site

City

Frankfurt

Country

Germany

Facility Name

Research Site

City

Lübeck

Country

Germany

Facility Name

Research Site

City

Mainz

Country

Germany

Facility Name

Research Site

City

Chuo-ku

Country

Japan

Facility Name

Research Site

City

Fujisawa-shi

Country

Japan

Facility Name

Research Site

City

Fukuoka-shi

Country

Japan

Facility Name

Research Site

City

Habikino-shi

Country

Japan

Facility Name

Research Site

City

Hiroshima-shi

Country

Japan

Facility Name

Research Site

City

Itabashi-ku

Country

Japan

Facility Name

Research Site

City

Kagoshima-shi

Country

Japan

Facility Name

Research Site

City

Kahoku-gun

Country

Japan

Facility Name

Research Site

City

Kishiwada-shi

Country

Japan

Facility Name

Research Site

City

Kobe-shi

Country

Japan

Facility Name

Research Site

City

Kyoto-shi

Country

Japan

Facility Name

Research Site

City

Maebashi-shi

Country

Japan

Facility Name

Research Site

City

Morioka-shi

Country

Japan

Facility Name

Research Site

City

Naka-gun

Country

Japan

Facility Name

Research Site

City

Sagamihara-shi

Country

Japan

Facility Name

Research Site

City

Sakaide-shi

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

Country

Japan

Facility Name

Research Site

City

Sumida-ku

Country

Japan

Facility Name

Research Site

City

Takatsuki-shi

Country

Japan

Facility Name

Research Site

City

Tomakomai-shi

Country

Japan

Facility Name

Research Site

City

Wakayama-shi

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

Country

Japan

Facility Name

Research Site

City

Bucheon-si

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

Country

Korea, Republic of

Facility Name

Research Site

City

Suwon-si

Country

Korea, Republic of

Facility Name

Research Site

City

Culiacan

Country

Mexico

Facility Name

Research Site

City

Guadalajara

Country

Mexico

Facility Name

Research Site

City

Morelia

Country

Mexico

Facility Name

Research Site

City

México

Country

Mexico

Facility Name

Research Site

City

Santiago de Querétaro

Country

Mexico

Facility Name

Research Site

City

Tampico

Country

Mexico

Facility Name

Research Site

City

Villahermosa

Country

Mexico

Facility Name

Research Site

City

Iloilo City

Country

Philippines

Facility Name

Research Site

City

Lipa City

Country

Philippines

Facility Name

Research Site

City

Quezon City

Country

Philippines

Facility Name

Research Site

City

Wrocław

Country

Poland

Facility Name

Research Site

City

Zabrze

Country

Poland

Facility Name

Research Site

City

Łódź

Country

Poland

Facility Name

Research Site

City

Ekaterinburg

Country

Russian Federation

Facility Name

Research Site

City

Moscow

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

Country

Russian Federation

Facility Name

Research Site

City

Vladikavkaz

Country

Russian Federation

Facility Name

Research Site

City

Yekaterinburg

Country

Russian Federation

Facility Name

Research Site

City

Barcelona

Country

Spain

Facility Name

Research Site

City

Madrid

Country

Spain

Facility Name

Research Site

City

Pamplona

Country

Spain

Facility Name

Research Site

City

Sagunto(Valencia)

Country

Spain

Facility Name

Research Site

City

Santander

Country

Spain

Facility Name

Research Site

City

Leicester

Country

United Kingdom

Facility Name

Research Site

City

Manchester

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

26231288

Citation

Brightling CE, Chanez P, Leigh R, O'Byrne PM, Korn S, She D, May RD, Streicher K, Ranade K, Piper E. Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Respir Med. 2015 Sep;3(9):692-701. doi: 10.1016/S2213-2600(15)00197-6. Epub 2015 Jul 28.

Results Reference

background

PubMed Identifier

28758192

Citation

Baverel PG, White N, Vicini P, Karlsson MO, Agoram B. Dose-Exposure-Response Relationship of the Investigational Anti-Interleukin-13 Monoclonal Antibody Tralokinumab in Patients With Severe, Uncontrolled Asthma. Clin Pharmacol Ther. 2018 May;103(5):826-835. doi: 10.1002/cpt.803. Epub 2017 Sep 28.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=51&filename=CAT-354_CP1049_Protocol_Legal%20IP_Redacted_02Sep14.pdf

Description

CD-RI-CAT-354-1049 Redacted Protocol

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=51&filename=CAT-354_CP1049_SAP_08Aug14.pdf

Description

CD-RI-CAT-354-1049 SAP

Learn more about this trial

A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

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A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial