A Safety and Efficacy Study of Tralokinumab in Adults With Asthma

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01402986
• Date of registration: 21/07/2011
• Prospective Registration: Yes
• Primary sponsor: MedImmune LLC
• Public title: A Safety and Efficacy Study of Tralokinumab in Adults With Asthma
• Scientific title: A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma
• Date of first enrolment: August 2011
• Target sample size: 689
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01402986
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Brazil, Canada, Chile, Czech Republic, France, Germany, Japan, Korea, Republic of, Mexico, Philippines, Poland, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: Christopher Brightling
• Affiliation: Institute for Lung Health

• Name: Edward Piper, MBBS
• Affiliation: Sponsor GmbH

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Biological: Tralokinumab 300 mg, Q2/4W

Biological: Tralokinumab 300 mg, Q2W

Other: Placebo, Q2/4W

Other: Placebo Q2W

Primary Outcome(s)

Annual Asthma Exacerbation Rate (AER) [Time Frame: Week 1 up to Week 53]

Secondary Outcome(s)

Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year [Time Frame: Week 1 up to Week 53]

Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53 [Time Frame: Baseline and Week 53]

Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status [Time Frame: Week 1 up to Week 53]

Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 [Time Frame: Baseline and Week 53]

Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home [Time Frame: Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)]

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) [Time Frame: Baseline and Week 75]

Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted [Time Frame: Week 1 up to Week 53]

Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups [Time Frame: Week 1 up to Week 53]

Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count [Time Frame: Week 1 up to Week 53]

Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53 [Time Frame: Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)]

Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 [Time Frame: Baseline and Week 53]

Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use [Time Frame: Week 1 up to Week 53]

Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 [Time Frame: Baseline and Week 53]

Change From Baseline in Overall Activity Limitations at Week 53 [Time Frame: Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)]

Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53 [Time Frame: Baseline and Week 53]

Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53 [Time Frame: Baseline and Week 53]

Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53 [Time Frame: Baseline and Week 53]

Time to First Severe Exacerbation Through Week 53 [Time Frame: Week 1 up to Week 53]

Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53 [Time Frame: Baseline and Week 53]

Change From Baseline in Percentage of Nighttime Awakening at Week 53 [Time Frame: Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)]

Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status [Time Frame: Week 1 up to Week 53]

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

Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count [Time Frame: Week 1 up to Week 53]

Change From Baseline in Rescue Medication Use at Week 53 [Time Frame: Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)]

Change From Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53 [Time Frame: Baseline and Week 53]

Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home [Time Frame: Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)]

Severe Annual Asthma Exacerbation Rate (AER) [Time Frame: Week 1 up to Week 53]

Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin [Time Frame: Week 1 up to Week 53]

Observed Serum Tralokinumab Concentration at Week 53 [Time Frame: Week 53]

Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home [Time Frame: Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)]

Percentage of Participants With Anti-Drug Antibodies (ADA) to Tralokinumab [Time Frame: Baseline and Week 75]

Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility [Time Frame: Week 1 up to Week 53]

Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups [Time Frame: Week 1 up to Week 53]

Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status [Time Frame: Week 1 up to Week 53]

Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility [Time Frame: Week 1 up to Week 53]

Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin [Time Frame: Week 1 up to Week 53]

Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53 [Time Frame: Baseline and Week 53]

Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53 [Time Frame: Week 53]

Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53 [Time Frame: Baseline and Week 53]

Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home [Time Frame: Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)]

Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups [Time Frame: Week 1 up to Week 53]

Time to First Exacerbation Through Week 53 [Time Frame: Week 1 up to Week 53]

Secondary ID(s)

2011-001360-21

CD-RI-CAT-354-1049

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01402986