Clinical trial NCT02902809: A Study to Evaluate the Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Official title: A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Inadequately Controlled Asthma
Keywords: open-label study
tralokinumab
subcutaneous
inadequately controlled asthma
asthma
medium to high-dose of inhaled corticosteroid
long-acting β2-agonist
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 28
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid plus Long-Acting β2-Agonist

Detailed description: This is a 52-week, open-label, multi-centre study designed to evaluate the safety of tralokinumab in a fixed 300 mg dose every 2 weeks, administered subcutaneously in adults and adolescents with indequately controlled asthma on medium to high dose inhaled corticosteroid plus long acting β-2 antagonist. Approximately 26 Japanese subjects will be recruited to receive 22 completed.

Eligibility criteria: Inclusion Criteria:

1. Age 12 - 75 yrs
2. Documented physician-diagnosed asthma
3. Documented treatment with inhaled corticosteroid (ICS) at a total daily dose corresponding to ≥500 µg fluticasone propionate dry powder formulation equivalents and a long-acting beta-2 agonist (LABA)
4. Pre-bronchodilator (BD) forced expiratory volume at one second (FEV1) value of ≥40% of their Predicted Normal Value (PNV)
5. Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5

Exclusion Criteria:

1. Pulmonary disease other than asthma
2. History of anaphylaxis following any biologic therapy
3. Hepatitis B, C or HIV
4. Pregnant of breastfeeding
5. History or cancer
6. Current tobacco smoking or a history or tobacco smoking for ≥10 pack-years
7. Previous receipt of tralokinumab

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
measure: Number of Participants With Abnormal Physical Examinations
timeFrame: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
measure: Number of Participants With Vital Signs Abnormalities
timeFrame: From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).
measure: Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
timeFrame: At Day -14 and Week 52.
Secondary outcomes:
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
facility: Research Site
city: Itabashi-ku
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
Study officials:
affiliation: Yokohama City University Graduate School of Medicine
name: Takeshi Kaneko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Panettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14.