D5180C00025_A Study to Evaluate the PK of Tezepelumab in Children ≥ 5-11 Years with Asthma
Research type
Research Study
Full title
A Phase I, Open-label Study to Evaluate the Pharmacokinetics of Tezepelumab in Children ≥ 5 to 11 Years of Age with Mild, Moderate, or Severe Asthma
IRAS ID
1003237
Contact name
Jonathan Grigg
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-000554-97
Research summary
This is an Open Label (participants and the medical team will know what treatments are
being given), Phase I, multicentre study. The purpose of this study is to assess the
Pharmacokinetic (PK) profile of the drug tezepelumab following a single 70 mg dose
injected under the skin (subcutaneous) in children aged ≥ 5 to 11 years with mild,
moderate, or severe asthma, and to find a more effective treatment for asthma in
children. The assessment of the PK profile will show how the level of the study drug in
the blood changes in the body. The study will also look at how safe and well tolerated the
study drug is and how certain factors in the immune system (the body’s defence against
infections) respond.
The study will be conducted in 5 sites in the United Kingdom.
Approximately 24 children will be enrolled such that at least 12 children complete the
study.
At least 12 paediatric participants aged ≥ 5 to 11 years (inclusive) will receive a single
SC 70 mg
dose of tezepelumab. At least 4 participants will have body weight < 25 kg and a
minimum of
3 participants will have body weight ≥ 25 kg to < 40 kg.
Children who are eligible to participate but do not go on to receive tezepelumab, or
children
who do not complete the required evaluations through to Day 85 may be replaced to
maintain
the required number of evaluable participants.
For each participant, the research study will last for 14 weeks (about 3.2 months). The
study will include a screening period of up to 2 weeks, a treatment visit (1 day), and
follow-up period of about 12 weeks. The child will have to come to the study centre for
about 9 visits over the next 14 weeks.
If required, a study nurse may perform the scheduled assessments at the child’s home on
the
Day 11 visit, if previously approved and agreed with AstraZeneca.
The participant has completed the study if he/she has completed his/her last scheduled
contact.
The end of study is defined as the date of the last visit of the last subject in the study.
Key Inclusion and Exclusion criteria:
Inclusion:
• Male and females age 5 to 11 years (inclusive) at Visit 1 and Visit 2 (Day 1).
• Written informed consent and written informed assent and any locally required
authorisation obtained from the subject and legal representative prior to any studyrelated
procedure taking place.
• Body weight ≥ 16 kg at Visit 1 and Visit 2 (Day 1).
• Body mass index for age at both screening and Day 1 that is between 5th and 95th
percentile (Centers for Disease Control Growth Charts)
Exclusion:
• History of any clinically significant disease or disorder other than asthma which, in the
opinion of the Investigator, may either put the child at risk because of participation in
the study, or influence the results or the child’s ability to participate in the study.
• History of a deterioration in asthma or asthma exacerbation that required a burst of
systemic corticosteroids within 3 months of Visit 1, up to and including Visit 2 (Day 1).
• Use of systemic or intra-articular glucocorticosteroids for conditions other than
asthma is
not allowed within 3 months prior to Visit 2 and is discouraged until end of study.
• History of hospitalisation (overnight admission) for asthma within 6 months of Visit 1,
up
to and including Visit 2 (Day 1).
• History of a life-threatening asthma exacerbation requiring intubation or mechanical
ventilation.
• History of systemic corticosteroid use for the maintenance treatment of asthma within
3 months of Visit 1, up to and including Visit 2 (Day 1) and discouraged until end of
study.
• History of cancer.
• History of hypersensitivity or anaphylactic reaction to any biologic therapy.
• Any clinical signs, symptoms, or abnormal findings during screening that may be
indicative of past or present MIS-C.
Enrolment timelines:
Planned start date in UK; 27 November 2020
Last participants in UK; February 2021
Enrolment period: 12 weeksREC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/1041
Date of REC Opinion
21 Oct 2020
REC opinion
Favourable Opinion