NCT04673630

Brief Summary

This study will evaluate the pharmacokinetic (PK) profile of a single subcutaneous (SC) dose of tezepelumab in children aged ≥ 5 to 11 years with asthma.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 asthma

Timeline
Completed

Started Feb 2021

Typical duration for phase_1 asthma

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 8, 2024

Completed
Last Updated

January 8, 2024

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

December 2, 2020

Results QC Date

March 29, 2023

Last Update Submit

March 29, 2023

Conditions

Asthma

Keywords

Mild asthmaModerate asthmaSevere asthma

Outcome Measures

Primary Outcomes (8)

  • Maximum Observed Serum Concentration (Cmax) of Tezepelumab

    Blood samples were collected to determine the Cmax of tezepelumab. The Pharmacokinetic (PK) parameters were estimated using non-compartmental analysis method.

    Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85

  • Time to Achieve Maximum Observed Serum Concentration (Tmax) of Tezepelumab

    Blood samples were collected to determine the tmax of tezepelumab. The PK parameters were estimated using non-compartmental analysis method.

    Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85

  • Area Under the Concentration-Time Curve From Time Zero to The Last Measurable Concentration (AUC0-last) of Tezepelumab

    Blood samples were collected to determine the AUC0-last of tezepelumab and calculated by linear up/log down trapezoidal summation. The PK parameters were estimated using non-compartmental analysis method.

    Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85

  • Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tezepelumab

    Blood samples were collected to determine the AUC0-inf of tezepelumab and calculated by linear up/log down trapezoidal summation and extrapolated to infinity by the addition of the last quantifiable concentration divided by the terminal rate constant. The PK parameters were estimated using non-compartmental analysis method.

    Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85

  • Terminal Phase Elimination Half-Life (t1/2) of Tezepelumab

    Blood samples were collected to determine the t1/2 of tezepelumab and calculated as ln(2)/λZ, where λZ is the first-order rate constant associated with the terminal (log-linear) elimination phase. The PK parameters were estimated using non-compartmental analysis method.

    Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85

  • Apparent Clearance (CL/F) of Tezepelumab

    Blood samples were collected to determine the CL/F of tezepelumab and estimated as dose divided by AUC0-inf. The PK parameters were estimated using non-compartmental analysis method.

    Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85

  • Apparent Steady-State Volume of Distribution (Vss/F) of Tezepelumab

    Blood samples were collected to determine the Vss/F of tezepelumab and estimated as CL/F\*mean residence time (MRT), where MRT=Area under the moment curve of the analyte in the sampled matrix from zero (predose) extrapolated to infinite time/(AUC0-inf). The PK parameters were estimated using non-compartmental analysis method.

    Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85

  • Apparent Volume of Distribution (Vz/F) of Tezepelumab

    Blood samples were collected to determine the Vz/F of tezepelumab and estimated as CL/F\*1/ λZ. The PK parameters were estimated using non-compartmental analysis method.

    Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85

Secondary Outcomes (1)

  • Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab

    Predose and within ± 1 hour of postdose on Day 1; on Days 29 and 85

Study Arms (1)

Tezepelumab

EXPERIMENTAL

Tezepelumab subcutaneous injection

Biological: Tezepelumab

Interventions

TezepelumabBIOLOGICAL

Single dose subcutaneous injection

Tezepelumab

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Written informed consent and written informed assent and any locally required authorisation obtained from the subject and legal representative prior to any study related procedure taking place.
  • Age 5 to 11 years (inclusive) at Visit 1 and Visit 2 (Day 1). Type of Subject and Disease Characteristics
  • Documented physician diagnosed asthma for at least 6 months prior to Visit 1.
  • Documented treatment with total daily dose of either low, medium, or high dose ICS for at least 6 months, as described in Step 2 to Step 4 of GINA guidelines (GINA 2020) with stable dose for at least 3 months prior to Visit 1.
  • Pre bronchodilator (BD) FEV1 of ≥ 50% of predicted normal value at Visit 1
  • Body weight ≥ 16 kg at Visit 1 and Visit 2 (Day 1).

You may not qualify if:

  • History of any clinically significant disease or disorder other than asthma which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
  • History of a deterioration in asthma or asthma exacerbation that required a burst of systemic corticosteroids within 6 weeks of Visit 1, up to and including Visit 2 (Day 1).
  • History of hospitalisation (overnight admission) for asthma within 3 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 6 weeks of Visit 1, up to and including Visit 2 (Day 1) and discouraged until EOS.
  • History of cancer.
  • History of hypersensitivity or anaphylactic reaction to any biologic therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Budapest, 1094, Hungary

Location

Research Site

Cape Town, 7700, South Africa

Location

Research Site

Bristol, BS2 8BJ, United Kingdom

Location

Research Site

Glasgow, G51 4TF, United Kingdom

Location

Research Site

London, E1 1BB, United Kingdom

Location

Research Site

London, SE5 9RS, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Global Clinical Lead
Organization
AstraZeneca
information.center@astrazeneca.com
1-877-240-9479

Study Officials

  • Jonathan Grigg, MD

    Royal London Hospital, United Kingdom

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking is used. All involved know the identity of the intervention assignment.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 17, 2020

Study Start

February 23, 2021

Primary Completion

September 27, 2022

Study Completion

September 27, 2022

Last Updated

January 8, 2024

Results First Posted

January 8, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
More information

Locations

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