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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

No masking is used. All involved know the identity of the intervention assignment.

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.

Study to Evaluate the Pharmacokinetics of Tezepelumab in Children with Asthma

CTIS Number

EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

Research Site

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 (TRAILHEAD)

To describe the pharmacokinetics (PK) of Tezepelumab administered subcutaneously (SC) in children ≥ 5 to 11 years of age with mild, moderate, or severe asthma.

To describe the pharmacokinetics
(PK) of Tezepelumab administered subcutaneously (SC) in children ≥ 5 to 11 years of age with mild, moderate, or severe asthma.

Age Continuous

Sex: Female, Male

Race/Ethnicity, Customized

The Safety analysis set included all participants who received at least 1 dose of tezepelumab.

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

The PK analysis set included participants in the Safety Analysis set that had at least 1 detectable tezepelumab serum concentration from a sample collected postdose that was assumed not to be affected by factors such as important protocol deviations (eg, incorrect dose of study drug received).

Maximum Observed Serum Concentration (Cmax) of Tezepelumab

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

Time to Achieve Maximum Observed Serum Concentration (tmax) 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.

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-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.

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

Terminal Phase Elimination Half-Life (t1/2) 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.

Apparent Clearance (CL/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.

Apparent Steady-State Volume of Distribution (Vss/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.

Apparent Volume of Distribution (Vz/F) of Tezepelumab

ADA prevalence

Only baseline ADA positive

Baseline and at least 1 post-baseline ADA positive

Baseline ADA positive regardless of post-baseline

Any post-baseline ADA positive

Treatment-induced ADA positive

Treatment-boosted ADA positive

Treatment-emergent ADA positive

Blood samples were analyzed for the presence of ADAs for tezepelumab using validated assays. ADA prevalence was defined as ADA positive at baseline and/or post baseline. ADA incidence was defined as the percentage of treatment-emergent ADA positive participants in a population. Treatment induced ADA positive was defined as ADA negative at baseline and post-baseline ADA positive. Treatment-boosted ADA positive was defined as baseline positive ADA titre that was boosted to a 4-fold or higher level following study drug administration. Treatment-emergent ADA positive was defined as either treatment-induced ADA positive or treatment-boosted ADA positive.

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

Overall Study

This study consists a screening period (14 days), and a single dose treatment (Day 1) and follow-up period (85 days). A total of 18 participants were treated in the study.

Global Clinical Lead

To evaluate the immunogenicity of tezepelumab.

Study to Evaluate the Pharmacokinetics of Tezepelumab in Children with Asthma - TRAILHEAD

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

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Inclusion Criteria

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Documents available

CSR Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator