PK/PD & Long Term Safety Study of Benralizumab in Children With Severe

Clinical Trial Summary

This study will evaluate the PK, PD and long-term safety of Benralizumab administered subcutaneously in 30 children aged 6 to 11 years with severe eosinophilic asthma. Up to an additional 3 Japanese patients aged 12 to 14 years will be enrolled to meet local regulatory requirements.

See also
	Status	Clinical Trial	Phase
	Completed	`NCT04200326` - Real-life First Dose Effect of Fasenra in Patients With Severe Uncontrolled Asthma

See also

Status

Clinical Trial

Phase

Completed

NCT04200326 - Real-life First Dose Effect of Fasenra in Patients With Severe Uncontrolled Asthma

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04305405
Study type	Interventional
Source	AstraZeneca
Contact
Status	Completed
Phase	Phase 3
Start date	November 21, 2019
Completion date	September 12, 2022

PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma — TATE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms