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Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma

NCT03706079 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 951

Last updated 2023-06-06

Study results available
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Summary

Subjects who completed either D5180C00007 or D5180C00009 will be offered the opportunity to consent for the Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma. The study consists of a treatment phase, followed by a follow-up phase where subjects will not receive IP. The length of the follow up phase is determined by which study the subject had previously completed.

Conditions

Interventions

BIOLOGICAL

Tezepelumab

Tezepelumab subcutaneous injection

OTHER

Placebo

Placebo subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Andrew Menzies-Gow, MD · Royal Brompton Hospital, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2021-10-26
Completion
2022-05-18
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Canada
  • France
  • Germany
  • Israel
  • Poland
  • Russia
  • Saudi Arabia
  • South Africa
  • South Korea
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03706079 on ClinicalTrials.gov