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Tezepelumab

Aliases
AMG 157, Experimental: Tezepelumab, Tezspire
Name
TEZSPIRE
INN Name
tezepelumab-ekko
FDA Approved
Yes

24 clinical trials

1 organization

14 indications

1 document

Indication
Asthma
Indication
Chronic Obstructive Pulmonary Disease
Indication
Eosinophilic Esophagitis
Indication
Chronic Rhinosinusitis
Indication
Chronic Spontaneous Urticaria
Indication
Healthy Control Participants
Indication
Atopic Dermatitis
Indication
Eosinophilic Granulomatosis With Polyangiitis
Indication
Airway Remodeling
Indication
Allergy
Indication
COPD exacerbation
Indication
Airway Disease
Indication
Immune System Disorder
Indication
Asthma with Allergic Rhinitis
Clinical trial
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)
Status: Completed, Estimated PCD: 2022-09-27
Clinical trial
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)
Status: Completed, Estimated PCD: 2023-11-10
Clinical trial
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING).
Status: Recruiting, Estimated PCD: 2026-05-01
Clinical trial
A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 28-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SUNRISE)
Status: Recruiting, Estimated PCD: 2025-04-07
Clinical trial
A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT)
Status: Active (not recruiting), Estimated PCD: 2024-10-04
Clinical trial
A Regional, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults With Severe Uncontrolled Asthma
Status: Active (not recruiting), Estimated PCD: 2024-05-29
Clinical trial
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging, Phase 2b Study to Evaluate Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria
Status: Completed, Estimated PCD: 2022-12-20
Clinical trial
A Multicentre, Randomised, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to < 12 Year Old Children With Severe Uncontrolled Asthma (HORIZON)
Status: Recruiting, Estimated PCD: 2027-04-23
Clinical trial
A Multicentre, Single-arm, Phase 3b Efficacy and Safety Study of Tezepelumab 210 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Participants With Severe Asthma on High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Long-term Oral Corticosteroid Therapy (WAYFINDER)
Status: Active (not recruiting), Estimated PCD: 2024-09-12
Clinical trial
A Multicenter, Single-arm, Open-label, Post-Authorization, Phase 4 Effectiveness and Safety Study of Tezepelumab in Adult and Adolescent Participants With Severe Asthma Including Several Under-Studied Populations in the United States (PASSAGE)
Status: Recruiting, Estimated PCD: 2025-07-08
Clinical trial
A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 157 in Healthy Subjects
Status: Completed, Estimated PCD: 2011-01-09
Clinical trial
Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 157 in Subjects With Mild Atopic Asthma
Status: Completed, Estimated PCD: 2013-04-05
Clinical trial
A 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 (DESTINATION)
Status: Completed, Estimated PCD: 2021-10-26
Clinical trial
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 157 in Healthy Subjects and Subjects With Moderate to Severe Atopic Dermatitis
Status: Completed, Estimated PCD: 2011-01-05
Clinical trial
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Adolescent and Young Adult Participants With Moderate to Severe Asthma (VECTOR)
Status: Completed, Estimated PCD: 2022-03-21
Clinical trial
A Two-arm, Placebo-controlled, Randomized Clinical Trial to Evaluate the Effect of Tezepelumab on Airway Structure and Function in Patients With Uncontrolled Moderate-to-severe Asthma
Status: Recruiting, Estimated PCD: 2024-09-01
Clinical trial
A RAndomised Placebo Controlled Trial - to Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis
Status: , Estimated PCD: 2025-10-01
Clinical trial
The Improvement of Cough Outcomes After Tezepelumab Treatment in Korean Severe Asthma Patients With Airway Hyperresponsiveness
Status: Not yet recruiting, Estimated PCD: 2025-05-12
Clinical trial
REVErsing Airway Remodelling With Tezepelumab : a Protocol for a Double-blind Randomized Controlled Trial for Patients With Asthma
Status: Recruiting, Estimated PCD: 2025-12-01
Clinical trial
A Phase 2 Multi-centre Randomized Double-blind Placebo-controlled Parallel Group Study to Examine the Effects of 24 Weeks Tezepelumab 210 mg sc q4wks on Methacholine Airway Hyperresponsiveness in Participants With Mild Allergic Asthma
Status: Not yet recruiting, Estimated PCD: 2024-12-30
Clinical trial
Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD A Randomized Double-blind, Placebo-controlled Trial of Tezepelumab UPSTREAM-COPD
Status: Recruiting, Estimated PCD: 2025-05-31
Clinical trial
Tezepelumab in the Treatment of Co-morbid Allergic Rhinitis and Allergic Asthma Study (TEZARS) - An Open-Label Exploratory Mechanistic Pilot Study to Evaluate Tezepelumab Efficacy in Asthma and Allergic Rhinitis
Status: Recruiting, Estimated PCD: 2026-04-30
Clinical trial
Patient Characteristics, Treatment Patterns and Outcomes of Patients Enrolled in the Tezepelumab Patient Access Programme; a Retrospective, Observational Medical Chart Review Conducted in UK Severe Asthma Centres
Status: Recruiting, Estimated PCD: 2024-09-23
Clinical trial
A Multicentre, Randomised, Open-Label, Parallel-Group, Phase IIIb Study to Assess the Potential for Tezepelumab-treated Patients With Severe Asthma to Reduce Background Therapy While Sustaining Asthma Control and Clinical Remission
Status: Not yet recruiting, Estimated PCD: 2027-06-30
Document
DailyMed Label: TEZSPIRE
Organization
Amgen, Inc