WHO ICTRP trial
Efficacy and safety of tezepelumab in participants with Severe Chronic…
EUCTR2020-003062-39-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2020-003062-39-DE |
|---|---|
| Public title | Efficacy and safety of tezepelumab in participants with Severe Chronic Rhinosinusitis with Nasal Polyposis |
| Scientific title | 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) - WAYPOINT |
| Primary sponsor | AstraZeneca AB |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Hungary;Canada;Spain;Poland;Denmark;Germany;United Kingdom;Japan;China |
| Conditions | Severe Chronic Rhinosinusitis with Nasal Polyposis MedDRA version: 20.1 Level: PT Classification code 10080060 Term: Chronic rhinosinusitis with nasal polyps System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders… |
| Interventions | Product Name: Tezepelumab via APFS Product Code: MEDI9929 anti-TSLP mAb (AMG157) Pharmaceutical Form: Solution for injection INN or Proposed INN: TEZEPELUMAB CAS Number: 1572943-04-4 Current Sponsor code: MEDI9929 Other descriptive name… |
| Registration date | Oct 27, 2020 |
| Target size | 400 |
| Secondary IDs | D5242C00001 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: