WHO ICTRP trial
Study to evaluate efficacy and safety of Tezepelumab in reducing oral…
EUCTR2021-005457-85-ES · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-005457-85-ES |
|---|---|
| Public title | Study to evaluate efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adult patients with severe asthma |
| Scientific title | 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 beta2 Agonist and Long-term Oral Corticosteroid Therapy… |
| 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;Spain;Lithuania;Italy;United Kingdom;France;Mexico;Puerto Rico;Argentina;Belgium;Poland;Bulgaria;Germany;Latvia |
| Conditions | Severe Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] |
| Interventions | Product Name: Tezepelumab via APFS Product Code: MDI9929 anti-TSLP mAb (AMG157) Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Tezepelumab CAS Number: 1572943-04-4 Current Sponsor code: MEDI9929 Other… |
| Registration date | Dec 4, 2022 |
| Target size | 300 |
| Secondary IDs | D5180C00037 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: