Clinical trials: sponsored by AstraZeneca
Pediatric Cancer, Solid Tumor Pediatric
Durvalumab and Tremelimumab for Pediatric Malignancies
The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and expand in a second phase to test the…
- Conditions
- Pediatric Cancer, Solid Tumor Pediatric, Hematological Malignancies
- Trial name
- NCT03837899
- Testing
- Durvalumab / Tremelimumab Combination Therapy
- Where
- 19 sites in United States, France and 5 more
- Volunteers
- 50 people
- Sponsor
- AstraZeneca
Neurofibromatosis Type 1
Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN
This study is designed to define a dosing regimen and assess the pharmacokinetics(PK) and safety of the granule formulation; the study will also include descriptive analyses of exploratory efficacy endpoints.
- Trial name
- SPRINKLE (NCT05309668)
- Testing
- Selumetinib granule formulation, Selumetinib capsule formulation
- Where
- 16 sites in United States, Germany and 5 more
- Volunteers
- 36 people
- Sponsor
- AstraZeneca
Asthma
Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States
To asses effectiveness and safety of tezepelumab in adult and adolescent participants with severe asthma including several under-studied populations in the United States.
- Trial name
- PASSAGE (NCT05329194)
- Testing
- Tezepelumab
- Where
- 37 sites in United States
- Volunteers
- 286 people
- Sponsor
- AstraZeneca
Hypereosinophilic Syndrome
A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)
This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase III study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with…
- Trial name
- NATRON (NCT04191304)
- Testing
- Benralizumab
- Where
- 52 sites in United States, Argentina and 15 more
- Volunteers
- 134 people
- Sponsor
- AstraZeneca
Asthma
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.
- Trial name
- LOGOS (NCT04609904)
- Testing
- BGF MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg, BFF MDI 320/9.6 μg
- Where
- 317 sites in United States, Brazil and 14 more
- Volunteers
- 2,187 people
- Sponsor
- AstraZeneca
Asthma
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care
- Trial name
- KALOS (NCT04609878)
- Testing
- BGF MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg, BFF MDI 320/9.6 μg
- Where
- 360 sites in United States, Argentina and 19 more
- Volunteers
- 2,274 people
- Sponsor
- AstraZeneca
COVID-19, SARS-CoV-2
Parent Study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOvel Anitbodies (SUPERNOVA Sub-study)
AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.
- Trial name
- SUPERNOVA (NCT05648110)
- Testing
- AZD5156 (Parent study Sentinel Safety Cohort), EVUSHELD™ (Parent study Main Cohort), AZD3152 (Parent study Main Cohort)
- Where
- 215 sites in United States, Australia and 16 more
- Volunteers
- 3,882 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Respiratory Syncytial Virus Infections
A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months.
- Trial name
- JUBILUS (NCT06042049)
- Testing
- Nirsevimab
- Where
- 9 sites in Japan
- Volunteers
- 33 people
- Sponsor
- AstraZeneca
Reflux Esophagitis, Gastric Ulcer
A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer
This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and…
- Conditions
- Reflux Esophagitis, Gastric Ulcer, Duodenal Ulcer
- Trial name
- NCT03553563
- Testing
- D961H capsule 10mg, D961H sachet 10mg
- Where
- 15 sites in Japan
- Volunteers
- 50 people
- Sponsor
- AstraZeneca
Asthma
A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS)
This is a 24 week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler in adults and adolescents with inadequately controlled asthma.
- Trial name
- VATHOS (NCT05202262)
- Testing
- BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, BD MDI 320 μg
- Where
- 142 sites in United States, Canada and 5 more
- Volunteers
- 645 people
- Sponsor
- AstraZeneca
Asthma
A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS)
This is a 12-week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler relative to budesonide metered dose inhaler in adults and adolescents with inadequately controlled asthma.
- Trial name
- LITHOS (NCT05755906)
- Testing
- BFF MDI 160/9.6 μg BID (320/19.2μg/day), BD MDI 160 μg BID (320 μg/day)
- Where
- 104 sites in United States, Canada and 5 more
- Volunteers
- 374 people
- Sponsor
- AstraZeneca
Asthma
CARE FOR ALL：an Evaluation of an Asthma QIP
This is an evaluation on an asthma Quality Improvement Program (QIP, including GINA guideline education/training and implementation) to understand the change of physician behaviours, which leads to the change of patient outcomes.
- Trial name
- CARE FOR ALL (NCT05440097)
- Testing
- QIP intervention
- Where
- 32 sites in China
- Volunteers
- 1,500 people
- Sponsor
- AstraZeneca
Relapsed or Refractory Classical Hodgkin Lymphoma
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of sabestomig (AZD7789) in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).
- Trial name
- NCT05216835
- Testing
- Sabestomig (AZD7789)
- Where
- 14 sites in United States, Canada and 5 more
- Volunteers
- 45 people
- Sponsor
- AstraZeneca
Eosinophilic Gastritis, Eosinophilic Gastroenteritis
Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
This is a 3-part study. Part A is randomized, double-blinded, placebo-controlled and includes patients with eosinophilic gastritis and/or duodenal-only disease.
- Trial name
- HUDSON GI (NCT05251909)
- Testing
- Benralizumab
- Where
- 20 sites in United States, Brazil and 7 more
- Volunteers
- 12 people
- Sponsor
- AstraZeneca
Asthma
US PRECISION Implementation Study
The primary objective of this community program intervention study is to assess the process and potential benefits of integrating the AIRQ®, Asthma Checklist, and educational resources (PRECISION program) into clinical practice…
- Trial name
- NCT04891978
- Testing
- AIRQ, Asthma Checklist, PRECISION Program (Educational Resources)
- Where
- 13 sites in United States
- Volunteers
- 857 people
- Sponsor
- AstraZeneca
SARS-CoV-2
AZD7442 Pharmacokinetics, Pharmacodynamics, and Safety Evaluation in Pediatrics
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD7442 administered intramuscularly (IM) or intravenously (IV) in pediatric participants aged ≥ 29 weeks GA to < 18 years.
- Trial name
- TRUST (NCT05281601)
- Testing
- AZD7442
- Where
- 11 sites in United States, Belgium and 3 more
- Volunteers
- 46 people
- Sponsor
- AstraZeneca
Coronavirus Disease 2019 (COVID-19)
A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19
A Phase II Randomized, Open-label, Multicenter, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, a Combination…
- Trial name
- ENDURE (NCT05375760)
- Testing
- AZD7442 (tixagevimab [AZD8895] + cilgavimab [AZD1061])
- Where
- 16 sites in United States
- Volunteers
- 251 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Type 2
Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old
The primary objective of this study is to determine if there will be a greater mean reduction from baseline in glycated hemoglobin (HbA1c) achieved after 26 weeks of oral double-blind add-on therapy of dapagliflozin or…
- Trial name
- NCT03199053
- Testing
- Dapagliflozin, Saxagliptin
- Where
- 122 sites in United States, Argentina and 21 more
- Volunteers
- 256 people
- Sponsor
- AstraZeneca
Asthma
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
This is a randomised, double-blind, parallel group, placebo-controlled study designed to evaluate the efficacy and safety of a fixed 30 mg dose of benralizumab administered subcutaneously for patients with a history of asthma…
- Trial name
- NCT03186209
- Testing
- Benralizumab
- Where
- 79 sites in China, Philippines and 2 more
- Volunteers
- 695 people
- Sponsor
- AstraZeneca
Puberty, Precocious, McCune-Albright Syndrome
Faslodex in McCune-Albright Syndrome
The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (PPP) (early puberty) in girls with…
- Trial name
- FMAS (NCT00278915)
- Testing
- Fulvestrant
- Where
- 16 sites in United States, France and 4 more
- Volunteers
- 30 people
- Sponsor
- AstraZeneca