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.

The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061.

Sub-study:

This Phase II sub-study of SUPERNOVA will assess the safety, PK, and predicted neutralizing activity of AZD3152 compared with EVUSHELD for pre-exposure prophylaxis of COVID-19.

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study

AstraZeneca

This is a Phase II, multi-center, double-blind, randomized, interventional study in approximately 120 subjects to evaluate clinical benefit of CX-4945 in adult outpatients with SARS-CoV-2 and influenza viral infection-associated pneumonia. The subjects will be recruited into two domains, including SARS-CoV-2 and influenza virus domains. The study will compare the efficacy of Standard of Care (SOC) combined with CX-4945 against SOC paired with a placebo, utilizing a 1:1 allocation ratio in each domain.

CX-4945 in Viral Community Acquired Pneumonia

Senhwa Biosciences

The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Department of Gastroenterology

The Helmsley Cancer Center - Oncological Day Hospital

Gastroenterology

Bydgoszcz, Poland

Cardiology Clinical Trials Unit

CHR Citadel - Department of Gyneacology and Obstetrics

Ematologia Clinical Trials Unit

UCSF Center for Colitis and Crohn's Disease

Ophthalmology, Ogden, UT

Medicina Interna - Ensayos Clinicos

Los Angeles, CA

Smidt Heart Institute

United Clinical Research - Los Alamitos

Clinical Research Unit

Omaha, NE

Rheumatology

Optimed Research, LTD

Tyler, TX

San Antonio, TX

Shreveport, LA

Victoria Gastroenterology

New Orleans, LA

Gastrointestinal Research and Clinical Trial Center of Georgia

JM Research SC

New Port Richey, FL

Omega Research Orlando, LLC

Orlando, FL

Tampa, FL

Clinical Protocols Department

Complejo Asistencial Dr. Sotero Del Rio - Investigaciones Medicas SSMSO Office

AbbVie

The study consists of 4 sub-studies, as follows:

* Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991;
* Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991;
* Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
* Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.
* OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

Find clinical trials for COVID-19 in Taipei City

Related conditions:

COVID-19 trials near Taipei City, TWN:

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study

CX-4945 in Viral Community Acquired Pneumonia

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA)

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis (COMMAND)

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease (FORTIFY)

Find clinical trials for COVID-19 in .css-epvm6{white-space:nowrap;}Taipei City

Related conditions:

COVID-19 trials near Taipei City, TWN:

Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study

CX-4945 in Viral Community Acquired Pneumonia

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA)

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis (COMMAND)

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease (FORTIFY)

Find clinical trials for COVID-19 in Taipei City