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

AstraZeneca

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

Gastroenterology

Bydgoszcz, Poland

Department of Gastroenterology

CHR Citadel - Department of Gyneacology and Obstetrics

Ematologia Clinical Trials Unit

Medicina Interna - Ensayos Clinicos

The Helmsley Cancer Center - Oncological Day Hospital

Clinical Research Unit

Rheumatology

Optimed Research, LTD

Omaha, NE

Gastrointestinal Research and Clinical Trial Center of Georgia

Orlando, FL

Omega Research Orlando, LLC

New Port Richey, FL

Tampa, FL

Shreveport, LA

Ophthalmology, Ogden, UT

New Orleans, LA

Tyler, TX

Victoria Gastroenterology

San Antonio, TX

UCSF Center for Colitis and Crohn's Disease

Clinical Protocols Department

Los Angeles, CA

United Clinical Research - Los Alamitos

JM Research SC

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

Cardiology Clinical Trials Unit

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 Warszawa, Mazowieckie

Related conditions:

COVID-19 trials near Warszawa, Mazowieckie, POL:

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

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;}Warszawa, Mazowieckie

Related conditions:

COVID-19 trials near Warszawa, Mazowieckie, POL:

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

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

Find clinical trials for COVID-19 in Warszawa, Mazowieckie