This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection.

It also contains a sub-study to enroll patients with severe COVID-19.

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

Seattle, WA

Clinical Trial Center

Ansun Biopharma

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.

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

Omaha, NE

Rheumatology

Optimed Research, LTD

Shreveport, LA

Tyler, TX

Gastrointestinal Research and Clinical Trial Center of Georgia

New Orleans, LA

Ophthalmology, Ogden, UT

San Antonio, TX

Victoria Gastroenterology

New Port Richey, FL

Omega Research Orlando, LLC

Orlando, FL

Tampa, FL

New Westminster, Canada

United Clinical Research - Los Alamitos

Smidt Heart Institute

Los Angeles, CA

Clinical Protocols Department

UCSF Center for Colitis and Crohn's Disease

JM Research SC

Medicina Interna - Ensayos Clinicos

Clinical Research Unit

Bydgoszcz, Poland

Ematologia Clinical Trials Unit

Department of Gastroenterology

Gastroenterology

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

The Helmsley Cancer Center - Oncological Day Hospital

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 Rochester, MN

Related conditions:

COVID-19 trials near Rochester, MN, USA:

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

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;}Rochester, MN

Related conditions:

COVID-19 trials near Rochester, MN, USA:

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

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 Rochester, MN