ACTIVE_NOT_RECRUITING

A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis and in Participants With Systemic Sclerosis-Associated Interstitial Lung Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks. Cohort 1 has completed enrollment and has been closed for further enrollment. Cohort 2 is enrolling participants.

Official Title

A Two-Cohort, Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of Vixarelimab Compared With Placebo in Patients With Idiopathic Pulmonary Fibrosis and in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease

Quick Facts

Study Start:2023-05-26
Study Completion:2026-01-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05785624

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Banner University Medicine Lung Institute
Phoenix, Arizona, 85006-2506
United States
Southern Arizona VA Health Care System NAVREF PPDS
Tucson, Arizona, 85723-0001
United States
University of California, San Francisco-Fresno
Fresno, California, 93701-2302
United States
University of Southern California Keck School of Medicine
Los Angeles, California, 90033-1036
United States
UCLA Rheumatology
Los Angeles, California, 90095-8344
United States
University of California, San Francisco Medical Center
San Francisco, California, 94143-2204
United States
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente
Torrance, California, 90502
United States
Renstar Medical Research
Ocala, Florida, 34470
United States
Coastal Pulmonary and Critical Care PLC
St. Petersburg, Florida, 33704-2733
United States
Weston Hospital
Weston, Florida, 33331-3609
United States
Piedmont Pulmonary and Sleep Medicine Buckhead
Atlanta, Georgia, 30309-1740
United States
Emory Clinic
Atlanta, Georgia, 30322
United States
GenHarp Clinical Solutions
Evergreen Park, Illinois, 60805-2758
United States
Northwestern Medicine - Northwestern Medicine Glen
Glenview, Illinois, 60026-8039
United States
IU Health Ball Memorial Physicians Pulmonary and Critical Care Medicine
Muncie, Indiana, 47303-3432
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109
United States
Hannibal Regional Healthcare System HRMG Hannibal
Hannibal, Missouri, 63401-6890
United States
Pulmonix LLC
Greensboro, North Carolina, 27403-4443
United States
Southeastern Research Center
Winston-Salem, North Carolina, 27103-4029
United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104-5417
United States
Baylor Scott and White Health - Advanced Lung Disease Specialists - Dallas
Dallas, Texas, 75246-2073
United States
IntraCare Health Center ? Prestige
Dallas, Texas, 75254
United States
El Paso Pulmonary Association Elligo PPDS
El Paso, Texas, 79902-1124
United States
McGovern Medical School
Houston, Texas, 77030-1501
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Utah - PPDS
Salt Lake City, Utah, 84108-1287
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-26
Study Completion Date2026-01-09

Study Record Updates

Study Start Date2023-05-26
Study Completion Date2026-01-09

Terms related to this study

Keywords Provided by Researchers

  • Systemic Sclerosis-Associated Interstitial Lung Disease

Additional Relevant MeSH Terms

  • Idiopathic Pulmonary Fibrosis
  • Systemic Sclerosis With Lung Involvement