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

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.

Conditions

Idiopathic Pulmonary Fibrosis, Systemic Sclerosis With Lung Involvement

Study Overview

Study Details

Study overview

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.

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

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

Condition
Idiopathic Pulmonary Fibrosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Phoenix

Banner University Medicine Lung Institute, Phoenix, Arizona, United States, 85006-2506

Tucson

Southern Arizona VA Health Care System NAVREF PPDS, Tucson, Arizona, United States, 85723-0001

Fresno

University of California, San Francisco-Fresno, Fresno, California, United States, 93701-2302

Los Angeles

University of Southern California Keck School of Medicine, Los Angeles, California, United States, 90033-1036

Los Angeles

UCLA Rheumatology, Los Angeles, California, United States, 90095-8344

San Francisco

University of California, San Francisco Medical Center, San Francisco, California, United States, 94143-2204

Torrance

The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente, Torrance, California, United States, 90502

Ocala

Renstar Medical Research, Ocala, Florida, United States, 34470

Orlando

Central Florida Pulmonary Group, PA, Orlando, Florida, United States, 32803

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to 85 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Genentech, Inc.,

    Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

    Study Record Dates

    2027-08-10