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

Phase 2

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis; Systemic Sclerosis With Lung Involvement
• Interventions: Drug: Vixarelimab; Drug: Placebo

• Registration Number: NCT05785624
• Lead Sponsor: Genentech, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-14
• Study First Posted: 2023-03-27
• Study Start: 2023-05-26
• Status Verified: 2025-11
• Last Update Submitted: 2025-11-03
• Last Update Posted: 2025-11-04
• Primary Completion: 2027-04-26
• Study Completion: 2027-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DBT: Cohort 1: Vixarelimab	Vixarelimab	Participants with IPF will receive vixarelimab, subcutaneously (SC), once every two weeks (Q2W) for 52 weeks in the DBT period. This cohort has completed enrollment and has been closed.
DBT: Cohort 1: Placebo	Placebo	Participants with IPF will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period. This cohort has completed enrollment and has been closed.
DBT: Cohort 2: Vixarelimab	Vixarelimab	Participants with SSC-ILD will receive vixarelimab, SC, Q2W for 52 weeks in the DBT period.
DBT: Cohort 2: Placebo	Placebo	Participants with SSC-ILD will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.
OLE Period: Cohort 1: Vixarelimab	Vixarelimab	Participants with IPF who complete 52 weeks of treatment in the DBT period can choose to enroll in the OLE period to receive vixarelimab, SC, Q2W for 52 weeks.
OLE Period: Cohort 2: Vixarelimab	Vixarelimab	Participants with SSC-ILD who complete 52 weeks of treatment in the DBT period can choose to enroll in the OLE period to receive vixarelimab, SC, Q2W for 52 weeks.

Primary Outcome Measures

Name	Time	Method
Cohorts 1 and 2: Absolute Change From Baseline in Forced Vital Capacity (FVC)	Baseline up to Week 52	FVC is a pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function.

Secondary Outcome Measures

Name	Time	Method
Cohorts 1 and 2: Absolute Change From Baseline in Percentage of Predicted FVC	Baseline up to Week 52	FVC is a pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function.
Cohorts 1 and 2: Change From Baseline in Health-Related Quality of Life (HRQoL) Measured Using King's Brief Interstitial Lung Disease (K-BILD) Questionnaire	Baseline up to Week 52	K-BILD is a questionnaire that assesses HRQoL in ILDs. It consists of 15 items grouped into psychological, breathlessness and activity, and chest symptom domains, each scored individually on a 7-point scale, with domain-level and total scores transformed 0-100, with higher scores indicating better quality of life. It uses a 2-week recall period.
Cohorts 1 and 2: Change From Baseline in Dyspnea Measured Using L-PF Symptoms Dyspnea Domain Score	Baseline up to Week 52	The L-PF symptoms module is a 23-item tool with domains capturing shortness of breath, cough, and energy symptoms using a 0-4 NRS response format and a 24-hour recall period. L-PF Symptoms Dyspnea Domain score (dyspnea score) ranges from 0 to 100, with higher score indicating greater impairment.
Cohorts 1 and 2: Time to First Acute Exacerbation of ILD, or Suspected Acute Exacerbation of ILD	From the start of study treatment until end of DBT (up to Week 52)
Cohorts 1, 2 and OLE Period: Number of Participants With Adverse Events (AEs)	Up to Week 52
Cohorts 1 and 2: Absolute Change From Baseline in 6-Minute Walk Test (6MWT) Distance	Baseline up to Week 52	The 6MWT test is performed indoors on a flat, straight corridor with a hard surface at least 30 meters (m) in length. 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes. 6MWT measure will be calculated as the simple difference between baseline distance walked over 6 minutes and week 52 distance walked over 6 minutes as measured in meters.
Cohorts 1 and 2: Change From Baseline in Diffusion Capacity of the Lung for Carbon Monoxide Adjusted for Hemoglobin (DLco [Hb])	Baseline up to Week 52	DLCO measures the ability of the lungs to transfer gas from inhaled air to the red blood cells in the blood. DLCO is adjusted for hemoglobin as small changes in hemoglobin concentration can affect the carbon monoxide transfer.
Cohorts 1 and 2: Time to Disease Progression	From the start of study treatment until disease progression or death, whichever occurs first (up to Week 52 of DBT)	Time to disease progression is defined as time to first occurrence of ≥10% absolute decline in percentage of predicted FVC, ≥15% relative decline in 6MWT distance, lung transplantation, or death. FVC=pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function. 6MWT test is performed indoors on a flat, straight corridor with a hard surface at least 30 m in length. 6MWT measures the distance a participant is able to walk quickly on a flat, hard surface in a period of 6 minutes. 6MWT measure will be calculated as the simple difference between baseline distance walked over 6 minutes and week 52 distance walked over 6 minutes as measured in meters.
Cohorts 1 and 2: Change From Baseline in Quantitative Lung Fibrosis on High-Resolution Computed Tomography (HRCT) Scan of the Thorax	Baseline up to Week 52	High-resolution computer tomography (HRCT) is a type of computed tomography (CT) with specific techniques to enhance image resolution. It is used in the diagnosis of various health problems, most commonly for lung disease. These images show cross sections (slices) through the lungs.
Cohort 2: Change From Baseline in Skin Sclerosis Assessed Using Modified Rodnan Skin Score (mRSS)	Baseline up to Week 52	mRSS is a measure of skin thickness. Skin thickness will be assessed by the investigator by palpation across 17 different body sites and scored on a scale of 0 (normal) to 3 (severe skin thickening). The total score is the sum of the individual skin scores from all of these sites and ranges from 0 (normal) to 51 (severe thickening in all 17 areas) units. Higher scores indicate disease worsening.
Cohorts 1 and 2: Change From Baseline in Cough Measured Using Living with Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score	Baseline up to Week 52	The L-PF symptoms module is a 23-item tool with domains capturing shortness of breath, cough, and energy symptoms using a 0-4 numeric response scale (NRS) response format and a 24-hour recall period. The cough scores ranges from 0 to 100 with higher scores indicating greater symptom burden/impairment.
Cohorts 1 and 2: Percentage of Participants with Deaths	Up to Week 52
Cohort 2: Change From Baseline in Pruritus Measured Using the Five-Dimension Itch Scale (5-D Itch) Total Score	Baseline up to Week 52	The 5-D-Itch questionnaire that measures itch and its impact. It consists of 8 items organized into 5 domains (duration, degree, direction, disability, and distribution). Each domain is scored 1 to 5 with a total score ranging from 5 to 25 with higher scores indicating greater itch severity.
Cohorts 1 and 2: Serum Concentration of Vixarelimab	Baseline up to Week 52
Cohorts 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Vixarelimab	Baseline up to Week 52

Trial Locations

Locations (117)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Banner University Medicine Lung Institute; 🇺🇸 Phoenix, Arizona, United States

Southern Arizona VA Health Care System NAVREF PPDS; 🇺🇸 Tucson, Arizona, United States

University of California, San Francisco-Fresno; 🇺🇸 Fresno, California, United States

University of Southern California Keck School of Medicine; 🇺🇸 Los Angeles, California, United States

UCLA Rheumatology; 🇺🇸 Los Angeles, California, United States

University of California, San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

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

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

Central Florida Pulmonary Group, PA; 🇺🇸 Orlando, Florida, United States

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