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NCT05785624RECRUITINGIRB Ready

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

Sponsored by Genentech, Inc.

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

for all Participants:
FVC โ‰ฅ45% predicted during screening as determined by the over-reader
Forced expiratory volume in 1 second (FEV1)/FVC ratio \>0.70 during screening as determined by the over-reader
DLco โ‰ฅ30% and โ‰ค90% of predicted during screening (Hgb corrected) as determined by the over-reader
Minimum 6-MWT distance of 150 m with maximum use of 6 liters per minute (L/min) at sea-level and up to 8 L/min at altitude (\> 5000 feet \[1524 m\] above sea level) of supplemental oxygen while maintaining oxygen saturation of \>83% during the 6MWT during screening
Participant and investigator consideration of all medicinal treatment options and/or possibly lung transplantation prior to consideration of participation in the study Inclusion Criteria for Cohort 1:
Age 40-85 years
Documented diagnosis of IPF or IPF (likely)
HRCT pattern consistent with the diagnosis of IPF, confirmed by central review of chest HRCT and central review of any available lung b

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

320 participants

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Age Range

18 Years - 85 Years

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Gender

ALL

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Sponsor

Genentech, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Birmingham

Alabama

Location available
View Birmingham location page
Unknown

Phoenix

Arizona

Location available
View Phoenix location page
Unknown

Tucson

Arizona

Location available
View Tucson location page
Unknown

Fresno

California

Location available
View Fresno location page
Unknown

Los Angeles

California

Location available
View Los Angeles location page
Unknown

Los Angeles

California

Location available
View Los Angeles location page
Unknown

San Francisco

California

Location available
View San Francisco location page
Unknown

Torrance

California

Location available
View Torrance location page
Unknown

Ocala

Florida

Location available
View Ocala location page

๐Ÿ“ And 19 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Pulmonary Fibrosis Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Pulmonary Fibrosis Treatment Options in Birmingham, Alabama

If you're searching for Pulmonary Fibrosis treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Phoenix, Tucson and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Pulmonary Fibrosis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 320 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Pulmonary Fibrosis?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Pulmonary Fibrosis

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Pulmonary Fibrosis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05785624. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.