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Evaluating Vixarelimab for Lung Diseases

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

PHASE2 · Genentech, Inc. · NCT05785624

This study is testing a new drug called vixarelimab to see if it can help people with lung diseases like idiopathic pulmonary fibrosis and systemic sclerosis-associated interstitial lung disease feel better and breathe easier.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment320 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorGenentech, Inc. (industry)
Drugs / interventionstocilizumab, vixarelimab
Locations113 sites (Birmingham, Alabama and 112 other locations)
Trial IDNCT05785624 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of vixarelimab compared to a placebo in participants with idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants will undergo a 52-week double-blind treatment period, with the option to continue receiving vixarelimab in an open-label extension for an additional 52 weeks. The study aims to assess improvements in lung function and overall health outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 40-85 with a documented diagnosis of IPF or SSc-ILD and specific lung function criteria.

Not a fit: Patients with less severe lung function or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients with these serious lung conditions.

How similar studies have performed: Other studies have shown promise in targeting similar lung diseases, but this specific approach with vixarelimab is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria for all Participants:

* FVC ≥45% 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 ≥30% and ≤90% 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 biopsy
* For participants receiving pirfenidone or nintedanib treatment for IPF: treatment for ≥3 months with a stable dose for ≥4 weeks prior to screening and during screening, with plans to continue treatment during the study period

Inclusion Criteria for Cohort 2:

* Age 18-85 years
* Diagnosis of SSc as defined using the American College of Rheumatology/European Alliance of Associations for Rheumatology (EULAR) criteria
* HRCT demonstrating ≥10% extent of fibrosis, confirmed by central review of Chest HRCT
* Evidence of progression of pulmonary fibrosis
* For participants receiving tocilizumab treatment for SSc-ILD: treatment for ≥3 months with a stable dose for ≥4 weeks prior to screening and during screening, with no contraindications according to local prescribing information, and no intention to change or modify their treatment regimen for the duration of the study
* For participants receiving nintedanib treatment for SSc-ILD: treatment for ≥ 3 months with a stable dose for ≥ 4 weeks prior to screening and during screening, with no contraindications according to local prescribing information, and no intention to change or modify their treatment regimen for the duration of the study
* Availability of skin for biopsy preferably on proximal forearms having Modified Rodnan Skin Score (mRSS) ≥2 at the biopsy location

Inclusion Criteria for OLE Period:

* Completion of 52 weeks of treatment in the double-blinded treatment period
* Investigator determination of a favorable benefit-risk for the individual participant, i.e., the expectation of reasonable likelihood for therapeutic benefit and tolerability of the study drug after evaluation of the preceding 52 weeks of double-blinded treatment

Exclusion Criteria for all Participants:

* Percentage of predicted FVC value showing improvement in the 6-month period prior to screening and including screening value
* Known post-bronchodilator response in FEV1 and/or FVC (defined as an increase in percent predicted values by ≥ 10)
* Resting oxygen saturation of \<89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (5000 feet \[1524 m\] above sea level) during screening
* History of lung transplant
* Previous treatment with vixarelimab
* Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening not successfully resolved by 4 weeks prior to screening visit
* Presence of pulmonary hypertension requiring treatment
* History of malignancy within the 5 years prior to screening
* Positive hepatitis C virus (HCV) antibody test result accompanied by a positive HCV ribonucleic acid (RNA) test at screening
* Known immunodeficiency
* Known evidence of active or untreated latent tuberculosis

Exclusion Criteria for Cohort 1:

* Evidence of other known causes of ILD
* Emphysema present on ≥50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT

Exclusion Criteria for Cohort 2:

* Evidence of other known causes of ILD
* Rheumatic autoimmune disease other than SSc
* Receiving pirfenidone treatment within 4 weeks prior to screening
* Receipt of nintedanib in combination with tocilizumab

Exclusion Criteria for OLE Period:

* Significant non-compliance in the double-blinded treatment period, per investigator's judgment
* Any new clinically significant pulmonary disease other than IPF or SSc-ILD since enrolling in the double-blinded treatment period

Where this trial is running

Birmingham, Alabama and 112 other locations

+63 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Idiopathic Pulmonary Fibrosis, Systemic Sclerosis With Lung Involvement, Systemic Sclerosis-Associated Interstitial Lung Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.