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
Idiopathic Pulmonary Fibrosis, Systemic Sclerosis With Lung Involvement
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Systemic Sclerosis-Associated Interstitial Lung Disease
Eligibility 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 progressive 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 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 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 by 12% and 200 milliliters [mL]) 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 anti-fibrotic treatment (e.g., nintedanib) within 4 weeks prior to screening 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
Sites / Locations
- University of Alabama at BirminghamRecruiting
- Renstar Medical ResearchRecruiting
- Central Florida Pulmonary Group, PARecruiting
- Coastal Pulmonary and Critical Care PLCRecruiting
- Hannibal Regional Healthcare System HRMG HannibalRecruiting
- Pulmonix LLCRecruiting
- Southeastern Research CenterRecruiting
- El Paso Pulmonary Association Elligo PPDSRecruiting
- Onze Lieve Vrouwziekenhuis AalstRecruiting
- CEC SpARecruiting
- Enroll SpA - PPDSRecruiting
- Hopital Louis PradelRecruiting
- Hopital Pasteur 2Recruiting
- Groupe Hospitalier Bichat Claude BernardRecruiting
- University General Hospital of HeraklionRecruiting
- Shamir Medical Center Assaf HarofehRecruiting
- Rabin Medical CenterRecruiting
- Presidio Ospedaliero GB Morgagni L PierantoniRecruiting
- CHUS H Clinico U de SantiagoRecruiting
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Experimental
DBT: Cohort 1: Vixarelimab
DBT: Cohort 1: Placebo
DBT: Cohort 2: Vixarelimab
DBT: Cohort 2: Placebo
OLE Period: Cohort 1: Vixarelimab
OLE Period: Cohort 2: Vixarelimab
Participants with IPF will receive vixarelimab, subcutaneously (SC), once every two weeks (Q2W) for 52 weeks in the DBT period.
Participants with IPF will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.
Participants with SSC-ILD will receive vixarelimab, SC, Q2W for 52 weeks in the DBT period.
Participants with SSC-ILD will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.
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.
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.