Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

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
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
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
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

Criterios de exclusión

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
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
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
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

Ubicaciones

Centro Médico Dra de Salvo

Buenos Aires, Argentina

Consultorios Médicos Dr. Doreski

Ciudad Autonoma Buenos Aires, Argentina

Instituto Ave Pulmo

Mar del Plata, Argentina

Fundacion Scherbovsky

Mendoza, Argentina

INSARES

Mendoza, Mendoza City, Argentina

Instituto Medico Rio Cuarto

Río Cuarto, Argentina

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Argentina

Instituto De Patologias Respiratorias

San Miguel de Tucumán, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Argentina

Centro de Investigaciones Reumatologicas

San Miguel de Tucumán, Argentina

Instituto Del Buen Aire

Santa Fe, Argentina

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Vixarelimab

Placebo

Ubicaciones

Centro Médico Dra de Salvo

Consultorios Médicos Dr. Doreski

Instituto Ave Pulmo

Fundacion Scherbovsky

INSARES

Instituto Medico Rio Cuarto

Instituto Medico de la Fundacion Estudios Clinicos

Instituto De Patologias Respiratorias

Centro de Investigaciones Medicas Tucuman

Centro de Investigaciones Reumatologicas

Instituto Del Buen Aire

Patrocinadores