A Study to Evaluate 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
Key facts
- Where
- Budapest XII és Székesfehérvár, MagyarországSee the 2 sites
- Phase
- 2. fázis
Where in Magyarország
- Koranyi National Institute For PulmonologyBudapest XII, MagyarországNo longer taking part
- Fejér Megyei Szent György Egyetemi Oktató KórházSzékesfehérvár, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genentech Inc.
- Trial code
- EU 2022-502828-42-00
- Record updated
- 2026. február 27.
- Original description
To evaluate the efficacy of vixarelimab compared with placebo on lung function for each cohortRead full original descriptionShow less
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
To evaluate the efficacy of vixarelimab compared with placebo on lung function for each cohort
Inclusion: Forced vital capacity (FVC) ≥45% predicted during screening as determined by the over-reader; FEV1/FVC ratio >0.70 during screening as determined by the over-reader; Diffusion capacity of the lung for carbon monoxide (DLCO) ≥30% and ≤90% of predicted during screening (Hgb corrected) as determined by the over-reader; Minimum 6-minute walk test (6MWT) distance of 150 meters with maximum use of 6 L/min at sea-level and up to 8 L/min at altitude (>5000 feet [1524 meters] above sea level) of supplemental oxygen while maintaining oxygen saturation of >83% during the 6MWT during screening; Cohort 1: Documented diagnosis of idiopathic pulmonary fibrosis (IPF) or IPF (likely) per the 2022 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ Latin American Thoracic Society (ALAT) Clinical Practice Guideline or high-resolution computed tomography (HRCT) pattern consistent with the diagnosis of IPF; Cohort 2: Diagnosis of systemic sclerosis (SSc), as defined using the American College of Rheumatology/European League against Rheumatism (EULAR) criteria.
Exclusion: Percentage of predicted FVC value showing improvement in the 6-month period prior to screening and including screening value, as assessed by the investigator; Receipt of nintedanib in combination with pirfenidone. Receipt of systemic (oral, IV, IM, or IA) corticosteroids equivalent to prednisone >10 mg/day or equivalent within 2 weeks prior to screening; History of lung transplant; 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 meters] above sea level) during screening; Inability to refrain from use of the following: – Short-acting bronchodilators within 4 hours before pulmonary function test (PFT), DLCO, and 6MWT assessments – Once-daily, long-acting bronchodilators within 24 hours before PFT, DLCO, and 6MWT assessments – Twice-daily, long-acting bronchodilators within 12 hours before PFT, DLCO, and 6MWT assessments.