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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
EU CTIS ID: 2022-502828-42-00
What this study is testing
To evaluate the efficacy of vixarelimab compared with placebo on lung function for each cohort
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Percentage of predicted FVC value showing improvement in the 6-month period prior to screening and including screening value, as assessed by the investigator
- 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
- History of lung transplant
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Mexico
- Canada
- Australia
- Taiwan
- Chile
- South Africa
- United States
- Argentina
- Brazil
- Israel
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Mexico; Canada; Australia; Taiwan; Chile and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.