WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
ConditionIdiopathic Pulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorMediar Therapeutics
About this trial
A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)
Eligibility criteria
Qualifiers
Participants with IPF of any gender ≥ 40 years of age at time of signing the informed consent.
Able to understand the study and provide signed, written informed consent.
Able to read and understand the language of the informed consent and other study-related materials.
Meet the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association (ATS/ERS/JRS/ALAT) 2019 criteria for the diagnosis of IPF; Diagnosed with IPF within 7 years of screening.
Disqualifiers
Acute exacerbation of IPF within 6 months of Screening or during the Screening Period.
Forced expiratory volume in 1 second (FEV1)/FVC ratio of <0.7 at Screening.
Requirement for continuous supplemental oxygen. Intermittent supplemental oxygen use (e.g., during exercise or sleep) is permitted.
Expected to receive a lung transplant within the study duration.
Trial design
Treatments tested in this trial
- MTX-463
- Placebo
Treatment groups
164 Participants
are divided into 2 treatment groupsLocations
69Argentina
WISPer Site in Buenos Aires, ArgentinaB1602DQD, Buenos Aires Argentina
WISPer Site in Cordoba, ArgentinaX5003DCE, Córdoba Argentina
WISPer Site in Mendoza, ArgentinaM5500, Mendoza Argentina
WISPer Site in Rosario, ArgentinaS2000DBS, Rosario Argentina
Sponsors and collaborators
Mediar Therapeutics
Lead sponsor
Source ClinicalTrials.gov