RecruitingIdiopathic Pulmonary Fibrosis

WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Eligible age

40+ yrs

Accepts

All genders

Locations

22 states

Healthy volunteers

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About this study

A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)

Sponsor: Mediar Therapeutics

You may qualify if…

✓ 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.
✓ If a participant is on treatment with pirfenidone, nintedanib, or nerandomilast, the dose of the medication must be stable for ≥ 90 days prior to Screening with plans to maintain the same dose throughout the study. Use of any of these 3 agents in combination with each other is not permitted.
✓ If a participant was on treatment with pirfenidone, nintedanib, or nerandomilast, and the agent has been discontinued, this must have occurred ≥ 30 days prior to Screening. At Screening, there must also be no plan to start either of these medications for the duration of the study. Participants newly diagnosed with IPF who, in the judgment of the treating physician, are considered in need of treatment with nintedanib, pirfenidone, or nerandomilast should not defer standard of care treatment and should be excluded from the study.
✓ FVC of ≥ 45 percent predicted (pp) at screening.
✓ DLCO of ≥ 25pp at screening.

You may not qualify if…

✕ 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.
✕ Current active bacterial infection or use of antibiotics for suspected lung infection in the 30 days prior to Screening.
✕ Planned surgery within the study duration.
✕ Clinically significant pulmonary hypertension.
✕ Use of immunosuppressive therapy (excluding corticosteroids). If previously on such agents, they should have been discontinued for at least 5 half-lives or 90 days, whichever is longer, prior to Screening.