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

Participants with IPF who meet the study's inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to receive MTX-463 or a matching placebo by intravenous (IV) infusion. Concomitant use of one of the approved IPF therapies, pifenidone or nintedanib, is permitted, and it is expected that about half the study population will be on one of those medications. Participants randomized to the MTX-463 arm of the study will receive an IV infusion every 4 weeks, beginning at Day 0 and ending at Week 20. The End of Treatment Visit will occur at Week 24, 4 weeks after the final infusion; and a final Safety Follow-Up Visit will occur at Week 28, 8 weeks after the final infusion. Assessments of FVC will occur at Screening, Baseline, and at all subsequent treatment visits up to and including Week 24. L-PF assessments will be performed at Baseline and Week 24. Participants will have blood drawn for safety assessment and to assess WISP1 levels at Baseline and every 4 weeks throughout the study. Blood will be drawn for serum PK analyses relative to the first and last doses of MTX-463.

Primary Outcome Measures

1. To assess the effect of MTX-463 on the change from Baseline in forced vital capacity (FVC)
   Change from Baseline to Week 24 in Forced Vital Capacity (FVC)

Secondary Outcome Measures

1. To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment emergent adverse events
   Incidence of treatment-emergent adverse events (TEAEs) from Baseline until Week 28 in each group
2. To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment related adverse events
   Incidence of treatment related adverse events from baseline until Week 28 in each group
3. To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of serious treatment emergent adverse events
   Incidence of serious treatment emergent adverse events from baseline until Week 28 in each group
4. To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of severe treatment emergent adverse events
   Incidence of severe treatment emergent adverse events from Baseline until week 28 in each group
5. To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment emergent abnormalities on clinical laboratory tests
   Incidence of treatment emergent abnormalities on clinical laboratory tests from baseline until Week 28 in each group
6. To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of abnormal findings on physical exam
   Incidence of abnormal findings on physical exam from baseline until Week 28 in each group
7. To assess the safety and tolerability of MTX-463 in participants with IPF, as measured by incidence of treatment discontinuations
   Incidence of treatment discontinuations from baseline until Week 28 in each group
8. To assess the effect of MTX-463 on the change from Baseline in the percent predicted FCV (FVCpp)
   Change from Baseline to Week 24 in the percent predicted FVC (FVCpp)
9. To collect sparse pharmacokinetics (PK) of MTX-463 in participants with IPF
   Samples will be collected from baseline until Week 24 to assess the trough serum concentrations of the study drug