A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
164
MTX-463 is an immunoglobin G1 (IgG1) monoclonal antibody directed against WNT-inducible signaling pathway protein 1 (WISP1). WISP1 (aka CCN-4) is a matricellular protein that appears to be upregulated locally in response to certain chronic diseases, including IPF, and malignancies.
Placebo
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)
Time frame: 24 Weeks
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
Time frame: 28 Weeks
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
Time frame: 28 Weeks
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
Time frame: 28 Weeks
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
Time frame: 28 Weeks
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
Time frame: 28 Weeks
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WISPer Site in Birmingham, AL
Birmingham, Alabama, United States
RECRUITINGWISPer site in Phoenix, AZ
Phoenix, Arizona, United States
RECRUITINGWISPer Site in Los Angeles, CA
Los Angeles, California, United States
RECRUITINGWISPer site in Newport Beach, CA
Newport Beach, California, United States
RECRUITINGWISPer Site in Palm Springs, CA
Palm Springs, California, United States
RECRUITINGWISPer Site in Denver, CO
Denver, Colorado, United States
RECRUITINGWISPer site in Loxahatchee, FL
Loxahatchee Groves, Florida, United States
RECRUITINGWISPer site in Champaign, IL
Champaign, Illinois, United States
RECRUITINGWISPer site in Kansas City, KS
Kansas City, Kansas, United States
RECRUITINGWISPer site in Shreveport, LA
Shreveport, Louisiana, United States
RECRUITING...and 34 more locations
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
Time frame: 28 Weeks
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
Time frame: 28 Weeks
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)
Time frame: 24 Weeks
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
Time frame: 24 Weeks