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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521278-32-00

Acronym

MTX-463-I201

Enrollment

Registered

2025-10-01

Start date

2025-12-04

Completion date

Unknown

Last updated

2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Brief summary

Change from Baseline to Week 24 in FVC

Detailed description

Incidence, seriousness, and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs); and incidence of dose interruptions and discontinuations • Clinically significant findings on physical examinations, vital signs, and clinical laboratory tests, Change from Baseline to Week 24 in the FVCpp, Sparse PK profiles will be evaluated by population PK analyses

Interventions

DRUGDEXTROSE/VIOSER 5% w/v Solution for Infusion

DRUGNaCl 0

DRUG9 % B. Braun

DRUGsolution pour perfusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from Baseline to Week 24 in FVC	—

Secondary

Measure	Time frame
Incidence, seriousness, and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs); and incidence of dose interruptions and discontinuations • Clinically significant findings on physical examinations, vital signs, and clinical laboratory tests, Change from Baseline to Week 24 in the FVCpp, Sparse PK profiles will be evaluated by population PK analyses	—

Countries

Belgium, Croatia, France, Ireland, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026