Actively Recruiting
Phase 2 Study Testing MTX-463 Infusions for Safety and Effectiveness in Adults Aged 40 and Older with Idiopathic Pulmonary Fibrosis
Led by Mediar Therapeutics · Updated on 2026-08-10
164
Participants Needed
71
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
The trial investigates the safety and effects of MTX-463, an antibody targeting WISP1, in adults aged 40 or older with idiopathic pulmonary fibrosis IPF. This Phase 2a study compares MTX-463 to a placebo, allowing participants to continue approved IPF treatments like pirfenidone, nintedanib, or nerandomilast if stable. Participants must meet specific diagnostic criteria and lung function thresholds to join. Participants receive either MTX-463 or placebo through intravenous infusions every 4 weeks from Day 0 to Week 20. The treatment phase concludes with a visit at Week 24, followed by a safety follow-up at Week 28. Lung function tests including forced vital capacity FVC and lung fibrosis assessments are done at screening, baseline, and during treatment visits. Blood samples are collected regularly to monitor safety and drug levels. Throughout the study, participants attend visits every 4 weeks for assessments of lung function, safety labs, and WISP1 protein levels. The main outcome measures include changes in FVC after 24 weeks and safety profiles over 28 weeks. Participant involvement spans from screening through final safety follow-up, with careful monitoring to evaluate the study drugs impact and tolerability in IPF.
CONDITIONS
Brief Title
WISPer: Evaluation of MTX-463 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Research Team
J
Jeffrey Bornstein, MD
K
Katherine Palu
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