MTX-463 for Pulmonary Fibrosis

Recruiting at 3 trial locations

Overseen By Jeffrey Bornstein, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mediar Therapeutics

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Pulmonary hypertension, Smoking, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 20 weeks

164 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Pablo Zertuche, MD

Principal Investigator

Mediar Therapeutics

Eligibility Criteria

This trial is for individuals with Idiopathic Pulmonary Fibrosis (IPF), a type of lung scarring. Participants should meet specific health criteria, but the provided information does not detail these requirements.

Inclusion Criteria

I am 40 or older with idiopathic pulmonary fibrosis.

Able to understand the study and provide signed, written informed consent

DLCO of ≥ 25pp at screening

Exclusion Criteria

I don't have any health issues that could affect my study participation.

I have not had a lung infection or taken antibiotics for one in the last 30 days.

I do not have hepatitis B, C, or HIV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive MTX-463 or placebo by IV infusion every 4 weeks, starting at Day 0 and ending at Week 20

20 weeks

5 visits (in-person)

End of Treatment

End of Treatment Visit occurs 4 weeks after the final infusion

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a final Safety Follow-Up Visit at Week 28

8 weeks

1 visit (in-person)

Treatment Details

Interventions

• MTX-463

Trial Overview The study tests MTX-463 against a placebo in people with IPF. It's a Phase 2a trial, meaning it focuses on the drug's effectiveness and safety. The process is double-blind, so neither participants nor researchers know who receives the actual drug or placebo.

Participant Groups

Group I: MTX-463 Experimental Treatment 1 Intervention

MTX-463

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Mediar Therapeutics

Lead Sponsor

Trials

2

Recruited

140+