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Evaluation of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF) - WISPer Trial

Clinical Trial | Research | Study | Pulmonary Disorders

This study is open to adults aged 40 and older who have idiopathic pulmonary fibrosis (IPF). The goal is to determine if a medicine called MTX-463 can benefit people with IPF.

The study involves 8 visits over a period of up to 32 weeks. Participants will be randomly assigned to receive either the study drug (MTX-463) or placebo through intravenous (IV) infusion. The placebo will look like MTX-463 but will contain no active medicine. There will be a 4 week screening period, a 24 week treatment period, and a 4 week safety follow-up period. Participants will receive 6 infusions throughout the treatment period, one infusion every 4 weeks.

At each visit, the study team will perform regular lung function tests to assess your breathing. These tests will be used to compare results between those taking MTX-463 and the placebo. The study will also monitor your overall health and document any side effects.

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Participation Requirements

  • Sex:

    Male, Female, Intersex

  • Eligible Ages:

    40 and up

Participation Criteria

Inclusion Criteria:
You may be eligible to participate if you:
1. Are 40 years old or older at the time of signed informed consent
2. Have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
3. Are on stable treatment with nintedanib or pirfenidone for at least 90 days OR not on treatment with nintedanib or pirfenidone for at least 30 days
Exclusion Criteria:
You may not be eligible to participate if you:
1. Are under the age of 40 years old
2. Have an acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) within 6 months prior to Screening
3. Are a current smoker/vaper

Study Location

University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contact Study Team

Study Sponsored By
University of Calgary
Participants Required
More Information
Study ID: REB25-1369