Deupirfenidone for Idiopathic Pulmonary Fibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Idiopathic Pulmonary FibrosisDeupirfenidone - Drug
Eligibility
40 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, LYT-100, to see if it is better than or as good as the current best treatment for idiopathic pulmonary fibrosis, pirfenidone, or if it is no better than a placebo.

Eligible Conditions
  • Idiopathic Pulmonary Fibrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 26 weeks

26 weeks
Rate of decline in Forced Vital Capacity over 26 weeks
Time to IPF progression
Time to hospitalization or mortality
Baseline to Week 26
FVC percent predicted change
FVC% predicted change

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

pirfenidone 801 mg TID
1 of 4
LYT-100 550 mg TID
1 of 4
LYT-100 825 mg TID
1 of 4
Placebo
1 of 4

Active Control

Experimental Treatment

Non-Treatment Group

240 Total Participants · 4 Treatment Groups

Primary Treatment: Deupirfenidone · Has Placebo Group · Phase 2

LYT-100 550 mg TID
Drug
Experimental Group · 1 Intervention: Deupirfenidone · Intervention Types: Drug
LYT-100 825 mg TID
Drug
Experimental Group · 1 Intervention: Deupirfenidone · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
pirfenidone 801 mg TID
Drug
ActiveComparator Group · 1 Intervention: Pirfenidone · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 26 weeks

Who is running the clinical trial?

PureTechLead Sponsor
4 Previous Clinical Trials
405 Total Patients Enrolled
Heather PadenStudy DirectorPureTech
Simon J Hatch, MDStudy DirectorPureTech

Eligibility Criteria

Age 40 - 80 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are either a treatment-naïve individual with Interstitial Pulmonary Fibrosis (IPF) as diagnosed according to the ATS/ERS/JRS/ALAT 2018 guidelines, or someone who has been exposed to nintedanib for less than 6 months.
You have Idiopathic Pulmonary Fibrosis on HRCT, as verified by a central reading within the last 12 months.
Your DLCO corrected for Hemoglobin is between 30% and 90% of the predicted normal range.
Your Forced Vital Capacity is at least 45% of the expected normal value.