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Unknown

Dose Level 1 for Idiopathic Pulmonary Fibrosis

Phase 2
Waitlist Available
Research Sponsored by Nitto Denko Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to visit 14 (day 169)

Summary

This trial tests a new drug called ND-L02-s0201 to see if it is safe and effective for people with Idiopathic Pulmonary Fibrosis (IPF). The study aims to find out if the drug can improve lung function and slow down lung damage.

Eligible Conditions
  • Idiopathic Pulmonary Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to visit 14 (day 169)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to visit 14 (day 169) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Discontinuing Study Treatment Due to TEAEs
Secondary study objectives
Absolute and Relative Change in FVC (L) From Baseline to Week 24
Absolute and Relative Change in ppFVC (%) From Baseline to Week 24
Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24
+12 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose Level 2Experimental Treatment1 Intervention
ND-L02-s0201 90mg
Group II: Dose Level 1Experimental Treatment1 Intervention
ND-L02-s0201 45mg
Group III: PlaceboPlacebo Group1 Intervention
Control Arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ND-L02-s0201 (High Dose)
2018
Completed Phase 2
~130
ND-L02-s0201 (Low Dose)
2018
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Nitto Denko CorporationLead Sponsor
5 Previous Clinical Trials
423 Total Patients Enrolled
~17 spots leftby Nov 2025
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