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JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to visit 14 (day 169)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to visit 14 (day 169)
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 moreTrial 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