NCT03538301

JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Nitto Denko Corporation · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.

Detailed description

All subjects were treated with ND-L02-s0201 or placebo for 24 weeks (a total of 12 doses). Subject's participation in the study was approximately 40 weeks including a Screening and Baseline period of up to 6 weeks, a treatment period of 24 weeks (including the 2 weeks after the last study treatment), and a follow-up period of 10 weeks after End-of-Treatment (EOT).

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	ND-L02-s0201 (Low Dose)	Intravenous administration every 2 weeks
DRUG	ND-L02-s0201 (High Dose)	Intravenous administration every 2 weeks
OTHER	Other: Placebo	Saline

Timeline

• Start date: 2018-06-18
• Primary completion: 2022-08-24
• Completion: 2022-08-24
• First posted: 2018-05-29
• Last updated: 2023-12-11
• Results posted: 2023-12-11

Locations

33 sites across 4 countries: United States, Germany, Japan, United Kingdom

Regulatory

• FDA-regulated drug study