CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
ND-L02-s0201 (Low Dose) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03538301
NCT03538301Phase 2Completed

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)

Nitto Denko Corporation·interventional·Posted May 29, 2018·Updated Dec 11, 2023

In Brief

A Phase 2 clinical trial evaluating ND-L02-s0201 (Low Dose), ND-L02-s0201 (High Dose), and 1 other intervention for Idiopathic Pulmonary Fibrosis. Completed, enrolled 123 participants across 33 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Japan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 29, 2018
Enrollment StartJun 18, 2018
Primary CompletionAug 24, 2022
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 8.1 years ago

Interventions

ND-L02-s0201 (Low Dose)drug

Intravenous administration every 2 weeks

ND-L02-s0201 (High Dose)drug

Intravenous administration every 2 weeks

Other: Placeboother

Saline