Clinical trial NCT03538301: JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Nitto Denko Corporation
Sponsor class: INDUSTRY
First posted: 2018-05-29
Enrollment: 123
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Forced vital capacity (FVC) ≥ 45% of predicted.
* Diffusion capacity of the lung for carbon monoxide (DLco) corrected for hemoglobin ≥ 30% of predicted value
* Ratio of forced expiratory volume in 1 second (FEV1) to FVC ≥ 0.70.

Exclusion Criteria:

* Best, acceptable FVC from separate screening spirometry that differ by ≥ 200 mL.
* Respiratory exacerbation(s) or hospitalization for IPF exacerbation within 3 months before screening.
* Anticipated to receive a lung transplant during the subject's participation in the study.
* Active smoker or smoking cessation within 12 weeks before screening.
* Malignancy within the last 5 years, with the exception of curable cancer that has received adequate treatment.
* Evidence of any unstable or untreated, clinically significant disease or condition that, in the opinion of the Investigator, might confound the interpretation of the study or place the subject at increased risk.
* Treatment with high dose corticosteroids, cytotoxic agents, unapproved IPF targeted therapy, and cytokine modulating agents within 8 weeks or 5 half-lives (whichever is longer) before screening
* Participation in an investigational study with the last dose of investigational product occurring within 8 weeks or 5 half-lives (whichever is longer) before screening.
* Pregnant or breastfeeding.
* Medical history of infection with HIV, hepatitis B, or hepatitis C.
* History of alcohol abuse and/or dependence within the last 2 years.
* History within the last 2 years of significant mental illness, or physical dependence on any opioid or illicit drugs.

Other protocol defined inclusion/exclusion criteria could apply.

Primary outcomes:
measure: Number of Participants Discontinuing Study Treatment Due to TEAEs
timeFrame: Change in the incidence and severity of adverse events related to study treatment from baseline to 24 weeks
Secondary outcomes:
measure: Rate of Decline in FVC From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Rate of Decline in ppFVC From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Absolute and Relative Change in FVC (L) From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Percent Change in FVC From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Absolute and Relative Change in ppFVC (%) From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Percent Change in ppFVC From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Summary of Study Treatment Response of FVC
timeFrame: Baseline to Visit 14 (Day 169)
measure: Summary of Study Treatment Response of ppFVC
timeFrame: Baseline to Visit 14 (Day 169)
measure: Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT
timeFrame: Baseline to Week 24
measure: Qualitative Changes of Interstitial Lung Abnormalities as Measured by HRCT
timeFrame: Baseline to Visit 14 (Day 169)
measure: Events of IPF Exacerbation or Death and Rate of First IPF Exacerbation
timeFrame: Baseline to study completion, up to Day 239
measure: Events of Hospitalization for Respiratory Ailments or Death
timeFrame: up to 12 weeks after the end of study treatment
measure: Total Events of Death Due to All Causes
timeFrame: up to 12 weeks after the end of study treatment
measure: Events of Deterioration of IPF Resulting in Lung Transplantation or Death and Rate of Deterioration of IPF Resulting in Lung Transplantation
timeFrame: Baseline to 12 weeks after end of study treatment
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner-University Medical Center Tucson Campus
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Northridge
country: United States
facility: Amicis Research Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco, Medical Center at Parnassus
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, PA
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Peoria
country: United States
facility: OSF HealthCare Saint Francis Medical Center
state: Illinois
city: Louisville
country: United States
facility: Norton Clinical Research Group
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Medical School
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center (DHMC)
state: New Hampshire
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio: First Outpatient Research Unit
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH
state: Baden-Wuerttemberg
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
state: Baden-Württemberg
city: Giessen
country: Germany
facility: Justus-Liebig-Universitaet Giessen
state: Hessen
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
state: Hesse
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
state: Lower Saxony
city: Essen
country: Germany
facility: Ruhrlandklinik, Universitatmedzin Essen
state: North Rhine-Westphalia
city: Himeji-Shi
country: Japan
facility: National Hospital Organization Himeji Medical Center
state: Hyogo
city: Naka-gun
country: Japan
facility: National Hospital Organization Ibarakihigashi National Hospital
state: Ibaraki
city: Yokohama-shi
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
state: Kanagawa
city: Osaka
country: Japan
facility: National Hospital Organization Kinki-chuo Chest Medical Center
state: Sakai-shi
city: Aichi
country: Japan
facility: Tosei General Hospital
state: Seto-shi
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: Nitto Denko Corporation
name: Nitto Denko Corporation
role: STUDY_DIRECTOR
References: