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

NCT03538301 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ND-L02-s0201-005
• Study Type: interventional
• Target: 123
• Locations: 4 countries
• Sites: 33

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Discontinuing Study Treatment Due to TEAEs

  The number of participants with TEAEs leading to discontinuation from the study treatment. The Safety Population (including all participants who received at least one dose of study treatment) is presented. TEAE = treatment-emergent adverse event

  Change in the incidence and severity of adverse events related to study treatment from baseline to 24 weeks

Secondary Outcomes (15)

• Rate of Decline in FVC From Baseline to Week 24

  Baseline to Week 24

• Rate of Decline in ppFVC From Baseline to Week 24

  Baseline to Week 24

• Absolute and Relative Change in FVC (L) From Baseline to Week 24

  Baseline to Week 24

• Percent Change in FVC From Baseline to Week 24

  Baseline to Week 24

• Absolute and Relative Change in ppFVC (%) From Baseline to Week 24

  Baseline to Week 24

Study Arms (3)

Dose Level 1

EXPERIMENTAL

ND-L02-s0201 45mg

Drug: ND-L02-s0201 (Low Dose)

Dose Level 2

EXPERIMENTAL

ND-L02-s0201 90mg

Drug: ND-L02-s0201 (High Dose)

Placebo

PLACEBO COMPARATOR

Control Arm

Other: Other: Placebo

Interventions

ND-L02-s0201 (Low Dose) DRUG

Intravenous administration every 2 weeks

Also known as: 45mg

Dose Level 1

ND-L02-s0201 (High Dose) DRUG

Intravenous administration every 2 weeks

Also known as: 90mg

Dose Level 2

Other: Placebo OTHER

Saline

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nitto Denko Corporation: lead

Study Sites (33)

Banner-University Medical Center Tucson Campus

Tucson, Arizona, 85724-0001, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Amicis Research Center

Northridge, California, 91324, United States

Location

University of California, San Francisco, Medical Center at Parnassus

San Francisco, California, 94143, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Central Florida Pulmonary Group, PA

Orlando, Florida, 32803, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

OSF HealthCare Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Norton Clinical Research Group

Louisville, Kentucky, 40218, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Minnesota Medical School

Minneapolis, Minnesota, 55455, United States

Location

Dartmouth-Hitchcock Medical Center (DHMC)

Lebanon, New Hampshire, 03756, United States

Location

Duke University Hospital

Durham, North Carolina, 27708, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

UT Health San Antonio: First Outpatient Research Unit

San Antonio, Texas, 78229, United States

Location

University of Utah Health

Salt Lake City, Utah, 84108, United States

Location

University of Washington

Seattle, Washington, 98195-0001, United States

Location

Universitatsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Thoraxklinik-Heidelberg gGmbH

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Justus-Liebig-Universitaet Giessen

Giessen, Hesse, 35392, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, Hesse, 34376, Germany

Location

Medizinische Hochschule Hannover (MHH)

Hanover, Lower Saxony, 30625, Germany

Location

Ruhrlandklinik, Universitatmedzin Essen

Essen, North Rhine-Westphalia, NRW 45239, Germany

Location

National Hospital Organization Himeji Medical Center

Himeji-Shi, Hyōgo, 670-8520, Japan

Location

National Hospital Organization Ibarakihigashi National Hospital

Naka-gun, Ibaraki, 319-1113, Japan

Location

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, 236-0051, Japan

Location

National Hospital Organization Kinki-chuo Chest Medical Center

Osaka, Sakai-shi, 5918555, Japan

Location

Tosei General Hospital

Aichi, Seto-shi, 489-8642, Japan

Location

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Nitto Denko Corporation Study Director
• Organization: Nitto Denko Corporation

clinicaltrialinfo005@nitto.com

858-255-3010

Study Officials

• Nitto Denko Corporation

  Nitto Denko Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 29, 2018
• Study Start: June 18, 2018
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: December 11, 2023
• Results First Posted: December 11, 2023

Record last verified: 2023-11

Locations

JP (5); GB (1); US (21); DE (6)