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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

Sponsor
Nitto Denko Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03538301
Collaborator
(none)
120
Enrollment
33
Locations
3
Arms
50.5
Anticipated Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jun 18, 2018
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ND-L02-s0201 (Dose Level 1)

Drug: ND-L02-s0201
Intravenous administration every 2 weeks
Experimental: ND-L02-s0201 (Dose Level 2)

Drug: ND-L02-s0201
Intravenous administration every 2 weeks
Placebo Comparator: Placebo

Other: Other: Placebo
Saline

Outcome Measures

Primary Outcome Measures

  1. Number of patients with treatment-related adverse events as assessed by CTCAE v5.0 [Change in the incidence and severity of adverse events related to study treatment from baseline to 24 weeks]

Secondary Outcome Measures

  1. Evaluate the biological activity of ND-L02-s0201 as measured by spirometry [Baseline vs. 24 weeks]

  2. Evaluate changes of interstitial lung abnormalities as measured by HRCT [Baseline vs. 24 weeks]

  3. Evaluate maximum plasma concentration (Cmax) [Over 24 weeks]

  4. Evaluate time to maximum plasma concentration (Tmax) [Over 24 weeks]

  5. Evaluate area under the plasma concentration-time curve (AUC) [Over 24 weeks]

  6. Evaluate area under the first moment of the plasma concentration-time curve (AUMC) [Over 24 weeks]

  7. Evaluate total plasma clearance of drug (CL) [Over 24 weeks]

  8. Evaluate apparent terminal elimination rate constant (Kel) [Over 24 weeks]

  9. Evaluate volume of distribution at steady state (Vss) [Over 24 weeks]

  10. Evaluate volume of distribution during the elimination phase (Vz) [Over 24 weeks]

  11. Evaluate apparent terminal elimination half-life (T1/2) [Over 24 weeks]

  12. Evaluate trough plasma concentration (Ctrough) [Over 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banner-University Medical Center Tucson Camppus Tucson Arizona United States 85724-0001
2 Cedars-Sinai Medical Center Los Angeles California United States 90048
3 Amicis Research Center Northridge California United States 91324
4 University of California, San Francisco, Medical Center at Parnassus San Francisco California United States 94143
5 Mayo Clinic Florida Jacksonville Florida United States 32224
6 Central Florida Pulmonary Group, PA Orlando Florida United States 32803
7 Emory University Atlanta Georgia United States 30322
8 Loyola University Medical Center Maywood Illinois United States 60153
9 OSF HealthCare Saint Francis Medical Center Peoria Illinois United States 61637
10 Norton Clinical Research Group Louisville Kentucky United States 40218
11 Massachusetts General Hospital Boston Massachusetts United States 02114
12 University of Minnesota Medical School Minneapolis Minnesota United States 55455
13 Dartmouth-Hitchcock Medical Center (DHMC) Lebanon New Hampshire United States 03756
14 Duke University Hospital Durham North Carolina United States 27708
15 Penn State Hershey Medical Center Hershey Pennsylvania United States 17033
16 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
17 Medical University of South Carolina Charleston South Carolina United States 29425
18 UT Southwestern Medical Center Dallas Texas United States 75390
19 UT Health San Antonio: First Outpatient Research Unit San Antonio Texas United States 78229
20 University of Utah Health Salt Lake City Utah United States 84108
21 University of Washington Seattle Washington United States 98195-0001
22 Thoraxklinik-Heidelberg gGmbH Heidelberg Baden-Wuerttemberg Germany 69126
23 Universitatsklinikum Freiburg Freiburg Baden-Württemberg Germany 79106
24 Justus-Liebig-Universitaet Giessen Giessen Hessen Germany 35392
25 Lungenfachklinik Immenhausen Immenhausen Hesse Germany 34376
26 Medizinische Hochschule Hannover (MHH) Hannover Lower Saxony Germany 30625
27 Ruhrlandklinik, Universitatmedzin Essen Essen North Rhine-Westphalia Germany NRW 45239
28 National Hospital Organization Himeji Medical Center Himeji-Shi Hyogo Japan 670-8520
29 National Hospital Organization Ibarakihigashi National Hospital Naka-gun Ibaraki Japan 319-1113
30 Kanagawa Cardiovascular and Respiratory Center Yokohama-shi Kanagawa Japan 236-0051
31 National Hospital Oganization Kinki-chuo Chest Medical Center Osaka Sakai-shi Japan 5918555
32 Tosei General Hospital Aichi Seto-shi Japan 489-8642
33 Royal Papworth Hospital NHS Foundation Trust Cambridge Cambridgeshire United Kingdom CB2 0AY

Sponsors and Collaborators

  • Nitto Denko Corporation

Investigators

  • Study Director: Nitto Denko Corporation, Nitto Denko Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nitto Denko Corporation
ClinicalTrials.gov Identifier:
NCT03538301
Other Study ID Numbers:
  • ND-L02-s0201-005
First Posted:
May 29, 2018
Last Update Posted:
Dec 3, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis

Study Results

No Results Posted as of Dec 3, 2021