Idiopathic Pulmonary FibrosisPhase 2NCT03538301
JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
A Phase 2 study testing ND-L02-s0201 (Low Dose) and ND-L02-s0201 (High Dose) in people with Idiopathic Pulmonary Fibrosis, run by Nitto Denko Corporation at 33 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- ND-L02-s0201 (Low Dose) and ND-L02-s0201 (High Dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 33 sitesin 4 countries
- Study dates
- 18 Jun 2018to 24 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
33 sites in 4 countries.
33 sites in 4 countries
United States21 sites
Emory University
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
UT Southwestern Medical Center
Dallas, Texas, 75390
Duke University Hospital
Durham, North Carolina, 27708
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Mayo Clinic Florida
Jacksonville, Florida, 32224
Dartmouth-Hitchcock Medical Center (DHMC)
Lebanon, New Hampshire, 03756
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Norton Clinical Research Group
Louisville, Kentucky, 40218
Loyola University Medical Center
Maywood, Illinois, 60153
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
Amicis Research Center
Northridge, California, 91324
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803
OSF HealthCare Saint Francis Medical Center
Peoria, Illinois, 61637
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Utah Health
Salt Lake City, Utah, 84108
UT Health San Antonio: First Outpatient Research Unit
San Antonio, Texas, 78229
University of California, San Francisco, Medical Center at Parnassus
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98195-0001
Banner-University Medical Center Tucson Campus
Tucson, Arizona, 85724-0001
Germany6 sites
Ruhrlandklinik, Universitatmedzin Essen
Essen, North Rhine-Westphalia, NRW 45239
Universitatsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Justus-Liebig-Universitaet Giessen
Giessen, Hesse, 35392
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, 30625
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, 69126
Lungenfachklinik Immenhausen
Immenhausen, Hesse, 34376
Japan5 sites
Tosei General Hospital
Aichi, Seto-shi, 489-8642
National Hospital Organization Himeji Medical Center
Himeji-Shi, Hyōgo, 670-8520
National Hospital Organization Ibarakihigashi National Hospital
Naka-gun, Ibaraki, 319-1113
National Hospital Organization Kinki-chuo Chest Medical Center
Osaka, Sakai-shi, 5918555
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, 236-0051
United Kingdom1 site
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0AY
About this study
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)
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.
Read the 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
- Being tested
- ND-L02-s0201 (Low Dose), ND-L02-s0201 (High Dose), Other: Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ND-L02-s0201 (Low Dose)Drug
Also called 45mg
Intravenous administration every 2 weeks
ND-L02-s0201 (High Dose)Drug
Also called 90mg
Intravenous administration every 2 weeks
Other: PlaceboOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | ND-L02-s0201 45mg Receives: Drug: ND-L02-s0201 (Low Dose) |
| Dose Level 2 | Experimental | ND-L02-s0201 90mg Receives: Drug: ND-L02-s0201 (High Dose) |
| Placebo | Placebo comparator | Control Arm Receives: Other: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Slope in FVC from Baseline to Week 24 (measured in L/week). The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.
Slope and standard error are presented. The slope is approximated as least square mean/24 weeks.
FVC = forced vital capacity
Measured: Baseline to Week 24
Rate of Decline in ppFVC From Baseline to Week 24
Slope in ppFVC from Baseline to Week 24 (measured in %/week). The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.
Slope and standard error are presented. The slope is approximated as least square mean/24 weeks.
ppFVC = percent predicted forced vital capacity
Measured: Baseline to Week 24
Absolute and Relative Change in FVC (L) From Baseline to Week 24
Absolute and Relative Change in FVC (L) from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.
FVC = forced vital capacity
Measured: Baseline to Week 24
Percent Change in FVC From Baseline to Week 24
Percent Change in FVC from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.
FVC = forced vital capacity
Measured: Baseline to Week 24
Absolute and Relative Change in ppFVC (%) From Baseline to Week 24
Absolute and Relative Change in ppFVC (%) from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.
ppFVC = percent predicted forced vital capacity
Measured: Baseline to Week 24
Percent Change in ppFVC From Baseline to Week 24
Percent Change in ppFVC from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.
ppFVC = percent predicted forced vital capacity
Measured: Baseline to Week 24
Summary of Study Treatment Response of FVC
Proportion of participants with an FVC response defined as either having improvement or a decline by 0 to less than or equal to 5%, more than 5% to less than or equal to 10%, and more than 10% at Visit 14 (Day 169).
Participants with an FVC response were defined as improvement in FVC (ie, FVC value higher than baseline) or a decline of less than or equal to 10% from baseline.
The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.
FVC = forced vital capacity
Measured: Baseline to Visit 14 (Day 169)
Summary of Study Treatment Response of ppFVC
Proportion of participants with an ppFVC response defined as either having improvement or a decline by 0 to less than or equal to 5%, greater than 5% to less than or equal to 10%, and greater than 10% at Visit 14 (Day 169).
Participants with an ppFVC response were defined as improvement in ppFVC (ie, ppFVC value higher than baseline) or a decline of less than or equal to 10% from baseline.
The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.
ppFVC = percent predicted forced vital capacity
Measured: Baseline to Visit 14 (Day 169)
Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24
Change in diffusion capacity of the lung for carbon monoxide (DLCO) and DLCO corrected for hemoglobin (mL/min/mmHg) from Baseline to Week 24.
The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.
Measured: Baseline to Week 24
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT
Changes of interstitial lung abnormalities as measured by high-resolution computed tomography (HRCT; ie, change in parenchymal feature [Baseline to Week 24]), as determined by qualitative assessment (central radiologist) and quantitative analysis (Quantitative Lung Fibrosis - QLF analysis).
Quantitative HRCT parameters included the following:
- Quantitative Lung Fibrosis (QLF) score (% of whole lung field volume)
- Ground glass opacity (GGO) (% of whole lung field volume)
- Reticulation (% of whole lung field volume)
- Honeycombing (% of whole lung field volume)
- Normal lung (% of whole lung field volume)
- Emphysema (low attenuation area [LAA]; % of whole lung field volume)
The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.
Measured: Baseline to Week 24
Qualitative Changes of Interstitial Lung Abnormalities as Measured by HRCT
Changes of interstitial lung abnormalities as measured by high-resolution computed tomography (HRCT; ie, change in parenchymal feature [Baseline to Visit 14 (Day 169)]), as determined by qualitative assessment (central radiologist). The Likert scale values are included in the descriptions presented.
The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) with HRCT assessment at Visit 14/Early Termination is presented.
Measured: Baseline to Visit 14 (Day 169)
Events of IPF Exacerbation or Death and Rate of First IPF Exacerbation
Total number of events of participants who experienced idiopathic pulmonary fibrosis (IPF) exacerbation (ie, an unexplained worsening of dyspnea, evidence of hypoxemia as defined by worsened or severely impaired gas exchange, new radiographic alveolar infiltrates, and an absence of an alternative explanation such as infection, pulmonary embolism, pneumothorax, or heart failure) or death (weeks).
Measured: Baseline to study completion, up to Day 239
Events of Hospitalization for Respiratory Ailments or Death
Events (participants who experienced hospitalization for respiratory ailments or died) for respiratory ailments are presented.
The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.
Measured: up to 12 weeks after the end of study treatment
Total Events of Death Due to All Causes
Rate of mortality due to all causes is presented. Overall survival was defined as the time from start of study treatment to death due to any cause.
Measured: up to 12 weeks after the end of study treatment
Events of Deterioration of IPF Resulting in Lung Transplantation or Death and Rate of Deterioration of IPF Resulting in Lung Transplantation
Events of deterioration of Idiopathic Pulmonary Fibrosis (IPF) resulting in lung transplantation (LP; up to 12 weeks after the end of study treatment) or death (weeks) and rate of deterioration of IPF resulting in lung transplantation (up to 12 weeks after the end of study treatment) are presented.
Total events = Participants who experience deterioration of IPF resulting in LP (or died).
Rate of Deterioration = Rate of Deterioration of IPF Resulting in LP.
Measured: Baseline to 12 weeks after end of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start18 Jun 2018
- Primary completion24 Aug 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nitto Denko Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nitto Denko Corporation, Study director, Nitto Denko Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538301
- Sponsor's protocol ID
- ND-L02-s0201-005
- Status last verified
- Nov 2023
- First submitted
- 2 May 2018
- Last updated
- 11 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03538301
- Acronym / sponsor ID
- ND-L02-s0201-005
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Nitto Denko CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Posted 11 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: ND-L02-s0201 (Low Dose)ND-L02-s0201 45mg |
| Dose Level 2 | Experimental | Drug: ND-L02-s0201 (High Dose)ND-L02-s0201 90mg |
| Placebo | Placebo comparator | Other: Other: PlaceboControl Arm |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ND-L02-s0201 (Low Dose)Also: 45mgIntravenous administration every 2 weeks | Drug | Dose Level 1 |
| ND-L02-s0201 (High Dose)Also: 90mgIntravenous administration every 2 weeks | Drug | Dose Level 2 |
| Other: PlaceboSaline | Other | Placebo |
Primary outcome
Number of Participants Discontinuing Study Treatment Due to TEAEs
Time frame: Change in the incidence and severity of adverse events related to study treatment from baseline to 24 weeks
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
15 secondary outcomes
Rate of Decline in FVC From Baseline to Week 24
Time frame: Baseline to Week 24
Rate of Decline in ppFVC From Baseline to Week 24
Time frame: Baseline to Week 24
Absolute and Relative Change in FVC (L) From Baseline to Week 24
Time frame: Baseline to Week 24
Percent Change in FVC From Baseline to Week 24
Time frame: Baseline to Week 24
Absolute and Relative Change in ppFVC (%) From Baseline to Week 24
Time frame: Baseline to Week 24
Percent Change in ppFVC From Baseline to Week 24
Time frame: Baseline to Week 24
Summary of Study Treatment Response of FVC
Time frame: Baseline to Visit 14 (Day 169)
Summary of Study Treatment Response of ppFVC
Time frame: Baseline to Visit 14 (Day 169)
Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24
Time frame: Baseline to Week 24
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT
Time frame: Baseline to Week 24
Qualitative Changes of Interstitial Lung Abnormalities as Measured by HRCT
Time frame: Baseline to Visit 14 (Day 169)
Events of IPF Exacerbation or Death and Rate of First IPF Exacerbation
Time frame: Baseline to study completion, up to Day 239
Events of Hospitalization for Respiratory Ailments or Death
Time frame: up to 12 weeks after the end of study treatment
Total Events of Death Due to All Causes
Time frame: up to 12 weeks after the end of study treatment
Events of Deterioration of IPF Resulting in Lung Transplantation or Death and Rate of Deterioration of IPF Resulting in Lung Transplantation
Time frame: Baseline to 12 weeks after end of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitto Denko Corporation study director
Nitto Denko Corporation
33 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ND-L02-s0201 (Low Dose) and ND-L02-s0201 (High Dose) in people with Idiopathic Pulmonary Fibrosis, run by Nitto Denko Corporation at 33 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Germany, Japan, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Discontinuing Study Treatment Due to TEAEs (time frame: Change in the incidence and severity of adverse events related to study treatment from baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.