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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 December 2023
• Main ID: NCT03538301
• Date of registration: 02/05/2018
• Prospective Registration: Yes
• Primary sponsor: Nitto Denko Corporation
• Public title: JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
• Scientific 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)
• Date of first enrolment: June 18, 2018
• Target sample size: 123
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03538301
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Germany, Japan, United Kingdom, United States

Contacts

• Name: Nitto Denko Corporation
• Affiliation: Nitto Denko Corporation

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Other: Other: Placebo

Drug: ND-L02-s0201 (High Dose)

Drug: ND-L02-s0201 (Low Dose)

Primary Outcome(s)

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]

Secondary Outcome(s)

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)]

Absolute and Relative Change in FVC (L) From Baseline to Week 24 [Time Frame: Baseline to Week 24]

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]

Summary of Study Treatment Response of ppFVC [Time Frame: Baseline to Visit 14 (Day 169)]

Absolute and Relative Change in ppFVC (%) 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]

Summary of Study Treatment Response of FVC [Time Frame: Baseline to Visit 14 (Day 169)]

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]

Events of IPF Exacerbation or Death and Rate of First IPF Exacerbation [Time Frame: Baseline to study completion, up to Day 239]

Percent Change in FVC 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]

Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24 [Time Frame: Baseline to Week 24]

Rate of Decline in FVC From Baseline to Week 24 [Time Frame: Baseline to Week 24]

Secondary ID(s)

ND-L02-s0201-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/12/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03538301