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

Nitto Denko

Status and phase: Completed; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: ND-L02-s0201 (High Dose); Other: Other: Placebo; Drug: ND-L02-s0201 (Low Dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03538301

ND-L02-s0201-005

Details and patient eligibility

About

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.

Full 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).

Enrollment: 123 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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123 participants in 3 patient groups, including a placebo group

Dose Level 1

Experimental group

Description:

ND-L02-s0201 45mg

Treatment:

Drug: ND-L02-s0201 (Low Dose)

Dose Level 2

Experimental group

Description:

ND-L02-s0201 90mg

Treatment:

Drug: ND-L02-s0201 (High Dose)

Placebo

Placebo Comparator group

Description:

Control Arm

Treatment:

Other: Other: Placebo