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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 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF

Nitto Denko Corporation

Shinagawa-Season-Terrace F26, 1-2-70 Konan, Minato-ku, Tokyo 108-0075, Japan

clinicaltrialinfo005@nitto.com

Nitto Denko Corporation

Shinagawa-Season-Terrace F26, 1-2-70 Konan, Minato-ku, Tokyo 108-0075, Japan

+81-3-6632-2101

communication_group@nitto.co.jp

completed

Feb. 13, 2020

Interventional

Multicenter, International, Double-Blind, Randomized

treatment purpose

2

- 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.

- 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.

Both

Idiopathic Pulmonary Fibrosis

investigational material(s)
Generic name etc : ND-L02-s0201 for Injection
INN of investigational material : -
Therapeutic category code : 229 Other agents affecting respiratory organs
Dosage and Administration for Investigational material : ND-L02-s0201 will be administered at 2 dose levels, Q2W for 24 weeks (a total of 12 doses).

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

1. Proportion of Participants Discontinuing Study Treatment Due to TEAEs [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

1. Rate of Decline in FVC and ppFVC [From Baseline to Week 24]
2. Absolute and Relative Change in FVC (L) and ppFVC (%) [From Baseline to Week 24]
3. Summary of Study Treatment Response of FVC [From Baseline to Visit 14 (Day 169)]
4. Summary of Study Treatment Response of ppFVC [From Baseline to Visit 14 (Day 169)]
5. Change in DLCO and DLCO Corrected for Hemoglobin [From Baseline to Week 24]
6. Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT [From Baseline to Week 24]
7. Qualitative Changes of Interstitial Lung Abnormalities as Measured by HRCT [From Baseline to Visit 14 (Day 169)]
8. Time to First IPF Exacerbation or Death and Rate of First IPF Exacerbation [From Baseline to Study Completion]
9. Time to Hospitalization for Respiratory Ailments or Death and Rate of Hospitalization for Respiratory Ailments [From Baseline to 12 weeks]
10. Overall Survival and Rate of Mortality Due to All Causes [From Baseline to End of Study]
11. Time to Deterioration of IPF Resulting in Lung Transplantation or Death and Rate of Deterioration of IPF Resulting in Lung Transplantation [From Baseline to 12 weeks after end of study treatment]

Dec. 11, 2019