Phase 2
Completed N=123
JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF
Source: ClinicalTrials.gov NCT03538301 ↗Enrolled (actual)
123
Serious AEs
15.5%
Results posted
Dec 2023
Primary outcomePrimary: Number of Participants Discontinuing Study Treatment Due to TEAEs — 1; 3; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Discontinuing Study Treatment Due to TEAEs |
1; 3; 4 | — |
| SECONDARY Rate of Decline in FVC From Baseline to Week 24 |
-0.003366; -0.007519; -0.005478 | 0.049 sig |
| SECONDARY Rate of Decline in ppFVC From Baseline to Week 24 |
-0.096455; -0.187694; -0.136051 | 0.098 |
| SECONDARY Absolute and Relative Change in FVC (L) From Baseline to Week 24 |
2.8754; 3.0242; 2.9032; 2.7946; 2.8438; 2.7717 | 0.049 sig |
| SECONDARY Percent Change in FVC From Baseline to Week 24 |
-3.10; -5.64; -4.23 | 0.668 |
| SECONDARY Absolute and Relative Change in ppFVC (%) From Baseline to Week 24 |
74.5701; 79.8896; 77.2260; 72.2552; 75.3849; 73.9607 | 0.098 |
| SECONDARY Percent Change in ppFVC From Baseline to Week 24 |
-3.10; -5.64; -4.23 | 0.700 |
| SECONDARY Summary of Study Treatment Response of FVC |
9; 7; 5; 10; 6; 10 | — |
| SECONDARY Summary of Study Treatment Response of ppFVC |
9; 7; 5; 10; 6; 10 | — |
| SECONDARY Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24 |
12.6709; 13.0723; 12.4800; 11.7541; 12.3015; 12.2669 | 0.708 |
| SECONDARY Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT |
33.59; 27.45; 27.22; 35.87; 29.24; 30.89 | 0.765 |
| SECONDARY Qualitative Changes of Interstitial Lung Abnormalities as Measured by HRCT |
0; 0; 0; 0; 0; 1 | 0.256 |
| SECONDARY Events of IPF Exacerbation or Death and Rate of First IPF Exacerbation |
7; 3; 4 | 0.517 |
| SECONDARY Events of Hospitalization for Respiratory Ailments or Death |
5; 3; 3 | 0.713 |
| SECONDARY Total Events of Death Due to All Causes |
1; 1; 0 | 0.937 |
| SECONDARY Events of Deterioration of IPF Resulting in Lung Transplantation or Death and Rate of Deterioration of IPF Resulting in Lung Transplantation |
3; 1; 0; 2; 0; 0 | 0.494 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03538301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.