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

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 18-006194
    NCT ID: NCT03538301
    Sponsor Protocol Number: ND-L02-s0201-005

About this study

This phase 2 clinical study will be a 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 idiopathic pulmonary fibrosis (IPF).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Tarik Haddad, M.D.

Open for enrollment

Contact information:

Judy Olmos R.N., C.C.R.C.

(904)953-7898

Olmos.Judy@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20446033

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