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

Recruiting at 35 trial locations

Overseen By Kathy Carr

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Nitto Denko Corporation

Must not be taking: High dose corticosteroids

Disqualifiers: Active smoker, Malignancy, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

123 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking high dose corticosteroids, cytotoxic agents, unapproved IPF targeted therapy, and cytokine modulating agents at least 8 weeks or 5 half-lives before screening. If you are on these medications, you will need to stop them before participating.

Is the treatment generally safe for humans?

The research articles discuss placebo treatments, which are often used as a control in clinical trials to compare against active treatments. Placebos are generally considered safe, but the articles highlight that they can sometimes cause reactions, which suggests that even inactive treatments can have side effects. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests a new drug called ND-L02-s0201 to see if it is safe and effective for people with Idiopathic Pulmonary Fibrosis (IPF). The study aims to find out if the drug can improve lung function and slow down lung damage.

Research Team

Nitto Denko Corporation

Principal Investigator

Nitto Denko Corporation

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 6 weeks

Treatment

Participants receive ND-L02-s0201 or placebo for 24 weeks, including 12 doses

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

Treatment Details

Interventions

• ND-L02-s0201
• Placebo

Participant Groups

Group I: Dose Level 2 Experimental Treatment 1 Intervention

ND-L02-s0201 90mg

Group II: Dose Level 1 Experimental Treatment 1 Intervention

ND-L02-s0201 45mg

Group III: Placebo Placebo Group 1 Intervention

Control Arm

Who Is Running the Clinical Trial?

Nitto Denko Corporation

Lead Sponsor

Trials

6

Recruited

550+

Findings from Research

The study systematically analyzed placebo effects from randomized, placebo-controlled trials, revealing that while placebos can influence clinical symptoms, they do not affect laboratory values like blood glucose in diabetics.

Placebo side effects were found to be similar to those of active treatments, highlighting the importance of careful placebo use in clinical research to ensure patient safety and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. Weihrauch, TR.[2019]

In a study involving 100 patients undergoing lumbar spine fusion surgeries, batroxobin and its combination with tranexamic acid significantly reduced both intraoperative and postoperative blood loss compared to a placebo.

The mean intraoperative blood loss was lowest in the batroxobin group (268.32 mL) and the combination group (256.96 mL), indicating their effectiveness, while no significant differences were found in blood transfusion needs or complications like deep vein thrombosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Batroxobin, Tranexamic Acid and a Combination in Reduction of Blood Loss in Lumbar Spinal Fusion Surgery. Nagabhushan, RM., Shetty, AP., Dumpa, SR., et al.[2021]

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

In a study involving 24 rabbits undergoing spine fusion, daily subcutaneous injections of abaloparatide resulted in a 100% fusion rate compared to only 45% in the control group, indicating its strong efficacy in promoting spinal fusion.

Radiographic analysis showed that abaloparatide significantly increased bone formation and quality, with higher bone volume and improved trabecular structure, suggesting it enhances the biological processes necessary for successful spinal fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abaloparatide Enhances Fusion and Bone Formation in a Rabbit Spinal Arthrodesis Model. Morse, KW., Moore, H., Kumagai, H., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Batroxobin, Tranexamic Acid and a Combination in Reduction of Blood Loss in Lumbar Spinal Fusion Surgery. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Abaloparatide Enhances Fusion and Bone Formation in a Rabbit Spinal Arthrodesis Model. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Placebo therapy of benign prostatic hyperplasia: a 25-month study. Canadian PROSPECT Study Group. [2019]