Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease (ILD-DLCO)

Double-Blind, Placebo-Controlled Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

This is a randomized, placebo-controlled study of Trans Sodium Crocetinate (TSC) in patients with Interstitial Lung Disease (ILD), age 30-85 (inclusive). The primary objective of the study is to determine the effect of TSC on lung function as measured by diffusing capacity of the lungs for carbon monoxide (DLCO) in patients with ILD; the secondary objectives are to determine the effect of TSC on the 6-minute walk test (6MWT), heart rate recovery (HRR), and Borg Scale in patients with ILD.

Study Overview

• Status: Terminated
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Drug: Trans Sodium Crocetinate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Pulmonary Associates, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or Female, age 30 to 85 years at screening
2. Able to provide informed consent and agree to adhere to all study visits and requirements
3. Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug
4. Established diagnosis of ILD (clinical, radiographic, or histologic)
5. SpO2 ≥ 88% at rest by pulse oximetry while breathing ambient air
6. Free of any active cardiovascular or neuromuscular disease, at PI discretion
7. Clinically stable disease with no major medication changes in the last 4 weeks
8. Forced vital capacity (FVC) ≥ 45% of predicted (within past 6 months)
9. DLCO corrected for hemoglobin 30-90% of predicted, inclusive (within past 6 months)
10. Sars-CoV-2 negative at screening

Exclusion Criteria:

1. Known allergy to study medication
2. Pregnancy or lactation
3. Current smoker
4. Inability to perform pulmonary function testing
5. Active infection at screening or day of study visit
6. Known pulmonary hypertension (PH) requiring PH-specific treatment
7. AST/ALT ≥ 3x ULN and/or total bilirubin ≥ 2x ULN
8. Received any investigational medicine (IMP) within past 30 days
9. Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant.
10. Current alcohol or substance abuse
11. Known active or latent hepatitis B or C
12. History of end-stage liver or renal disease

13. Positive COVID test anytime within 3 months of screening. Note:

    Patients who were previously vaccinated for COVID are allowed

14. History of venous thromboembolic disease
15. History of acute or chronic ophthalmologic conditions currently requiring treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2.5 mg/kg Trans Sodium Crocetinate; Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC.	Drug: Trans Sodium Crocetinate; Single IV Bolus
Placebo Comparator: Placebo; Subjects will receive a single IV bolus dose of 7 mL Normal Saline.	Drug: Placebo; Single IV Bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline at 30 minutes in DLCO after administration of a single dose of TSC versus placebo in patients with ILD	Compare the proportion of patients who achieve a prespecified level of improvement in DLCO 30 minutes after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in 6MWT after administration of a single dose of TSC versus placebo in patients with ILD	Compare the proportion of patients who achieve a pre-specified level of improvement in 6 minute walk test (6MWT) after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms.	60 minutes
Change from baseline in HRR after each 6MWT	Compare the proportion of patients who achieve a pre-specified level of improvement in heart rate recovery (HRR) after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms.	60 minutes
Change from baseline in the Borg Scale after the 6MWT	Compare the proportion of patients who achieve a pre-specified level of improvement in the Borg dyspnea scale after administration of the study drug (TSC or placebo) between the 2 randomized treatment arms.	60 minutes

Collaborators and Investigators

• Sponsor: Diffusion Pharmaceuticals Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2021
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 27, 2022

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Antioxidants; Anticarcinogenic Agents; Trans-sodium crocetinate
• Other Study ID Numbers: 100-601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No