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

• Sponsor: Diffusion Pharmaceuticals Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT05079126
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.8
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease	Drug: Trans Sodium Crocetinate; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-Blind, Placebo-Controlled Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease
• Actual Study Start Date: Dec 2, 2021
• Actual Primary Completion Date: May 25, 2022
• Actual Study Completion Date: May 27, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline at 30 minutes in DLCO after administration of a single dose of TSC versus placebo in patients with ILD [30 minutes]

   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.

Secondary Outcome Measures

1. Change from baseline in 6MWT after administration of a single dose of TSC versus placebo in patients with ILD [60 minutes]

   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.

2. Change from baseline in HRR after each 6MWT [60 minutes]

   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.

3. Change from baseline in the Borg Scale after the 6MWT [60 minutes]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. History of venous thromboembolic disease

2. History of acute or chronic ophthalmologic conditions currently requiring treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pulmonary Associates, P.A.	Phoenix	Arizona	United States	85032

Sponsors and Collaborators

• Diffusion Pharmaceuticals Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Diffusion Pharmaceuticals Inc
• ClinicalTrials.gov Identifier: NCT05079126
• Other Study ID Numbers: 100-601
• First Posted: Oct 15, 2021
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Interstitial; Trans-sodium crocetinate

Study Results

No Results Posted as of Aug 10, 2022