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

Primary Purpose

Interstitial Lung Disease

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Trans Sodium Crocetinate

Placebo

About this trial

This is an interventional treatment trial for Interstitial Lung Disease

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or Female, age 30 to 85 years at screening
Able to provide informed consent and agree to adhere to all study visits and requirements
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
Established diagnosis of ILD (clinical, radiographic, or histologic)
SpO2 ≥ 88% at rest by pulse oximetry while breathing ambient air
Free of any active cardiovascular or neuromuscular disease, at PI discretion
Clinically stable disease with no major medication changes in the last 4 weeks
Forced vital capacity (FVC) ≥ 45% of predicted (within past 6 months)
DLCO corrected for hemoglobin 30-90% of predicted, inclusive (within past 6 months)
Sars-CoV-2 negative at screening

Exclusion Criteria:

Known allergy to study medication
Pregnancy or lactation
Current smoker
Inability to perform pulmonary function testing
Active infection at screening or day of study visit
Known pulmonary hypertension (PH) requiring PH-specific treatment
AST/ALT ≥ 3x ULN and/or total bilirubin ≥ 2x ULN
Received any investigational medicine (IMP) within past 30 days
Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant.
Current alcohol or substance abuse
Known active or latent hepatitis B or C
History of end-stage liver or renal disease
Positive COVID test anytime within 3 months of screening. Note:
Patients who were previously vaccinated for COVID are allowed
History of venous thromboembolic disease
History of acute or chronic ophthalmologic conditions currently requiring treatment

Sites / Locations

Pulmonary Associates, P.A.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

2.5 mg/kg Trans Sodium Crocetinate

Placebo

Arm Description

Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC.

Subjects will receive a single IV bolus dose of 7 mL Normal Saline.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT05079126

First Posted

October 4, 2021

Last Updated

August 8, 2022

Sponsor

Diffusion Pharmaceuticals Inc

1. Study Identification

Unique Protocol Identification Number

NCT05079126

Brief Title

Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

Acronym

ILD-DLCO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

Due to, among other things, positive results from the 200-302 trial, the trial has been terminated early. Resources shifted to new 200-208 GBM trial using information gained from 200-302.

Study Start Date

December 2, 2021 (Actual)

Primary Completion Date

May 25, 2022 (Actual)

Study Completion Date

May 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Diffusion Pharmaceuticals Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Interstitial Lung Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2.5 mg/kg Trans Sodium Crocetinate

Arm Type

Experimental

Arm Description

Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects will receive a single IV bolus dose of 7 mL Normal Saline.

Intervention Type

Drug

Intervention Name(s)

Trans Sodium Crocetinate

Intervention Description

Single IV Bolus

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single IV Bolus

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Change from baseline in 6MWT after administration of a single dose of TSC versus placebo in patients with ILD

Description

Time Frame

60 minutes

Title

Change from baseline in HRR after each 6MWT

Description

Time Frame

60 minutes

Title

Change from baseline in the Borg Scale after the 6MWT

Description

Time Frame

60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or Female, age 30 to 85 years at screening Able to provide informed consent and agree to adhere to all study visits and requirements 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 Established diagnosis of ILD (clinical, radiographic, or histologic) SpO2 ≥ 88% at rest by pulse oximetry while breathing ambient air Free of any active cardiovascular or neuromuscular disease, at PI discretion Clinically stable disease with no major medication changes in the last 4 weeks Forced vital capacity (FVC) ≥ 45% of predicted (within past 6 months) DLCO corrected for hemoglobin 30-90% of predicted, inclusive (within past 6 months) Sars-CoV-2 negative at screening Exclusion Criteria: Known allergy to study medication Pregnancy or lactation Current smoker Inability to perform pulmonary function testing Active infection at screening or day of study visit Known pulmonary hypertension (PH) requiring PH-specific treatment AST/ALT ≥ 3x ULN and/or total bilirubin ≥ 2x ULN Received any investigational medicine (IMP) within past 30 days Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant. Current alcohol or substance abuse Known active or latent hepatitis B or C History of end-stage liver or renal disease Positive COVID test anytime within 3 months of screening. Note: Patients who were previously vaccinated for COVID are allowed History of venous thromboembolic disease History of acute or chronic ophthalmologic conditions currently requiring treatment

Facility Information:

Facility Name

Pulmonary Associates, P.A.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

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