Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

NCT05079126 | Terminated Phase 2 FDA Drug

• 1 other identifier: 100-601
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  60 minutes

• Change from baseline in HRR after each 6MWT

  60 minutes

• Change from baseline in the Borg Scale after the 6MWT

  60 minutes

Study Arms (2)

2.5 mg/kg Trans Sodium Crocetinate

EXPERIMENTAL

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

Drug: Trans Sodium Crocetinate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Trans Sodium Crocetinate DRUG

Single IV Bolus

2.5 mg/kg Trans Sodium Crocetinate

Placebo DRUG

Single IV Bolus

Placebo

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diffusion Pharmaceuticals Inc: lead

Study Sites (1)

Pulmonary Associates, P.A.

Phoenix, Arizona, 85032, United States

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

trans-sodium crocetinate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 15, 2021
• Study Start: December 2, 2021
• Primary Completion: May 25, 2022
• Study Completion: May 27, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)