Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

Phase 2

Terminated

• Conditions: Interstitial Lung Disease
• Interventions: Drug: Placebo; Drug: Trans Sodium Crocetinate

• Registration Number: NCT05079126
• Lead Sponsor: Diffusion Pharmaceuticals Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-15
• Study Start: 2021-12-02
• Primary Completion: 2022-05-25
• Study Completion: 2022-05-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will receive a single IV bolus dose of 7 mL Normal Saline.
2.5 mg/kg Trans Sodium Crocetinate	Trans Sodium Crocetinate	Subjects will receive a single IV bolus dose of 2.5 mg/kg TSC.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Pulmonary Associates, P.A.; 🇺🇸 Phoenix, Arizona, United States