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

Diffusion Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Interstitial Lung Disease

Treatments: Drug: Placebo; Drug: Trans Sodium Crocetinate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05079126

100-601

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

2.5 mg/kg Trans Sodium Crocetinate

Experimental group

Description:

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

Treatment:

Drug: Trans Sodium Crocetinate

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo