H01 in Adults With Interstitial Lung Disease (The SOLIS Study)

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title: Phase IIa Investigation of H01 in Adults With Interstitial Lung Disease (The SOLIS Study)

Status Not yet recruiting

Clinical Trial Summary

Background:

Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years.

Objective:

To test a study drug (hymecromone) in people with interstitial lung disease or lung fibrosis.

Eligibility:

People aged 18 years and older with interstitial lung disease or lung fibrosis.

Design:

Participants will have at least 7 clinic visits over 5 months.

Participants will have screening and baseline visits. They will have blood tests and tests of their heart function. They will give a sputum sample. Other tests will include:

Spirometry: Participants will breathe in and out through a mouthpiece to measure how much air they can hold in their lungs and how hard they can breathe.

Diffusion capacity of lungs for carbon monoxide: Participants will breathe in a gas that contains a small amount of carbon monoxide. Then they will breathe through a mouthpiece. This test measures how well oxygen moves from the air into the blood.

Resting energy expenditure. Participants will lie still for 30 minutes with a clear dome over their head. This test measures the calories their body burns at rest.

6-minute walk test. Participants will walk at their normal pace for 6 minutes. Their vital signs and blood oxygen levels will be checked.

Hymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning and 2 tablets every night for 12 weeks. Tests will be repeated at study visits.

Clinical Trial Description

Study Description:

Phase 2a, open-label, study to evaluate the safety, tolerability, and efficacy of H01 in adults with progressive interstitial lung disease. Up to 37 participants will be enrolled.

Objectives:

Primary Objective: Evaluate the efficacy of H01 in reducing hyaluronan levels in participants with progressive interstitial lung disease.

Secondary Objectives:

• Evaluate the safety and tolerability of oral H01 in participants with progressive interstitial lung disease.

• Evaluate the change in clinical and functional measures in participants with progressive interstitial lung disease treated with H01.

• Evaluate biomarkers of fibrosis in participants with progressive interstitial lung disease treated with H01.

• Evaluate pharmacokinetic changes from baseline in participants with progressive interstitial lung disease treated with H01

Endpoints:

Primary Endpoint: Serum HA levels before and after initiation of treatment with H01 over a period of 12 weeks.

Secondary Endpoints:

• Safety and tolerability (according to Common Terminology Criteria for Adverse Events)

• Change in sputum hyaluronan levels

• Change in 6-minute walk test (6MWT)

• Change in pulmonary function test (PFT) including: FVC, DLCO

• Change in symptom score on Saint George s Respiratory Questionnaire (SGRQ) and King s Brief Interstitial Lung Disease (KBILD) Questionnaire

• Change in right ventricular (RV) pressures in echocardiography before treatment and after 12 weeks of H01 treatment

• RV Systolic Pressure, Right Atrial Pressure, presence of pericardial effusion, RV size and function via Tricuspid Annular Plane Systolic Excursion /RV Fractional Area Change, Left Ventricular function and Ejection Fraction

Exploratory:

• Markers of fibrosis (e.g., monocyte count, monocyte/lymphocyte ratio, cytokine analysis (other, e.g., circulating fibrocytes)

• Pharmacokinetic changes from baseline to study visits and study follow-up for H01 and active metabolite (4-MU, and 4-MUG) ;

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

• NCT number: NCT06325696
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: NIEHS Join A Study Recruitment Group
• Phone: (855) 696-4347
• Email: myniehs@nih.gov
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 26, 2024
• Completion date: December 31, 2025