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

Phase 2

Not yet recruiting

• Conditions: Lung Diseases, Interstitial; Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis
• Interventions: Drug: hymecromone

• Registration Number: NCT06325696
• Lead Sponsor: National Institute of Environmental Health Sciences (NIEHS)

Brief 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.

Detailed 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)

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2024-03-19
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-22
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Study Start: 2025-01-14
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	hymecromone	Adults, male and female with a diagnosis of interstitial lung disease, take 2 doses of 400 mg H01, morning and evening

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD	Serum HA levels before and after initiation of treatment with H01 over a period of 12 weeks

Secondary Outcome Measures

Name	Time	Method
Evaluate biomarkers of fibrosis in participants with progressive ILD treated with H01.	On-going throughout study; each study visit
Evaluate the change in clinical and functional measures in participants with progressive ILD treated with H01.	On-going throughout study; each study visit
Evaluate pharmacokinetic changes from baseline in participants with progressive ILD treated with H01.	On-going throughout study; each study visit
Evaluate the safety and tolerability of oral H01 in participants with progressive ILD.	On-going throughout study; each study visit

Trial Locations

Locations (1)

NIEHS Clinical Research Unit (CRU); 🇺🇸 Research Triangle Park, North Carolina, United States