Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325696
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-03-21
Brief Title:
H01 in Adults With Interstitial Lung Disease The SOLIS Study
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase IIa Investigation of H01 in Adults With Interstitial Lung Disease The SOLIS Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03-19
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg monocyte count monocytelymphocyte ratio cytokine analysis other eg circulating fibrocytes
Pharmacokinetic changes from baseline to study visits and study follow-up for H01 and active metabolite 4-MU and 4-MUG
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 eg monocyte count monocytelymphocyte ratio cytokine analysis other eg circulating fibrocytes
Pharmacokinetic changes from baseline to study visits and study follow-up for H01 and active metabolite 4-MU and 4-MUG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001577-E | None | None | None |