BridgeMD
New treatment option for Interstitial Lung Disease
Official title H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
ClinicalTrials.gov ID: NCT06325696
What this study is testing
What is hymecromone?
hymecromone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for interstitial lung disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability of subject to understand, and the willingness to sign a written informed consent document and comply with requirements of the study
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or Female participants ages \>18 years
- MD diagnosis of Idiopathic Pulmonary Fibrosis or other progressive ILD as defined previously
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Active on lung transplantation list
- On supplemental oxygen at rest
- Evidence of an acute respiratory infection or exacerbation of pulmonary fibrosis
- Known diagnosis of celiac disease or wheat or gluten allergies
- Cirrhosis or active viral or non-viral hepatitis: Bilirubin, AST and ALT values higher than twice the upper range of normal, or a Child-Pugh score of...
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability of subject to understand, and the willingness to sign a written informed consent document and comply with requirements of the study
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or Female participants ages \>18 years
- MD diagnosis of Idiopathic Pulmonary Fibrosis or other progressive ILD as defined previously
- DLCO\>30% and FVC\>45%
- people in reproductive age who are heterosexually active must use an acceptable method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or...
- Agreement to adhere to Lifestyle Considerations throughout study duration
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Active on lung transplantation list
- On supplemental oxygen at rest
- Evidence of an acute respiratory infection or exacerbation of pulmonary fibrosis
- Known diagnosis of celiac disease or wheat or gluten allergies
- Cirrhosis or active viral or non-viral hepatitis: Bilirubin, AST and ALT values higher than twice the upper range of normal, or a Child-Pugh score of 7 or more
- people with history of active Inflammatory Bowel Disease, dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills
- people with significant renal impairment defined as eGFR lower than 40 ml/min.
- people with a baseline corrected Fridericia's QT interval (QTcF) \>450ms or baseline ECG abnormalities which, in the opinion of the study physician, are clinically significant and would place the participant at...
- people with ongoing alcohol or illegal drug use disorder
- people who are pregnant, lactating or attempting to conceive
- Participants able to become pregnant (have not completed menopause, had a hysterectomy and/or both tubes and/or both ovaries removed) must use effective birth control methods to try and not become pregnant while...
- Male participants able to father children with a partner able to become pregnant must agree to use effective birth control (listed above) to participate in this study.
- Known allergy to hymecromone or any component thereof
- Chronic therapy with medications that are known potent human UDP-glucuronosyltransferase inhibitors: canagliflozin, temazepam, tacrolimus.
- Physician concern that participant may not adhere to the study protocol
- Current participation in another clinical treatment trial for ILD. May participate after 12 weeks from conclusion of another treatment trial.
- Changing dose of other ILD medications over the 3 months prior to baseline
- Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that place the participant at increased risk for adverse effects, as determined by the study physician. Participants who completed...
The study team makes the final eligibility decision.
Where it's taking place
- Research Triangle Park, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Research Triangle Park, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.