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

Launched by NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS) · Mar 21, 2024

Keywords

ClinConnect Summary

The SOLIS Study is a clinical trial that is testing a new drug called hymecromone for adults with interstitial lung disease, a condition that causes scarring in the lungs and can make it hard to breathe. This study aims to see if hymecromone can help improve lung function in people suffering from this serious disease. To participate, individuals must be 18 years or older and diagnosed with a specific type of lung disease called Idiopathic Pulmonary Fibrosis or another progressive interstitial lung disease.

Participants in the study will have at least seven clinic visits over five months. During these visits, they will undergo various tests, including breathing tests and blood tests, to check their lung and heart function. Participants will take hymecromone tablets twice daily for 12 weeks, and their progress will be monitored through follow-up tests. It’s important for potential participants to understand that they must commit to the study requirements and have no serious health issues that could interfere with their participation. This study is currently recruiting, and everyone is welcome to apply, regardless of gender.

Gender

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Eligibility criteria

• * INCLUSION 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% \<80%, FVC\>45% and \<80%
• • Subjects 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 Hormone-based contraceptive
• • Agreement to adhere to Lifestyle Considerations throughout study duration
• EXCLUSION CRITERIA:
• 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 at any time during enrollment or study
• • 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
• • Subjects with history of active Inflammatory Bowel Disease, dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills
• • Subjects with significant renal impairment defined as eGFR lower than 60 ml/min.
• • Subjects 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 increased risk for adverse effects.
• • Subjects with ongoing alcohol or illegal drug use disorder
• • Subjects 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 participant in this study. Methods include (a) partner vasectomy, (b) bilateral tubal ligation, (c) intrauterine devices (IUDs), (d) hormonal implants (such as Implanon), or (e) other hormonal methods (birth control pills, injections, patches, vaginal rings).
• • 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 UDPglucuronosyltransferase 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.