Testing hymecromone in adults with interstitial lung disease
Phase IIa Investigation of H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
This study is testing a new medication called hymecromone to see if it can help adults with progressive interstitial lung disease feel better and improve their lung function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Research Triangle Park, North Carolina) |
| Trial ID | NCT06325696 on ClinicalTrials.gov |
What this trial studies
This Phase 2a open-label study aims to evaluate the safety, tolerability, and efficacy of hymecromone in adults diagnosed with progressive interstitial lung disease. Up to 37 participants will undergo a series of assessments over five months, including blood tests, lung function tests, and sputum samples. The primary objective is to measure the reduction of hyaluronan levels in participants, while secondary objectives include assessing clinical and functional changes, safety, and pharmacokinetics of the drug.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with idiopathic pulmonary fibrosis or other forms of progressive interstitial lung disease.
Not a fit: Patients with severe lung impairment or those who do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that may slow the progression of interstitial lung disease and improve patients' quality of life.
How similar studies have performed: While this approach is novel, similar studies targeting hyaluronan levels in lung diseases have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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% and FVC\>45% * 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 * 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 40 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 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.
Where this trial is running
Research Triangle Park, North Carolina
- NIEHS Clinical Research Unit (CRU) — Research Triangle Park, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Stavros Garantziotis, M.D. — National Institute of Environmental Health Sciences (NIEHS)
- Study coordinator: NIEHS Join A Study Recruitment Group
- Email: myniehs@nih.gov
- Phone: (855) 696-4347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.