Phase 2 Interstitial Lung Disease Trial, Recruiting NCT06153173 Sponsor: Children's Hospital Medical Center, Cincinnati Condition: Interstitial Lung Disease
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Phase 2 Interstitial Lung Disease Trial, Recruiting

NCT06153173
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 2 years or older who have been diagnosed with a histiocytic disorder (a rare disease affecting certain immune cells) that needs treatment throughout the body.
  • People whose diagnosis has been confirmed through a tissue sample (biopsy) reviewed by a specialist pathologist, or who have tissue available for genetic testing if genetic testing has not yet been done.
  • People with disease only in the pituitary gland or brain where a biopsy is not possible, provided a specific blood test shows a gene mutation linked to this type of disease along with matching clinical signs.
  • People who have measurable signs of their disease visible on a PET scan or brain MRI.
  • People whose kidneys, liver, and blood counts are working at a minimum level as determined by specific lab tests (confirm exact values with trial site).
  • People whose organ function falls outside the normal ranges listed, if the trial doctors determine this is caused directly by the histiocytic disease itself.

Who may not be able to join:

  • People who have received certain types of chemotherapy that affect bone marrow cell growth (such as cytarabine, cladribine, clofarabine, mercaptopurine, methotrexate, or vinblastine) within the 14 days before joining the trial.
  • People who have taken a MEK inhibitor medication within 30 days (or longer, depending on the specific drug) before joining, or whose disease got worse while taking a MEK inhibitor.
  • People who have used steroid medications (by mouth, inhaled, or as eye drops) within 14 days before starting the trial drug, or who need to take steroids for more than 30 days in a row during the study — except people who need low-dose steroids because their body does not produce enough hormones naturally.
  • People who have received radiation therapy within 14 days before joining, or who have ever received radiation to the eye area at any time.
  • People who have certain risk factors for a serious eye condition called retinal vein occlusion, including high eye pressure, uncontrolled glaucoma or significant eye abnormalities, very high cholesterol (above 300 mg/dL), very high triglycerides (above 300 mg/dL), high blood sugar, or uncontrolled high blood pressure (confirm specific thresholds with trial site).
  • People whose heart pumping function is below 55% on a heart scan, or who have a significant heart condition, unless it is directly caused by the histiocytic disease.
  • People who are pregnant, breastfeeding, at risk of becoming pregnant, or at risk of fathering a child and are unable or unwilling to use an acceptable form of birth control for the duration of the study.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Ashish Kumar, MD, PhD, Children's Hospital Medical Center, Cincinnati

Phone: (513) 803-8574

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
5 February 2024
Est. completion
1 March 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Response rate to mirdametinib

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov