Phase 2 COPD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been clinically diagnosed with chronic graft-versus-host disease (cGVHD) — a condition that can occur after a stem cell or bone marrow transplant — with at least one recognised sign or symptom of the condition (a formal NIH classification is not required)
• If the only affected area is the eyes, the condition must have been confirmed by an eye doctor (ophthalmologist or optometrist)
• People who have not had any new immune-suppressing medications added to their treatment in the two weeks before joining the study (continuing existing medications at the same or lower doses is generally permitted, but increases in steroid doses are not allowed in that two-week window — confirm details with the trial site)
• People aged 18 or older
• People who are generally well enough to carry out most normal daily activities (measured by a performance score of 70 or above on a standard medical scale — confirm with trial site)
• People who are able to swallow and take oral (by mouth) medications
• People who have signed a consent form agreeing to take part in the study
• People whose liver enzyme levels (ALT and AST) are within an acceptable range (no more than 3 times the upper limit of normal)
• People whose bilirubin level (a measure of liver function) is within an acceptable range, unless any elevation is due to a harmless inherited condition called Gilbert's disease
• People whose kidneys are functioning at an adequate level (an estimated filtration rate of at least 30 mL/min/1.73 m²)
• Women who could potentially become pregnant must have a negative pregnancy test at the start of the study
• Women of childbearing potential who are sexually active must agree to use two forms of contraception throughout the study and for 3 months after the last dose of the study drug (accepted methods include an IUD plus a barrier method, hormonal contraception plus a barrier method, two barrier methods, surgical sterilisation, or a vasectomised partner)
• Men who are sexually active with a female partner who could become pregnant must agree to use two forms of contraception during the study and for at least 3 months after the last dose, and must agree not to donate sperm during that period
• People with no current signs of active cancer

Who may not be able to join:

• People currently receiving any systemic (whole-body) immune-suppressing treatment for cGVHD (topical or localised treatments are allowed)
• People who are planning to start systemic immune-suppressing therapy for cGVHD, or to increase their steroid dose, within 14 days of the planned study start date
• People taking prednisone or an equivalent steroid at a dose of 0.25 mg/kg/day or higher at the time of screening
• People with a history of not following medical instructions, which in the opinion of the study doctor could interfere with participation
• People with an uncontrolled psychiatric (mental health) condition
• Women who are pregnant or breastfeeding
• People who have previously been treated with the study drug, belumosudil
• People with a known allergy or sensitivity to belumosudil or any similar type of medication (known as a ROCK2 inhibitor)
• People who have taken part in another clinical trial involving an experimental treatment within 28 days before joining (or within 5 half-lives of that treatment, whichever is the longer period)

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