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:

• You are 18 years of age or older
• You are able to understand the study information and are willing to sign a consent form agreeing to take part
• You have previously received a stem cell transplant from a donor and have been diagnosed with active chronic graft-versus-host disease (cGVHD) — a condition where the donor cells attack your body — that requires treatment
• You have a specific type of cGVHD that causes skin hardening (called sclerosis), rated at a certain severity level, or your ability to move your joints is significantly limited because of this condition (confirm with trial site)
• Your skin hardening from cGVHD was first diagnosed within the past 24 weeks (about 6 months)
• You have not started any new non-steroid immune-suppressing medications in the past 28 days, or if you have, there is a plan to stop them within 21 days of starting the study drug; steroid medications up to a certain dose are allowed
• If you have already been treated for skin hardening caused by cGVHD, either the treatment lasted at least 60 days and did not work or your condition got worse, OR the treatment lasted less than 60 days and will be stopped within 21 days of starting the study drug (confirm with trial site)
• You are well enough to carry out at least some daily activities, as measured by a standard health scale (confirm with trial site)
• Your white blood cell count (specifically neutrophils, which help fight infection) is at or above a minimum level, checked during a screening period
• Your platelet count (cells that help blood clot) is at or above a minimum level, without having had a blood transfusion in the past 2 weeks
• Your liver function test results are within acceptable ranges, checked during screening (different limits apply depending on whether your liver is affected by cGVHD)
• Your kidneys are working well enough, based on a blood test that estimates how well they filter waste
• If you could become pregnant or father a child, you are willing to use effective birth control from the start of the study until 90 days after your last dose of the study drug; female participants who could become pregnant must also have a negative pregnancy test within 72 hours before starting treatment and must not breastfeed during this period

Who may not be able to join:

• You were hospitalised for an infection in the 28 days before screening
• You have a serious problem with another organ that the study doctor feels makes the trial unsuitable for you
• You are currently taking more than a certain daily dose of steroid medication (prednisone or equivalent)
• You have a history of not following medical instructions or treatment plans
• You have an uncontrolled mental health condition that might make it difficult to follow the study requirements
• You have taken part in another clinical trial or received an experimental treatment within the past 28 days
• There is any sign that the original cancer you had a transplant for has come back, or that you have developed a related condition called post-transplant lymphoproliferative disease
• You have been diagnosed with a different cancer (other than the one the transplant was for) within the past 3 years, unless it was fully treated and cured (for example, certain skin cancers that were completely removed)
• You have active hepatitis B or hepatitis C (specific blood test results apply — confirm with trial site)
• You are suspected of having active or hidden (latent) tuberculosis, based on a blood test
• You have a history of inflammation of the pancreas (pancreatitis)
• You have a history of muscle inflammation (myositis)
• You are currently pregnant or breastfeeding
• You have previously received a type of treatment that targets a specific protein called CSF-1R (confirm with trial site)

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