Phase 2 Interstitial Lung Disease 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 have been diagnosed with a specific immune system condition called Common Variable Immunodeficiency (CVID), confirmed using international guidelines.
• You are 4 years old or older.
• Your blood tests show your immune protein levels (IgG) are significantly lower than normal for your age.
• Your blood tests also show low levels of at least one other immune protein (IgA and/or IgM).
• Your immune system does not respond normally to vaccines.
• Your CVID is not caused by another condition or medication.
• You have been receiving immunoglobulin replacement therapy for at least 6 months and are willing to continue this throughout the study.
• You have been diagnosed with a specific type of lung disease (called granulomatous-lymphocytic interstitial lung disease with a lymphocytic component), confirmed by a lung tissue sample (biopsy) taken before joining the study.
• Your lung disease has stayed the same or gotten worse, shown by at least two lung scans (CT scans) taken at least 6 months apart, with the most recent scan done within 3 months of joining.
• You are willing to sign a consent form agreeing to take part.
• You are willing to allow your biological samples to be stored for future medical research.
• If you are a woman who could become pregnant, you must agree to use an effective form of contraception (such as hormonal contraception, an IUD, condoms, having a surgically sterile partner, or abstinence).
• If you are a man who could father a child, you must agree to use condoms throughout the study and for 3 months after your last dose.

Who may not be able to join:

• You have previously had an allergic reaction to the study drug (abatacept) or any of its ingredients.
• You have received certain medications that reduce the number of white blood cells (such as rituximab, alemtuzumab, or ATG) in the past 6 months.
• You have received abatacept, cyclophosphamide, TNF-blocking drugs, or very high-dose steroids in the past 3 months.
• You have started or had your dose increased for certain immune-suppressing drugs (such as azathioprine, methotrexate, or mycophenolate mofetil) within 3 months of enrolling or within 3 months of your most recent lung CT scan.
• You have a confirmed HIV infection.
• You have untreated, long-term hepatitis B or C infection (confirmed by a specific blood test).
• You have active tuberculosis (TB), or a history of latent TB without proof of completing treatment.
• You have had consistently high levels of a virus called Epstein-Barr Virus (EBV) in your blood on two separate tests at least one month apart.
• You have another infection that is not currently under control.
• You have received a live vaccine (such as MMR or chickenpox vaccine) within 6 weeks before starting the trial.
• You currently have cancer, or have been treated for cancer within the past year.
• You are currently pregnant or breastfeeding.
• Your doctors estimate your life expectancy is less than one month.
• You are unwilling to give yourself (or have a parent or caregiver give you) injections under the skin at home.
• You have another condition that the trial doctors feel would make it unsafe for you to participate (confirm with trial site).

For the Extended Treatment part of this trial (if applicable):

• You must have already completed the main part of this trial and shown a positive response to the study drug, and you must provide consent to continue — patients who experienced serious side effects during the main trial that were linked to the treatment may not be able to continue.

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