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New treatment option for Interstitial Lung Disease
Official title Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease
ClinicalTrials.gov ID: NCT04925375
What this study is testing
What is Abatacept?
Abatacept is an investigational medicine, being studied as a potential treatment for interstitial lung disease.
Also referred to as Orencia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept has recently looked promising for the treatment of patients with complex CVID.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 and older
You may be able to join if
- Diagnosis of CVID according to the international consensus document (ICON)
- Age 4 years or above
- Serum IgG at least 2 standard deviations below the age adjusted normal
- Decreased serum IgA and/or serum IgM
- Abnormal specific antibody response to immunization
You likely can't join if
- History of hypersensitivity to abatacept or any of its components
- Has received any lymphocyte depleting agents including anti-CD20 monoclonal antibodies, alemtuzumab, ATG in the preceding 6 months
- Has received abatacept, cyclophosphamide, tumor necrosis factor inhibitors, or pulse steroids (defined as \>15mg/kg/day of methylprednisone or...
- Have started or increased any of the following immune modulating drugs within 3 months of enrolling and 3 months from initial CT chest: azathioprine...
- History of HIV infection (positive PCR)
- Chronic untreated hepatitis B or C (positive PCR)
See the full eligibility criteria
- Diagnosis of CVID according to the international consensus document (ICON)
- Age 4 years or above
- Serum IgG at least 2 standard deviations below the age adjusted normal
- Decreased serum IgA and/or serum IgM
- Abnormal specific antibody response to immunization
- Exclusion of secondary immunodeficiency
- On replacement immunoglobulin for at least 6 months and willing to maintain throughout study
- Granulomatous-lymphocytic interstitial lung disease with a lymphocytic component diagnosed by lung biopsy prior to study entry, wedge biopsy preferred.
- Persistence or worsening of interstitial lung disease measured on serial CT imaging of the lung at least 6 months apart, with the latest assessment within 3 months of study entry.
- Signed written informed consent
- Willing to allow storage of biological specimens for future use in medical research.
- Female people of childbearing potential must agree to an effective form of birth control such as hormone based contraceptive, intrauterine device, condoms/barrier, surgically sterile partner, or abstinence.
- Fertile, non-vasectomized males with a female partner of childbearing potential should use condoms throughout the study and for 3 months after the last dose
- History of hypersensitivity to abatacept or any of its components
- Has received any lymphocyte depleting agents including anti-CD20 monoclonal antibodies, alemtuzumab, ATG in the preceding 6 months
- Has received abatacept, cyclophosphamide, tumor necrosis factor inhibitors, or pulse steroids (defined as \>15mg/kg/day of methylprednisone or corticosteroid equivalent) within the past 3 months
- Have started or increased any of the following immune modulating drugs within 3 months of enrolling and 3 months from initial CT chest: azathioprine, cyclosporine, tacrolimus, mercaptopurine, methotrexate, mycophenolate...
- History of HIV infection (positive PCR)
- Chronic untreated hepatitis B or C (positive PCR)
- Active tuberculosis (TB) by positive QuantiFERON gold. If history of latent TB, then must supply evidence of completing treatment.
- Persistent Epstein-Barr Virus (EBV) load ≥ 1,000 units/mL blood checked twice at least 1 month apart
- Other uncontrolled infections
- Live vaccine given within 6 weeks of the start of the trial
- Malignancy or treated for malignancy within the past year
- Currently pregnant or breast feeding
- Life expectancy less than 1 month
- people unwilling to self-administer or have a parent/caregiver self-administer subcutaneous injections at home
- Other conditions that the investigators feel contraindicate participation in the study Inclusion criteria for Extended Treatment Plan:
- Patients must have completed the abatacept for the treatment of Interstitial Lung Disease in Common Variable Immunodeficiency (ABCVILD) trial
- Patients must have demonstrated positive response to abatacept.
- Patients must provide informed consent to participate in the Extended Treatment Plan. Exclusion criteria for Extended Treatment Plan:
- Patients who experienced SAEs during the original trial, and such SAEs were determined as related to treatment, or patients who in the opinion of the investigator would not benefit from the extended treatment option.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Tampa, Florida, United States
- Burlington, Massachusetts, United States
- Rochester, Minnesota, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Tampa, Florida, United States; Burlington, Massachusetts, United States; Rochester, Minnesota, United States; Durham, North Carolina, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.