Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age4+
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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. This study is a multi-site, phase II, randomized, blinded/placebo-controlled clinical trial in pediatric and adult subjects to determine the efficacy of abatacept compared to placebo for treatment of subjects with GLILD in the context of CVID.
Funding Source - FDA OOPD
Eligibility criteria
Qualifiers
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
Disqualifiers
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 mofetil, or sirolimus
Trial design
Treatments tested in this trial
- Abatacept
- Placebo
Treatment groups
38 Participants
are divided into 2 treatment groupsSponsors and collaborators
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov