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 groupsLocations
6California
University of California, San Francisco94143, San Francisco United States
Florida
University of South Florida33620, Tampa United States
Massachusetts
Lahey Hospital and Medical Center01805, Burlington United States
Minnesota
Mayo Clinic55902, Rochester United States
Sponsors and collaborators
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov