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Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease

ConditionsInterstitial Lung DiseaseCommon Variable Immunodeficiency
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Abatacept

    Drug

    Abatacept is a selective costimulation modulator, inhibiting T lymphocyte activation by binding to CD80 and CD86, thereby blocking interaction with CD28. Orencia solution supplied in a prefilled syringe should be refrigerated at 2C to 8C (36F to 46F). Orencia should not be used beyond the expiration date on the prefilled syringe. The product should be protected from light by storing in the original package until time of use. The prefilled syringe should not be frozen.

  • Placebo

    Other intervention

    The composition of the placebo for Orencia is the same as the active study drug without the abatacept. The placebo will be packaged and labeled as described above for the Orencia prefilled syringes. To maintain the blind, injection volumes will be the same as the active treatment.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: AbataceptExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

High Resolution CT Scan of the chest (HRCT)

Proportion of subjects achieving a significant response (defined as \>30 percent change in lung tissue disease burden by GLILD) on HRCT after 6 months of abatacept therapy.

Time frame
6 months

Secondary outcomes

1

Forced vital capacity (FVC)

Forced vital capacity (FVC)

Time frame
6 months, 12 months
2

Forced expiratory volume (FEV)

Forced expiratory volume (FEV)

Time frame
6 months, 12 months
3

Diffusion capacity of carbon monoxide (DLCo)

Diffusion capacity of carbon monoxide (DLCo)

Time frame
6 months, 12 months
4

Incidence

Incidence of new onset autoimmune/inflammatory diseases while on abatacept or placebo

Time frame
6 months, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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