Actively Recruiting
Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-11-06
38
Participants Needed
6
Research Sites
259 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CVID according to international consensus criteria
- Age 4 years or older
- Serum IgG at least 2 standard deviations below normal for age
- Decreased serum IgA and/or IgM
- Abnormal antibody response to immunization
- No secondary immunodeficiency
- On immunoglobulin replacement for at least 6 months and willing to maintain it
- Diagnosed granulomatous-lymphocytic interstitial lung disease with lymphocytic component by lung biopsy (wedge biopsy preferred)
- Persistence or worsening of lung disease on CT scans at least 6 months apart, with latest within 3 months of entry
- Signed informed consent
- Willing to allow storage of biological specimens for future research
- Female subjects of childbearing potential must agree to effective birth control
- Fertile, non-vasectomized males with female partners of childbearing potential must use condoms during study and 3 months after last dose
You will not qualify if you...
- History of allergy to abatacept or its components
- Received lymphocyte depleting agents (anti-CD20, alemtuzumab, ATG) within 6 months
- Received abatacept, cyclophosphamide, TNF inhibitors, or high-dose steroids within 3 months
- Started or increased immune modulating drugs (azathioprine, cyclosporine, tacrolimus, mercaptopurine, methotrexate, mycophenolate mofetil, sirolimus) within 3 months
- History of HIV infection
- Chronic untreated hepatitis B or C
- Active tuberculosis or incomplete latent TB treatment
- Epstein-Barr Virus load ≥ 1,000 units/mL on two tests at least 1 month apart
- Other uncontrolled infections
- Live vaccine within 6 weeks before trial start
- Malignancy or cancer treatment within past year
- Currently pregnant or breastfeeding
- Life expectancy less than 1 month
- Unwillingness to self-administer or have caregiver administer injections
- Other conditions deemed unsafe by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
University of South Florida
Tampa, Florida, United States, 33620
Actively Recruiting
3
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55902
Actively Recruiting
5
Duke University Health System
Durham, North Carolina, United States, 27710
Actively Recruiting
6
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
M
Michael Jordan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here