Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease (ABCVILD)
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- STATUS
- Recruiting
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- End date
- Jul 27, 2025
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- participants needed
- 60
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- sponsor
- Children's Hospital Medical Center, Cincinnati
Summary
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
Description
There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept is a recombinant, human fusion protein of cytotoxic T lymphocyte-associated protein 4 (CTLA-4) and human IgG1 that blocks T cell activation by binding to CD80 and CD86, thereby blocking CD28 engagement- the "second signal" needed for T cell activation. 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 adult and pediatric subjects ≥50 kg (cohort 1), with an additional cohort (#2) of pediatric subjects <50 kg tested as a single arm, receiving open-label abatacept. Cohort 1 utilizes a 'delayed-start' design to obtain maximum statistical power from this cohort. Cohort 2 will be open label due to the lack of a suitable placebo for pediatric dose abatacept syringes. A total of 45 evaluable subjects will be treated in cohort 1 and 15 evaluable subjects in cohort 2.
Details
| Condition | Interstitial Lung Disease, Common Variable Immunodeficiency |
|---|---|
| Treatment | Placebo, Abatacept |
| Clinical Study Identifier | NCT04925375 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Last Modified on | 27 May 2022 |
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