# Clinical trial of omalizumab for allergen sensitized and exposed individuals with COPD

> **NIH NIH U01** · JOHNS HOPKINS UNIVERSITY · 2024 · $2,520,503

## Abstract

Project Summary
Chronic Obstructive Pulmonary Disease (COPD) is a heterogeneous disease with significant variation in
disease manifestation, progression, and outcomes. There is increasing interest in precision medicine strategies
in COPD to identify disease traits that, when targeted for treatment, result in improved outcomes. There has
been increasing recognition of the prevalence of allergic disease and allergic sensitization in COPD, but the
clinical significance of this overlapping trait has been unclear. Blood eosinophils have been recognized as a
trait to help target treatment with inhaled corticosteroids among individuals with COPD but are imprecise as a
biomarker of type 2 inflammation. We recently published compelling results showing that individuals with
COPD having both allergic sensitization as well as concomitant exposure to common indoor aeroallergens,
also having elevated total IgE, have a substantially higher risk of adverse outcomes. It is also well established
that individuals with allergic asthma having sensitization with exposure to common indoor aeroallergens have
significant benefit from treatment with omalizumab. Accordingly, we propose the Clinical trial of omalizumab for
allergen sensitized and exposed individuals with COPD (COPD OMA) a masked, randomized, placebo-
controlled multi-center phase 2 clinical trial of omalizumab versus placebo among individuals with COPD
having sensitization with concomitant exposure to common indoor allergens. The trial will enroll 330 individuals
with moderate to severe COPD in partnership with the American Lung Association-Airways Clinical Research
Centers (ALA-ACRC) and will test whether omalizumab leads to treatment response, including improvement in
exacerbation risk (primary outcome), disease status (measured by St. George's Respiratory Questionnaire and
COPD Assessment Test Score), and lung function (secondary outcomes) over the course of 12 months. The
study will be conducted at twenty centers throughout the US. In a mechanistic aim, we also propose to explore
molecular signatures of IL-4 and IL-13 cytokines to understand drivers of disease morbidity as well as
treatment response in this population. Accordingly, this is an ideal phase II clinical trial with the goals of
detecting a signal for efficacy of omalizumab in improving relevant clinical outcomes among a high-risk
subgroup of individuals; and understanding relevant biologic endotypes with increased responsiveness to
treatment.

## Key facts

- **NIH application ID:** 10927604
- **Project number:** 1U01AI177195-01A1
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Nadia N Hansel
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $2,520,503
- **Award type:** 1
- **Project period:** 2024-08-15 → 2031-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10927604

## Citation

> US National Institutes of Health, RePORTER application 10927604, Clinical trial of omalizumab for allergen sensitized and exposed individuals with COPD (1U01AI177195-01A1). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/10927604. Licensed CC0.

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