Education and Training

Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)

The primary objective of the study is to evaluate the efficacy of dupilumab on lung function in participants with Allergic Bronchopulmonary Aspergillosis (ABPA).

The secondary objectives of the study are:

- To evaluate the effects of dupilumab on exacerbations in participants with ABPA

- To evaluate the effects of dupilumab on ABPA-related exacerbations

- To evaluate the effects of dupilumab on hospitalization/emergency department (ED)/urgent care visits in participants with ABPA

- To evaluate the effects of dupilumab on asthma control in participants with ABPA

- To evaluate the effects of dupilumab on health-related quality of life (HRQoL) in participants with ABPA

- To evaluate the effects of dupilumab on serum total immunoglobulin E (IgE) and Aspergillus-specific IgE concentrations

- To evaluate the effects of dupilumab on Fractional exhaled Nitric Oxide (FeNO) levels

- To evaluate safety and tolerability of dupilumab in participants with ABPA

- To evaluate dupilumab concentrations in serum and the incidence of anti-dupilumab antibodies in participants with ABPA

Stanford is currently accepting patients for this trial.

Intervention(s):

  • drug: dupilumab
  • drug: Placebo

Eligibility


Key Inclusion Criteria:

   - Diagnosis of both ABPA and asthma

   - On a maintenance therapy for their asthma with controller medication which must
   include inhaled corticosteroids (ICS) and may include 1 or more additional controller
   medications including a long-acting beta agonist (LABA), leukotriene receptor
   antagonist (LTRA), and/or long-acting muscarinic receptor antagonist (LAMA), etc for
   at least 12 weeks, with a stable dose and regimen with no change in the dose or
   frequency of administration for at least 4 weeks prior to the screening visit and
   between the screening and baseline/randomization visits

   - For participants on OCS (oral corticosteroid): must be on a chronic stable dose (no
   change in the dose) of OCS of up to 10 mg/day (for participants taking daily
   corticosteroids) or up to 30 mg every alternate day (for participants taking alternate
   day corticosteroids) (prednisone/prednisolone or the equivalent) for at least 4 weeks
   prior to the screening visit and between the screening and the baseline/randomization
   visit

   - Must have experienced ≥1 severe respiratory exacerbation requiring treatment with
   systemic corticosteroids or hospitalization or treatment in ED/urgent care within 12
   months prior to the screening visit or must be receiving chronic stable low-dose OCS
   per above criteria

Key Exclusion Criteria:

   - Weight less than 30.0 kilograms

   - Current smoker or e-cigarette user, cessation of smoking or e-cigarette use within 6
   months prior to randomization, or >=10 pack-years smoking history

   - Post-bronchodilator FEV1 <30% predicted normal at screening

   - Respiratory exacerbation requiring systemic corticosteroids within 4 weeks prior to
   screening and between screening and baseline visit (for patients on daily or alternate
   day OCS, exacerbation requiring at least double the maintenance dose of
   corticosteroids)

   - Upper or lower respiratory tract infection within the 4 weeks prior to screening
   (visit 1) or between the screening and randomization visits

   - Significant chronic pulmonary disease other than asthma complicated with ABPA (eg,
   physician-diagnosed bronchiectasis due to a condition other than ABPA; cystic
   fibrosis; sarcoidosis; interstitial lung disease not due to ABPA; chronic obstructive
   pulmonary disease [COPD] not due to ABPA; hypereosinophilic syndrome; etc), a
   diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil
   counts

   - Diagnosis or suspected diagnosis of eosinophilic granulomatosis with polyangiitis
   (EGPA) (also called Churg-Strauss Syndrome)

NOTE: Other protocol defined inclusion / exclusion criteria applies.

Ages Eligible for Study

12 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jeanette Smith
650 736 8083
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