Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids (KB003-04)

Humanigen

Status and phase

Completed

Phase 2

Conditions

Moderate-to-Severe Asthma

Treatments

Other: Placebo

Biological: Anti-GM-CSF Monoclonal Antibody 400mg

Study type

Interventional

Funder types

Industry

Identifiers

KB003-04

Details and patient eligibility

About

This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma.

Enrollment

160 patients

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

A diagnosis of asthma established for at least 2 years
Symptomatic asthma as defined by the Juniper Asthma Control Questionnaire
Symptomatic asthma despite stable treatment with inhaled corticosteroids fluticasone or budesonide, or other corticosteroids, for at least 12 weeks
Currently receiving inhaled long-acting beta agonist (LABA) or previously documented LABA intolerability or lack of responsiveness
At least 2 exacerbations (no more than 6) in the previous 12 months that required systemic corticosteroids or at least a doubling of daily oral dose

Key Exclusion Criteria:

Acute asthma worsening (requiring emergency room visit, hospitalization, urgent care, physician visit, or change in asthma medications) or lower respiratory tract infection requiring the use of antibiotics, within 4 weeks prior to Screening Visit.
History of life-threatening asthma with admission to the intensive care unit requiring the use of mechanical ventilation within the past 12 months
Use of any immunosuppressive or immunomodulatory agents within 12 weeks or an investigational agent within 4 weeks prior to Screening Visit
History of any cardiovascular, neurological, hepatic, or renal condition
History of smoking within the past 12 months