A Study of RO5036505 in Patients With Moderate to Severe Asthma
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of RO5036505 in patients with inadequately controlled moderate to severe asthma. Patients will be randomized to receive either RO5036505 (380mg iv infusion once weekly) or placebo for 8 weeks. Patients will be on a standardized inhaled corticosteroid/long-acting beta-agonist regimen during study treatment. Target sample size is 50-100 individuals.
Sex
Ages
Volunteers
Inclusion criteria
- adult patients, 18-70 years of age
- moderate to severe asthma for >/=2 years
- ACQ score >/= 1.5
- ICS and LABA regimen at moderate to high dose
- non-smokers
Exclusion criteria
- oral corticosteroid use within 4 weeks prior to screening
- current escalating immunotherapy
- acute infection/antibiotic therapy within 4 weeks prior to screening, or chronic infection
- pulmonary disease other than asthma
- therapy with any approved monoclonal antibody or biologic agent within 12 months prior to screening
- previous exposure to investigational monoclonal antibodies or biologics
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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