A Multi-center, Randomized, Double-Blind, Multiple-Dose, Placebo-controlled Asthma Control Study Evaluating the Efficacy, Safety, and Tolerability of RO5036505 in Subjects With Moderate-to-Severe Asthma
Overview
- Phase
- Phase 2
- Intervention
- RO5036505
- Conditions
- Asthma
- Sponsor
- Hoffmann-La Roche
- Primary Endpoint
- Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Intervention: RO5036505
2
Intervention: placebo
Outcomes
Primary Outcomes
Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters
Time Frame: assessed every week, laboratory parameters every 3-4 weeks, up to day 95
ACQ questionnaire, spirometry assessments, PEFR
Time Frame: every week up to day 95
Secondary Outcomes
- Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance(sampling every week up to day 95)