A Study of RO5036505 in Patients With Moderate to Severe Asthma

Hoffmann-La Roche

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Asthma

Interventions

RO5036505DRUG

380mg iv infusion once weekly for 8 weeks

placeboDRUG

iv infusion once weekly for 8 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (16)

Unnamed facility

Little Rock, Arkansas, United States

Unnamed facility

San Diego, California, United States

Unnamed facility

Denver, Colorado, United States

Outcomes

Primary Outcomes

ACQ questionnaire, spirometry assessments, PEFR

Time frame: every week up to day 95

Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters

Time frame: assessed every week, laboratory parameters every 3-4 weeks, up to day 95

Secondary Outcomes

Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance

Time frame: sampling every week up to day 95

Data from ClinicalTrials.gov

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