A Study of RO5036505 in Patients With Moderate to Severe Asthma

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00967590

Enrollment

Registered

2009-08-28

Start date

2009-09-30

Completion date

2010-08-31

Last updated

2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DRUGRO5036505

380mg iv infusion once weekly for 8 weeks

DRUGplacebo

iv infusion once weekly for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy 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

Design outcomes

Primary

Measure	Time frame
ACQ questionnaire, spirometry assessments, PEFR	every week up to day 95
Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters	assessed every week, laboratory parameters every 3-4 weeks, up to day 95

Secondary

Measure	Time frame
Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance	sampling every week up to day 95

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026