A Study of RO5036505 in Patients With Moderate to Severe Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00967590
• Other study ID #: PP22666
• Secondary ID: 2009-013379-23
• Status: Withdrawn
• Phase: Phase 2
• First received: August 21, 2009
• Last updated: August 23, 2016
• Start date: September 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• RO5036505
380mg iv infusion once weekly for 8 weeks
• placebo
iv infusion once weekly for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACQ questionnaire, spirometry assessments, PEFR		every week up to day 95	No
Primary	Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters		assessed every week, laboratory parameters every 3-4 weeks, up to day 95	No
Secondary	Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance		sampling every week up to day 95	No