AsthmaPhase 2NCT00967590
A Study of RO5036505 in Patients With Moderate to Severe Asthma
A Phase 2 study testing RO5036505 in people with Asthma, run by Hoffmann-La Roche at 16 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- RO5036505
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Sep 2009to Aug 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States14 sites
Study site
Boston, Massachusetts, 02115
Study site
Cincinnati, Ohio, 45242
Study site
Cleveland, Ohio, 44195
Study site
Denver, Colorado, 80206
Study site
Galveston, Texas, 77555-0561
Study site
Little Rock, Arkansas, 72202
Study site
Madison, Wisconsin, 53792
Study site
Normal, Illinois, 61761
Study site
Omaha, Nebraska, 68131
Study site
Pittsburgh, Pennsylvania, 15213
Study site
River Forest, Illinois, 60305
Study site
San Diego, California, 92103
Study site
Spartanburg, South Carolina, 29303
Study site
St Louis, Missouri, 63130
United Kingdom2 sites
Study site
Hereford, HR1 2ER
Study site
Manchester, M23 9QZ
About this study
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
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.
- Conditions
- Asthma
- Being tested
- RO5036505, placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5036505Drug
380mg iv infusion once weekly for 8 weeks
placeboDrug
iv infusion once weekly for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RO5036505 |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACQ questionnaire, spirometry assessments, PEFR
Measured: every week up to day 95
Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters
Measured: assessed every week, laboratory parameters every 3-4 weeks, up to day 95
Secondary outcomes (1)
Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance
Measured: sampling every week up to day 95
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startSep 2009
- Study completionAug 2010 (estimated)
Why it stopped: No patients dosed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967590
- Sponsor's protocol ID
- PP22666
- Other IDs
- 2009-013379-23, 2009
- Status last verified
- Aug 2016
- First submitted
- 21 Aug 2009
- Last updated
- 24 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00967590
- Acronym / sponsor ID
- PP22666
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients dosed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Study completion
- Aug 2010 (estimated)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RO5036505 |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO5036505380mg iv infusion once weekly for 8 weeks | Drug | 1 |
| placeboiv infusion once weekly for 8 weeks | Drug | 2 |
Primary outcome
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
1 secondary outcome
Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance
Time frame: sampling every week up to day 95
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO5036505 in people with Asthma, run by Hoffmann-La Roche at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACQ questionnaire, spirometry assessments, PEFR (time frame: every week up to day 95). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.