AsthmaPhase 2NCT01018550
AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma
A Phase 2 study testing AMG 853 in people with Asthma, run by Amgen.
Trial summary
The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- AMG 853
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 397 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Mar 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 18 to 65 years of age
- Percent of predicted FEV1 ≥ 50% and ≤ 80%
- At least 12% reversibility over pre-bronchodilator FEV1
- Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent.
- Ongoing asthma symptoms with ACQ score ≥ 1.5 points
Who cannot join
- History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
- Any uncontrolled, clinically significant systemic disease
- Respiratory infection within 4 weeks of the screening visit
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects With Inadequately Controlled Asthma
The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.
- Conditions
- Asthma
- Being tested
- AMG 853, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 853Drug
AMG 853 5 mg (BID)
AMG 853Drug
AMG 853 200 mg (QD)
AMG 853Drug
AMG 853 25 mg (BID)
AMG 853Drug
AMG 853 100 mg (BID)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AMG 853 | Experimental | Not described Receives: Drug: AMG 853 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.
Measured: Baseline to Week 12
Secondary outcomes (5)
Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)
Measured: Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days)
Measured: Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)
Measured: Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR)
Measured: Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ)
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Who is masked
- Participant, Investigator
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018550
- Sponsor's protocol ID
- 20080615
- Status last verified
- Feb 2016
- First submitted
- 19 Nov 2009
- Last updated
- 23 Mar 2016
- Results posted
- No
Publications
Busse WW, Wenzel SE, Meltzer EO, Kerwin EM, Liu MC, Zhang N, Chon Y, Budelsky AL, Lin J, Lin SL. Safety and efficacy of the prostaglandin D2 receptor antagonist AMG 853 in asthmatic patients. J Allergy Clin Immunol. 2013 Feb;131(2):339-45. doi: 10.1016/j.jaci.2012.10.013. Epub 2012 Nov 20.
PubMed 23174659
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects With Inadequately Controlled Asthma
- ClinicalTrials.gov ID
- NCT01018550
- Acronym / sponsor ID
- 20080615
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 Nov 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.
The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 853 | Experimental | Drug: AMG 853 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females 18 to 65 years of age
- Percent of predicted FEV1 ≥ 50% and ≤ 80%
- At least 12% reversibility over pre-bronchodilator FEV1
- Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent.
- Ongoing asthma symptoms with ACQ score ≥ 1.5 points
Key exclusion criteria (3 listed)
- History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
- Any uncontrolled, clinically significant systemic disease
- Respiratory infection within 4 weeks of the screening visit
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 |
|---|---|---|
| AMG 853AMG 853 5 mg (BID) | Drug | AMG 853 |
| AMG 853AMG 853 200 mg (QD) | Drug | AMG 853 |
| AMG 853AMG 853 25 mg (BID) | Drug | AMG 853 |
| AMG 853AMG 853 100 mg (BID) | Drug | AMG 853 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.
Time frame: Baseline to Week 12
5 secondary outcomes
Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)
Time frame: Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days)
Time frame: Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)
Time frame: Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR)
Time frame: Baseline to Week 12
Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ)
Time frame: Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- Background: PubMed 23174659Busse WW, Wenzel SE, Meltzer EO, Kerwin EM, Liu MC, Zhang N, Chon Y, Budelsky AL, Lin J, Lin SL. Safety and efficacy of the prostaglandin D2 receptor antagonist AMG 853 in asthmatic patients. J Allergy Clin Immunol. 2013 Feb;131(2):339-45. doi: 10.1016/j.jaci.2012.10.013. Epub 2012 Nov 20.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 853 in people with Asthma, run by Amgen.
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 3 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: finished, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12. (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01018550, which also lists 1 linked publication.
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 23 Mar 2016.