AsthmaPhase 2NCT00436670
Phase II Study to Evaluate the Efficacy of AMG 317
A Phase 2 study testing AMG 317 75 mg, AMG 317 150 mg and AMG 317 300 mg in people with Asthma, run by Amgen.
Trial summary
A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom 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 317 75 mg, AMG 317 150 mg and AMG 317 300 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Feb 2009
- 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 at the time of screening
- Baseline percent of predicted FEV1 ≥ 50% to ≤ 80% at screening
- At least 12% reversibility over baseline FEV1 with beta agonist inhalation, which can be demonstrated in the office or documented by medical record within the past 12 months
- Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent. Stable ICS dose for ≥ 30 days before screening and dose expected to remain stable during treatment with investigational agent. Must have used ICS for at least the last 3 consecutive months before screening
- If receiving allergen immunotherapy, a stable dose for > 3 months before screening and anticipated to remain stable for the duration of the study
- Positive to skin prick or RAST
- Ongoing asthma symptoms with ACQ score at screening and baseline ≥ 1.5 points
- Nonsmoker or ex-smoker with < 10 pack-years (eg, 1 pack per day for 10 years) who stopped ≥ 1 year ago
Who cannot join
- Acute asthma exacerbation requiring emergency room (ER) treatment or hospitalization within 3 months
- History of endotracheal intubation for asthma-related exacerbation within 3 years of screening
- Respiratory illness within 4 weeks of screening
- History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma
- Received long-acting beta agonist, theophylline, inhaled anticholinergics, oral beta 2 agonists, or cromolyn therapeutics within 1 week of first run-in visit.
- Leukotriene antagonists within 2 weeks before first run-in visit
Show all 9Show fewer
- Oral or parenteral corticosteroids within 6 weeks before first run-in visit
- Live/attenuated vaccinations within 4 weeks of screening or during the study
- Any uncontrolled, clinically significant systemic disease (eg, chronic renal failure, uncontrolled hypertension, liver disease)
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 317 in Subjects With Moderate to Severe Asthma
A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.
- Conditions
- Asthma
- Being tested
- AMG 317 75 mg, AMG 317 150 mg, AMG 317 300 mg, Placebo
- Keywords
- Asthma, Allergy, IL-13, IL-4, IL-4R
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 317 75 mgBiological
75 mg SC weekly injection
AMG 317 150 mgBiological
Also called AMG 317 300 mg dose
150 mg SC once weekly injection
AMG 317 300 mgBiological
300 mg weekly SC injection
PlaceboBiological
Placebo SC once weekly injection
| Study group | Role | What they receive |
|---|---|---|
| AMG 317 75 mg | Experimental | 75 subjects Receives: Biological: AMG 317 75 mg |
| Placebo Arm | Placebo comparator | 75 subjects Receives: Biological: Placebo |
| AMG 317 300 mg | Experimental | 75 subjects Receives: Biological: AMG 317 300 mg |
| AMG 317 150 mg | Experimental | 75 subjects Receives: Biological: AMG 317 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.
Measured: 12 weeks
Secondary outcomes (7)
Change from baseline in frequency of rescue beta agonist use during week 12
Measured: 12 weeks
Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation)
Measured: 12 weeks
Change in pre and post bronchodilator FEV1 at week 12 from baseline
Measured: 12 weeks
Number of asthma symptom-free days
Measured: 16 weeks
Change from baseline in daily asthma symptoms during week 12
Measured: 12 weeks
Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs
Measured: 16 weeks
Change in AQLQ score at week 12 from baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 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
- NCT00436670
- Sponsor's protocol ID
- 20060161
- Status last verified
- Feb 2016
- First submitted
- 15 Feb 2007
- Last updated
- 23 Mar 2016
- Results posted
- No
Publications
Meltzer EO, Busse WW, Wenzel SE, Belozeroff V, Weng HH, Feng J, Chon Y, Chiou CF, Globe D, Lin SL. Use of the Asthma Control Questionnaire to predict future risk of asthma exacerbation. J Allergy Clin Immunol. 2011 Jan;127(1):167-72. doi: 10.1016/j.jaci.2010.08.042. Epub 2010 Nov 18.
PubMed 21093024Corren J, Busse W, Meltzer EO, Mansfield L, Bensch G, Fahrenholz J, Wenzel SE, Chon Y, Dunn M, Weng HH, Lin SL. A randomized, controlled, phase 2 study of AMG 317, an IL-4Ralpha antagonist, in patients with asthma. Am J Respir Crit Care Med. 2010 Apr 15;181(8):788-96. doi: 10.1164/rccm.200909-1448OC. Epub 2010 Jan 7.
PubMed 20056900
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 317 in Subjects With Moderate to Severe Asthma
- ClinicalTrials.gov ID
- NCT00436670
- Acronym / sponsor ID
- 20060161
- Conditions
- Asthma
- Keywords
- Asthma, Allergy, IL-13, IL-4, IL-4R
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 19 Feb 2007 (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.
A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AMG 317 75 mg | Experimental | Biological: AMG 317 75 mg75 subjects |
| Placebo Arm | Placebo comparator | Biological: Placebo75 subjects |
| AMG 317 300 mg | Experimental | Biological: AMG 317 300 mg75 subjects |
| AMG 317 150 mg | Experimental | Biological: AMG 317 150 mg75 subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females 18 to 65 years of age at the time of screening
- Baseline percent of predicted FEV1 ≥ 50% to ≤ 80% at screening
- At least 12% reversibility over baseline FEV1 with beta agonist inhalation, which can be demonstrated in the office or documented by medical record within the past 12 months
- Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent. Stable ICS dose for ≥ 30 days before screening and dose expected to remain stable during treatment with investigational agent. Must have used ICS for at least the last 3 consecutive months before screening
- If receiving allergen immunotherapy, a stable dose for > 3 months before screening and anticipated to remain stable for the duration of the study
Key exclusion criteria (9 listed)
- Acute asthma exacerbation requiring emergency room (ER) treatment or hospitalization within 3 months
- History of endotracheal intubation for asthma-related exacerbation within 3 years of screening
- Respiratory illness within 4 weeks of screening
- History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma
- Received long-acting beta agonist, theophylline, inhaled anticholinergics, oral beta 2 agonists, or cromolyn therapeutics within 1 week of first run-in 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 317 75 mg75 mg SC weekly injection | Biological | AMG 317 75 mg |
| AMG 317 150 mgAlso: AMG 317 300 mg dose150 mg SC once weekly injection | Biological | AMG 317 150 mg |
| AMG 317 300 mg300 mg weekly SC injection | Biological | AMG 317 300 mg |
| PlaceboPlacebo SC once weekly injection | Biological | Placebo Arm |
Primary outcome
The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.
Time frame: 12 weeks
7 secondary outcomes
Change from baseline in frequency of rescue beta agonist use during week 12
Time frame: 12 weeks
Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation)
Time frame: 12 weeks
Change in pre and post bronchodilator FEV1 at week 12 from baseline
Time frame: 12 weeks
Number of asthma symptom-free days
Time frame: 16 weeks
Change from baseline in daily asthma symptoms during week 12
Time frame: 12 weeks
Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs
Time frame: 16 weeks
Change in AQLQ score at week 12 from baseline
Time frame: 12 weeks
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.
- Derived from this study: PubMed 21093024Meltzer EO, Busse WW, Wenzel SE, Belozeroff V, Weng HH, Feng J, Chon Y, Chiou CF, Globe D, Lin SL. Use of the Asthma Control Questionnaire to predict future risk of asthma exacerbation. J Allergy Clin Immunol. 2011 Jan;127(1):167-72. doi: 10.1016/j.jaci.2010.08.042. Epub 2010 Nov 18.
- Derived from this study: PubMed 20056900Corren J, Busse W, Meltzer EO, Mansfield L, Bensch G, Fahrenholz J, Wenzel SE, Chon Y, Dunn M, Weng HH, Lin SL. A randomized, controlled, phase 2 study of AMG 317, an IL-4Ralpha antagonist, in patients with asthma. Am J Respir Crit Care Med. 2010 Apr 15;181(8):788-96. doi: 10.1164/rccm.200909-1448OC. Epub 2010 Jan 7.
- 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 317 75 mg, AMG 317 150 mg and AMG 317 300 mg 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 8 inclusion and 9 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 evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12. (time frame: 12 weeks). 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 NCT00436670, which also lists 2 linked publications.
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.