AsthmaPhase 2NCT01478360
Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma
A Phase 2 study testing AIN457 (secukinumab) in people with Asthma, run by Novartis Pharmaceuticals at 9 sites in 2 countries.
Trial summary
This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial asthma that is poorly controlled with the current standard of care. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- AIN457 (secukinumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Mar 2012to Nov 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with asthma >1 year duration diagnosed according to the GINA guidelines (GINA 2010).
- Daily treatment with > 1000μg beclomethasone dipropionate or equivalent, plus a long acting beta agonist for ≥ 3 months prior to Day 1, that has been stable for at least 4 weeks prior to screening.
- Asthma which is not adequately controlled on current treatment
- Peripheral blood eosinophil count < 400/μl at screening
Who cannot join
- Women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
- Use of other investigational drugs at the time of screening, or within 30 days of screening.
- Smokers
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany5 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Großhansdorf, 22927
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Wiesbaden, Germany, 65187
United Kingdom4 sites
Novartis Investigative Site
Leicester, LE3 9QP
Novartis Investigative Site
London, United Kingdom, SE11YR
Novartis Investigative Site
London, SW3 6PH
Novartis Investigative Site
Manchester, M23 9QZ
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous Administration of Secukinumab (AIN457) in Patients With Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting Beta-agonists.
This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial asthma that is poorly controlled with the current standard of care.
- Conditions
- Asthma
- Being tested
- AIN457 (secukinumab), Placebo
- Keywords
- Asthma, Secukinumab, Therapeutic Uses, Respiratory, Lung, Pulmonary, inhaled, corticosteroids
- Medical subject headings
- Asthma, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIN457 (secukinumab)Drug
Secukinumab intravenous injection
PlaceboDrug
Placebo intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| AIN457 | Experimental | AIN457 10 mg/kg Receives: Drug: AIN457 (secukinumab) |
| Placebo | Placebo comparator | Placebo intravenous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score
The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores.
Measured: Baseline and 85 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Further investigations would require changes in study design; the use of different endpoints, a different IL-17 antibody or a different patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478360
- Sponsor's protocol ID
- CAIN457D2204
- Status last verified
- Oct 2015
- First submitted
- 17 Nov 2011
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous Administration of Secukinumab (AIN457) in Patients With Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting Beta-agonists.
- ClinicalTrials.gov ID
- NCT01478360
- Acronym / sponsor ID
- CAIN457D2204
- Conditions
- Asthma
- Keywords
- Asthma, Secukinumab, Therapeutic Uses, Respiratory, Lung, Pulmonary, inhaled, corticosteroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Further investigations would require changes in study design; the use of different endpoints, a different IL-17 antibody or a different patient population.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Posted 20 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a preliminary proof of efficacy study of AIN457 in patients with bronchial asthma that is poorly controlled with the current standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIN457 | Experimental | Drug: AIN457 (secukinumab)AIN457 10 mg/kg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo intravenous injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with asthma >1 year duration diagnosed according to the GINA guidelines (GINA 2010).
- Daily treatment with > 1000μg beclomethasone dipropionate or equivalent, plus a long acting beta agonist for ≥ 3 months prior to Day 1, that has been stable for at least 4 weeks prior to screening.
- Asthma which is not adequately controlled on current treatment
- Peripheral blood eosinophil count < 400/μl at screening
Key exclusion criteria (3 listed)
- Women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
- Use of other investigational drugs at the time of screening, or within 30 days of screening.
- Smokers
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 |
|---|---|---|
| AIN457 (secukinumab)Secukinumab intravenous injection | Drug | AIN457 |
| PlaceboPlacebo intravenous injection | Drug | Placebo |
Primary outcome
Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score
Time frame: Baseline and 85 Days
The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
9 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 AIN457 (secukinumab) in people with Asthma, run by Novartis Pharmaceuticals at 9 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 4 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: stopped early, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, 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?
Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score (time frame: Baseline and 85 Days). 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 20 Nov 2015.