AsthmaPhase 3NCT01449162
Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids
A Phase 3 study testing Masitinib in people with Asthma, run by AB Science at 8 sites in 6 countries.
Trial summary
The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Masitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Jan 2011to Nov 2019
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main inclusion criteria:
- Patient with severe asthma and already treated with oral corticosteroids at a minimal daily dose of 7.5 mg prednisone or equivalent for at least 3 months prior to screening visit
- Patient treated with oral corticosteroids during at least one period of 21 days, from 1 year prior to screening to 3 months before screening
- Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit
- Non-smoker patient for at least 1 year and with a prior tobacco consumption < 10 packs/year
Main exclusion criteria:
- Patient with active lung disease other than asthma (e.g. chronic bronchitis)
- Female patient who is pregnant or lactating
- Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
- Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
France3 sites
Hospital La Cavale Blanche
Brest, 29609
l'Hopital Albert Calmette
Lille
l'Hopital de la Croix Rousse
Lyon, 69317
Hungary1 site
University of Debrecen Medical and Health Science Center
Debrecen, 4032
About this study
Official title: A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and the Safety of Masitinib at 6 mg/kg/Day Versus Placebo in the Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids
The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.
Read the detailed description
Masitinib is a selective tyrosine kinase inhibitor. It is known that activation of inflammatory cells, such as mast cells, and fibrous tissue remodeling are associated with c-Kit, Lyn and PDGFR kinase signaling pathways; all key targets of masitinib. The objective of this study is to compare the efficacy and safety of masitinib at 6 mg/kg/day versus matched placebo in severe persistent asthma patients that is uncontrolled with oral corticosteroids. The primary outcome measure will be severe asthma exacerbation rate over duration of the treatment.
- Conditions
- Asthma
- Being tested
- Masitinib, Placebo
- Keywords
- severe persistent asthma, tyrosine kinase inhibitor
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MasitinibDrug
Also called AB1010
6 mg/kg/day
PlaceboDrug
Also called Placebo Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Masitinib as add-on to oral corticosteroids | Experimental | Participants receive masitinib (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids Receives: Drug: Masitinib |
| Placebo as add-on to oral corticosteroids | Placebo comparator | Participants receive placebo (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe asthma exacerbation rate
The number of severe asthma exacerbations over time frame of outcome measure
Measured: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
Secondary outcomes (2)
Asthma exacerbation rate
The number of asthma exacerbations over time frame of outcome measure
Measured: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
ACQ Score
Asthma Control Questionnaire (ACQ) Score
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2019
- Study completionNov 2019
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lavinia Davidescu, MD, PhD, Principal investigator, University of Medicine and Pharmacy Oradea, Oradea, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449162
- Sponsor's protocol ID
- AB07015
- Status last verified
- Feb 2021
- First submitted
- 6 Oct 2011
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and the Safety of Masitinib at 6 mg/kg/Day Versus Placebo in the Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids
- ClinicalTrials.gov ID
- NCT01449162
- Acronym / sponsor ID
- AB07015
- Conditions
- Asthma
- Keywords
- severe persistent asthma, tyrosine kinase inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Jan 2011 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 10 Oct 2011 (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 study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.
Detailed description
Masitinib is a selective tyrosine kinase inhibitor. It is known that activation of inflammatory cells, such as mast cells, and fibrous tissue remodeling are associated with c-Kit, Lyn and PDGFR kinase signaling pathways; all key targets of masitinib. The objective of this study is to compare the efficacy and safety of masitinib at 6 mg/kg/day versus matched placebo in severe persistent asthma patients that is uncontrolled with oral corticosteroids. The primary outcome measure will be severe asthma exacerbation rate over duration of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Masitinib as add-on to oral corticosteroids | Experimental | Drug: MasitinibParticipants receive masitinib (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids |
| Placebo as add-on to oral corticosteroids | Placebo comparator | Drug: PlaceboParticipants receive placebo (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MasitinibAlso: AB10106 mg/kg/day | Drug | Masitinib as add-on to oral corticosteroids |
| PlaceboAlso: Placebo Oral Tablet | Drug | Placebo as add-on to oral corticosteroids |
Primary outcome
Severe asthma exacerbation rate
Time frame: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
The number of severe asthma exacerbations over time frame of outcome measure
2 secondary outcomes
Asthma exacerbation rate
Time frame: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
ACQ Score
Time frame: 36 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 10 Feb 2021.
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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.
Lavinia Davidescu, MD, PhD principal investigator
University of Medicine and Pharmacy Oradea, Oradea, Romania
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Masitinib in people with Asthma, run by AB Science at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Bulgaria, Czechia, Hungary, India and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Severe asthma exacerbation rate (time frame: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months). 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 10 Feb 2021.