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Predictive factors and magnitude of response to omalizumab and mepolizumab in allergic and eosinophilic severe asthma: PREDICTUMAB, an open-label, controlled, randomized multinational pragmatic trial.
EU CTIS ID: 2024-516783-29-00
What this study is testing
To compare the rate and magnitude of response to omalizumab and mepolizumab in patients with severe allergic and eosinophilic asthma, in terms of annual rate of severe exacerbations (primary outcome).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent form (ICF)
- Age >18+ years (18-90 years old) at time of signing ICF
- Able to comply with the study protocol, in the investigator’s judgment
- Documented physician-diagnosed asthma
- Eligible to omalizumab and mepolizumab and who have not yet received any of these therapies
You likely can't join if
- History of evidence of drug/substance abuse that would pose a risk to patient safety, interfere with the conduct of study, have an impact on the study results, or affect the patient’s ability to participate in the study, in the opinion of the investigator
- Difficult to treat asthma and others severe respiratory diseases
- Patient already currently/actively enrolled in a clinical therapeutic trial (testing another drug); the concomitant inclusion in a Registry, which may include biosampling, is not an exclusion criterion
- Protected subjects (sous tutelle or curatelle), patients who are unable to express their consent, subjects who are deprived of liberty, subjects who are hospitalized without consent, subjects who are admitted in a health-care or social institute with another aim than that of the research, inclusion in an emergency situation, patient who is subject to a court order
- Pregnant, post-partum or lactating women
- Known sensitivity to any of the active substances or their excipients to be administered during the study
See the full eligibility criteria
- Signed informed consent form (ICF)
- Age >18+ years (18-90 years old) at time of signing ICF
- Able to comply with the study protocol, in the investigator’s judgment
- Documented physician-diagnosed asthma
- Eligible to omalizumab and mepolizumab and who have not yet received any of these therapies
- History of evidence of drug/substance abuse that would pose a risk to patient safety, interfere with the conduct of study, have an impact on the study results, or affect the patient’s ability to participate in the study, in the opinion of the investigator
- Difficult to treat asthma and others severe respiratory diseases
- Patient already currently/actively enrolled in a clinical therapeutic trial (testing another drug); the concomitant inclusion in a Registry, which may include biosampling, is not an exclusion criterion
- Protected subjects (sous tutelle or curatelle), patients who are unable to express their consent, subjects who are deprived of liberty, subjects who are hospitalized without consent, subjects who are admitted in a health-care or social institute with another aim than that of the research, inclusion in an emergency situation, patient who is subject to a court order
- Pregnant, post-partum or lactating women
- Known sensitivity to any of the active substances or their excipients to be administered during the study
- Active malignancy or malignancy in remission over less than 5 years
- Patient not affiliated to a health insurance plan (FR)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.