Severe AsthmaPhase 4PREDICTUMABNCT03476109
Study of Magnitude and Prediction of Response to Omalizumab and Mepolizumab in Adult Severe Asthma.
A Phase 4 study testing Randomisation to omalizumab and Randomisation to mepolizumab in people with Severe Asthma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 13 sites in Belgium.
Trial summary
Pragmatic trial to define the magnitude and the predictive factors of the response to omalizumab and mepolizumab in adult patients with severe refractory asthma and eligible to both therapies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Asthma
- What is being tested?
- Randomisation to omalizumab and Randomisation to mepolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 13 sitesBelgium
- Study dates
- 10 May 2019to 31 Dec 2024
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18+ years at time of signing ICF,
- Able to comply with the study protocol, in the investigator's judgment,
- Documented physician-diagnosed asthma ,
- Patients with severe disease and eligible to omalizumab and mepolizumab, and who have not yet received any of these therapies.
Who cannot join
- 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
- Treatment with any investigational therapy within 6 months or 5 drug half-lives prior to enrolment.
- Known sensitivity to any of the active substances or their excipients to be administered during the study.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Belgium13 sites, 13 recruiting
- Not yet recruiting
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, 1090
Shane Hanon, MD
- Not yet recruiting
Centre Hospitalier Universitaire Saint Pierre
Brussels, 1000
Vincent Ninane, MD
- Not yet recruiting
Brugmann University Hospital
Brussels, 1020
Olivier Michel, MD, PhD
- Not yet recruiting
Erasme University Hospital
Brussels, 1070
Alain Michils, MD
- Recruiting
Cliniques universitaires St-Luc
Brussels, 1200
Pilette Charles, MD PhD, 003227642866 ext. 2866, charles.pilette@uclouvain.be
Irina Kaidalina-Mambour, Inf, 003227642813 ext. 2813, irina.kaidalina-mambour@uclouvain.be
- Not yet recruiting
CHU de Charleroi
Charleroi, Hainaut, 6000
Rudi Peche, MD
- Not yet recruiting
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6000
Pol-Marie Mingeot, MD
- Not yet recruiting
University Hospital, Ghent
Ghent, 9000
Guy Brusselle, MD, PhD
- Not yet recruiting
Katholieke Universiteit Leuven
Leuven, Vlaams Brabant, 3000
Lieven Dupont, MD, PhD
- Not yet recruiting
University Hospital of Liege
Liège, 4000
Florence Schleich, MD, PhD
- Not yet recruiting
CHR Namur
Namur, 5000
Vincent Hers, MD
- Not yet recruiting
Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
Namur, 5530
Olivier Vandenplas, MD, PhD
- Not yet recruiting
AZ Delta Roeselare
Roeselare, West-vlaanderen, 8800
Ulriche Himpe, MD
About this study
Official title: Predictive Factors and Magnitude of Response to Omalizumab and Mepolizumab in Allergic and Eosinophilic Severe Asthma: a Pragmatic Multicenter Trial in Belgium.
Pragmatic trial to define the magnitude and the predictive factors of the response to omalizumab and mepolizumab in adult patients with severe refractory asthma and eligible to both therapies.
Read the detailed description
Title "PREDICTUMAB: Predictive factors and magnitude of response to omalizumab and mepolizumab in allergic and eosinophilic severe asthma: a multicenter, open, active-controlled, randomized trial in adult patients in Belgium".
Rationale and background New treatments are now available to treat severe refractory asthma, which affects about 3 to 5% of asthma patients. In particular, biological therapies using monoclonal antibodies targeted to immunoglobulin E (IgE) or interleukin (IL)-5 (and in the future other cytokines or growth factors) benefit to certain patients. Identifying those patients who will better benefit from a specific treatment requires the validation of features (clinical traits, biomarkers) that are predictive of the therapeutic outcome. Such predictive strategy is not available to decide whether anti-IgE (omalizumab) or anti-IL-5 (mepolizumab) should be prioritized in patients who are eligible to both therapies. In addition, the comparison of the magnitude of the clinical benefits achieved by these therapies remains unexplored in this population.
Study Design
The study is designed to initially randomly allocate patients from two strata (with or without maintenance oral corticosteroids) to oma- vs mepolizumab. According to the evaluation of response (at 4 or 6 months, respectively), subjects will then be either prolonged (for 12 months, for both therapies) on the same therapy, or switched to the other. For those who were switched, treatment will be prolonged (or not, in dual failers) after 4 or 6 months according to their evaluation of response. Time-points for analysis will be at 4 or 6 months, 10 months (interim analysis) and 18 or 22 months (final, posttreatment analysis).
State-of-the-art
Asthma is one of the most frequent chronic diseases, affecting 5 to 10% of the population worldwide. Omalizumab and mepolizumab represent the approved antibodies that are indicated in allergic and eosinophilic phenotypes of severe asthma respectively. However, if some patients fall into only one phenotypic category based on these criteria, a substantial number of patients are potentially eligible to both therapies. In those patients, no information is available to orientate towards a preferable therapy as the predictive weight of additional phenotypic traits, such as associated nasal polyps or early- versus late onset of disease, remains unknown. In addition, no head-to-head comparison of these therapies is available in this population.
Objectives of the study
Primary objectives To determine clinical features and blood (or sputum) biomarkers able to predict a better response to omalizumab or mepolizumab in severe asthma patients eligible to both therapies.
To determine the magnitude of response, in terms of improvement in symptoms, exacerbation rate and/or lung function, in responders to omalizumab vs mepolizumab.
Secondary objectives To compare the global baseline characteristics (clinical and biological features) of patients responding to omalizumab vs mepolizumab.
Management and reporting of adverse events.
If during the study, an adverse event (AE) (serious or non-serious) is identified as attributed to omalizumab or mepolizumab, this will be documented as appropriate in routine good clinical practice, to the Federal Agency of Medicines and Products of Health (AFMPS) as well as to the Central Ethic Committee.
Confidentiality of data.
The identity and participation of subjects will remain strictly confidential, according to Belgian laws dated 8 Dec 1992 related to the protection of private life and dated 22 Aug 2002 related to patient rights.
Specimens and associated data will be labeled with unique patient identification number.
Data will be anonymized in all files, results and publications related to the study.
The promoter confirms to authorize the regulatory surveillance, examination and controls by competent authorities, by allowing direct access to database/files, and this in full respect of confidentiality.
- Conditions
- Severe Asthma
- Being tested
- Randomisation to omalizumab, Randomisation to mepolizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomisation to omalizumabDrug
Also called Active-controlled
The only intervention will be that allocation of patients to omalizumab or mepolizumab (to both of which patients will be eligible) will be randomized, to avoid that the initial decision is biased by confounding factors that are likely, but unproven, to affect the treatment response. Then, in case of non-response, patients will be switched to the other drug, as routine clinical practice would indicate.
Randomisation to mepolizumabDrug
Also called Active-controlled
The only intervention will be that allocation of patients to omalizumab or mepolizumab (to both of which patients will be eligible) will be randomized, to avoid that the initial decision is biased by confounding factors that are likely, but unproven, to affect the treatment response. Then, in case of non-response, patients will be switched to the other drug, as routine clinical practice would indicate.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Active comparator | Patients randomized to omalizumab and then prolonged or not (based on their response at 4 months) until the end of the study (22mo).
Non responders will be switched to mepolizumab arm. Receives: Drug: Randomisation to mepolizumab |
| Mepolizumab | Active comparator | Patients randomized to mepolizumab and then prolonged or not (based on their response at 6 months) until the end of the study (22mo).
Non responders will be switched to omalizumab arm. Receives: Drug: Randomisation to omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy on asthma symptoms
Asthma Control Test: 5 items of score 1 to 5 about symptoms, with result of 20 or above indicates good control; 15 to 19 indicates no good control and below 15 indicates no control at all, and a change of 3 points considered as clinically significant.
Measured: Up to 22 months
Efficacy on lung function
Lung function measured as forced expiratory volume in one sec (FEV1), % predicted value (normal value of 80% predicted or above, and change of 100 mL considered as clinically significant).
Measured: Up to 22 months
Efficacy on severe exacerbations
Number of exacerbation(s) per period of time (corrected per year) requiring systemic corticosteroid treatment for at least 3 days, and/or emergency visit or hospitalization for acute asthma.
Measured: Up to 22 months
Secondary outcomes (1)
Predictive factors of therapeutic response
The putative predictive factors of therapeutic response to omalizumab or mepolizumab which will be assayed are the following: age at onset, year (> or < 30yrs); presence of nasal polyps, Y/N; blood eosinophils, n/microliter (< or > 300/microl); serum total IgE, units/L; serum periostin, ng/ml. A proteomic analysis will also be carried out on plasma samples.
Measured: Baseline features (and according to response at 22 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start10 May 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Severe asthma patients who are eligible to both anti-IgE (omalizumab) and anti-IL-5 (mepolizumab) therapies, will be randomized to decide the first treatment to start. Patients will then be prolonged or switched to the other according to the clinical response. There will be 5 possibilities: oma(lizumab) group, mepo(lizumab) group, oma-mepo switch, mepo-oma switch, and oma/mepo failure.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, University of Liege, CHU de Charleroi, Erasme University Hospital, Centre Hospitalier Universitaire UCLouvain Namur, Universitair Ziekenhuis Brussel, Brugmann University Hospital, Grand Hôpital de Charleroi, AZ Delta, Centre Hospitalier Universitaire Saint Pierre, KU Leuven
- Responsible party
- Sponsor
- Investigators
- Charles Pilette, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476109
- Sponsor's protocol ID
- 2017/19JUI/325
- Other IDs
- PNEU-ASTHMA-02, 2017-002473-19, 2017
- Acronym
- PREDICTUMAB
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2017
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors and Magnitude of Response to Omalizumab and Mepolizumab in Allergic and Eosinophilic Severe Asthma: a Pragmatic Multicenter Trial in Belgium.
- ClinicalTrials.gov ID
- NCT03476109
- Acronym / sponsor ID
- PREDICTUMAB / 2017/19JUI/325
- Conditions
- Severe Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, University of Liege, CHU de Charleroi, Erasme University Hospital, Centre Hospitalier Universitaire UCLouvain Namur, Universitair Ziekenhuis Brussel, Brugmann University Hospital, Grand Hôpital de Charleroi, AZ Delta, Centre Hospitalier Universitaire Saint Pierre, KU Leuven
- Study start
- 10 May 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Mar 2018 (actual)
- 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.
Pragmatic trial to define the magnitude and the predictive factors of the response to omalizumab and mepolizumab in adult patients with severe refractory asthma and eligible to both therapies.
Detailed description
Title "PREDICTUMAB: Predictive factors and magnitude of response to omalizumab and mepolizumab in allergic and eosinophilic severe asthma: a multicenter, open, active-controlled, randomized trial in adult patients in Belgium".
Rationale and background New treatments are now available to treat severe refractory asthma, which affects about 3 to 5% of asthma patients. In particular, biological therapies using monoclonal antibodies targeted to immunoglobulin E (IgE) or interleukin (IL)-5 (and in the future other cytokines or growth factors) benefit to certain patients. Identifying those patients who will better benefit from a specific treatment requires the validation of features (clinical traits, biomarkers) that are predictive of the therapeutic outcome. Such predictive strategy is not available to decide whether anti-IgE (omalizumab) or anti-IL-5 (mepolizumab) should be prioritized in patients who are eligible to both therapies. In addition, the comparison of the magnitude of the clinical benefits achieved by these therapies remains unexplored in this population.
Study Design
The study is designed to initially randomly allocate patients from two strata (with or without maintenance oral corticosteroids) to oma- vs mepolizumab. According to the evaluation of response (at 4 or 6 months, respectively), subjects will then be either prolonged (for 12 months, for both therapies) on the same therapy, or switched to the other. For those who were switched, treatment will be prolonged (or not, in dual failers) after 4 or 6 months according to their evaluation of response. Time-points for analysis will be at 4 or 6 months, 10 months (interim analysis) and 18 or 22 months (final, posttreatment analysis).
State-of-the-art
Asthma is one of the most frequent chronic diseases, affecting 5 to 10% of the population worldwide. Omalizumab and mepolizumab represent the approved antibodies that are indicated in allergic and eosinophilic phenotypes of severe asthma respectively. However, if some patients fall into only one phenotypic category based on these criteria, a substantial number of patients are potentially eligible to both therapies. In those patients, no information is available to orientate towards a preferable therapy as the predictive weight of additional phenotypic traits, such as associated nasal polyps or early- versus late onset of disease, remains unknown. In addition, no head-to-head comparison of these therapies is available in this population.
Objectives of the study
Primary objectives To determine clinical features and blood (or sputum) biomarkers able to predict a better response to omalizumab or mepolizumab in severe asthma patients eligible to both therapies.
To determine the magnitude of response, in terms of improvement in symptoms, exacerbation rate and/or lung function, in responders to omalizumab vs mepolizumab.
Secondary objectives To compare the global baseline characteristics (clinical and biological features) of patients responding to omalizumab vs mepolizumab.
Management and reporting of adverse events.
If during the study, an adverse event (AE) (serious or non-serious) is identified as attributed to omalizumab or mepolizumab, this will be documented as appropriate in routine good clinical practice, to the Federal Agency of Medicines and Products of Health (AFMPS) as well as to the Central Ethic Committee.
Confidentiality of data.
The identity and participation of subjects will remain strictly confidential, according to Belgian laws dated 8 Dec 1992 related to the protection of private life and dated 22 Aug 2002 related to patient rights.
Specimens and associated data will be labeled with unique patient identification number.
Data will be anonymized in all files, results and publications related to the study.
The promoter confirms to authorize the regulatory surveillance, examination and controls by competent authorities, by allowing direct access to database/files, and this in full respect of confidentiality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Severe asthma patients who are eligible to both anti-IgE (omalizumab) and anti-IL-5 (mepolizumab) therapies, will be randomized to decide the first treatment to start. Patients will then be prolonged or switched to the other according to the clinical response. There will be 5 possibilities: oma(lizumab) group, mepo(lizumab) group, oma-mepo switch, mepo-oma switch, and oma/mepo failure.
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Active comparator | Drug: Randomisation to mepolizumabPatients randomized to omalizumab and then prolonged or not (based on their response at 4 months) until the end of the study (22mo). Non responders will be switched to mepolizumab arm. |
| Mepolizumab | Active comparator | Drug: Randomisation to omalizumabPatients randomized to mepolizumab and then prolonged or not (based on their response at 6 months) until the end of the study (22mo). Non responders will be switched to omalizumab arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18+ years at time of signing ICF,
- Able to comply with the study protocol, in the investigator's judgment,
- Documented physician-diagnosed asthma ,
- Patients with severe disease and eligible to omalizumab and mepolizumab, and who have not yet received any of these therapies.
Key exclusion criteria (3 listed)
- 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
- Treatment with any investigational therapy within 6 months or 5 drug half-lives prior to enrolment.
- Known sensitivity to any of the active substances or their excipients to be administered during the study.
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 |
|---|---|---|
| Randomisation to omalizumabAlso: Active-controlledThe only intervention will be that allocation of patients to omalizumab or mepolizumab (to both of which patients will be eligible) will be randomized, to avoid that the initial decision is biased by confounding factors that are likely, but unproven, to affect the treatment response. Then, in case of non-response, patients will be switched to the other drug, as routine clinical practice would indicate. | Drug | Mepolizumab |
| Randomisation to mepolizumabAlso: Active-controlledThe only intervention will be that allocation of patients to omalizumab or mepolizumab (to both of which patients will be eligible) will be randomized, to avoid that the initial decision is biased by confounding factors that are likely, but unproven, to affect the treatment response. Then, in case of non-response, patients will be switched to the other drug, as routine clinical practice would indicate. | Drug | Omalizumab |
Primary outcome
Efficacy on asthma symptoms
Time frame: Up to 22 months
Asthma Control Test: 5 items of score 1 to 5 about symptoms, with result of 20 or above indicates good control; 15 to 19 indicates no good control and below 15 indicates no control at all, and a change of 3 points considered as clinically significant.
Efficacy on lung function
Time frame: Up to 22 months
Lung function measured as forced expiratory volume in one sec (FEV1), % predicted value (normal value of 80% predicted or above, and change of 100 mL considered as clinically significant).
Efficacy on severe exacerbations
Time frame: Up to 22 months
Number of exacerbation(s) per period of time (corrected per year) requiring systemic corticosteroid treatment for at least 3 days, and/or emergency visit or hospitalization for acute asthma.
1 secondary outcome
Predictive factors of therapeutic response
Time frame: Baseline features (and according to response at 22 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Severe Asthma
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
RecruitingPhase 2
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Asthma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig ( PF-07275315) in People With Severe Asthma
Asthma
RecruitingPhase 3
Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab
Severe Asthma
Active, not recruitingPhase 3
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Asthma
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.
Charles Pilette principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Randomisation to omalizumab and Randomisation to mepolizumab in people with Severe Asthma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 13 sites in Belgium.
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: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Belgium. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Pilette, MD PhD (003227642866 ext. 2866, charles.pilette@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy on asthma symptoms (time frame: Up to 22 months). The study lists 3 primary outcomes in all. 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 27 Oct 2022.