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Study of Magnitude and Prediction of Response to Omalizumab and Mepolizumab in Adult Severe Asthma. (PREDICTUMAB)

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ClinicalTrials.gov Identifier: NCT03476109
Recruitment Status : Not yet recruiting
First Posted : March 23, 2018
Last Update Posted : April 10, 2019
Sponsor:
Collaborators:
University Hospital, Ghent
University Hospital of Liege
CHU de Charleroi
Erasme University Hospital
Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
Universitair Ziekenhuis Brussel
Brugmann University Hospital
Grand Hôpital de Charleroi
AZ Delta
Centre Hospitalier Universitaire Saint Pierre
KU Leuven
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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.

Condition or disease Intervention/treatment Phase
Severe Asthma Drug: Randomisation to omalizumab Drug: Randomisation to mepolizumab Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: The analysis of the response rate and magnitude, as well as of biomakers predicting the response, will be performed by an independent assessor and a biostatistician.
Primary Purpose: Treatment
Official Title: Predictive Factors and Magnitude of Response to Omalizumab and Mepolizumab in Allergic and Eosinophilic Severe Asthma: a Pragmatic Multicenter Trial in Belgium.
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Omalizumab

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.

Drug: Randomisation to mepolizumab
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.
Other Name: Active-controlled

Active Comparator: Mepolizumab

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.

Drug: Randomisation to omalizumab
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.
Other Name: Active-controlled




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.


Secondary Outcome Measures :
  1. Predictive factors of therapeutic response [ Time Frame: Baseline features (and according to response at 22 months) ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: • Signed informed consent form (ICF),

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476109


Contacts
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Contact: Charles Pilette, MD PhD 003227642866 ext 2866 charles.pilette@uclouvain.be
Contact: Irina KAIDALINA-MAMBOUR, Inf 003227642813 ext 2813 irina.kaidalina-mambour@uclouvain.be

Locations
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Belgium
Universitair Ziekenhuis Brussel Not yet recruiting
Brussel, Brussels, Belgium, 1090
Contact: Shane Hanon, MD         
CHU de Charleroi Not yet recruiting
Charleroi, Hainaut, Belgium, 6000
Contact: Rudi Peche, MD         
Grand Hôpital de Charleroi Not yet recruiting
Charleroi, Hainaut, Belgium, 6000
Contact: Pol-Marie Mingeot, MD         
Katholieke Universiteit Leuven Not yet recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Lieven Dupont, MD, PhD         
AZ Delta Roeselare Not yet recruiting
Roeselare, West-vlaanderen, Belgium, 8800
Contact: Ulriche Himpe, MD         
Cliniques universitaires St-Luc Not yet recruiting
Brussels, Belgium, 1200
Contact: Pilette Charles, MD PhD    003227642866 ext 2866    charles.pilette@uclouvain.be   
Contact: Irina Kaidalina-Mambour, Inf    003227642813 ext 2813    irina.kaidalina-mambour@uclouvain.be   
Centre Hospitalier Universitaire Saint Pierre Not yet recruiting
Bruxelles, Belgium, 1000
Contact: Vincent Ninane, MD         
Brugmann University Hospital Not yet recruiting
Bruxelles, Belgium, 1020
Contact: Olivier Michel, MD, PhD         
Erasme University Hospital Not yet recruiting
Bruxelles, Belgium, 1070
Contact: Alain Michils, MD         
University Hospital, Ghent Not yet recruiting
Gent, Belgium, 9000
Contact: Guy Brusselle, MD, PhD         
University Hospital of Liege Not yet recruiting
Liège, Belgium, 4000
Contact: Florence Schleich, MD, PhD         
CHR Namur Not yet recruiting
Namur, Belgium, 5000
Contact: Vincent Hers, MD         
Centre Hospitalier Universitaire Dinant Godinne - UCL Namur Not yet recruiting
Namur, Belgium, 5530
Contact: Olivier Vandenplas, MD, PhD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
University Hospital, Ghent
University Hospital of Liege
CHU de Charleroi
Erasme University Hospital
Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
Universitair Ziekenhuis Brussel
Brugmann University Hospital
Grand Hôpital de Charleroi
AZ Delta
Centre Hospitalier Universitaire Saint Pierre
KU Leuven
Investigators
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Principal Investigator: Charles Pilette Cliniques universitaires Saint-Luc

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03476109     History of Changes
Other Study ID Numbers: 2017/19JUI/325
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Asthma
Lung Diseases, Obstructive
Lung Diseases
Anti-Asthmatic Agents
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Respiratory System Agents