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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cliniques Universitaires Saint-Luc

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

16 Apr 2018 → 12 Jun 2025

Decision date (initial)

2024-11-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novartis Europharm Limited · GlaxoSmithKline Trading Services Limited

External identifiers

EU CT number

2024-516783-29-00

EudraCT number

2017-002473-19

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Therapy, Efficacy

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).

Secondary objectives 5

1. To determine theranostic features, i.e. clinical features and blood/urine/mucosal (nasal, sputum) biomarkers able to predict a better response to omalizumab or mepolizumab in severe asthma patients eligible to both therapies. Posthoc analyses will be performed to analyze whether those features/biomarkers are associated with better clinical responses to each biologics
2. To compare effects of omalizumab and mepolizumab on secondary outcomes, i.e. asthma symptom scores, asthma-related quality of life, lung function, and nasal symptoms
3. To record the baseline clinical characteristics of severe asthma patients eligible to both biotherapies, as compared to those eligible to omalizumab according to the PERSIST study
4. To compare, in responders, effects of omalizumab and mepolizumab on clinical and biological features
5. To determine if IgE+ B-cell Repertoire, IgE glycosylation patterns or subsets of T cells (Th2, Tfh2, Tfh13, Tfr) are reliable predictive biomarkers of omalizumab or mepolizumab response (sub study, FR)

Conditions and MedDRA coding

Severe allergic and eosinophilic asthma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Signed informed consent form (ICF)
2. Age >18+ years (18-90 years old) at time of signing ICF
3. Able to comply with the study protocol, in the investigator’s judgment
4. Documented physician-diagnosed asthma
5. Eligible to omalizumab and mepolizumab and who have not yet received any of these therapies

Exclusion criteria 8

1. 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
2. Difficult to treat asthma and others severe respiratory diseases
3. 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
4. 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
5. Pregnant, post-partum or lactating women
6. Known sensitivity to any of the active substances or their excipients to be administered during the study
7. Active malignancy or malignancy in remission over less than 5 years
8. Patient not affiliated to a health insurance plan (FR)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary criterion for judgment will be the rate of severe exacerbation during one year in patients on omalizumab vs mepolizumab, in the overall population. An additional primary criterion will be the rate of response to omalizumab vs that for mepolizumab, in the overall and stratified population(s).

Secondary endpoints 2

1. Clinical features and biomarkers (or array signatures) analyzed in blood, mucosal and urine samples will be tested for their putative ability to predict a better response to oma- or mepolizumab (theranostic value). The candidate features are age at (severe) disease onset and presence of nasal polyps or aspirin hypersensitivity as well as serum specific/total IgE ratio and blood eosinophil levels.
2. Asthma-related outcomes other than exacerbations – i.e. disease control reflected by ACT and ACQ6, asthma-related quality of life questionnaire reflected by AQLQ, lung function reflected by FEV1 % predicted and absolute change - as well as nasal symptoms (VAS and, for nasal polyps, endoscopic scoring) will be assessed in the oma- and mepolizumab groups, in the overall and stratified populations.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cliniques Universitaires Saint-Luc

Sponsor organisation

Cliniques Universitaires Saint-Luc

Address

Hippokrateslaan 10, Batiment 54 Batiment 54

City

Sint-Lambrechts-Woluwe

Postcode

1200

Country

Belgium

Scientific contact point

Organisation

Cliniques Universitaires Saint-Luc

Contact name

Charles Pilette

Public contact point

Organisation

Cliniques Universitaires Saint-Luc

Contact name

Charles Pilette

Locations

2 EU/EEA countries · 22 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications