Kliniske forsøg Nct side

Summary
EudraCT Number:2017-003958-16
Sponsor's Protocol Code Number:NL63056.018.17
National Competent Authority:Netherlands - Competent Authority
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2018-06-06
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedNetherlands - Competent Authority
A.2EudraCT number2017-003958-16
A.3Full title of the trial
Effect of Reslizumab on small airways in asthma. RESSAPEA
Effect van Reslizumab op de kleine luchtwegen
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Effect of Reslizumab on small airways in asthma. RESSAPEA
Effect van Reslizumab op de kleine luchtwegen
A.3.2Name or abbreviated title of the trial where available
RESSAPEA
A.4.1Sponsor's protocol code numberNL63056.018.17
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorAcademic Medical Center, University of Amsterdam
B.1.3.4CountryNetherlands
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportAcademic Medical Center
B.4.2CountryNetherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationAcademic Medical Center
B.5.2Functional name of contact pointAcademic Medical Center
B.5.3 Address:
B.5.3.1Street AddressMeubergdreef 9
B.5.3.2Town/ cityAmsterdam
B.5.3.3Post code1100 DD
B.5.3.4CountryNetherlands
B.5.4Telephone number31205663554
B.5.5Fax number31205669001
B.5.6E-mailp.f.mau-asam@amc.uva.nl
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Cinqaero
D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharmaceuticals Limited
D.2.1.2Country which granted the Marketing AuthorisationNetherlands
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.4Pharmaceutical form Solution for infusion
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntravenous use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Yes
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboSolution for infusion
D.8.4Route of administration of the placeboIntravenous use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
1.Patients with severe eosinophilic asthma
Ernstig eosinofiel astma patiënten
E.1.1.1Medical condition in easily understood language
Patients with severe eosinophilic asthma
Ernstig eosinofiel astma patiënten
E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10068462
E.1.2Term Eosinophilic asthma
E.1.2System Organ Class 100000004855
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
1.To investigate the effect of 3 months treatment with Reslizumab on air trapping, by using different techniques
Het effect van 3 maanden behandeling met Reslizumab op air trapping met verschillende technieken bepaald
E.2.2Secondary objectives of the trial
To investigate the degree of (dynamic) hyperinflation in patients with severe eosinophilic asthma, and relate it to the percentage of eosinophils in peripheral blood and sputum Study.
De mate van hyperinflatie bepalen bij patiënten met eosinofiel astma en dit relateren aan het percentage eosinofielen in perifeer bloed en sputum
E.2.3Trial contains a sub-study No
E.2.3.1Full title, date and version of each sub-study and their related objectives
Not applicable
Niet van toepassing
E.3Principal inclusion criteria
•Blood eosinophil counts ≥0.4 x 10E9/L despite adequate treatment with high doses of inhaled corticosteroids (>800mcg/day fluticaone equivalent)
Bloed eosinofilien ≥0.4 x 10E9/L ondanks behandeling met hoge dosis inhalatie medicatie (>800mcg/dd fluticasone
E.4Principal exclusion criteria
•Eosinophilic Diseases: Subjects with other conditions that could lead to elevated eosinophils such as Hyper eosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis.
Hyper eosinofiel syndroom, Churg Strauss of eosinofiel oesofagitis
E.5 End points
E.5.1Primary end point(s)
in this study is the change from baseline in regional image based hyperinflation (iVlobes ) and in (specific) iVaw after 3 months Reslizumab treatment compared to changes in the placebo group.
de verandering op baseline van iVlobes en iVaw na s maanden Reslizumab behandeling vergeleken met placebo
E.5.1.1Timepoint(s) of evaluation of this end point
Baseline and 12 weeks
Baseline en 12 weeks
E.5.2Secondary end point(s)
(specific) iRaw, exploratory parameters from FRI, iVlung, air trapping specific imaged-based airway volume (s)iVaw) at TLC, internal lobar airflow distribution, low attenuation or emphysema score, blood vessel density, airway wall thickness and aerosol deposition concentrations, Also correlations between changes in HRCT parameters and SGRQ, AQLQ, ACQ, FEV1/FVC, FVC, FRC, RV/TLC, FeNO and cell differential counts in sputum and blood.
Kwaliteit van leven vragenlijsten, longfunctie, stikstof meting, bepaling eosinofielen in bloed en sputum en FRI
E.5.2.1Timepoint(s) of evaluation of this end point
Baseline and 12 weeks
Baseline en 12 weeks
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety No
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial2
E.8.3 The trial involves single site in the Member State concerned Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
LVLS
Laatst visite, laatste patiënt
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 22
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 11
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state33
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
Continuing treatment with Reslizumab after 3 months in SoC
behandeling met Resllizumab na 3 maanden in SoC
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2018-06-06
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2018-08-10
P. End of Trial
P.End of Trial StatusOngoing

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