Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
130
Countries
1
Sites
8
Asthma
Compare compliance and asthma control after 6 months of treatment by Mepolizumab (M+ 1 after the 6th injection) between: A1 - Group of patients receiving Mepolizumab using a pre-filled syringe (PFS) administered monthly by a nurse, using a pre-filled syringe (PFS) B1 - Group of patients receiving sel…
Key facts
- Sponsor
- Hospices Civils De Lyon
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 13 Dec 2022 → 27 Mar 2025
- Decision date (initial)
- 2022-10-03
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- GlaxoSmithKline
External identifiers
- EU CT number
- 2022-501029-19-00
- ClinicalTrials.gov
- NCT05626777
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Compare compliance and asthma control after 6 months of treatment by Mepolizumab (M+ 1 after the 6th injection) between:
A1 - Group of patients receiving Mepolizumab using a pre-filled syringe (PFS) administered monthly by a nurse, using a pre-filled syringe (PFS)
B1 - Group of patients receiving self-administered Mepolizumab monthly, using an auto-injector pen (AIP)
Secondary objectives 16
- Compare Asthma control a. between groups A2 and B2 (see study design §4 below for groups description) b. between groups A1 and A2 c. between groups B1 and B2
- Mean change in ACT score in each group
- Proportion of patients with an ACT score change of at least 4 points in each group
- The number of exacerbation of asthma after 6 and 12 months of treatment (between A and B)
- The number of exacerbation of asthma requiring a visit to the emergency service or hospitalization after 6 and 12 months of treatment (between A and B)
- The reduction of exacerbation of asthma before and during the 12 months of treatment between A et B
- The proportion of patients requiring unscheduled medical consultation for asthma, after 12 months of treatment between A et B
- Oral corticosteroids consumption before and after Mepolizumab between group A and B
- Treatment compliance between groups A and B
- Bronchial inflammation by measurement of FeNO after 6 and 12 months of treatment (between groups A and B)
- Blood eosinophilia evolution after 6 and 12 months of treatment in each group
- Respiratory function measurement after 6 and 12 months of treatment (between A and B)
- Safety of treatment with Mepolizumab
- Patients’ quality of life in each group
- Patient satisfaction regarding asthma treatment in each group
- Patient dyspnea in each group
Conditions and MedDRA coding
Asthma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10003553 | Asthma | 100000004855 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Nucala Pre-filled syringe / Nucala Auto-injector pen Multicenter, prospective, comparative, open interventional, randomized study
|
Randomised Controlled | None | Pre-filled syringe: 6 months of treatment : Mepolizumab, 100mg/month Administred by nurse 6 months of treatment : Mepolizumab, 100mg/month Administred by patient Auto-injector pen: 6 months of treatment : Mepolizumab, 100mg/month, Administred by patient 6 months of treatment : Mepolizumab, 100mg/month, Administred by patient |
|
| 2 | Nucala Pre-filled syringe / Nucala Auto-injector pen Multicenter, prospective, comparative, open interventional, randomized study
|
Randomised Controlled | None | Pre-filled syringe: 6 months of treatment : Mepolizumab, 100mg/month Administred by nurse 6 months of treatment : Mepolizumab, 100mg/month Administred by patient Auto-injector pen: 6 months of treatment : Mepolizumab, 100mg/month, Administred by patient 6 months of treatment : Mepolizumab, 100mg/month, Administred by patient |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Patient aged ≥ 18 years
- Severe asthma diagnosed by a pulmonologist and followed for at least a year
- Blood eosinophilia ≥ 0.15 G / L in the 12 months preceding inclusion in the trial.
- At least 2 exacerbations in the past 12 months, each time treated with oral corticosteroid therapy or an increase in dosage of oral corticosteroid therapy prescribed for a long time, for at least 72 hours
- High dose inhaled corticosteroid therapy (> 800 μg / d budesonide,> 500 μg / d fluticasone,> 1000 μg / d beclometasone, etc.) and at least one second controller asthma treatment with LABA or LAMA
- Patient affiliated to a social security scheme
- Patient able to give free, informed and written consent.
- Patient must have an efficient contraception method
Exclusion criteria 10
- Pregnant woman (urinary beta-HCG positive at inclusion) or breastfeeding
- Active smoking or ex-smoking for less than 6 months and more than 10 pack-years
- Exacerbation in the 4 weeks preceding first mepolizumab injection
- Patient who has already been treated with Mepolizumab or another anti-IL-5 or -5R treatment
- Patient currently using a biotherapy indicated in severe asthma other than anti-IL5 or 5R treatments or stopped for less than 2 months
- Treatment underway with another biotherapy not indicated for severe asthma
- Patient participating in other interventional research, excluding routine care research (old regulation) and category 2 research not interfering with primary endpoint analysis
- Other chronic respiratory pathology (bronchiectasis, COPD, pulmonary fibrosis, etc.)
- Any other uncontrolled chronic pathology, the presence of which would be considered incompatible with the performance of the study by the investigator
- Patient under guardianship, curatorship or legal protection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Composite endpoint: Treatment compliance using Pharmacy accountability of study treatment and monthly patient diary after 6 months of treatment with Mepolizumab. Patient will be considered as compliant if all treatment doses of period have been used. Proportion of compliant patients will be compared between groups of patients. Proportion of patients with controlled asthma using the ACT score, after a period of 6 months of treatment with Mepolizumab will be compared between groups of patients.
Secondary endpoints 16
- Proportion of patients with asthma control assessed by the ACT score between: group receiving Mepolizumab self-administered, using PFS and group receiving M. self-administered using an AI from 6 months to 12 months (between groups A2 and B2); M. administered by a PFS by a nurse for first 6 months & self-administered by a PFS for the following 6 months between groups A1 and A2; M. self-administered by an AI during first 6 months &self-administered by an AI the 6 months between groups B1 and B2
- 2. Comparison of the mean change in ACT score from baseline between groups: A1 vs B1, A2 vs B2, A1 vs A2, B1 vs B2, and A vs B
- 3. Comparison of the proportion of patients with a change in ACT score of at least 4 points from baseline between groups: A1 vs B1, A2 vs B2, A1 vs A2, B1 vs B2, and A vs B
- 4. Comparison of the proportion of patients with an exacerbation of asthma during the 12 months of treatment (between groups A and B)
- 5. Comparison of the proportion of patients with an exacerbation of asthma requiring an emergency service visit or hospitalization during the 12 months of treatment (between groups A and B)
- 6. Comparison of the proportion of patients with an exacerbation of asthma during the 12 months of treatment with Mepolizumab versus the proportion of patients with an exacerbation of asthma during the 12 months prior to treatment with Mepolizumab
- 7. The proportion of patients requiring unscheduled medical consultation for asthma during the 12 months of treatment (between groups A and B)
- 8. Cumulative dose of oral corticosteroids before and after 12 months of treatment with Mepolizumab (exacerbation treatment excluded) between group A and B
- 9. Treatment compliance using the MARS-5 questionnaire administered after 6 and 12 months of treatment with Mepolizumab. The MARS-5 score will be compared between both groups of patients.
- 10. Carrying out a FeNO at V1, V2 and V3 after 6 and 12 months of Mepolizumab treatment between groups A and B
- 11. Performing a hemogram on peripheral blood to measure eosinophilia evolution at M0, M3, M6, M9 and M12
- 12. FEV1 measurement, % of theoretical FEV1 value, FEV1 / FVC at V1, V2 and V3
- 13. Collection of adverse events related to the study treatment, according to grade 1 to 5.
- 14. Calculation of the mini-AQLQ quality of life score and SNOT-22 score at V1, V2 and V3
- 15. Patient satisfaction questionnaire SATQ-F at V1, V2 and V3 and assessment of the preferences of patients in each group with respect to the Mepolizumab administration system at V1, V2 and V3
- 15.16. Calculation of mMRC score for dyspnea at V1, V2 and V3 visits
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Nucala 100 mg solution for injection in pre-filled syringe
PRD7486157 · Product
- Active substance
- Mepolizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03DX09 — -
- Marketing authorisation
- EU/1/15/1043/005
- MA holder
- GLAXOSMITHKLINE TRADING SERVICES LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Nucala 100 mg solution for injection in pre-filled pen
PRD7486155 · Product
- Active substance
- Mepolizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03DX09 — -
- Marketing authorisation
- EU/1/15/1043/003
- MA holder
- GLAXOSMITHKLINE TRADING SERVICES LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 16
Enerzair Breezhaler 114 micrograms/46 micrograms/136 micrograms inhalation powder, hard capsules
PRD8176455 · Product
- Active substance
- Mometasone Furoate
- Pharmaceutical form
- INHALATION POWDER
- Route of administration
- INHALATION
- Max daily dose
- 150 µg microgram(s)
- Max total dose
- 150 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03AL12 — -
- Marketing authorisation
- EU/1/20/1438/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Formodual NEXThaler 200 microgrammes/6 microgrammes par inhalation, poudre pour inhalation
PRD3683961 · Product
- Active substance
- Formoterol Fumarate Dihydrate
- Pharmaceutical form
- INHALATION POWDER
- Route of administration
- INHALATION
- Max daily dose
- 800 µg microgram(s)
- Max total dose
- 800 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03AK08 — -
- Marketing authorisation
- 34009 300 399 3 9
- MA holder
- CHIESI S.A.S.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SPIRIVA RESPIMAT 2,5 microgrammes/dose, solution à inhaler
PRD7011948 · Product
- Active substance
- Tiotropium Bromide Monohydrate
- Pharmaceutical form
- INHALATION SOLUTION
- Route of administration
- INHALATION
- Max daily dose
- 5 µg microgram(s)
- Max total dose
- 5 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03BB04 — TIOTROPIUM BROMIDE
- Marketing authorisation
- 34009 301 684 4 8
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Symbicort Turbuhaler 400/12, 400 microgram / 12 microgram per dosis, inhalatiepoeder
PRD399363 · Product
- Active substance
- Budesonide
- Pharmaceutical form
- INHALATION POWDER
- Route of administration
- INHALATION
- Max daily dose
- 1600 µg microgram(s)
- Max total dose
- 1600 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03AK07 — FORMOTEROL AND OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
- Marketing authorisation
- RVG 27690
- MA holder
- ASTRAZENECA BV
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed
PRD1598607 · Product
- Active substance
- Umeclidinium Bromide
- Pharmaceutical form
- INHALATION POWDER, PRE-DISPENSED
- Route of administration
- INHALATION
- Max daily dose
- 65 µg microgram(s)
- Max total dose
- 65 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03BB07 — -
- Marketing authorisation
- EU/1/14/922/001
- MA holder
- GLAXOSMITHKLINE (IRELAND) LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Innovair NEXThaler 200 microgrammes/6 microgrammes par dose, poudre pour inhalation.
PRD3683899 · Product
- Active substance
- Formoterol Fumarate Dihydrate
- Pharmaceutical form
- INHALATION POWDER
- Route of administration
- INHALATION
- Max daily dose
- 800 µg microgram(s)
- Max total dose
- 800 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03AK08 — -
- Marketing authorisation
- 3400930039946
- MA holder
- CHIESI S.A.S.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9747468 · Product
- Active substance
- Fluticasone Propionate
- Substance synonyms
- PF-00241939, S-FLUOROMETHYL 6A,9A-DIFLUORO-11B,17A-DIHYDROXY-16A-METHYL-3-OXOANDROSTA-1,4-DIENE-17B-CARBOTHIOATE 17-PROPIONATE
- Pharmaceutical form
- INHALATION POWDER, PRE-DISPENSED
- Route of administration
- INHALATION
- Max daily dose
- 1000 µg microgram(s)
- Max total dose
- 1000 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03AK06 — SALMETEROL AND OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
- Marketing authorisation
- NL42624
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
TIOTROPIUM VIATRIS 18 microgrammes, poudre pour inhalation en gélule
PRD9381783 · Product
- Active substance
- Tiotropium
- Pharmaceutical form
- INHALATION POWDER, HARD CAPSULE
- Route of administration
- INHALATION
- Max daily dose
- 18 µg microgram(s)
- Max total dose
- 18 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03BB04 — TIOTROPIUM BROMIDE
- Marketing authorisation
- NL48351
- MA holder
- VIATRIS SANTE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Seebri Breezhaler 44 micrograms inhalation powder, hard capsules
PRD4008747 · Product
- Active substance
- Glycopyrronium Bromide
- Pharmaceutical form
- INHALATION POWDER
- Route of administration
- INHALATION
- Max daily dose
- 55 µg microgram(s)
- Max total dose
- 55 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03BB06 — -
- Marketing authorisation
- EU/1/12/788/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SERETIDE DISKUS 500 microgrammes/50 microgrammes/dose, poudre pour inhalation en récipient unidose
PRD353793 · Product
- Active substance
- Fluticasone Propionate
- Pharmaceutical form
- INHALATION POWDER, PRE-DISPENSED
- Route of administration
- INHALATION
- Max daily dose
- 1000 µg microgram(s)
- Max total dose
- 1000 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03AK06 — SALMETEROL AND OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
- Marketing authorisation
- NL25848
- MA holder
- LABORATOIRE GLAXOSMITHKLINE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
PRD2403638 · Product
- Active substance
- Budesonide
- Pharmaceutical form
- INHALATION POWDER
- Route of administration
- INHALATION
- Max daily dose
- 1280 µg microgram(s)
- Max total dose
- 1280 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03AK07 — FORMOTEROL AND OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
- Marketing authorisation
- EU/1/14/920/001
- MA holder
- TEVA PHARMA B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD8991834 · Product
- Active substance
- Fluticasone Propionate
- Pharmaceutical form
- INHALATION POWDER
- Route of administration
- INHALATION
- Max daily dose
- 1000 µg microgram(s)
- Max total dose
- 1000 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03AK06 — SALMETEROL AND OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
- Marketing authorisation
- 34009 302 310 5 0
- MA holder
- BIOGARAN
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution
PRD5227853 · Product
- Active substance
- Glycopyrronium Bromide
- Substance synonyms
- CHF 5259.02, AHR-504, CHF-5259, GLYCOPYRROLATE
- Pharmaceutical form
- PRESSURISED INHALATION, SOLUTION
- Route of administration
- INHALATION
- Max daily dose
- 348 µg microgram(s)
- Max total dose
- 348 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03AL09 — -
- Marketing authorisation
- EU/1/17/1208/001
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed
PRD2139577 · Product
- Active substance
- Fluticasone Furoate
- Pharmaceutical form
- INHALATION POWDER, PRE-DISPENSED
- Route of administration
- INHALATION
- Max daily dose
- 184 µg microgram(s)
- Max total dose
- 184 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03AK10 — -
- Marketing authorisation
- EU/1/13/886/001
- MA holder
- GLAXOSMITHKLINE (IRELAND) LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SPIRIVA 18 microgrammes poudre pour inhalation en gélule
PRD299586 · Product
- Active substance
- Tiotropium Bromide Monohydrate
- Pharmaceutical form
- INHALATION POWDER
- Route of administration
- INHALATION
- Max daily dose
- 18 µg microgram(s)
- Max total dose
- 18 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- R03BB04 — TIOTROPIUM BROMIDE
- Marketing authorisation
- 34009 368 692 0 2
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed
PRD1601205 · Product
- Active substance
- Fluticasone Furoate
- Pharmaceutical form
- INHALATION POWDER, PRE-DISPENSED
- Route of administration
- INHALATION
- Max daily dose
- 184 µg microgram(s)
- Max total dose
- 184 µg microgram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- R03AK10 — -
- Marketing authorisation
- EU/1/14/929/001
- MA holder
- GLAXOSMITHKLINE (IRELAND) LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospices Civils De Lyon
- Sponsor organisation
- Hospices Civils De Lyon
- Address
- 103 Grande Rue De La Croix Rousse
- City
- Lyon Cedex 04
- Postcode
- 69317
- Country
- France
Scientific contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Pr Gilles DEVOUASSOUX
Public contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Pr Gilles DEVOUASSOUX
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 130 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Reims
Respiratory and Allergy Diseases, 45 Rue Cognacq Jay, 51100, Reims
Assistance Publique Hopitaux De Paris
Pneumology and Rare Pumonary Diseases Reference Center, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Hospices Civils De Lyon
Service de Pneumologie, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Centre Hospitalier Universitaire De Montpellier
Pneumology, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Toulouse
Pneumology and Allergology, Cedex 9, 2 Rue Viguerie, Toulouse
Centre Hospitalier Universitaire De Dijon
Pneumology, 14 Rue Paul Gaffarel, 21000, Dijon
CHUR Of Besançon
Pneumology, Respiratory and Allergological Functional Explorations unit, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Hopital Cardiologique
Pneumology, Boulevard Du Professeur Jules Leclercq, 59037, Lille
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2022-12-13 | 2023-03-09 | 2024-07-09 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-06-24 | France | Acceptable 2022-10-03
|
2022-10-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-10-26 | France | Acceptable | 2022-11-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-05-05 | France | Acceptable 2023-06-16
|
2023-06-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-10-23 | France | Acceptable 2024-01-10
|
2024-01-15 |