Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
243
Countries
9
Sites
48
Generalized Myasthenia Gravis with autoantibodies against acetylcholine receptor (AChR)
To assess the efficacy of ALXN1720 compared with placebo in the treatment of gMG based on change in MG-ADL total score
Key facts
- Sponsor
- Alexion Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 16 Nov 2022 → ongoing
- Decision date (initial)
- 2024-05-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508284-77-00
- EudraCT number
- 2022-000460-21
- ClinicalTrials.gov
- NCT05556096
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety, Pharmacodynamic, Pharmacokinetic
To assess the efficacy of ALXN1720 compared with placebo in the treatment of gMG based on change in MG-ADL total score
Secondary objectives 1
- To assess the efficacy of ALXN1720 compared with placebo in the treatment of gMG based on change in QMG total score
Conditions and MedDRA coding
Generalized Myasthenia Gravis with autoantibodies against acetylcholine receptor (AChR)
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Must be ≥ 18 years of age at the time of signing the informed consent
- "Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV "
- Positive serological test for autoantibodies against AChR.
Exclusion criteria 4
- History of thymectomy or any other thymic surgery within 12 months prior to Screening
- Untreated thymic malignancy, carcinoma, or thymoma
- History of Neisseria meningitidis infection
- Pregnancy, breastfeeding, or intention to conceive during the course of the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 26
Secondary endpoints 5
- Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26
- Percentage of Responders Based on Reduction of the MG-ADL Total Score at Week 26
- Percentage of Responders based on Reduction of the QMG Total Score at Week 26
- Change From Baseline in Myasthenia Gravis Composite (MGC) Total Score at Week 26
- Change from Baseline in the QMG total score at Week 4
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11070852 · Product
- Active substance
- Gefurulimab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 131 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ALEXION PHARMACEUTICALS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Alexion Pharmaceuticals Inc.
- Sponsor organisation
- Alexion Pharmaceuticals Inc.
- Address
- 121 Seaport Boulevard
- City
- Boston
- Postcode
- 02210-2050
- Country
- United States
Scientific contact point
- Organisation
- Alexion Pharmaceuticals Inc.
- Contact name
- European Clinical Trial Information
Public contact point
- Organisation
- Alexion Pharmaceuticals Inc.
- Contact name
- European Clinical Trial Information
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other, Other, Other, Other |
Locations
9 EU/EEA countries · 48 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 2 | 3 |
| Denmark | Ongoing, recruitment ended | 5 | 2 |
| France | Ongoing, recruitment ended | 10 | 7 |
| Germany | Ongoing, recruitment ended | 14 | 5 |
| Italy | Ongoing, recruitment ended | 15 | 12 |
| Netherlands | Ended | 1 | 1 |
| Poland | Ongoing, recruitment ended | 27 | 6 |
| Portugal | Ongoing, recruitment ended | 4 | 2 |
| Spain | Ongoing, recruitment ended | 14 | 10 |
| Rest of world
China, United Kingdom, Brazil, United States, Serbia, Japan, Canada, Turkey, Taiwan, Korea, Republic of, Argentina, Israel
|
— | 151 | — |
Investigational sites
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Universitätsklinik für Neurologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Klinikum Wels-Grieskirchen GmbH
Neurologie, Grieskirchner Strasse 42, 4600, Wels
Medizinische Universitaet Innsbruck
Universitätsklinik für Neurologie, Anichstrasse 35, 6020, Innsbruck
Rigshospitalet
Klinik for Nerve- og Muskelsygdomme & Copenhagen Neuromuscular Center, Blegdamsvej 9, 2100, Copenhagen Oe
Aalborg University Hospital
Department of Neurology, Ladegaardsgade 5, 9000, Aalborg
Centre Hospitalier Regional De Marseille
Centre de référence des Maladies neuromusculaires et de la SLA/ Pôle des Neurosciences Cliniques, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Nice
Neurologie, 30 Voie Romaine, 06000, Nice
Raymond-Poincare Hospital
Service de Réanimation Médicochirurgicale, 104 Boulevard Raymond Poincare, 92380, Garches
Centre Hospitalier Universitaire De Montpellier
Service Explorations Neurologiques, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Les Hopitaux Universitaires De Strasbourg
Département de Neurologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Assistance Publique Hopitaux De Paris
Service de Neurologie, 43 Boulevard De L Hopital, 75013, Paris
Centre Hospitalier Universitaire De Lille
Département de Neurologie A, Rue Emile Laine, 59037, Lille Cedex
Universitaetsklinikum Duesseldorf AöR
Klinik für Neurologie, Moorenstrasse 5, Bilk, Duesseldorf
Ludwig Maximilian University Of Munich
Friedrich-Bauer-Institut Neurologische Klinik und Poliklinik, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
Klinikum Wuerzburg Mitte gGmbH
Klinikum für Neurologie, Salvatorstrasse 7, Frauenland, Wuerzburg
Charite Universitaetsmedizin Berlin KöR
Klinik für Neurologie, Chariteplatz 1, Mitte, Berlin
Klinikum rechts der Isar der TU Muenchen AöR
Klinik und Poliklinik für Neurologie, Ismaninger Strasse 22, Au-Haidhausen, Munich
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
UOC Neurofisiopatologia, Via Antonio Cardarelli 9, 80131, Naples
Azienda Ospedaliero Universitaria Pisana
Medicina Clinica e Sperimentale – UO Neurologia, Via Roma 67, 56126, Pisa
Azienda Ospedaliero-Universitaria Sant Andre
Clinica Neurologica II - Dipartimento di Scienze Neurologica, Via Di Grottarossa 1035-1039, 00189, Rome
Careggi University Hospital
Dip di Neurofarba – Neurologia 2, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Sanitaria Universitaria Friuli Centrale
Clinica Neurologica e di Neuroriabilitazione, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
IRCCS Foundation Istituto Neurologico Carlo Besta
UOC Neurologia IV, Via Giovanni Celoria 11, 20133, Milan
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
UOSD di Neurofisiopatologia, Via Del Vespro 129, 90127, Palermo
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
UO Neurologia II, Piazzale Spedali Civili 1, 25123, Brescia
Universita Degli Studi Di Napoli Federico II
Dipartimento Di Neuroscienze E Scienze Riproduttive Ed Odontostomatologiche, Via Sergio Pansini 5, 80131, Naples
Azienda Unita Locale Socio Sanitaria N. 2 Marca Trevigiana
Bonifati, Piazzale Ospedale 1, 31100, Treviso
Azienda Ospedaliera Papa Giovanni XXIII
UO Neurologia, Piazza Oms 1, 24127, Bergamo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Neurologia, Largo Agostino Gemelli 8, 00168, Rome
Amsterdam UMC Stichting
Department of Neurology, Meibergdreef 9, 1105 AZ, Amsterdam
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Bydgoszcz, Ul. Jana Karola Chodkiewicza 19c, 85-065, Bydgoszcz
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Odd Neurologiczny z Pododdzialem Udarowym i z Pododdzialem Rehabilitacji Neurologicznej, Ul. Pradnicka 80, 31-202, Cracow
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Clinical Research Center Sp. z o.o. Medic-R sp.k., Ul. Feliksa Nowowiejskiego 5, 61-731, Poznan
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
NZOZ Neuromed M. I M. Nastaj. sp.p., Ul. Polnocna 8/3, 20-064, Lublin
Krakowska Akademia Neurologii Sp. z o.o.
Centrum Neurologii Klinicznej, Ul. Arianska 7/3, 31-505, Cracow
Neurologia Slaska Centrum Medyczne
Neurologia Slaska Centrum Medyczne, Malachowskiego 51, 40-689, Katowice
Unidade Local De Saude De Santo Antonio E.P.E.
Neurociencias, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude De Almada-Seixal E.P.E.
Neurologia, Avenida Torrado Da Silva, 2805-267, Almada
Hospital Universitario Reina Sofia
Neurología, Avenida Menendez Pidal S/n, 14004, Cordoba
Clinica Universidad De Navarra
Neurología, Avenue Pio XII 36, 31008, Pamplona
Hospital Clinico San Carlos
Neurología, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario La Paz
Neurología, Paseo De La Castellana 261, 28046, Madrid
Bellvitge University Hospital
Neurología, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Hospital Universitario Regional De Malaga
Neurología, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario Infanta Sofía
Neurología, Paseo De Europa 34, 28702, San Sebastian De Los Reyes
Hospital Universitario Virgen De La Macarena
Neurología, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Ramon Y Cajal
Neurología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Germans Trias I Pujol
Neurología, Carretera Canyet 1a Planta, 08916, Badalona
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 |
|---|---|---|---|---|---|
| Austria | 2023-05-11 | 2023-06-12 | 2023-10-23 | ||
| Denmark | 2023-04-24 | 2023-08-29 | 2024-10-29 | ||
| France | 2023-01-31 | 2023-02-09 | 2024-10-09 | ||
| Germany | 2023-02-07 | 2023-04-17 | 2024-10-29 | ||
| Italy | 2023-02-06 | 2023-03-14 | 2024-10-29 | ||
| Netherlands | 2023-12-06 | 2024-09-10 | 2024-09-10 | ||
| Poland | 2023-03-08 | 2023-03-10 | 2024-10-28 | ||
| Portugal | 2023-08-23 | 2023-10-30 | 2024-09-25 | ||
| Spain | 2022-11-16 | 2022-12-20 | 2024-08-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 98 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-508284-77-00_redacted | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_AT_MG-ADL | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_AT_MGC | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_AT_QMG | 2.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_DE_MG-ADL | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_DE_MGC | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_DE_QMG | 2.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_EN_MG-ADL | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_EN_MGC | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_EN_QMG | 2.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_ES_MG-ADL | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_ES_MGC | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_ES_QMG | 2.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_FR_MG-ADL | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_FR_MGC | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_FR_QMG | 2.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_IT_MG-ADL | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_IT_MGC | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_IT_QMG | 2.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_PT_MG-ADL | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_PT_MGC | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_PT_QMG | 2.1 |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement_Redacted | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Redacted | NA |
| Recruitment arrangements (for publication) | K2_Recruitment Material companion orientation brochure | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material PAG Slides | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material PAG Slides | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Brochure | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material patient brochure | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Fact Sheet | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Study Fact Sheet | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Study Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Website Listing | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Community Letter_ES | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Half Page Ad_ES | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Landing page website | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PAG Slides | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Fact Sheet | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Poster_ES | NA |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adult_redacted | 8.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF pregnant partner | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_ES_Redacted | 7.0 ES |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult_redacted | 11 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_Redacted_IT | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_PL_Redacted | 6.00 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Caregiver | 3.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Caregiver_ES | 3.0 ES |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Caregiver_IT_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF future research_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant | 0.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_ES | 2.0 ES 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_IT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partners_PL | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject_DE_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult_Dutch_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_DE | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_Dutch_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_EN | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_FR | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_caregiver_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_DE | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main addendum_FR | 3.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_EN_redacted | 5.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FR_redacted | 6.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP_EN | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP_FR | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partners_DE | 2 |
| Subject information and informed consent form (for publication) | L1_Site-specific data of the planned clinical trial sites_Austria_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Patient Brochure | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Study Fact Sheet | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Companion Orientation Brochure | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Leaflet_Dine rettigheder | NA |
| Subject information and informed consent form (for publication) | L2_Other subject material_Companion Orientation Brochure_ES | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject material_ICF Tool_ES | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject material_Patient Brochure_ES | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject material_Study Fact Sheet_ES | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Language Synopsis_2023-508284-77-00_DE | 3.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Language Synopsis_2023-508284-77-00_EN | 3.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Language Synopsis_2023-508284-77-00_ES | 3.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Language Synopsis_2023-508284-77-00_FR | 3.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Language Synopsis_2023-508284-77-00_IT | 3.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Language Synopsis_2023-508284-77-00_NL | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Language Synopsis_2023-508284-77-00_PL | 3.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Lay Language Synopsis_2023-508284-77-00_PT | 3.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Scientific Synopsis_2023-508284-77-00_AT | 5.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol Scientific Synopsis_2023-508284-77-00_IT | 5.0 |
Application history
15 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-10 | Denmark | Acceptable 2024-05-13
|
2024-05-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-02 | Denmark | Acceptable 2024-09-23
|
2024-09-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-26 | Acceptable | 2024-12-18 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-03 | Denmark | Acceptable 2024-09-23
|
2025-01-03 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-07 | Denmark | Acceptable 2025-04-28
|
2025-04-28 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-26 | Acceptable | 2025-08-06 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-06-26 | Acceptable | 2025-08-04 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-27 | Denmark | Acceptable | 2025-07-21 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-06-27 | Acceptable | 2025-08-11 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-06-27 | Acceptable | 2025-07-24 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-06-27 | Acceptable | 2025-08-19 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-06-27 | Acceptable | 2025-07-24 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-06-30 | Acceptable | 2025-08-18 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-11-07 | Acceptable | 2025-11-17 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-13 | 2026-02-06 | Denmark | Acceptable 2026-04-27
|
2026-04-27 |