Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
93
Countries
7
Sites
23
Juvenile Psoriatic Arthritis Enthesitis Related Arthritis
To evaluate the efficacy of ixekizumab in children with JIA subtypes of ERA (including JoAS) and JPsA based on the JIA American College of Rheumatology (ACR) 30 response
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 22 Feb 2021 → ongoing
- Decision date (initial)
- 2023-10-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507184-19-00
- EudraCT number
- 2018-000681-10
- WHO UTN
- U1111-1297-0670
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Diagnosis, Pharmacokinetic, Efficacy, Safety
To evaluate the efficacy of ixekizumab in children with JIA subtypes of ERA (including JoAS) and JPsA based on the JIA American College of Rheumatology (ACR) 30 response
Conditions and MedDRA coding
Juvenile Psoriatic Arthritis Enthesitis Related Arthritis
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-001050-PIP02-18
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants must have active juvenile idiopathic arthritis (categories of enthesitis related arthritis or juvenile psoriatic arthritis)
- Participants must have weight of at least 10 kilograms (Kg), age starting at 2 years for participants with juvenile psoriatic arthritis and starting at 6 years for participants with enthesitis related arthritis
- Participants must have all immunizations up-to-date in agreement with current immunization guidelines, in the opinion of the investigator
Exclusion criteria 5
- Participants must not have active or history of inflammatory bowel disease
- Participants must not have active uveitis
- Participants must not have active or latent tuberculosis
- Participants must not have an active infection
- Participants must not have concurrent use of biologic agents for the treatment of the juvenile idiopathic arthritis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Percentage of Participants Achieving JIA ACR 30
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP12479549 · ATC
- Active substance
- Ixekizumab
- Substance synonyms
- LY2439821
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AC13 — IXEKIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SCP80590651 · ATC
- Active substance
- Adalimumab
- Substance synonyms
- ABP 501, BI 695501, MSB11022
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — ADALIMUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Eurofins Panlabs Inc. ORG-100044318
|
Saint Charles, United States | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Data management |
| Macrostat (Shanghai) Clinical Research Co. Ltd. ORG-100048828
|
Shanghai, China | Code 10 |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Praxis Communications LLC ORG-100045170
|
Buffalo, United States | Other |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
Locations
7 EU/EEA countries · 23 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 2 | 3 |
| Czechia | Ongoing, recruitment ended | 2 | 3 |
| France | Ongoing, recruitment ended | 3 | 5 |
| Germany | Ongoing, recruitment ended | 30 | 6 |
| Italy | Ongoing, recruitment ended | 6 | 3 |
| Netherlands | Ended | 1 | 1 |
| Spain | Ongoing, recruitment ended | 4 | 2 |
| Rest of world
Argentina, Mexico, United Kingdom, Switzerland
|
— | 45 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Hematology oncology pediatric, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Kinderreumatologie, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Pediatric rheumatology, Herestraat 49, 3000, Leuven
Fakultni Nemocnice V Motole
Oddělení revmatologie dětí a dospělých, V Uvalu 84/1, Motol, Prague 5
University Hospital Olomouc
Dětská klinika, Dětská revmatologie, Zdravotniku 248/7, 779 00, Olomouc
Vseobecni Fakultni Nemocnice V Praze
Klinika dětského a dorostového lékařství, Ke Karlovu 455/2, 121 00, Praha 2
Centre Hospitalier Universitaire De Montpellier
Service de consultation pédiatrique, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
Bicetre Hospital
Rhumatologie pediatrique et CEREMAIA, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Hopital Necker Enfants Malades
Pédiatrique, 149 Rue De Sevres, 75015, Paris
Centre Hospitalier Universitaire De Poitiers
Rhumatologie pédiatrique, 2 Rue De La Miletrie, 86000, Poitiers
Hospices Civils De Lyon
Service rhumatologie, 59 Boulevard Pinel, 69500, Bron
HELIOS Klinikum Berlin-Buch GmbH
Klinik für Kinder- und Jugendmedizin Fachambulanz Kinderrheumatologie, Schwanebecker Chaussee 50, Buch, Berlin
Zentrum Fuer Kinder Und Jugendrheumatologie
N/A, Dehnhaide 120, 22081, Hamburg
Charite Universitaetsmedizin Berlin KöR
SPZ Kinderrheumatologie, Kinderklinik, Augustenburger Platz 1, Wedding, Berlin
Klinikum Bremen-Mitte gGmbH
Eltern-Kind-Zentrum Prof. Hess, Strasse-Juergen-Strasse 1, 28205, Bremen
Medical Center - University Of Freiburg
Zentrum für Kinder u. Jugendmedizin (Rheumatologie & Infektiologie), Mathildenstrasse 1, Stuehlinger, Freiburg Im Breisgau
Asklepios Klinik Sankt Augustin GmbH
Pädiatrie, Arnold-Janssen-Strasse 29, 53757, Sankt Augustin
Azienda Ospedaliera Universitaria Meyer IRCCS
Reumatologia, Viale Gaetano Pieraccini 24, 50139, Florence
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
UOC PEDIATRIA MEDIA INTENSITA' DI CURA, Via Della Commenda 12, 20122, Milan
Azienda Ospedaliera Universitaria Federico II Di Napoli
Dipartimento Scienze Mediche Traslazionali, Via Sergio Pansini 5, 80131, Naples
Wilhelmina Childrens Hospital
Paediatric immunologist & rheumatologist, Lundlaan 6, 3584 EA, Utrecht
Hospital Universitario Y Politecnico La Fe
Pediatric Reumatology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Sant Joan De Deu Barcelona Hospital
Pediatric Reumatology, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
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 |
|---|---|---|---|---|---|
| Belgium | 2021-03-16 | 2022-03-07 | 2023-10-04 | ||
| Czechia | 2021-06-10 | 2022-03-22 | 2023-10-10 | ||
| France | 2021-02-22 | 2021-07-29 | 2023-10-11 | ||
| Germany | 2021-03-02 | 2021-04-13 | 2023-09-26 | ||
| Italy | 2021-04-08 | 2021-11-03 | 2023-10-11 | ||
| Netherlands | 2021-09-14 | 2023-12-21 | 2023-02-23 | 2023-03-14 | |
| Spain | 2021-05-06 | 2022-11-18 | 2023-10-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 120 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-507184-19-00_Redacted | c |
| Protocol (for publication) | Patient Documents Copyright | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_List of participating sites_TC | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangments | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | List of participating sites | 2.0 |
| Subject information and informed consent form (for publication) | Assent Form_older | 3.0 |
| Subject information and informed consent form (for publication) | Assent Form_older_BEDU | 3.0 |
| Subject information and informed consent form (for publication) | Assent Form_older_BEFR | 3.0 |
| Subject information and informed consent form (for publication) | Assent Form_younger | 3.0 |
| Subject information and informed consent form (for publication) | Assent Form_younger_BEDU | 3.0 |
| Subject information and informed consent form (for publication) | Assent Form_younger_BEFR | 3.0 |
| Subject information and informed consent form (for publication) | L1_Informed Consent Form_ Summary of Changes_Redacted | NA |
| Subject information and informed consent form (for publication) | L1_Older Children Assent | 3.0 |
| Subject information and informed consent form (for publication) | L1_Patienteninformation fur 16-18 years_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_Patienteninformation fur Eltern_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_Patienteninformation_Volljahrige_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form 12-14yr | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form 12-14yr_338spec | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form 12-14yr_Highligted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form 15-17yr_338spec_Highligted_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form 15-17yr_338spec_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form 15-17yr_Highligted_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent form 15-17yr_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Teenager_12-17 | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent younger children_7-11 | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Privacy Addendum ICF adults | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Privacy Addendum ICF parents | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ICF adults_338spec_Highligted_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ICF adults_338spec_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ICF adults_Highlighted_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ICF adults_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ICF parents 338spec_Highlighted_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ICF parents 338spec_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ICF parents_Highlighted_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ICF parents_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Adult_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Parent_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 11-14ans_v3_17nov22 | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 15-17ans_v3_17nov22_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 6-10ans_v3_17nov22 | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent older child | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent younger child | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Adults_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Parents_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_patient mineur_v4_24Feb2023_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_rep legaux_v4_24Feb2023_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes 1_Adults_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes 1_Parents_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Young Children Assent | 3.0 |
| Subject information and informed consent form (for publication) | L2_ Subject Retention Materials_Thank you card | 1 |
| Subject information and informed consent form (for publication) | L2_Carte Patient | 1.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_IXE Administration Patient log _Onsite Visits_Final 2_RHCG | 2.0 |
| Subject information and informed consent form (for publication) | L2_Ixekizumab Formulaire dadministration a domicile_V1 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Ixekizumab Patient Administration Home Log | 2.0 |
| Subject information and informed consent form (for publication) | L2_Ixekizumab_Instructions dutilisation_V1 | 1.0 |
| Subject information and informed consent form (for publication) | L2_IXEKIZUMAB-PFS-IFU-CT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Instructions for Use_IMP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient administration home log | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient administration home log_BEDU | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient administration home log_BEFR | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient administration onsite log | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient administration onsite log_BEDU | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient administration onsite log_BEFR | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient Emergency Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material PFS-IFU-CT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material PFS-IFU-CT_BEDU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material PFS-IFU-CT_BEFR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Subject Thank You Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information Material_ADA accountability log _ patient RHCG v2_1FEB21_IT | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Ixekizumab_Patient_Administration_Home_Log_V1_19May23_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_IXEKIZUMAB-PFS-IFU-CT-RHCG_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Particpant Administration Home Log | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Card Italy | 1.0 |
| Subject information and informed consent form (for publication) | L2_RHCG_COSPIRIT Folder | 1 |
| Subject information and informed consent form (for publication) | L2_RHCG_COSPIRIT VisitGuide | 1 |
| Subject information and informed consent form (for publication) | L2_RHCG_COSPIRIT_ThankYouCard | 1 |
| Subject information and informed consent form (for publication) | L2_RHCG_CospiritPassportBook | 1 |
| Subject information and informed consent form (for publication) | L2_Subject Retention Materials Passport BOOK | 1 |
| Subject information and informed consent form (for publication) | L2_Subject Retention Materials_Folder | 1 |
| Subject information and informed consent form (for publication) | L2_Subject Retention Materials_guida partecipante | 1 |
| Subject information and informed consent form (for publication) | L3_Rationale for race ethnicity data collection_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | Main ICF_BEDU_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | Main ICF_BEFR_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | Main ICF_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | Pregnant Participant ICF | 1.0 |
| Subject information and informed consent form (for publication) | Pregnant Participant ICF_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | Pregnant Participant ICF_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | Pregnant Partner ICF | 1.0 |
| Subject information and informed consent form (for publication) | Pregnant Partner ICF_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | Pregnant Partner ICF_BEFR | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Adalimumab | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BEDE 2023-507184-19_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BEDU 2023-507184-19_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BEFR 2023-507184-19_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS_CZ_2018-000681-10_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EN_2023-507184-19-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2018-000681-10_ES _TC_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2018-000681-10_ES_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2023-507184-19-00_redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_v4_01dec2023_RHCG_clean_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_v4_01dec2023_RHCG_TC_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | Protocol Synopsis c_NLD_Redacted | c |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-14 | Spain | Acceptable 2023-10-24
|
2023-10-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-15 | Spain | Acceptable 2024-02-29
|
2024-02-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-07 | Spain | Acceptable 2025-04-10
|
2025-04-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-23 | Acceptable | 2025-04-29 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-04-23 | Acceptable | 2025-06-06 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-04-28 | Acceptable | 2025-06-12 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-02 | Acceptable | 2025-06-03 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-05-02 | Acceptable | 2025-06-13 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-05-14 | Spain | Acceptable | 2025-06-13 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-24 | Acceptable | 2025-07-24 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-12-16 | Acceptable | 2026-03-04 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-02-24 | Spain | Acceptable | 2026-03-23 |