Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
433
Countries
3
Sites
12
Early Alzheimer’s Disease
To assess the effects of BMS-986446 vs placebo on brain tau deposition in Participants (age: 50 to 80) with early AD
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 8 Nov 2024 → ongoing
- Decision date (initial)
- 2024-09-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Bristol-Myers Squibb Services Unlimited Company
External identifiers
- EU CT number
- 2023-504840-32-00
- WHO UTN
- U1111-1290-3539
- ClinicalTrials.gov
- NCT06268886
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others, Efficacy
To assess the effects of BMS-986446 vs placebo on brain tau deposition in Participants (age: 50 to 80) with early AD
Secondary objectives 4
- To determine the superiority of BMS-986446 vs placebo on delay of clinical decline in Participants (age: 50-80) with early AD
- To assess the effects of BMS-986446 vs placebo on delay of cognitive and functional decline in Participants (age: 50 to 80) with early AD
- To assess the effects of BMS-986446 vs placebo on delay of cognitive decline in Participants (age:50 to 80) with early AD
- To assess the effects of BMS-986446 vs placebo on delay of functional decline in Participants (age:50 to 80) with early AD
Conditions and MedDRA coding
Early Alzheimer’s Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | LLT | 10086384 | Early onset Alzheimer´s disease | 100000004848 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria.
- Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box score of 0.5 and greater at screening and Baseline.
- Evidence of AD pathology.
- Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory Subtest II (WMS-IV LM II).
- Mini Mental Status Examination (MMSE) score ≥ 20 to 28 (inclusive).
Exclusion criteria 6
- Any evidence of a condition that may affect cognition other than AD.
- Contraindications to PET imaging.
- Inability to tolerate or contraindication to magnetic resonance imaging.
- Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments.
- Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline at Week 76 in brain tau deposition, as measured by tau positron emission tomography (PET)
Secondary endpoints 5
- Change from baseline at Week 76 in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score
- Change from baseline at Week 76 in integrated Alzheimer’s Disease Rating Scale (iADRS) score
- Change from baseline at Week 76 in Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS- Cog14) score
- Change from baseline at Week 76 in Mini Mental State Examination (MMSE) score
- Change from baseline at Week 76 in Alzheimer’s Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11249487 · Product
- Active substance
- PRX005
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- 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
Auxiliary 1
PRD11254720 · Product
- Active substance
- Florquinitau (18F)
- Substance synonyms
- Florquinitau F18, [18F] MK-6240
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 9999 mg/l milligram(s)/litre
- Max total dose
- 9999 mmol/g millimole(s)/gram
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CERVEAU TECHNOLOGIES INC., A WHOLLY OWNED SUBSIDIARY OF LANTHEUS MEDICAL IMAGING, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254 Blanchardstown Corporate Park 2, Ballycoolin Ballycoolin
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Clario ORL-000001208
|
Princeton, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| Accenture Services Pvt. Ltd. ORL-000000127
|
Bengaluru, India | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| C2n Diagnostics LLC ORG-100049457
|
Saint Louis, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
| Fortrea Inc. ORG-100012602
|
Durham, United States | On site monitoring, Code 12, Code 2, Code 8, Code 9 |
Locations
3 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 16 | 5 |
| Spain | Ongoing, recruitment ended | 21 | 6 |
| Sweden | Ongoing, recruitment ended | 5 | 1 |
| Rest of world
Japan, United States, Singapore, United Kingdom, Canada, Korea, Republic of, Australia
|
— | 391 | — |
Investigational sites
Hopital Erasme
Neurology, Lennikse Baan 808, 1070, Anderlecht
UZ Leuven
Neurology, Herestraat 49, 3000, Leuven
Antwerp University Hospital
Neurology, Drie Eikenstraat 655, 2650, Edegem
Cliniques Universitaires Saint-Luc
Neurology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Algemeen Ziekenhuis Groeninge
Neurology, President Kennedylaan 4, 8500, Kortrijk
Hospital Del Mar
Neurology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital De La Santa Creu I Sant Pau
Neurology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitari Vall D Hebron
Neurology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitari General De Catalunya
Neurology, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Hospital Clinic De Barcelona
Neurology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari De Santa Maria
Neurology, Av Alcalde Rovira Roure 44, 25198, Lleida
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 | 2024-11-12 | 2024-12-03 | 2025-03-28 | ||
| Spain | 2024-11-08 | 2024-11-15 | 2025-03-28 | ||
| Sweden | 2024-11-25 | 2025-01-09 | 2025-03-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 132 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-504840-32-00 redacted | PA03 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_redacted placeholder_BE_DE | NA |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_redacted placeholder_BE_DU | NA |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_redacted placeholder_BE_EN | NA |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_redacted placeholder_BE_FR | NA |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_redacted placeholder_DK_DA | NA |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_redacted placeholder_ES_ES | NA |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_redacted placeholder_FR_FR | NA |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_redacted placeholder_NL_NL | NA |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_redacted placeholder_PL_PL | NA |
| Protocol (for publication) | D4_Patient facing documents_questionnaire_redacted placeholder_SE_SWE | NA |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure ENG | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material banner 120x600 | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material banner_160x600 | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material banner_200x200 | 1NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material banner_250x250 | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material banner_300x250 | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material banner_300x600 | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material banner_320x50 | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material banner_336x280 | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material banner_468x60 | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material banner_728x90 | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material banner_970x90 | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 120x600 DUT | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 120x600 FRE | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 160x600 Alt Headline DUT | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 160x600 Alt Headline FRE | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 200x200 DUT | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 200x200 FRE | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 250x250 DUT | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 250x250 FRE | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 300x250 DUT | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 300x250 FRE | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 300x600 DUT | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 300x600 FRE | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 320x50 DUT | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 320x50 FRE | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 336x280 DUT | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 336x280 FRE | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 468x60 DUT | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 468x60 FRE | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 728x90 Alt Headline DUT | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 728x90 Alt Headline FRE | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 970x90 DUT | NA |
| Recruitment arrangements (for publication) | K2_Recruitment materia Banner 970x90 FRE | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Online Outreach Text | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material AD Brochure | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material AD Brochure DUT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material AD Brochure ENG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material AD Brochure FRE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material AD Poster | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Banner 120x600_ENG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Banner 160x600 Alt Headline_ENG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Banner 200x200_ENG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Banner 250x250_ENG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Banner 300x250_ENG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Banner 300x600_ENG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Banner 320x50_ENG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Banner 336x280_ENG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Banner 468x60_ENG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Banner 728x90 Alt Headline_ENG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Banner 970x90_ENG | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material Consent Discussion Aid DUT | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Consent Discussion Aid ENG | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Consent Discussion Aid FRE | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Consent Discussion Aid_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer DUT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer ENG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Flyer FRE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Online Outreach Text DUT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Online Outreach Text ENG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Online Outreach Text FRE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Brochure DUT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Brochure ENG | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Brochure FRE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Brochure_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Flyer | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Poster DUT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Poster ENG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Poster FRE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Partner Brochure | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Partner Brochure DUT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Partner Brochure ENG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Partner Brochure FRE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_AD Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_AD Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner 120x600 | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner 160x600 Alt Headline | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner 200x200 | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner 250x250 | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner 300x250 | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner 300x600 | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner 320x50 | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner 336x280 | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner 468x60 | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner 728x90 Alt Headline | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner 970x90 | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Consent Discussion Aid_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Online Outreach Text | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Partner Brochure | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_DUT_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ENG_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FRE_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Substudy_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_DUT_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_ENG_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_FRE_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_DUT_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_ENG_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_FRE_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Partner_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Sub Study_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE_DE_2023-504840-32-00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE_DU_2023-504840-32-00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE_FR_2023-504840-32-00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2023-504840-32-00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-504840-32-00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2023-504840-32-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_2023-504840-32-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2023-504840-32-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SE_2023-504840-32-00 | 3.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-08 | Sweden | Acceptable 2024-09-02
|
2024-09-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-18 | Sweden | Acceptable 2024-12-02
|
2024-12-03 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-18 | Sweden | Acceptable 2024-12-02
|
2024-12-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-25 | Sweden | Acceptable 2025-06-09
|
2025-06-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-22 | Sweden | Acceptable 2025-10-06
|
2025-10-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-18 | Sweden | Acceptable 2026-03-10
|
2026-03-10 |