REIMAGINE – Real-world EvaluatIon of Mepolizumab in severe Asthma achievinG on treatment clinIcal remissioN, a prospEctive study.

2023-509026-21-00 Protocol 219871 Therapeutic use (Phase IV) Ongoing, recruitment ended

Start 3 Jun 2024 · Status Ongoing, recruitment ended · 6 EU/EEA countries · 29 sites · Protocol 219871

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruitment ended
Participants planned 336
Countries 6
Sites 29

severe asthma

1. Describe the proportion of patients that achieved clinical remission at 12 months, in the principal stratum of patients’ adherent to NUCALA

Key facts

Sponsor
Glaxosmithkline Research & Development Limited
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration
3 Jun 2024 → ongoing
Decision date (initial)
2024-05-14
Transition trial
No
Low-intervention
Yes
Rare-disease indication
Yes
Vulnerable population
Yes
Funding sources
GlaxoSmithKline Research & Development Limited

External identifiers

EU CT number
2023-509026-21-00
ClinicalTrials.gov
NCT06041386

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

1. Describe the proportion of patients that achieved clinical remission at 12 months, in the principal stratum of patients’ adherent to NUCALA

Secondary objectives 1

  1. 1. Summarize the rate of clinically significant asthma exacerbations in patients over the follow-up period, in the principal stratum of patients’ adherent to NUCALA 2. Describe the proportion of patients that achieved OCS sparing and 3-component clinical remission at 12 months, in the principal stratum of patients’ adherent to NUCALA 3. Evaluate the change from baseline in HRQoL, in the principal stratum of patients’ adherent to NUCALA

Conditions and MedDRA coding

severe asthma

VersionLevelCodeTermSystem organ class
21.1 LLT 10068462 Eosinophilic asthma 10038738

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 assessment phase
Data will be collected at usual asthma healthcare visits (scheduled or unscheduled). If a participant is seen by their physician for a monthly NUCALA injection, data such as asthma exacerbations, healthcare utilization, medication use, lung function, the PROs (i.e., ACT, mini-AQLQ, CAAT, WPAI-Asthma, WSI) and biomarkers will be collected in the eCRF, monthly, as available per SoC. When participants are seen less frequently (injection of NUCALA administered at home via an auto-injector formulation of NUCALA), these data will be collected at the usual asthma healthcare visit at a less frequent basis, as per SoC. At approximately 3-month intervals, until the end of the study, participants will be offered a short questionnaire for completion during usual asthma healthcare visit. This would only include validated PRO questionnaires to maintain realworld practice. Lung function via spirometry, ACT, mini-AQLQ, CAAT, WPAI-Asthma and WSI will be collected per-protocol; at baseline, 6-month, 12-month and 24-month visits, in addition to other data collection per SoA. ACQ-6 will be collected at baseline and 12 months per SoA (see Protocol Section 1.2)
 Not Applicable None

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. 1. Adults aged 18 years or over
  2. 2. Participant has a confirmed asthma diagnosis with physician decision to initiate treatment with NUCALA
  3. 3. Participants with ≥60% predicted FEV1 and ≤4 exacerbations per year, as confirmed by the physician.
  4. 4. Written informed consent.

Exclusion criteria 7

  1. 1. Investigator concerns about participant’s willingness to adhere to biologic treatment for any reason (e.g., cost, behavior, difficulty with access to healthcare)
  2. 2. Any NUCALA use in the 6 months prior to enrollment.
  3. 3. Participants currently on maintenance oral corticosteroids (mOCS) or intramuscular corticosteroids.
  4. 4. Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment.
  5. 5. Participating in an interventional study with a treatment intervention.
  6. 6. Other clinically significant respiratory conditions (e.g., bronchiectasis, pulmonary fibrosis).
  7. 7. Current smokers.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 1. Endpoint: Achieving 4-component clinical remission Summary Measure: Proportion and 95% confidence interval of patients that achieved clinical remission at 12 months

Secondary endpoints 1

  1. 1. • Clinically Significant Asthma Exacerbations (CSE) • CSE leading to hospitalization/Emergency room (ER) visits 2. • Achieving oral corticosteroids (OCS) sparing remission • Achieving 3-component clinical remission 3. Change in the 15-item mini-AQLQ overall score from baseline to 12 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Nucala 100 mg solution for injection in pre-filled syringe

PRD7486157 · Product

Active substance
Mepolizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
2500 mg milligram(s)
Max treatment duration
24 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
2500 mg milligram(s)
Max treatment duration
24 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

Nucala 100 mg solution for injection in pre-filled syringe

PRD9305739 · Product

Active substance
Mepolizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
2500 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
R03DX09 — -
Marketing authorisation
EU/1/15/1043/008
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 syringe

PRD7486158 · Product

Active substance
Mepolizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
2500 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
R03DX09 — -
Marketing authorisation
EU/1/15/1043/006
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

PRD7486156 · Product

Active substance
Mepolizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
2500 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
R03DX09 — -
Marketing authorisation
EU/1/15/1043/004
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

PRD9305729 · Product

Active substance
Mepolizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
100 mg milligram(s)
Max total dose
2500 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
R03DX09 — -
Marketing authorisation
EU/1/15/1043/007
MA holder
GLAXOSMITHKLINE TRADING SERVICES LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Glaxosmithkline Research & Development Limited

85 Total trials 24 Recruiting 53 Ended
Commercial
Sponsor organisation
Glaxosmithkline Research & Development Limited
Address
G S K House, 980 Great West Road 980 Great West Road
City
Brentford
Postcode
TW8 9GS
Country
United Kingdom

Scientific contact point

Organisation
Glaxosmithkline Research & Development Limited
Contact name
EU GSK Clinical Trials Call Center

Public contact point

Organisation
Glaxosmithkline Research & Development Limited
Contact name
EU GSK Clinical Trials Call Center

Third parties 3

OrganisationCity, countryDuties
Syneos Health Netherlands B.V.
ORG-100013861
 Amsterdam, Netherlands On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Code 5, Data management, E-data capture, Code 8, Code 9
eResearchTechnology GmbH
ORG-100044103
 Estenfeld, Germany Other, Code 5, Data management, E-data capture
Eresearchtechnology Inc.
ORG-100013039
 Philadelphia, United States Other

Locations

6 EU/EEA countries · 29 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruitment ended 12 2
France Ongoing, recruitment ended 24 6
Germany Ongoing, recruitment ended 40 7
Italy Ongoing, recruitment ended 40 8
Poland Ongoing, recruitment ended 18 3
Spain Ongoing, recruitment ended 36 3
Rest of world
Japan, United Kingdom, Canada, United States
 — 166 —

Investigational sites

Belgium

2 sites · Ongoing, recruitment ended
Algemeen Ziekenhuis Groeninge
Pneumology/Allergy, President Kennedylaan 4, 8500, Kortrijk
Centre hospitalier universitaire de Liege
Pneumology, Avenue De L'hopital 1, 4000, Liege

France

6 sites · Ongoing, recruitment ended
Hospices Civils De Lyon
Centre Intégré d’Expertise et de Recherche sur l’Asthme, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Centre Hospitalier Regional Et Universitaire De Brest
Service Pneumologie, Boulevard Tanguy Prigent, 29609, Brest Cedex 2
Centre Hospitalier De Cannes Simone Veil
Service Pneumologie, 15 Avenue Des Broussailles, Cs 50008, Cannes Cedex
Les Hopitaux Universitaires De Strasbourg
Service Asthme et Allergologie - Pneumologie, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire De Toulouse
Service Pneumologie et Allergologie, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Lille
Service Pneumologie et Immuno-Allergologie, Boulevard Du Professeur Jules Leclercq, 59000, Lille

Germany

7 sites · Ongoing, recruitment ended
IKF Pneumologie GmbH & Co. KG
Not applicable, 2nd Floor, Schaumainkai 101-103, Frankfurt Am Main
Pneumologie, Allergologie Praxis Dr. Thomas Ginko
Not applicable, Vorgebirgsstr. 43, 53119, Bonn
Pneumo Studien Darmstadt GmbH
Not applicable, Grafenstrasse 13, 64283, Darmstadt
Lungenpraxis Bonn
Pneumologische Gemeinschaftspraxis, Am Burgweiher 54, 53123, Bonn
Praxisgemeinschaft Weinkellerstrasse GbR
Facharztpraxis Pneumologie, Weinkellerstrasse 36, 09337, Hohenstein-Ernstthal
Universitaetsklinikum Aachen AöR
Klinik fuer Kardiologie, Pneumologie, Angiologie und Internistische Intensivmedizin, Pauwelsstrasse 30, 52074, Aachen
Studienzentrum Dr. Keller
Not applicable, Usinger Straße 5, 60389, Frankfurt

Italy

8 sites · Ongoing, recruitment ended
IRCCS Ospedale Policlinico San Martino
Dipartimento di Medicina Interna, Viale Benedetto XV 6, 16132, Genoa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOSD DH Medicina Interna e malattie dell’apprato digerente, Largo Francesco Vito 1, 00168, Rome
Fondazione Policlinico Universitario Campus Bio-Medico
Unit Internal medicine, Via Alvaro Del Portillo N 200, 00128, Rome
Centro Ricerche Cliniche Di Verona S.r.l.
UOC Pneumology, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Azienda Ospedaliero-Universitaria Di Cagliari
Allergology and Clinical Immunology Unit, Via Ospedale N. 54, 09124, Cagliari
Humanitas Research Hospital
Pnueumology and Allergology, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Unita Locale Socio Sanitaria N. 2 Marca Trevigiana
UO Pneumologia, Piazzale Ospedale 1, 31100, Treviso
Azienda Ospedaliera Dei Colli
Pneumology and Oncology department, Via Leonardo Bianchi, 80131, Naples

Poland

3 sites · Ongoing, recruitment ended
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
N/A, Ul. Pomorska Nr 251, 92-213, Lodz
Uniwersyteckie Centrum Kliniczne
Gdański Uniwersytet Medyczny, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Clinical Department of Internal Diseases, Asthma and Allergy with Pediatric Ward, Ul. Dr Stefana Kopcinskiego 22, 90-153, Lodz

Spain

3 sites · Ongoing, recruitment ended
Hospital De La Santa Creu I Sant Pau
Pneumology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Arnau De Vilanova De Valencia
Pneumology, Calle De San Clemente 12, 46015, Valencia
Pectus Respiratory Health S.L.
Pneumology, Calle Del Doctor Roux 78, 08017, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2024-06-05 2024-07-04 2025-01-31
France 2024-06-03 2024-07-30 2025-01-31
Germany 2024-06-11 2024-08-06 2025-01-31
Italy 2024-07-11 2024-09-11 2025-01-31
Poland 2024-09-24 2024-11-27 2025-01-31
Spain 2024-06-14 2024-09-04 2025-01-31

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 83 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2023-509026-21-00_Redacted 4
Protocol (for publication) D4_Patient facing documents_ACQ-6_BE-DUT_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_ACQ-6_BE-FRE_Redacted 2.0
Protocol (for publication) D4_Patient facing documents_ACQ-6_DE-GER_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_ACQ-6_ENG_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_ACQ-6_FR-FRE_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_ACQ-6_ITA_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_ACQ-6_POL_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_ACQ-6_SPA_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_ACT_BE-DUT 1.0
Protocol (for publication) D4_Patient facing documents_ACT_BE-FRE 1.0
Protocol (for publication) D4_Patient facing documents_ACT_DE-GER 1.0
Protocol (for publication) D4_Patient facing documents_ACT_ENG 1.0
Protocol (for publication) D4_Patient facing documents_ACT_FR-FRE 1.0
Protocol (for publication) D4_Patient facing documents_ACT_ITA 1.0
Protocol (for publication) D4_Patient facing documents_ACT_POL 1.0
Protocol (for publication) D4_Patient facing documents_ACT_SPA 1.0
Protocol (for publication) D4_Patient facing documents_CAAT_BE-DUT 1.0
Protocol (for publication) D4_Patient facing documents_CAAT_BE-FRE 1.0
Protocol (for publication) D4_Patient facing documents_CAAT_DE-GER 1.0
Protocol (for publication) D4_Patient facing documents_CAAT_ENG 1.0
Protocol (for publication) D4_Patient facing documents_CAAT_FR-FRE 1.0
Protocol (for publication) D4_Patient facing documents_CAAT_ITA 1.0
Protocol (for publication) D4_Patient facing documents_CAAT_POL 1.0
Protocol (for publication) D4_Patient facing documents_CAAT_SPA 1.0
Protocol (for publication) D4_Patient facing documents_miniAQLQ_BE-DUT_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_miniAQLQ_DE-GER_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_miniAQLQ_ENG_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_miniAQLQ_FR- and BE-FRE_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_miniAQLQ_ITA_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_miniAQLQ_POL_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_miniAQLQ_SPA_Redacted 1.0
Protocol (for publication) D4_Patient facing documents_WPAI-Asthma_BE-DUT 1.0
Protocol (for publication) D4_Patient facing documents_WPAI-Asthma_BE-FRE 1.0
Protocol (for publication) D4_Patient facing documents_WPAI-Asthma_DE-GER 1.0
Protocol (for publication) D4_Patient facing documents_WPAI-Asthma_ENG 2.0
Protocol (for publication) D4_Patient facing documents_WPAI-Asthma_FR-FRE 1.0
Protocol (for publication) D4_Patient facing documents_WPAI-Asthma_ITA 1.0
Protocol (for publication) D4_Patient facing documents_WPAI-Asthma_POL 2.0
Protocol (for publication) D4_Patient facing documents_WPAI-Asthma_SPA 1.0
Protocol (for publication) D4_Patient facing documents_WSI_BE-DUT 2.0
Protocol (for publication) D4_Patient facing documents_WSI_BE-FRE 2.0
Protocol (for publication) D4_Patient facing documents_WSI_DE-GER 2.0
Protocol (for publication) D4_Patient facing documents_WSI_ENG 2.0
Protocol (for publication) D4_Patient facing documents_WSI_ES-SPA 2.0
Protocol (for publication) D4_Patient facing documents_WSI_FR-FRE 2.0
Protocol (for publication) D4_Patient facing documents_WSI_IT-ITA 2.0
Protocol (for publication) D4_Patient facing documents_WSI_PL-POL 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_DE N/A
Recruitment arrangements (for publication) K1_Recruitment arrangements_ESP N/A
Recruitment arrangements (for publication) K1_Recruitment arrangements_FR NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_IT N/A
Recruitment arrangements (for publication) K1_Recruitment arrangements_PL 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Recruitment and Informed consent procedure_BE 1.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Main_IT_Redacted 3.1.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Pregnancy_IT_Redacted 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main DUT_BE_Redacted 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main ENG_BE_Redacted 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main FRE_BE_Redacted 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_DE_Redacted 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnancy_DE 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnant Partner DUT_BE_Redacted 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnant Partner ENG_BE_Redacted 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Pregnant Partner FRE_BE_Redacted 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_FR_Intercash_Redacted 1.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_ESP 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_FR_Redacted 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_PL 3.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_PP_ESP 2.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_PP_FR 2.1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Participant_PL 3.1.0
Subject information and informed consent form (for publication) L2_Other subject info_GP letter_IT 1.1.0
Subject information and informed consent form (for publication) L2_Other subject information material_eCOA Privacy Notice_FR 2.1
Subject information and informed consent form (for publication) L2_Other Subject information material_Redacted_Placeholder 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Nucala 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_2023-509026-21-00_ENG_Redacted 3.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_BE_2023-509026-21-00_DUT_Redacted 3.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_BE_2023-509026-21-00_FRE_Redacted 3.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_BE_2023-509026-21-00_GER_Redacted 3.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_2023-509026-21-00_SPA_Redacted 3.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_FR_2023-509026-21-00_FRE_Redacted 3.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_IT_2023-509026-21-00_ITA_Redacted 3.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_PL_2023-509026-21-00_POL_Redacted 3.0

Application history

6 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-01-24 Germany Acceptable
2024-05-10
 2024-05-14
2 SUBSTANTIAL MODIFICATION SM-1 2024-08-23 Germany Acceptable
2024-10-07
 2024-10-08
3 NON SUBSTANTIAL MODIFICATION NSM-1 2025-02-26 Germany Acceptable
2024-10-07
 2025-02-26
4 SUBSTANTIAL MODIFICATION SM-2 2025-06-02 Acceptable 2025-06-26
5 SUBSTANTIAL MODIFICATION SM-3 2025-06-04 Acceptable 2025-07-01
6 SUBSTANTIAL MODIFICATION SM-4 2025-11-04 Acceptable 2025-12-10

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