A Clinical Study that will measure how well SEP-363856 works and how safe it is in adults with Generalized Anxiety Disorder

2022-502077-42-00 Protocol SEP361-226 Phase II and Phase III (Integrated) Ended

Start 14 Sep 2023 · End 26 Sep 2025 · Status Ended · 6 EU/EEA countries · 30 sites · Protocol SEP361-226

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)
Status Ended
Participants planned 434
Countries 6
Sites 30

generalised anxiety disorder

To evaluate the efficacy of flexible doses of SEP-363856 (50 – 75 mg/day) compared with placebo in subjects with GAD as measured by the Hamilton Anxiety Rating Scale (HAM-A) total score

Key facts

Sponsor
Otsuka Pharmaceutical Development & Commercialization Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Psychiatry and Psychology [F] - Mental Disorders [F03]
Trial duration
14 Sep 2023 → 26 Sep 2025
Decision date (initial)
2023-07-26
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
SUNOVION PHARMACEUTICALS INC.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

To evaluate the efficacy of flexible doses of SEP-363856 (50 – 75 mg/day) compared with placebo in subjects with GAD as measured by the Hamilton Anxiety Rating Scale (HAM-A) total score

Secondary objectives 1

  1. To evaluate the efficacy of flexible doses of SEP-363856 (50 - 75 mg/day) compared with placebo in subjects with GAD as measured by the Clinical Global Impression-Severity (CGI-S) score

Conditions and MedDRA coding

generalised anxiety disorder

VersionLevelCodeTermSystem organ class
21.1 PT 10018075 Generalised anxiety disorder 100000004873

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Male or female subject between 18 to 65 years of age.
  2. Subject meets DSM-5 criteria for a diagnosis of Generalized Anxiety Disorder
  3. Subject must be willing and able to comply with the study procedures and visit schedule and must be able to understand and follow verbal and written instructions.

Exclusion criteria 5

  1. Subject has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than Generalized Anxiety Disorder, that is the primary focus of treatment
  2. Subjects who report an inadequate response to more than 3 antidepressant treatments
  3. Subject is at significant risk of harming self or others based on Investigator’s judgement.
  4. Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject’s ability to complete and/or participate in the study.
  5. Female subject who is pregnant, lactating, or plans to get pregnant during the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Endpoint.

Secondary endpoints 1

  1. Change from Baseline in Clinical Global Impression-Severity (CGI-S) score at Endpoint.

Investigational products

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

Test 3

Ulotaront

PRD11128377 · Product

Active substance
Ulotaront
Substance synonyms
SEP-363856, (S)-1-(4,7-dihydro-5H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine, SEP-856
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
25 mg milligram(s)
Max total dose
75 mg milligram(s)
Max treatment duration
3 Day(s)
Authorisation status
Not Authorised
MA holder
OTSUKA PHARMACEUTICAL CO., LTD.
Paediatric formulation
No
Orphan designation
No

Ulotaront

PRD11128379 · Product

Active substance
Ulotaront
Substance synonyms
SEP-363856, (S)-1-(4,7-dihydro-5H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine, SEP-856
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
75 mg milligram(s)
Max total dose
3900 mg milligram(s)
Max treatment duration
52 Day(s)
Authorisation status
Not Authorised
MA holder
OTSUKA PHARMACEUTICAL CO., LTD.
Paediatric formulation
No
Orphan designation
No

Ulotaront

PRD11128378 · Product

Active substance
Ulotaront
Substance synonyms
SEP-363856, (S)-1-(4,7-dihydro-5H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine, SEP-856
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
50 mg milligram(s)
Max total dose
200 mg milligram(s)
Max treatment duration
4 Day(s)
Authorisation status
Not Authorised
MA holder
OTSUKA PHARMACEUTICAL CO., LTD.
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo SEP-365856

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

Otsuka Pharmaceutical Development & Commercialization Inc.

12 Total trials 5 Recruiting 7 Ended
Commercial
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization Inc.
Address
2440 Research Boulevard
City
Rockville
Postcode
20850-3238
Country
United States

Scientific contact point

Organisation
Otsuka Pharmaceutical Development & Commercialization Inc.
Contact name
Brian Rothman

Public contact point

Organisation
Otsuka Pharmaceutical Development & Commercialization Inc.
Contact name
Jose Contreras

Third parties 10

OrganisationCity, countryDuties
Frontage Laboratories Inc.
ORG-100011515
 Exton, United States Other
Iqvia Limited
ORG-100008655
 Reading, United Kingdom On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Code 5, Data management, Code 8
Sharp Clinical Services Inc.
ORG-100022936
 Bethlehem, United States Other
Q Squared Solutions Limited
ORG-100042527
 Reading, United Kingdom Laboratory analysis
Verified Clinical Trials LLC
ORG-100045692
 Garden City, United States Other
Labcorp Central Laboratory Services LP
ORG-100032236
 Indianapolis, United States Other
Manufacturing Packaging Farmaca (MPF) B.V.
ORG-100011536
 Heerenveen, Netherlands Other
Medidata Solutions Inc.
ORG-100016256
 New York, United States E-data capture
Signant Health Global LLC
ORG-100040604
 Blue Bell, United States Other
Oracle America Inc.
ORG-100039874
 Redwood City, United States Code 14

Locations

6 EU/EEA countries · 30 investigational sites

By country

CountryMS statusPlanned subjectsSites
Bulgaria Ended 89 10
Estonia Ended 14 1
Finland Ended 37 4
Slovakia Ended 37 4
Spain Ended 42 7
Sweden Ended 36 4
Rest of world
United States, Japan
 — 179 —

Investigational sites

Bulgaria

10 sites · Ended
Diagnostics-Consultancy Center Mladost M Varna OOD
N/A, Bulevard Republika 15, 9020, Varna
Diagnostics-Consultancy Center Mladost M Varna OOD
N/A, Bulevard Republika 15, 9020, Varna
Medical Center Intermedica Ltd.
N/A, Belite Brezim, Ulitsa Nishava 62, Sofiya
Medical Center Saint Naum EOOD
N/A, Ulitsa D-R Lyuben Rusev 1, 1113, Sofiya
Medical Center Medconsult Pleven OOD
N/A, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
Mental Health Center Sofia
N/A, Bulevard Slivnitsa 309, 1202, Sofia
Medical Center Hera EOOD
N/A, Ulitsa Klisura 20, 1510, Sofiya
Medical Center Spectar Plovdiv EOOD
N/A, Ulitsa Makedoniya 107, 4004, Plovdiv
DCC St. Vrach and St. St. Kuzma and Damian OOD
N/A, 17, Dimitar Manov Str., Sofia
Medical Center Mentalcare Ltd.
N/A, Bulevard Aleksandir Stamboliyski 107, 4004, Plovdiv

Estonia

1 site · Ended
Marienthali Kliinik OÜ
N/A, Kotka Tn 12, Kristiine Linnaosa, Tallinn

Finland

4 sites · Ended
Savon Psykiatripalvelu Oy
Savon Psykiatripalvelu Oy, Asemakatu 46 B 23, 70110, Kuopio
Satakunnan Psykiatripalvelu
Satakunnan Psykiatripalvelu at Mehiläinen Tampere Finlayson, Itäinenkatu 3, 33210, Tampere
Oulu Mentalcare Oy
Oulu Mentalcare Oy, Isokatu 8 B 8, 90100, Oulu
Laeaekaerikeskus Aava Oy
Lääkärikeskus Aava Kamppi, Annankatu 32, 00100, Helsinki

Slovakia

4 sites · Ended
EPAMED s.r.o.
Psychiatricka ambulancia, Hlavna 37/68, 040 01, Kosice
PsychoLine s.r.o.
Psychiatricka ambulancia, Dobsinskeho 4861, 97901, Rimavska Sobota
Crystal Comfort s.r.o.
Psychiatricka ambulancia, M R Stefanika 2427, 093 01, Vranov Nad Toplou
MENTUM, s.r.o.
Psychiatricka ambulancia, Ruzinovska 10, 820 07, Bratislava

Spain

7 sites · Ended
Hospital de Antequera
Psychiatry Unit, Avenida Poeta Munoz Rojas S/n, 29200, Antequera
Hospital Valle del Nalon
Psychiatry, Polígono de Riaño, 1, Langreo
University Hospital Son Espases
Psychiatry, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Fundacion Alcorcon
Psychiatry, Calle Budapest 1, 28022, Madrid
Hospital Universitario Infanta Leonor
Psychiatry, Avenida Gran Via Del Este 80, 28031, Madrid
Institucion Hospitalaria Hestia Palau
Psychiatry, c/ de Sant Antoni Maria Claret, 135, Barcelona
Hospital De La Santa Creu I Sant Pau
Psychiatry, Calle De San Antonio Maria Claret 167, 08025, Barcelona

Sweden

4 sites · Ended
ProbarE i Stockholm AB
N/A, Vegagatan 8, Gustav Vasa, Stockholm
ProbarE i Lund AB
N/A, S Domkyrkofors., Lilla Fiskaregatan 10, Lund
PharmaSite AB
N/A, Foreningsgatan 26, Malmo S:t Johannes, Malmo
Sahlgrenska Universitetssjukhuset - Östra sjukhuset
FOU-enhet/Kliniska FOU-enhet/Kliniska prövningar, 5 Journalvägen, 416 50, Göteborg

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Bulgaria 2023-09-14 2024-09-19 2023-09-28 2024-06-25
Estonia 2023-10-03 2025-06-11 2023-10-19 2025-06-11
Finland 2023-09-27 2025-06-17 2023-11-13 2025-06-17
Slovakia 2023-09-19 2025-09-17 2023-10-24 2025-07-03
Spain 2023-10-26 2024-07-25 2023-12-12 2024-06-25
Sweden 2023-10-20 2025-09-10 2023-10-20 2025-07-03

Results and documents

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

Documents 270 files

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

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Protocol (for publication) D1_Protocol Blinded Addendum Agency_2022-502077-42-00_red-san 1
Protocol (for publication) D1_Protocol SEP361-226 EU Specific_Redacted 3.0B
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Protocol (for publication) D4_Patient facing documents Patient ID Card_SE_san V01 SWE
Protocol (for publication) D4_Patient Study Guide_BGR-BG_red-san V02 BGR-bg
Protocol (for publication) D4_Patient Study Guide_ESP-ES_red-san V02 ESP-es
Protocol (for publication) D4_Patient Study Guide_Global-EN_red-san V02 Global
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Recruitment arrangements (for publication) K1_Recruitment arrangements_red_san V1
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Recruitment arrangements (for publication) K1_Recruitment arrangements_red-san 1.0
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Recruitment arrangements (for publication) K2_Recruitment material_Online Ads_Social Media_Clinical Trial Posts_san 01
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_san V01FIN01
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_san 01SVK01
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure_san V01SWE(sv)
Recruitment arrangements (for publication) K2_Recruitment material_Patient Flyer_san V01FIN01
Recruitment arrangements (for publication) K2_Recruitment material_Patient Flyer_san 01SVK01
Recruitment arrangements (for publication) K2_Recruitment material_Patient Flyer_san V01SWE(sv)
Recruitment arrangements (for publication) K2_Recruitment material_Print Ad Large_san 01
Recruitment arrangements (for publication) K2_Recruitment material_Print Ad Large_san V01SWE(sv)
Recruitment arrangements (for publication) K2_Recruitment material_Print Ad Small_san 01
Recruitment arrangements (for publication) K2_Recruitment material_Print Ad Small_san V01SWE(sv)
Recruitment arrangements (for publication) K2_Recruitment material_Social Media_san V01SWE(sv)
Recruitment arrangements (for publication) K2_Recruitment material_Waiting Room Ad_san V01FIN(fi)
Recruitment arrangements (for publication) K2_SE_sv_Recruitment material_Advertisement N/A
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Banner Ads_et 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Banner Ads_ru 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Digital Waiting Room Ad_et 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Digital Waiting Room Ad_ru 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Online Ads_Social Media_Clinical Trial Posts_et 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Online Ads_Social Media_Clinical Trial Posts_ru 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Patient Brochure_et 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Patient Brochure_ru 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Patient Flyer_et 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Patient Flyer_ru 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Patient ID Card_et 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Patient ID Card_ru 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Print Ad Large_et 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Print Ad Large_ru 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Print Ad Small_et 01
Recruitment arrangements (for publication) K2_SEP361-226 GAD_Print Ad Small_ru 01
Recruitment arrangements (for publication) K2_SK_sk_Recruitment material_Advertisement N/A
Subject information and informed consent form (for publication) L1_4_1_VCT ICF EU_English 2021-6-N
Subject information and informed consent form (for publication) L1_4_2_VCT ICF EU_EN _Country adapted_Bulgaria_Clean_san 1.0
Subject information and informed consent form (for publication) L1_4_3_VCT ICF EU_Bulgarian_Clean_san V1.0BGR1.0
Subject information and informed consent form (for publication) L1_BG_ICF_Main_bg_Redacted V5.0BGR1.0
Subject information and informed consent form (for publication) L1_BG_ICF_Main_Redacted 1.0
Subject information and informed consent form (for publication) L1_BG_ICF_Optional PG_bg_Redacted V1.3BGR1.0
Subject information and informed consent form (for publication) L1_BG_ICF_Optional PG_Redacted 1.0
Subject information and informed consent form (for publication) L1_BG_ICF_Pregnant Partner 1.0
Subject information and informed consent form (for publication) L1_BG_ICF_Pregnant Partner_bg V1.3BGR1.0
Subject information and informed consent form (for publication) L1_EE_ICF_Main et V8.0EST1.0
Subject information and informed consent form (for publication) L1_EE_ICF_Main_et_Redacted V5.0EST1.0
Subject information and informed consent form (for publication) L1_EE_ICF_Main_ru V8.0EST1.0
Subject information and informed consent form (for publication) L1_EE_ICF_Main_ru_redacted V5.0EST1.0
Subject information and informed consent form (for publication) L1_EE_ICF_Optional PG_et_Redacted V1.3EST1.0
Subject information and informed consent form (for publication) L1_EE_ICF_Optional PG_ru_Redacted V1.3EST1.0
Subject information and informed consent form (for publication) L1_EE_ICF_Pregnant Partner_et V1.3EST1.0
Subject information and informed consent form (for publication) L1_EE_ICF_Pregnant Partner_ru V1.3EST1.0
Subject information and informed consent form (for publication) L1_FI_ICF_Main Appendix_fi_Redacted V5.0FIN1.0
Subject information and informed consent form (for publication) L1_FI_ICF_Main_fi_Redacted V5.0FIN1.0
Subject information and informed consent form (for publication) L1_FI_ICF_Pregnant Partner_fi V1.3FIN1.0
Subject information and informed consent form (for publication) L1_Global_ICF_Main_Redacted 5.0
Subject information and informed consent form (for publication) L1_Global_ICF_Optional PG_Redacted 1.3
Subject information and informed consent form (for publication) L1_Global_ICF_Pregnant Partner 1.3
Subject information and informed consent form (for publication) L1_SE_ICF_Main_sv_Redacted V5.0SWE1.0
Subject information and informed consent form (for publication) L1_SE_ICF_Optional PG_sv_Redacted V1.3SWE1.0
Subject information and informed consent form (for publication) L1_SIS and ICF VCT_san 2021-6-N
Subject information and informed consent form (for publication) L1_SIS and ICF VCT_san N/A
Subject information and informed consent form (for publication) L1_SIS and ICF VCT_san 2021-6-N
Subject information and informed consent form (for publication) L1_SIS and ICF_VCT ICF EU 2021-6-N-Estonian_san N/A
Subject information and informed consent form (for publication) L1_SIS and ICF_VCT ICF EU 2021-6-N-Russian_san N/A
Subject information and informed consent form (for publication) L1_SK_ICF_Main_sk_Redacted V5.0SVK1.0
Subject information and informed consent form (for publication) L1_SK_ICF_Optional PG_sk_Redacted V1.3SVK1.0
Subject information and informed consent form (for publication) L1_SK_ICF_Pregnant Partner_sk V1.3SVK1.0
Subject information and informed consent form (for publication) L2_1_SEP361-226 GAD_Patient Brochure_san V01BGR(bg)
Subject information and informed consent form (for publication) L2_2_SEP361-226 GAD_Patient Flyer_san V01BGR(bg)
Subject information and informed consent form (for publication) L2_3_SEP361-226 GAD_Online Ads_Social Media_Clinical Trial Posts_san V01BGR(bg)
Subject information and informed consent form (for publication) L2_4_SEP361-226 GAD_Digital Waiting Room Ad_san V01BGR(bg)
Subject information and informed consent form (for publication) L2_5_SEP361-226 GAD_Banner Ads_BGRbg N/A
Subject information and informed consent form (for publication) L2_6_SEP361-226 GAD_Print Ad Large_san V01BGR(bg)
Subject information and informed consent form (for publication) L2_7_SEP361-226 GAD_Print Ad Small_san V01BGR(bg)
Subject information and informed consent form (for publication) L2_FI_fi_Other subject information_Data processing_Redacted 4.0
Subject information and informed consent form (for publication) L2_Questionnaire BARS_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire C-SSRS B-S_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire C-SSRS SLV_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire CCQ_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire CSFQ-14F_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire CSFQ-14M_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire HAM-A female_Slovakia_Slovak_red-san 2
Subject information and informed consent form (for publication) L2_Questionnaire HAM-A male_Slovakia_Slovak_red-san 2
Subject information and informed consent form (for publication) L2_Questionnaire HCRU_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire MSQ_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire PCRS P-B_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire PCRS S_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire PSQI_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire SCID-5-CT_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire SDS_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire SF-36v2_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire SIGH-A_Slovakia_Slovak_red-san 1.0
Subject information and informed consent form (for publication) L2_Questionnaire SIGMA_Slovakia_Slovak_red-san 1.0
Synopsis of the protocol (for publication) D1_Protocol SEP361-226 EU-Specific Synopsis 3.0B
Synopsis of the protocol (for publication) D1_Protocol SEP361-226 EU-Specific Synopsis_bg 2.01B
Synopsis of the protocol (for publication) D1_Protocol SEP361-226 EU-Specific Synopsis_sk 3.0B
Synopsis of the protocol (for publication) D1_Protocol SEP361-226 EU-Specific Synopsis_sv 3.0B
Synopsis of the protocol (for publication) D1_Protocol synopsis_ESP-ES_2022-502077-42-00_red-san 2.0

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-04-03 Spain Acceptable
2023-07-21
 2023-07-24
2 NON SUBSTANTIAL MODIFICATION NSM-1 2023-07-28 Acceptable
2023-07-21
 2023-07-28
3 NON SUBSTANTIAL MODIFICATION NSM-2 2023-08-02 Acceptable
2023-07-21
 2023-08-02
4 NON SUBSTANTIAL MODIFICATION NSM-3 2023-08-18 Spain Acceptable
2023-07-21
 2023-08-18
5 SUBSTANTIAL MODIFICATION SM-1 2023-09-25 Spain Acceptable
2023-11-27
 2023-11-27
6 SUBSTANTIAL MODIFICATION SM-2 2024-04-29 Spain Acceptable
2024-07-04
 2024-07-04
7 NON SUBSTANTIAL MODIFICATION NSM-4 2024-08-14 Acceptable
2024-07-04
 2024-08-14
8 SUBSTANTIAL MODIFICATION SM-3 2024-08-27 Acceptable
2024-10-22
 2024-10-22
9 NON SUBSTANTIAL MODIFICATION NSM-6 2024-10-29 Spain Acceptable
2024-10-22
 2024-10-29
10 SUBSTANTIAL MODIFICATION SM-4 2024-11-11 No conclusion
2025-01-27
 2025-01-30
11 NON SUBSTANTIAL MODIFICATION NSM-7 2025-02-26 Spain No conclusion
2025-01-27
 2025-02-26
12 SUBSTANTIAL MODIFICATION SM-5 2025-06-12 Acceptable
2025-07-21
 2025-07-25

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