Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
780
Countries
14
Sites
84
Crohn’s Disease
To evaluate the long-term efficacy and safety of mirikizumab in participants with Crohn’s disease
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 12 Aug 2020 → ongoing
- Decision date (initial)
- 2024-06-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502841-91-00
- EudraCT number
- 2019-002687-27
- WHO UTN
- U1111-1304-8349
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety, Therapy
To evaluate the long-term efficacy and safety of mirikizumab in participants with Crohn’s disease
Conditions and MedDRA coding
Crohn’s Disease
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
- If female, participant must meet the contraception requirements.
Exclusion criteria 4
- Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.
- Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study.
- Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.
- Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Percentage of Participants Achieving Endoscopic Response (Endoscopic response based on Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score) [Time Frame: Week 52]
- Percentage of Participants Achieving Clinical Remission (Clinical remission based on CDAI) [Time Frame: Week 52]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10082863 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10725963 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10082852 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION OR INFUSION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- 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 15
| Organisation | City, country | Duties |
|---|---|---|
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Code 10 |
| Praxis Communications LLC ORG-100045170
|
Buffalo, United States | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Code 12, Code 5 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Data management |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | E-data capture |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Code 11 |
| Alimentiv Inc. ORG-100006515
|
London, Canada | Laboratory analysis |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Code 13 |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
Locations
14 EU/EEA countries · 84 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 9 | 3 |
| Belgium | Ongoing, recruitment ended | 11 | 4 |
| Croatia | Ended | 5 | 1 |
| Czechia | Ongoing, recruitment ended | 58 | 14 |
| France | Ongoing, recruitment ended | 3 | 3 |
| Germany | Ongoing, recruitment ended | 31 | 10 |
| Hungary | Ongoing, recruitment ended | 31 | 9 |
| Italy | Ongoing, recruitment ended | 3 | 3 |
| Latvia | Ongoing, recruitment ended | 2 | 1 |
| Lithuania | Ongoing, recruitment ended | 4 | 1 |
| Netherlands | Ongoing, recruitment ended | 8 | 2 |
| Poland | Ongoing, recruiting | 142 | 24 |
| Romania | Ongoing, recruitment ended | 17 | 4 |
| Slovakia | Ongoing, recruitment ended | 14 | 5 |
| Rest of world
Ukraine, Israel, Argentina, Korea, Republic of, Australia, Canada, China, Brazil, Japan, Russian Federation, Serbia, Switzerland, Turkey, United Kingdom, Mexico, India, United States
|
— | 442 | — |
Investigational sites
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Universitätsklinik für Innere Medizin I, Muellner Hauptstrasse 48, 5020, Salzburg
Medical University Of Vienna
Abteilung für Gastroenterologie und Hepatologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Medizinische Universitaet Innsbruck
Universitätsklinik für Innere Medizin I Innsbruck, Anichstrasse 35, 6020, Innsbruck
Universitair Ziekenhuis Gent
Gastroenterology, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Gastroenterology, Herestraat 49, 3000, Leuven
Imelda
Gastroenterology, Imeldalaan 9, 2820, Bonheiden
Hopital Erasme
Gastroenterology, Lennikse Baan 808, 1070, Anderlecht
University Hospital Centre Zagreb
Department of Gastroenterology and Hepatology, Ulica Mije Kispatica 12, 10000, Zagreb
Synexus Czech s.r.o.
N/A, Karlovo Namesti 2097/10, Nove Mesto, Prague
EndoArt s.r.o.
N/A, Hladnovska 1255/23, 710 00, Slezska Ostrava
Institute For Clinical And Experimental Medicine
Klinika hepatogastroenterologie, Videnska 1958/9 Krc, 140 00, Prague
Iscare a.s.
Klinické a výzkumné centrum pro střevní záněty, Ceskomoravska 2510/19, Liben, Prague
PreventaMed s.r.o.
N/A, Domovina 774/2, 779 00, Olomouc
Fakultni Nemocnice V Motole
Interní klinika 2. LF UK a FN Motol, V Uvalu 84/1, Motol, Prague
Vojenska Nemocnice Brno
Interní oddělení, Zabrdovicka 3, Zabrdovice, Brno-Zidenice
Krajska Nemocnice T Bati a.s.
Interní odd. - Gastroenterologie, Havlickovo Nabrezi 600, 760 01, Zlin
Krajska zdravotni a.s.
Interní odd.- Gastroenterologie, Socialni Pece 3316/12a, Severni Terasa, Usti Nad Labem
MUDr. GREGAR s.r.o.
N/A, Cajkovskeho 67/14, 779 00, Nova Ulice
Hepato-Gastroenterologie HK s.r.o.
Gastroenterologie, Trida Edvarda Benese 1549/34, 500 12, Hradec Kralove
Axon Clinical s.r.o.
N/A, Ostrovskeho 253/3, Smichov, Prague 5
Oblastni Nemocnice Nachod a.s.
Endoskopické centrum, Purkynova 446, 547 01, Nachod
Fakultni Thomayerova nemocnice
Interní klinika 3. LF UK a TN, Videnska 800, Krc, Prague 4
Centre Hospitalier Universitaire De Montpellier
HEGA, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
CHRU De Nancy
Gastroenterology - clinical Investgation Unit, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Centre Hospitalier Universitaire De Poitiers
Hépato-gastroentérologie et assistance nutritive, 2 Rue De La Miletrie, 86000, Poitiers
Universitaetsklinikum Wuerzburg AöR
Universitaetsklinikum Wuerzburg Loc. 1, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
Studiengesellschaft BSF UG (haftungsbeschraenkt)
Studiengesellschaft BSF Unternehmergesellschaft Loc. 7, Grosse Nikolaistrasse 7, Altstadt, Halle (Saale)
Synexus Clinical Research GmbH
Synexus Clinical Research GmbH Loc. 13, Bleichstrasse 55, Innenstadt, Frankfurt Am Main
Universitaetsklinikum Schleswig-Holstein AöR
Allgemeine Innere Medizin I Loc. 1, Arnold-Heller-Strasse 3, Brunswik, Kiel
Siloah St Trudpert Klinikum
Zentrum für Innere Medizin Loc. 1, Wilferdinger Strasse 67, Nordstadt, Pforzheim
Medizinische Hochschule Hannover
Medizinische Hochschule Hannover Loc. 25, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Tumorzentrum Nordthueringen GmbH
Tumorzentrum Nordthüringen, Grimmelallee 2a, 99734, Nordhausen
Studiengesellschaft Jakobeit UG
Gemeinschaftspraxis Jakobeit Loc. 5, Hochstrasse 49, 51688, Wipperfuerth
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
RED-Institut GmbH, Markt 15, 23758, Oldenburg In Holstein
Synexus Clinical Research GmbH
Synexus Leipzig Clinical Research Centre Loc. 3, Johannisplatz 1, Zentrum-Suedost, Leipzig
Gyongyosi Bugat Pal Korhaz
N/A, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
Clinfan Kft.
Gasztroenterológiai Rendelő, Pollack Mihaly Utca 50, 7100, Szekszard
SYNEXUS Magyarorszag Kft.
N/A, Nurnbergi Utca 1/b, 5700, Gyula
Bekes Varmegyei Koezponti Korhaz
Rethy Pal tagkorhaz, II. Belgyogyaszat - IV. Gasztroenterologia, Gyulai Ut 18, 5600, Bekescsaba
Pannonia Maganorvosi Centrum Kft.
N/A, Pannonia Utca 35-37, 1136, Budapest XIII
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
N/A, Dozsa Gyorgy Ut 77, 2800, Tatabanya
SYNEXUS Magyarorszag Kft.
N/A, Becsi Ut 61, 1036, Budapest III
DRC Kft.
N/A, Ady Endre Utca 12/b, 8230, Balatonfured
Javorszky Oedoen Korhaz
Gasztronenterológiai Osztály, Argenti Dome Ter 1-3, 2600, Vac
Azienda Socio Sanitaria Territoriale Rhodense
Gastroenterologia ed Endoscopia Digestiva, Corso Europa 250, 20017, Rho
IRCCS Policlinico San Donato
Gastroenterologia, Piazza Edmondo Malan 2, 20097, San Donato Milanese
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Gastroenterologia ed Endoscopia, Via Della Commenda 12, 20122, Milan
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Gastroenterology, Eiveniu G. 2, Kauno M. Sav., Kaunas
St. Elisabeth Hospital Tilburg
Department of Gastroenterology and Hepatology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Amsterdam UMC Stichting
Inflammatory Bowel Disease, Meibergdreef 9, 1105 AZ, Amsterdam
Gastromed ZOZ
NA, ul. Onyksowa 10, 20-582, Lublin
Korczowski Bartosz, Gabinet Lekarski
NA, ul. Litewska 4A/7, 35-302, Rzeszów
WIP Warsaw IBD Point Profesor Kierkus
NA, Ul. Plowiecka 103, 04-501, Warsaw
Synexus Polska Sp. z o.o.
NA, Ul. Marii Curie-Sklodowskiej 12, 50-381, Wroclaw
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.
NA, Ul Prowiantowa 15/4, 15-707, Bialystok
Synexus Polska Sp. z o.o.
NA, Ul. Maurycego Beniowskiego 23, 80-382, Gdansk
Manermed Sp. z o.o.
NA, Ul. Garbary 5/l4, 85-229, Bydgoszcz
Synexus Polska Sp. z o.o.
NA, Ul. Konckiego 3, 40-040, Katowice
Centrum Medyczne Medyk Sp. z o.o.
NA, Ul. Fryderyka Szopena 1, 35-055, Rzeszow
Niepubliczny Zaklad Opieki Zdrowotnej Twoje Zdrowie El Sp. z o.o.
NA, Ul. Robotnicza 79, 82-300, Elblag
Synexus Polska Sp. z o.o.
NA, Ul. Glogowska 31/33, 60-702, Poznan
Synexus Polska Sp. z o.o.
NA, Aleja Najswietszej Maryi Panny 15, 42-202, Czestochowa
Dc-Med Sp. z o.o. S.K.
NA, Ul. Dworcowa 5, 58-100, Swidnica
Nzoz For Med Sp. z o.o.
NA, Ul. Lwowska 93, 34-100, Wadowice
Centrum Zdrowia MDM
NA, ul. Inflancka 4 A, 00-189, Warszawa
Sonomed Sp. z o.o.
NA, Ul. Ks. Bp. Wladyslawa Bandurskiego 98/u12, 71-685, Szczecin
Melita Medical Sp. z o.o.
NA, Ul. Gen. Romualda Traugutta 1/7, 50-449, Wroclaw
Synexus Polska Sp. z o.o.
NA, Ul. Luzycka 3c, 81-537, Gdynia
Endoskopia Sp. z o.o.
NA, Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
Kiepury Clinic
NA, ul. Jana Kiepury 47, 41-200, Sosnowiec
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j.
NA, Ul. Pigwowa 4 A, 52-210, Wroclaw
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
NA, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
ETG Zamość
NA, Gęsia 3, 22-400, Zamość
Topolowa Medicenter Mrozek i Wspolnicy Sp.J.
NA, ul. Topolowa 33/7, 31-505, Krakow
Delta Health Care S.R.L.
Gastroenterology, Strada Caramfil G. Nicolae Nr 85a, 014142, Bucharest
Centrul De Gastroenterologie Dr. Goldis S.R.L.
Gastroenterology, Strada Blaga Lucian Nr 4, 300002, Timisoara
Memorial Healthcare International S.R.L.
Gastroenterology, Soseaua Ionescu-Sisesti Gheorghe 1, 013821, Bucharest
Monza-Ares S.R.L.
Gastroenterology, Strada Bulandra Tony Actor Nr. 27 Sectorul 2, 021967, Bucharest
Endomed s.r.o.
Gastroenterologická ambulancia, Americka Trieda 19, Sidlisko Tahanovce, Kosice
Gastro LM s.r.o.
Gastroenterologická ambulancia, Jurkovicova 7081/18, 080 01, Presov
F D Roosevelt University General Hospital Of Banska Bystrica
Gastroenterologická ambulancia, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
Cliniq s.r.o.
Gastroenterologicke Centrum, Bezrucova 5, Stare Mesto, Bratislava
Gastromedic s.r.o.
Gastroenterologická ambulancia, J. Krala 8760/3, 940 02, Nove Zamky
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 | 2020-11-12 | 2020-11-25 | 2022-10-12 | ||
| Belgium | 2020-10-12 | 2020-11-06 | 2023-08-16 | ||
| Croatia | 2024-06-19 | 2025-11-05 | 2024-06-19 | 2024-06-19 | |
| Czechia | 2020-10-14 | 2020-12-09 | 2023-08-24 | ||
| France | 2021-09-23 | 2021-10-11 | 2023-08-28 | ||
| Germany | 2021-09-17 | 2021-09-30 | 2023-09-04 | ||
| Hungary | 2020-08-24 | 2020-09-16 | 2023-08-03 | ||
| Italy | 2021-10-18 | 2021-10-29 | 2022-11-08 | ||
| Latvia | 2024-06-19 | 2024-06-19 | 2024-06-19 | ||
| Lithuania | 2024-07-19 | 2024-07-19 | 2024-07-19 | ||
| Netherlands | 2020-08-12 | 2020-10-06 | 2023-02-16 | ||
| Poland | 2020-11-17 | 2020-12-03 | |||
| Romania | 2020-12-03 | 2020-12-08 | 2023-09-05 | ||
| Slovakia | 2021-03-08 | 2021-03-24 | 2023-07-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 230 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2022-502841-91-00_Redacted | e |
| Protocol (for publication) | D4_Patient Facing Documents Copyright | 1 |
| Recruitment arrangements (for publication) | Blank document Template_AMAX | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| 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 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_List of Sites_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material List of sites | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material List of sites_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Master Visit Guide_FR_AMAX_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K3_List of Planned Sites_Belgium_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | E1E2a Patient Information and Informed Consent Form_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | E1E2c Patient Information and Informed Consent Form without greenphire_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | E1E2e Continued Access Period ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_AMAX_ Addendum Informed Consent Form_Germany_1-17 May 2023_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_AMAX_CAP ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_AMAX_Main ICF_DE_Version 5_10Feb2023_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_AMAX_Patient Reimbursement Program_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_Continued access period ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_GP Letter_IT_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum ePFS_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF SoC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Summary of Changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_Reimbursement ICF_clean | 2.1 |
| Subject information and informed consent form (for publication) | L1_Reimbursement ICF_TC | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner _Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF addendum _Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Continued Access Period Consent_CZ_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Enhanced Prefilled Syringe_CZ_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Pregnant Patient_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Continiued access _Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Continued Access Period Consent ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Continued Access_red_san | V1.0LTU2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Continued Access_ru_red_san | V1.0LAT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF DPA ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF DPA ICF_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enhanced Prefilled Syringe ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main _Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_CZ_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_lv_red_san | V05LAT01 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | v5.0LTU1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ru_red_san | V05LAT01 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_UA_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement_CZ_Redacted | 2.0 |
| 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_Amendment ICF Summary_SK_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Amendment ICF_CZ_Summary_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access_AMAX_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued access_redacted | V01HRV02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued_Access_Addendum_BEDU_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued_Access_Addendum_BEFR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued_Access_Addendum_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Informed Consent Form_AMAX_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_redacted | V01HRV02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ICF_BEDU_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ICF_BEFR_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ICF_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_site 611_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_site 614_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_site 620_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_SoC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF | V01HRV02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Subject ICF | V01HRV02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Participant_ICF | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Participant_ICF_BEDU | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Participant_ICF_BEFR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_ICF_BEDU_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_ICF_BEFR_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Self injection addendum_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes 1_FRA_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes SoC_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_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes_redacted | V1.0HR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_v1_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ISF_CoA Addendum_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and site ICF Main SoC_red_san | V1.0LTU2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and site ICF Main SoC_red_san | V1.0LAT1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Fecal Calprotectin-Home Collection Instructions_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Fecal Pathogen-Home Collection Instructions_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Master Visit Guide_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_MIRIKIZUMAB-PFS-IFU-CT_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient Study Drug Self-Administration Log_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_thank you card | 2 |
| Subject information and informed consent form (for publication) | L2_ePFS IFU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Fecal Calprotectin-Home Collection Instructions | 1.0 |
| Subject information and informed consent form (for publication) | L2_Fecal Pathogen-Home Collection Instructions | 1.0 |
| Subject information and informed consent form (for publication) | L2_Info Re insurance Conditions for Patient | 1 |
| Subject information and informed consent form (for publication) | L2_List of ssICF contact details_Redacted | 4 |
| Subject information and informed consent form (for publication) | L2_MIRIKIZUMAB IFU_FR_AMAX_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other study related ICF_SPRIS redacted | v1.0LTU2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Emergency Card AMAX | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Greenphire_Fee_Schedule_SK | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Abdominal Pain_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Program Overview | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation_Item_Program_Summary | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation_Program_Overview_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ApptReminderCard | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ApptReminderCard_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ApptReminderCard_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bowel Movement Count_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bowel Movement Question_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bristol Stool Chart_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Device Label Croatia_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Emergency Toilet Card BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Emergency Toilet Card BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EmergencyToiletCard | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ePFS IFU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ePFS IFU_SK_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ePFS_IFU _Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ePFS-IFU-CT_CZ_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fecal Calprotectin-Home _V1 16Apr2020_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Fecal Calprotectin-Home Collection Instructions BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Fecal Calprotectin-Home Collection Instructions_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fecal Calprotectin-Home Collection Instructions_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fecal Calprotectin-Home Collection Instructions_SK | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Fecal Pathogen-Home Collection Instructions_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Fecal Pathogen-Home Collection Instructions_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fecal Pathogen-Home Collection Instructions_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fecal Pathogen-Home Collection Instructions_SK | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fecal Pathogen-Home Collection Instructions_V1 16Apr2020_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_General Well-Being_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Msg Templates | 6 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Msg Templates_CZ | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Msg Templates_SK | 6 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Travel Ref Guide for Subjects_CZ | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Travel Ref Guide for Subjects_redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Travel Ref Guide_SK | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire EC packet w Data Laws_CZ | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire EU Generic ClinCard_CZ | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire EU Generic_SK | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Temp EU Generic ClinCard_redacted | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Travel Contact Card_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Travel Contact Card_redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Travel Contact Card_SK | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Card_Carrier_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Card_Carrier_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Card_Carrier_SK | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Cardholder_FAQ_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Cardholder_FAQ_EU_redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Cardholder_FAQ_SK | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_Fee_Schedule | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_Fee_Schedule_CZ | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_SK_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU-CT_CZ_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Instructions for use BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Instructions for use BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Master Visit Guide_CZ_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Pain NRS_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant ID Card | 1 |
| 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 Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card_SK | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient IP Self-Administration Log _CZ_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient IP Self-Administration Training Log_CZ_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Letter Template_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Self-Administration Log_SK_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient_Home Pregnancy Test Log_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient_Home Pregnancy Test Log_SK | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PFS IFU_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PFS QR video link_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PFS QR video_SK | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PFS-IFU-CT_v1_18Feb2020_PL _Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGRS_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SDAL V3 07Nov2023_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SDAL_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SDATL V3 07Nov2023_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SDATL__Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Study Drug Administration Log BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Study Drug Administration Log BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Study Drug Training Log BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Study Drug Training Log BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Retention Materials_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Thank You Card_SK | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Thank You Card BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Thank You Card BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ThankyouCard_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Urgency NRS_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Visit Guide BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_Visit Guide BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide V1 19Oct2023_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide_SK_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Study Drug Self-Administration Training Log_SK_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Participant appointment guide_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Card_FR_AMAX | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient card_PI Heeren | 2 |
| Subject information and informed consent form (for publication) | L2_Patient card_PI Koch | 2 |
| Subject information and informed consent form (for publication) | L2_Patient card_PI Reinisch | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Information Card | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2022-502841-91-00_CZ_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-502841-91-00_AT_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-502841-91-00_Hungary_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2022-502841-91-00_SK_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BEDE_2022-502841-91_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BEDU_2022-502841-91_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BEFR_2022-502841-91_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2022-502841-91_redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2022-502841-91-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_HR_2022-502841-91_redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2022-502841-91_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_LT_2022-502841-91-00_red_san | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Netherlands_2022-502841-91-00_redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2022-502841-91-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RO_2022-502841-91_Redacted | e |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-13 | Netherlands | Acceptable with conditions 2024-06-19
|
2024-06-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-09 | Netherlands | Acceptable with conditions 2024-06-19
|
2024-08-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-04 | Acceptable with conditions | 2024-10-28 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-06 | Acceptable with conditions | 2024-09-17 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-08 | Netherlands | Acceptable 2025-03-03
|
2025-03-03 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-03-19 | Acceptable 2025-03-03
|
2025-03-19 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-21 | Netherlands | Acceptable | 2025-06-19 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-04-28 | Acceptable | 2025-06-13 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-07 | 2025-07-07 | ||
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-07-25 | Acceptable | 2025-09-05 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-07-30 | Acceptable | 2025-09-29 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-08-11 | Acceptable | 2025-09-16 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-10-01 | 2025-10-01 | ||
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-10-02 | 2025-10-02 | ||
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-10-10 | 2025-10-10 | ||
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-11-19 | Netherlands | 2025-11-19 | |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2025-11-20 | 2025-11-20 | ||
| 18 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-11-20 | Acceptable | 2026-03-09 | |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-10 | 2026-04-01 | Acceptable | 2026-04-01 |