Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,030
Countries
14
Sites
88
Ulcerative Colitis
The main purpose of this study is to find out if long-term treatment with the study medication, mirikizumab, can help patients with ulcerative colitis.
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
- 13 Sep 2018 → ongoing
- Decision date (initial)
- 2023-11-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507657-15-00
- EudraCT number
- 2017-004092-31
- WHO UTN
- U1111-1297-1001
- ClinicalTrials.gov
- NCT03519945
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Pharmacoeconomic, Pharmacogenomic, Therapy, Pharmacokinetic
The main purpose of this study is to find out if long-term treatment with the study medication, mirikizumab, can help patients with ulcerative colitis.
Conditions and MedDRA coding
Ulcerative Colitis
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 from Study AMAC (NCT02589665) or AMBG (NCT03524092) who have had at least one study drug administration and have not had early termination of study drug.
- Female participants must agree to contraception requirements.
Exclusion criteria 4
- Participants must not have developed a new condition, including cancer in the originator study.
- Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
- Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
- Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of participants in clinical remission. Clinical remission is based on the modified Mayo Score (MMS).
Secondary endpoints 4
- Percentage of participants in endoscopic remission, based on the Mayo Endoscopic Score (ES).
- Percentage of participants who are hospitalized due to UC over time.
- Percentage of participants who undergo UC surgeries over time.
- IBDQ scores over time
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10082863 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- 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
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- 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
Locations
14 EU/EEA countries · 88 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 6 | 3 |
| Belgium | Ended | 14 | 3 |
| Czechia | Ended | 35 | 9 |
| Denmark | Ended | 3 | 3 |
| France | Ongoing, recruitment ended | 22 | 11 |
| Hungary | Ongoing, recruitment ended | 25 | 8 |
| Italy | Ended | 18 | 9 |
| Latvia | Ongoing, recruitment ended | 20 | 1 |
| Lithuania | Ended | 11 | 3 |
| Netherlands | Ended | 16 | 3 |
| Poland | Ended | 101 | 19 |
| Romania | Ongoing, recruitment ended | 9 | 5 |
| Slovakia | Ended | 10 | 4 |
| Spain | Ended | 8 | 7 |
| Rest of world
Japan, Mexico, Switzerland, Ukraine, India, Serbia, Canada, United States, Moldova, Republic of, Israel, Australia, Taiwan, Russian Federation, Turkey, Korea, Republic of, Argentina, China
|
— | 732 | — |
Investigational sites
Medizinische Universitaet Innsbruck
Department of Internal Medicine I, Anichstrasse 35, 6020, Innsbruck
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department of Internal Medicine I, Muellner Hauptstrasse 48, 5020, Salzburg
Medical University of Vienna
Department of Gastroenterology and Hepatology, Waehringer Guertel 18-20, Alsergrund, Vienna
UZ Leuven
Gastroenterology - Inflammatory Bowel Disease, Herestraat 49, 3000, Leuven
Uz Gent
Gastroenterology, Corneel Heymanslaan 10, 9000, Gent
centre Hospitalier de Wallonie Picarde
Gastroenterology, Avenue Delmee 9, 7500, Tournai
Mediendo s.r.o.
N/A, Thamova 289/13, Karlin, Prague 8
Fakultní Nemocnice Královské Vinohrady
II. Interni klinika – gastroenterologie, Srobarova 1150/50, Vinohrady, Prague 10
Fakultni Nemocnice U Sv Anny V Brne
II. Interni klinika, Pekarska 53, Stare Brno, Brno-Stred
A-Shine s.r.o.
N/A, Sumavska 2, Vychodni Predmesti, Plzen 3
Iscare a.s.
N/A, Ceskomoravska 2510/19, Liben, Prague
Vojenska Nemocnice Brno
Interni oddeleni, Zabrdovicka 3, Zabrdovice, Brno-Zidenice
Hepato-Gastroenterologie HK s.r.o.
N/A, Trida Edvarda Benese 1549/34, 500 12, Hradec Kralove
MUDr. GREGAR s.r.o.
N/A, Cajkovskeho 67/14, 779 00, Nova Ulice
PreventaMed s.r.o.
N/A, Domovina 774/2, 779 00, Olomouc
Sygehusenheden Nyborg
N/A, Vestergade 17, 5800, Nyborg, Syddanmark
Herlev Hospital
Department of Gastroenterol D, Borgmester Ib Juuls Vej 1, 2730, Herlev
Region Sjaelland
Dept Medicine, Lykkebaekvej 1, 4600, Koege
Centre Hospitalier Universitaire De Bordeaux
Hépato-gastroentérologie, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Saint Etienne
Gastro entérologie, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Hospitalier Universitaire De Lille
Maladies appareil digestif, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier De Pau
Hépato-gastroentérologie, 4 Boulevard Hauterive, Cs 17595, Pau Cedex
Centre Hospitalier Universitaire Amiens Picardie
Hepato-gastroentérology, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Hopital Saint Eloi
N/A, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Hopital Saint Louis
N/A, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Regional Universitaire De Tours
Hépato-gastroentérologie, Avenue De La Republique, 37170, Chambray Les Tours
Centre Hospitalier Lyon Sud
Gastroenterology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Medico Chirurgical Ambroise Pare Hartmann
Institut des MICI, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
Centre Hospitalier Universitaire De Nice
N/A, 151 Route De Saint Antoine, 06200, Nice
Semmelweis University
Belgyogyaszati es Hematologiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
I. Belgyogyaszat, Gasztroenterologia, Vasvari Pal Utca 2-4, 9024, Gyor
Javorszky Oedoen Korhaz
Gasztroenterologiai Osztaly, Argenti Dome Ter 1-3, 2600, Vac
Bekes Varmegyei Koezponti Korhaz
IV. Belgyogyaszat, Gyulai Ut 18, 5600, Bekescsaba
University Of Szeged
I.sz. Belgyogyaszati Klinika, Kalvaria Sugarut 57, 6725, Szeged
Endomedix Kft.
Endomedix Kft., Dozsa Gyorgy Ut 12, 3525, Miskolc
Clinfan Kft.
Gasztroenterologiai Rendelo, Pollack Mihaly Utca 50, 7100, Szekszard
Eszak-Budai Szent Janos Centrumkorhaz
I. Belgyogyaszat, Gasztroenterologia, Kutvolgyi Ut 4, 1125, Budapest XII
Azienda Socio Sanitaria Territoriale Rhodense
Gastroenterologia ed Endoscopia Digestiva, Corso Europa 250, 20017, Rho
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Gastroenterologia, Viale Oxford 81, 00133, Rome
Humanitas Research Hospital
Malattie infiammatorie croniche intestinali, Via Alessandro Manzoni 56, 20089, Rozzano
Ospedale Mauriziano Umberto I
Gastroenterology Unit, Largo Filippo Turati 62, 10128, Torino
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Gastroenterologia, Largo Agostino Gemelli 8, 00168, Rome
IRCCS Ospedale Policlinico San Martino
Gastroenterologia ad Indirizzo Interventistico, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Ospedaliero Universitaria Pisana
Gastroenterologia e Malattie Infettive, Via Paradisa 2, 56124, Pisa
Azienda ospedaliero-universitaria Mater Domini
Fisiopatologia Digestiva, Viale Europa, 88100, Catanzaro
Sandro Pertini Hospital
Centro per le Malattie infiammatorie croniche intestinali, Via Dei Monti Tiburtini 385, 00157, Rome
Klaipėdos Miesto poliklinika
Gastroenterology, Taikos pr. 76, 93200, Klaipeda
Panevezys Republican Hospital, Public Institution
Gastroenterology, Smelynes str. 25, LT-35144, Panevezys
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Gastroenterology, Eiveniu G. 2, Kauno M. Sav., Kaunas
Amsterdam UMC, locatie AMC
Inflammatory Bowel Disease, Meibergdreef 9, 1105, Amsterdam
Universitair Medisch Centrum Utrecht
N/A, Heidelberglaan 100, 3584 CX, Utrecht
St. Elisabeth Hospital Tilburg
Department of Gastroenterology and Hepatology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Szpital Miejski Sw. Jana Pawla II W Elblagu
Oddzial Chorob Wewnetrznych, Ul. Jana Amosa Komenskiego 35, 82-300, Elblag
Sonomed Sp. z o.o.
Sonomed Sp. z o.o., Ul. Ks. Bp. Wladyslawa Bandurskiego 98/u12, 71-685, Szczecin
Wojewodzki Szpital Specjalistyczny W Olsztynie
Oddzial Gastroenterologii, Ul. Zolnierska 18, 10-561, Olsztyn
NZOZ Medica
WIP Warsaw IBD Point Profesor Kierkus, ul. Plowiecka 103, 04-501, Warszawa
Gastromed Sp. z o.o.
GASTROMED Kopon Zmudzinski i Wspolnicy S.J. Specjalistyczne Centrum Gastrologii i Endoskopii, Ul. Grudziadzka 11/13-14, 87-100, Torun
Gastromed ZOZ
Poradnia Gastroenterologiczna z Pracownia Endoskopowa, ul. Onyksowa 10, 20-582, Lublin
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia - Szczecinskie Centrum Medyczne, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Nzoz For Med Sp. z o.o.
Niepubliczny Zaklad Opieki Zdrowotnej FORMED, Ul. Lwowska 93, 34-100, Wadowice
Topolowa Medicenter Mrozek i Wspolnicy Sp.J.
Topolowa Medicenter Mrozek i Wspolnicy Sp.J., ul. Topolowa 33/7, 31-505, Krakow
Centrum Medyczne Lux Med
Poradnia Gastroenterologii, ul. Stanislawa Jablonskiego 2/4, 35-068, Rzeszow
Gabinet Endoskopii Przewodu Pokarmowego
Piotr, ul. Szewska 4/5, 31-009, Krakow
Planetmed Sp. z o.o.
PlanetMed Sp.z o.o., Ul. Lubinowa 12/8, 52-210, Wroclaw
Endoskopia Sp. z o.o.
Endoskopia Sp.z.o.o, Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
Eb Group Sp. z o.o.
N/A, Ul. Inflancka 4a, 00-189, Warsaw
Economicus Sp. z o.o.
Zaklad Gastroenterologii, Ul. Harcerzy Wrzesnia 1939 5, 40-659, Katowice
Manermed Sp. z o.o.
Poradnia Chorob Jelitowych, Ul. Garbary 5/l4, 85-229, Bydgoszcz
Vivamed Sp. z o.o.
NA, Ul. Zamiejska 17, 03-580, Warsaw
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Oddzial Gastroenterologii, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Pro Life Medica Sp. z o.o.
NA, Ul. Gesia 3, 22-400, Zamosc
Spitalul Clinic Colentina Bucuresti
Gastroenterology, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Pelican Impex S.R.L.
Gastroenterology, Calea Coposu Corneliu 14a-14b, 410469, Oradea
Policlinica CCBR S.R.L.
Gastroenterology, Aleea Buchetului 2 Block C2 Sector 3, 030463, Bucharest
Memorial Healthcare International S.R.L.
Gastroenterology, Soseaua Ionescu-Sisesti Gheorghe Nr 8a, 013823, Bucharest
Monza-Ares S.R.L.
Gastroenterology, Strada Bulandra Tony Actor Nr. 27 Sectorul 2, 021967, Bucharest
F D Roosevelt University General Hospital Of Banska Bystrica
Gastroenterologická ambulancia, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
KM Management spol. s r.o.
Gastroenterologické a hepatologické centrum, Hodzova 408/46, 949 01, Nitra
Endomed s.r.o.
Gastroenterologická ambulancia, Hlovkova 2696, 093 01, Vranov Nad Toplou
Cliniq s.r.o.
Gastroenterologické centrum, Bezrucova 5, Stare Mesto, Bratislava
El Hospital Universitario De Gran Canaria Dr. Negrin
Digestivo, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitario Marques De Valdecilla
Digestivo, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitari De Girona Doctor Josep Trueta
Digeativo, Avinguda De Franca S/n, 17007, Girona
Hospital Universitario La Paz
Digestivo, Paseo Castellana 261, 28046, Madrid
Hospital Universitario Central De Asturias
Digestivo, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario De Fuenlabrada
Digestivo, Camino Del Molino 2, 28942, Fuenlabrada
Hospital De Sagunto
medicina interna digestivo, Calle De Ramon Y Cajal 46, 46520, Sagunto
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 | 2020-07-02 | 2025-01-09 | 2020-08-20 | 2021-10-04 | |
| Belgium | 2018-09-13 | 2025-04-03 | 2018-12-03 | 2023-04-11 | |
| Czechia | 2018-09-17 | 2025-06-13 | 2018-11-07 | 2021-11-03 | |
| Denmark | 2018-11-23 | 2024-09-26 | 2019-04-22 | 2021-03-26 | |
| France | 2019-06-05 | 2019-09-05 | 2023-12-09 | ||
| Hungary | 2019-04-19 | 2019-04-19 | 2022-02-01 | ||
| Italy | 2019-08-14 | 2025-07-08 | 2019-12-20 | 2021-11-08 | |
| Latvia | 2019-08-26 | 2019-11-13 | 2023-11-30 | ||
| Lithuania | 2018-09-28 | 2026-03-19 | 2018-10-04 | 2021-08-26 | |
| Netherlands | 2018-10-10 | 2025-05-15 | 2018-10-31 | 2021-10-28 | |
| Poland | 2019-01-08 | 2025-07-28 | 2019-02-11 | 2022-09-30 | |
| Romania | 2020-02-26 | 2021-01-20 | 2021-11-04 | ||
| Slovakia | 2020-02-12 | 2026-04-28 | 2020-04-15 | 2023-12-09 | |
| Spain | 2019-11-25 | 2025-01-08 | 2019-11-25 | 2021-09-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 199 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-507657-15-00_Redacted | e |
| Protocol (for publication) | Patient Documents Copyright Template | 1 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangements form template | 1 |
| Recruitment arrangements (for publication) | Blank document Template | 1 |
| Recruitment arrangements (for publication) | Blank document Template | 1.0 |
| Recruitment arrangements (for publication) | Blank document Template | 1.0 |
| Recruitment arrangements (for publication) | Blank document Template | 1.0 |
| Recruitment arrangements (for publication) | Blank document Template | 1.0 |
| Recruitment arrangements (for publication) | Blank document Template | 1.0 |
| Recruitment arrangements (for publication) | Blank document Template | 1 |
| Recruitment arrangements (for publication) | Blank document Template_v1 | 1.0 |
| Recruitment arrangements (for publication) | Blank document__AMAP_ | 1.0 |
| Recruitment arrangements (for publication) | Blanket Statement - Document not published anymore | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement and ICF procedure declaration | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_List of sites_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Mirikizumab How to Inject Video Script_ENG | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material QR PFS video link_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material QR PFS video link_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Thank You Card_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Thank You Card_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Thank You Card_ENG | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_List of participating sites_CZ_Redacted | 1 |
| Recruitment arrangements (for publication) | K3_List of Planned Sites_Belgium_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | E1E2 I6T-MC-AMAP_Pregnant Partner ICF_NL_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | E1E2a Continued Access Addendum ICF NL Clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Addendum ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_Addendum Informed Consent Form | 2.0 |
| Subject information and informed consent form (for publication) | L1_Continued Access Add ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_GP Letter_IT | 4.0 |
| Subject information and informed consent form (for publication) | L1_GP Letter_IT_TC | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Continued Access_BEDU | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Continued Access_BEDU_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Continued Access_BEFR | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Continued Access_BEFR_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Continued Access_ENG | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Continued Access_ENG_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Home IP_BEDU | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Home IP_BEFR | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Home IP_ENG | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF Adults_BEDU_Final_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_ICF Adults_BEFR_Final_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Participant_BEDU | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Participant_BEFR | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner_BEDU | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner_BEFR | 1.2 |
| Subject information and informed consent form (for publication) | L1_ICF Protocol Addendum_AMAP_Poland | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_main_AMAP_Poland_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_Main PIS-ICF | 7.0 |
| Subject information and informed consent form (for publication) | L1_Participant Travel Partner Release of PI | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patient_AddendumICF_clean | 1.1 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_clean_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Reimbursement ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Continued Access | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Patient Survey | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_san | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Privacy Addendum | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_san | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Protocol Addendum 17_2 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Protocol Addendum 17_2 ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement _Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Travel Partner ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Travel Partner ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum 17-2 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Continued Access_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_lv_san | V02LAT02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_ru_san | V02LAT02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Addendum_Redacted | 2.5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_lv_san | V06LAT02 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 11.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ru_san | V06LAT02 |
| 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_Main_TC_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP ICF_lv_san | V01LAT03 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP ICF_ru_san | V01LAT03 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Protocol Addendum 18_1_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_Site facing material_EN_HCP Survey Consent | 1.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire ClinCard Travel Ref Guide for Subjects | 3.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire EU Generic ClinCard | 3.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire Fee Schedule | 3.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire Travel Contact Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire Welcome to ClinCard | 1.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire_CC Ref Guide Overall | 7.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire_ClinCard Card Carrier | 1.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire_ClinCard Cardholder FAQ EU | 2.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire_ClinCard Msg Templates | 6 |
| Subject information and informed consent form (for publication) | L2_Greenphire_ClinCard_Card_Carrier | 1 |
| Subject information and informed consent form (for publication) | L2_Greenphire_ClinCard_Cardholder_FAQ_EU | 2 |
| Subject information and informed consent form (for publication) | L2_Greenphire_ConneX Austria Travel Contact Card | 1 |
| Subject information and informed consent form (for publication) | L2_Greenphire_ConneX Austria Travel Ref Guide for Subjects | 1 |
| Subject information and informed consent form (for publication) | L2_Greenphire_EC packet | 1.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire_EC packet w Data Privacy as applied to GP | 5 |
| Subject information and informed consent form (for publication) | L2_Greenphire_Fee_Schedule | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient Information Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Other Information Given to Subjects | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material Patient Emergency Card_BE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Retention Materials_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Ancillary Item Listing | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Directions for use_Miri PFS How to Inject Video_OnScreen | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Directions for use_Miri PFS How to Inject Video_script | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_directions for use_PFS QR video link | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Directions for use_siringe IFU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Msg Templates | 6.0 |
| 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 Travel Ref Guide for Subjects | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Travel Ref Guide for Subjects | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Travel Contact Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Travel Contact Card | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Card_Carrier | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Card_Carrier | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Cardholder_FAQ | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_EU_Card Design | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_Fee_Schedule | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_Fee_Schedule_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_How to Inject Video | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Thank You Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Visit Guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Informed Consent Procedure | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Instructions For Use | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Leitfaden Termine | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_List of ssICF contact details_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Mirikizumab PFS IFU Self Injection_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Mirikizumab PFS IFU Self Injection_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Mirikizumab PFS IFU Self Injection_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participants_Patient_Survey_Instructions_Reimbursement | 3 |
| 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 Emergency Card Italy | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Self-Administration Log mirikizumab | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Survey | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Survey | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Survey Instructions | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Survey Instructions | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_R_R Materials MOCK-Ups and Explanations_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Retention material_Thank you card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Study Hub Onboarding Patient User Guide_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Study Hub Onboarding Patient User Guide_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Study Hub Onboarding Patient User Guide_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Thank You Card | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank you card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Toiletten Karte | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Directions for use_How to Inject Video_Subtitles | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Greenphire_ClinCard_Cardholder | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Instructions for Use_Self Injection | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient Card France_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Retention material_Presentation du sac isothermique | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Retention material_Study Visits Guide | 1.0 |
| Subject information and informed consent form (for publication) | L2_Site facing material_EN_HCP Survey | 2.2 |
| Subject information and informed consent form (for publication) | L2_Site facing material_EN_HCP Survey Instructions | 1.0 |
| Subject information and informed consent form (for publication) | L3_Ancillary Item Listing | 3.0 |
| Subject information and informed consent form (for publication) | L3_Ancillary Item Listing | 1 |
| Subject information and informed consent form (for publication) | L3_Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L3_PFS QR video link | 1.0 |
| Subject information and informed consent form (for publication) | L4_Patient Card | 2.1 |
| Subject information and informed consent form (for publication) | L4_Patient Card_PI Heeren | 2 |
| Subject information and informed consent form (for publication) | L4_Patient Card_PI Koch | 2 |
| Subject information and informed consent form (for publication) | L4_Patient Card_PI Reinisch | 2 |
| Subject information and informed consent form (for publication) | L5_Directions for Use | 1 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_How to Inject Video Script_OnScreenText | 1 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_How to Inject Video Script_Subtitles | 1 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_HU | 1.1 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_HU_Patient Injection Video_Link | 1.0 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_HU_Patient Injection Video_OnScreen text | 1.0 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_HU_Patient Injection Video_Script text | 1.0 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_QR video link | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol e synopsis_HU 2023-507657-15 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES 2023-507657-15-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES 2023-507657-15-00_TC | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-507657-15-00_Netherlands | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ATDE | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDE 2023-507657-15-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDU 2023-507657-15-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEFR 2023-507657-15-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2023-507657-15-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DK_2023-507657-15-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2023-507657-15-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2023-507657-15-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU 2023-507657-15 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2023-507657-15 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_LTU_2023-507657-15-00 | e |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_PL_2023-507657-15-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RO_2023-507657-15-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SK_2023-507657-15-00 | e |
Application history
22 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-11 | Latvia | Acceptable 2023-11-29
|
2023-11-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-12 | Latvia | Acceptable 2024-07-15
|
2024-07-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-13 | Acceptable | 2024-10-07 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-26 | Acceptable | 2024-10-23 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-23 | Latvia | 2024-10-23 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-11-21 | Acceptable | 2025-02-20 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-22 | Acceptable | 2025-01-13 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-25 | Acceptable | 2025-01-21 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-12-05 | Acceptable | 2025-03-04 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-12 | 2024-12-06 | Acceptable | 2025-02-28 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-12-13 | Acceptable | 2025-03-31 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-12-20 | Acceptable | 2025-02-26 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-01-08 | Acceptable | 2025-03-17 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-01-10 | Latvia | Acceptable | 2025-04-04 |
| 15 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-02-05 | Acceptable | 2025-02-28 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-02-06 | Acceptable | 2025-03-13 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-17 | 2025-03-26 | Acceptable | 2025-05-05 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-18 | 2025-04-01 | Acceptable | 2025-05-07 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-05-01 | Acceptable | 2025-06-16 | |
| 20 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-24 | Acceptable | 2025-06-24 | |
| 21 | SUBSTANTIAL MODIFICATION | SM-19 | 2025-07-30 | Acceptable | 2025-09-29 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-20 | 2025-09-22 | Acceptable | 2025-12-08 |