Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
912
Countries
12
Sites
86
High-Risk Metastatic Hormone-Sensitive Prostate Cancer
To determine whether adding abemaciclib to abiraterone plus prednisone improves radiographic progression-free survival (rPFS).
Key facts
- Sponsor
- Eli Lilly Cork Limited, Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Sep 2022 → ongoing
- Decision date (initial)
- 2022-09-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-500461-28-06
- ClinicalTrials.gov
- NCT05288166
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacogenomic, Safety, Therapy, Pharmacokinetic
To determine whether adding abemaciclib to abiraterone plus prednisone improves radiographic progression-free survival (rPFS).
Secondary objectives 4
- To evaluate improvements in other clinically relevant efficacy endpoints with the addition of abemaciclib to abiraterone plus prednisone
- To characterize the safety of adding abemaciclib to abiraterone plus prednisone
- To characterize the PK of abemaciclib when administered in combination with abiraterone.
- To assess patient-reported pain and HRQoL
Conditions and MedDRA coding
High-Risk Metastatic Hormone-Sensitive Prostate Cancer
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Parallel Assignment N/A
|
Randomised Controlled | Double | [{"id":173191,"code":1,"name":"Subject"},{"id":173192,"code":2,"name":"Investigator"}] | Experimental: Abemaciclib + Abiraterone + Prednisone/Prednisolone Active Comparator: Placebo + Abiraterone + Prednisone/Prednisolone |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-500461-28-00 | CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination with Abiraterone plus Prednisone in Men with High-Risk Metastatic Hormone-Sensitive Prostate Cancer | Eli Lilly Cork Limited |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Prostate cancer that has spread to other parts of the body and is expected to respond to hormone treatments designed to lower testosterone (metastatic hormone-sensitive prostate cancer)
- Cancer that has spread to the bones significantly and/or to the viscera, which are the soft internal organs of the body (for example, the lungs, liver, and the organs of the digestive system).
- Adequate organ function
Exclusion criteria 4
- Received prior treatment with abemaciclib or other drugs that work in the same way
- Received previous treatment(s) for metastatic cancer except for up to 3 months of androgen deprivation therapy (ADT) or up to 6 courses of chemotherapy with ADT
- Serious or uncontrolled medical conditions such as certain cardiovascular disorders, active or chronic liver disease, uncontrolled hypertension, active systemic infections or currently treated for cancer other than prostate
- Prostate cancer that has spread to the central nervous system that is not treated and stable
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Radiographic progression-free survival (rPFS) assessed by the investigator.
Secondary endpoints 11
- rPFS by blinded, independent, central review (BICR)
- Clinical PFS (cPFS)
- Castration-resistant prostate cancer (CRPC)-free survival
- Time to symptomatic progression
- Time to PSA progression
- Time to initiation of new anticancer therapy
- Overall survival (OS).
- The safety endpoints evaluated will include, but are not limited to, the following: AEs, TEAEs, SAEs, clinical laboratory tests, ECGs, vital signs, and physical examinations.
- Concentrations of abemaciclib.
- Time to pain progression
- Time to deterioration in HRQoL measured by the FACT-P (Physical Well-Being and PCS scores) and EQ-5D-5L.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Verzenios 50 mg film-coated tablets
PRD6701098 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 11200 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Different primary packaging (bottles) than in marketing authorisation and clinical trial specific packaging and labeling.
Comparator 3
SUB10018MIG · Substance
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 140 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 140 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB31647 · Substance
- Active substance
- Abiraterone Acetate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 28000 mg milligram(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo to Match LY2835219 50-mg Tablets
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
Eli Lilly Cork Limited
- Sponsor organisation
- Eli Lilly Cork Limited
- Address
- Island House Eastgate Road, Eastgate Business Park, Little Island Eastgate Business Park Little Island
- City
- Cork
- Country
- Ireland
Scientific contact point
- Organisation
- Eli Lilly Cork Limited
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly Cork Limited
- Contact name
- Lilly Clinical Trials information desk
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Laboratory analysis |
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifissia, Greece | On site monitoring, Code 12, Other, Code 2, Code 5 |
| Iqvia Rds Spain S.L. ORG-100014508
|
Madrid, Spain | On site monitoring |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100012849
|
Meyrin, Switzerland | Laboratory analysis |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
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 Cork Limited
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly Cork Limited
- Contact name
- Lilly Clinical Trials information desk
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100012849
|
Meyrin, Switzerland | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Laboratory analysis |
| Iqvia Rds Spain S.L. ORG-100014508
|
Madrid, Spain | On site monitoring |
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifissia, Greece | On site monitoring, Code 12, Other, Code 2, Code 5 |
Sponsor responsibilities
- Article 77 compliance
- Eli Lilly Cork Limited
- Contact point sponsor
- Eli Lilly Cork Limited
- Article 77 implementation
- Eli Lilly Cork Limited
Locations
12 EU/EEA countries · 86 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 21 | 5 |
| Czechia | Ongoing, recruitment ended | 57 | 8 |
| Denmark | Ended | 11 | 3 |
| France | Ongoing, recruitment ended | 35 | 11 |
| Germany | Ongoing, recruitment ended | 33 | 16 |
| Greece | Ongoing, recruitment ended | 17 | 5 |
| Hungary | Ended | 21 | 4 |
| Italy | Ongoing, recruitment ended | 35 | 7 |
| Netherlands | Ended | 22 | 4 |
| Poland | Ongoing, recruitment ended | 30 | 8 |
| Romania | Ongoing, recruitment ended | 25 | 8 |
| Spain | Ongoing, recruitment ended | 28 | 7 |
| Rest of world
Australia, Taiwan, China, Canada, Mexico, United States, Turkey, Brazil, Israel, United Kingdom, Korea, Republic of, Japan, Argentina
|
— | 577 | — |
Investigational sites
Algemeen Ziekenhuis Groeninge
Urology, President Kennedylaan 4, 8500, Kortrijk
ZNA Jan Palfijn
Oncology, Lange Bremstraat 70, 2170, Antwerp
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-Ucl-Namur
Oncology, Place Louise Godin 15, 5000, Namur
Onze Lieve Vrouw Hospital
Urology, Moorselbaan 164, 9300, Aalst
Universitair Ziekenhuis Gent
Urology, Corneel Heymanslaan 10, 9000, Gent
Fakultní Nemocnice Hradec Králové
Klinika onkologie a radioterapie, Sokolska 581/581, Novy Hradec Kralove, Hradec Kralove 5
Oblastní Nemocnice Příbram a.s.
Onkologie, Gen. R. Tesarika 80, 261 01, Pribram I
Masaryk Memorial Cancer Institute
Klinika komplexni onkologicke pece, Zluty Kopec 543/7, Stare Brno, Brno
Urocentrum Praha s.r.o.
Onkologie, Karlovo Namesti 319/3, Nove Mesto, Prague
Fakultni Thomayerova nemocnice
Onkologicka klinika 1. LF UK, Videnska 800, Krc, Prague 4
Fakultní Nemocnice Královské Vinohrady
Radioterapeuticka a onkologicka klinika, Srobarova 50, 100 34, Prague
Fakultni Nemocnice U Sv Anny V Brne
Onkologicko-chirurgické oddělení, Pekarska 53, Stare Brno, Brno
NH Hospital a.s.
Onkologicky Stacionar, Okruhova 1135 44, 155 00, Prague 5
Vejle Hospital
Onkologisk Afdeling, Kabbeltoft 25, 7100, Vejle
Næstved Hospital
Onkologisk Afdeling, Ringstedgade 61, 4700, Naestved
Rigshospitalet
Afdeling for Kræftbehandling, Blegdamsvej 9, 2100, Copenhagen Ø
Polyclinique De Blois
Clinique privée, 1 Rue Robert Debre, 41260, La Chaussee-Saint-Victor
Centre Leon Berard
Medical Oncology Department, 28 Rue Laennec, 69008, Lyon
Assistance Publique Hopitaux De Paris
Service d'Oncologie Médicale, 20 Rue Leblanc, 75015, Paris
Centre Georges Francois Leclerc
Centre de Recherche Clinique, 1 Rue Professeur Marion, 21079, Dijon Cedex
Centre De Cancérologie Du Grand Montpellier
Clinique privée, 25 Rue De Clementville, 34070, Montpellier
Centre Hospitalier Regional Et Universitaire De Brest
Institut de cancérologie et hématologie, 2 Avenue Marechal Foch, 29200, Brest
Clinique Victor Hugo
Oncology-Radiotherapy, 18 Rue Victor Hugo, Cs 81514, Le Mans Cedex 2
Clcc Nantes Antantique Centre Rene Gauducheau
Oncologie Médicale, Bd Du Professeur Jacques Monod, 44800, St Herblain
L'Hopital Prive Du Confluent
Service d'oncologie médicale, 4 Rue Eric Tabarly, 44277, Nantes Cedex 2
CHUR Of Besançon
Service d'oncologie médicale, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Institut Paoli-Calmettes
Dept d'Oncologie Medicale, 232 Boulevard De Sainte Marguerite, 13009, Marseille
Studienpraxis Urologie
Private research practice, Steinengrabenstrasse 17, 72622, Nuertingen
University Hospital Hamburg- Eppendorf
Onkologisches Zentrum, Martinistrasse 52, 20246, Hamburg
Universitaetsmedizin Der Johannes Gutenberg-Universitat Mainz KöR
Department of Urology, Langenbeckstrasse 1, Oberstadt, Mainz
Urologicum Duisburg
Urologicum Duisburg, Fahrner Str 123, 47169, Duisburg
Universitatsklinikum Frankfurt AöR
Klinik fuer Urologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Institut Für Versorgungsforschung In Der Onkologie
Private research facility, Neversstrasse 5, Sued, Koblenz
Urologie Neandertal
Private praxis, Adlerstrasse 1, 40822, Mettmann
Urologie Heinsberg
Private Praxis, Stiftsstraße 21, 52525, Heinsberg
Medical Center - University of Freiburg
Klinik fuer Urologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitaetsklinikum Tuebingen
Urologie, Geissweg 3, Innenstadt, Tübingen
Urologische Gemeinschaftspraxis
Private practice, Kaiserring 21-23, Innenstadt, Wesel
University Hospital Muenster AöR
Klinik für Urologie, Gebaeude A1, Albert-Schweitzer-Campus 1, Muenster
University Hospital Of Ulm AöR
Urologie und Kinderurologie, Albert-Einstein-Allee 23, Eselsberg, Ulm
Nationales Centrum Fuer Tumorerkrankungen Heidelberg
Oncology, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Klinikum Nürnberg
5. Med. Klinik, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Nuklearmedizinische Klinik Und Poliklinik Der Technischen Universitaet Muenchen Klinikum Rechts Der Isar
Urologische Klinik und Poliklinik, Ismaninger Strasse 22, Au-Haidhausen, Munich
St Savas Hospital
2nd Department of Internal Medicine - Oncology, Alexandras Avenue 171, 115 22, Athens
University General Hospital Of Heraklion
Internal Medicine-Oncology Clinic, Stavrakia And Voutes, 715 00, Heraklion
Alexandra Hospital
Oncology Department, University Clinic of Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
General University Hospital Of Patras
Internal Medicine Clinic, Division of Oncology, Rio, 265 04, Patras
University General Hospital Attikon
2nd Propaedeutic Pathology Clinic, Oncology Unit, Rimini Street 1, 124 62, Athens
Central Hospital Of Northern Pest Military Hospital
Onkológia, Podmaniczky Utca 109, 1062, Budapest VI
Bacs-Kiskun Varmegyei Oktatokorhaz
Onkoradiológiai Központ, Nyiri Ut 38, 6000, Kecskemet
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Onkoradiológiai osztály, Vasvari Pal Utca 2-4, 9024, Gyor
Orszagos Onkologiai Intezet
Urogenitális Tumorok és Klinikai Farmakológiai Osztály, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Veneto Institute Of Oncology
Dipartimento Oncologia 3, Via Gattamelata 64, 35128, Padova
Azienda Provinciale Per I Servizi Sanitari
Medical Oncology, Via Alcide De' Gasperi 79, 38123, Trento
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
European Institute Of Oncology S.r.l.
Divisione di Oncologia Medica Urogenitale e Cervico Facciale, Via Giuseppe Ripamonti 435, 20141, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncologia Medica, Largo Francesco Vito 1, 00168, Rome
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori (I.R.S.T.) S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliera S Maria Di Terni
Oncologia Medica, Viale Tristano Di Joannuccio 1, 05100, Terni
St Antonius Hospital
Internal Medicine, Soestwetering 1, 3543 AZ, Utrecht
Canisius Wilhelmina Hospital
Urology, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
St. Elisabeth Hospital Tilburg
Internal Medicine, Hilvarenbeekseweg 60, 5022 GC, Tilburg
University Medical Center Groningen
Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
Dolnośląskie Centrum Onkologii, Pulmonologii I Hematologii
Oncology, Pl. Ludwika Hirszfelda 12, 53-413, Wroclaw
Clinical Best Solutions Sp. z o.o. S.K.
Oncology, Aleja Jozefa Pilsudskiego 11, 20-011, Lublin
Narodowy Instytut Onkologii Im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Oncology, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Salve Medica Sp. z o.o. S.K.
Oncology, Ul. Sw. Anny 62, 95-060, Brzeziny
Wielkopolskie Centrum Onkologii Im. Marii Skłodowskiej-Curie
Oncology, Ul. Garbary 15, 61-866, Poznan
Provita Profamilia
Provita Profamilia, ul. Kostromska 66a, 97-300, Piotrków Tryb
Szpitale Pomorskie Sp. z o.o.
Oncology, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego
Oncology, Ul. Katowicka 66a, 45-061, Opole
Gral Medical S.R.L.
Medical Oncology, Strada Popovici Traian 79-91, 031422, Bucharest
Oncopremium - Team S.R.L.
Oncology, Strada Progresului Nr. 5, 430291, Baia Mare
Radiotherapy Center Cluj S.R.L.
Oncologie Medicala, Strada Oitelor 7, 040278, Bucharest
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Oncology, Strada Crisului Nr. 1, 500283, Brasov
Radiology Therapeutic Center S.R.L.
Oncology, Strada Oitelor Nr 7, 040278, Bucharest
Ovidius Clinical Hospital S.R.L.
Oncology, Dn 2a Km 202 880, 905900, Ovidiu
Centrul De Oncologie SF Nectarie S.R.L.
Medical Oncology, Strada Caracal Nr. 109, 200542, Craiova
Focus Lab Plus S.R.L.
Oncologie 2, Strada Ciresului Nr. 1, 024103, Bucharest
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
University Hospital Ramón Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Catalan Institute Of Oncology
Oncology, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Infanta Cristina
Oncology, Avenida Elvas S/n, 06006, Badajoz
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2022-09-15 | 2024-03-25 | 2022-11-16 | 2023-06-15 | |
| Czechia | 2022-11-04 | 2022-11-25 | 2023-05-12 | ||
| France | 2022-10-17 | 2022-10-21 | 2023-06-27 | ||
| Germany | 2022-09-27 | 2022-09-28 | 2023-07-11 | ||
| Greece | 2023-03-10 | 2023-03-20 | 2023-05-19 | ||
| Hungary | 2023-03-16 | 2026-04-01 | 2023-03-21 | 2023-05-23 | |
| Italy | 2022-10-20 | 2022-12-29 | 2023-06-14 | ||
| Netherlands | 2022-11-02 | 2024-03-27 | 2023-01-05 | 2023-06-16 | |
| Poland | 2022-10-07 | 2022-10-18 | 2023-05-18 | ||
| Romania | 2023-03-14 | 2023-03-28 | 2023-05-17 | ||
| Spain | 2022-10-07 | 2022-10-11 | 2023-05-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 138 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | I3Y-MC-JPEG_EQ-5D-5L Paper Self-Complete_v1_1_WS_Paper_Hungarian-HU | 1.1 |
| Protocol (for publication) | I3Y-MC-JPEG_EQ-5D-5L Paper Self-Complete_v1_WS_Paper_Dutch-NL | 1 |
| Protocol (for publication) | I3Y-MC-JPEG_FACT-P_WS_Paper_Dutch-Universal_nlNL | 4 |
| Protocol (for publication) | I3Y-MC-JPEG_Patient Diary_Trans_Paper_Dutch-NL | 1 |
| Protocol (for publication) | I3Y-MC-JPEG_Patient_Mitra_Micro_Sampling_Instructions_Trans_Paper_Dutch-NL | 1 |
| Protocol (for publication) | I3Y-MC-JPEG_PRO_CTCAE_WS_Paper_Dutch-Universal_nlNL | 1 |
| Protocol (for publication) | I3Y-MC-JPEG_Worst Pain NRS-24Hours_v1_WS_Paper_Dutch-Universal_nlNL | 1 |
| Protocol (for publication) | JPEG 05 Protocol _Redacted | d |
| Protocol (for publication) | JPEG Protocol track changes comparison from JPEG Tracked _Redacted | c |
| Protocol (for publication) | JPEG_Protocol Amend translated_GREECE_Redacted | e |
| Protocol (for publication) | Justification to collect patients race or ethnicity data_Redacted | 1.0 |
| Protocol (for publication) | Patient Facing Doc For Publication | 1 |
| Protocol (for publication) | Protocol_GR_TC_Redacted | d |
| Recruitment arrangements (for publication) | Italy_List of planned Sites and Subjects | 1.0 |
| Recruitment arrangements (for publication) | JPEG - Recruitment Arrangements For Publication | 1 |
| Recruitment arrangements (for publication) | JPEG - Recruitment Arrangements For Publication Final | 1 |
| Recruitment arrangements (for publication) | JPEG - Recruitment Arrangements For Publication Final | 1.0 |
| Recruitment arrangements (for publication) | JPEG - Recruitment Arrangements For Publication Final | 1 |
| Subject information and informed consent form (for publication) | EC_packet_w_Data_Privacy_as_applied_to_GP | 7 |
| Subject information and informed consent form (for publication) | ELI LILLY_JPEG_Appointment Reminder Card_POL | 1 |
| Subject information and informed consent form (for publication) | ELI LILLY_JPEG_Diarrhea Guidance_ITA_V1_28July2022 | 1.1 |
| Subject information and informed consent form (for publication) | ELI LILLY_JPEG_Diarrhea Guidance_POL | 1 |
| Subject information and informed consent form (for publication) | ELI LILLY_JPEG_Diarrhea Guidance_ROM | 1 |
| Subject information and informed consent form (for publication) | ELI LILLY_JPEG_Medication Guidance_ITA | 1.0 |
| Subject information and informed consent form (for publication) | ELI LILLY_JPEG_Medication Guidance_POL | 1 |
| Subject information and informed consent form (for publication) | ELI LILLY_JPEG_Medication Guidance_ROM | 1 |
| Subject information and informed consent form (for publication) | ELI LILLY_JPEG_Participant ID Card_POL | 1 |
| Subject information and informed consent form (for publication) | ELI LILLY_JPEG_Participant Study Guide_ITA | 1.0 |
| Subject information and informed consent form (for publication) | ELI LILLY_JPEG_Participant Study Guide_POL | 1 |
| Subject information and informed consent form (for publication) | General_ConneX_EC_packet_w_Data_Privacy_as_applied_to_GP | 2 |
| Subject information and informed consent form (for publication) | General_ConneX_EC_packet_w_Data_Privacy_as_applied_to_GP | 2 |
| Subject information and informed consent form (for publication) | Greenphire ClinCard Msg Templates | 6 |
| Subject information and informed consent form (for publication) | Greenphire ClinCard Travel Ref Guide for Subjects | 3 |
| Subject information and informed consent form (for publication) | Greenphire Travel Contact Card | 2 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Card_Carrier | 1 |
| Subject information and informed consent form (for publication) | Greenphire_ClinCard_Cardholder_FAQ_EU | 3 |
| Subject information and informed consent form (for publication) | Greenphire_Fee_Schedule | 4 |
| Subject information and informed consent form (for publication) | I3Y-MC-JPEG Foglio Informativo e Consenso Informato_Italia_TC_GMV_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | I3Y-MC-JPEG ICF_IT_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | I3Y-MC-JPEG ICF_IT_TC_Redacted | 5.0 |
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| Subject information and informed consent form (for publication) | I3Y-MC-JPEG_Addendum Foglio Informativo e Consenso Informato_IT V2_03Mar2023_TC | 2.0 |
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| Subject information and informed consent form (for publication) | Poland - Greenphire_ClinCard_Cardholder_FAQ_EU | 3 |
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Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-05-12 | Belgium | Acceptable 2022-08-29
|
2022-09-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-11-10 | Belgium | Acceptable 2023-01-26
|
2023-01-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-03-13 | Acceptable | 2023-04-03 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-04-07 | Belgium | Acceptable 2023-07-03
|
2023-07-03 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-08-02 | Acceptable | 2023-08-21 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-09-29 | Belgium | Acceptable 2024-01-22
|
2024-01-22 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-01-31 | Belgium | Acceptable | 2024-03-19 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-03-01 | Acceptable | 2024-04-15 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-03-25 | Acceptable | 2024-04-30 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-14 | Belgium | Acceptable | 2024-05-14 |
| 11 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-08-23 | Acceptable | 2024-10-16 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-10-02 | Acceptable | 2024-11-15 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-03-12 | No conclusion 2025-04-29
|
2025-05-02 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-08-11 | No conclusion | 2025-10-02 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-08-15 | No conclusion | 2025-09-23 | |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-17 | Belgium | No conclusion | 2025-11-17 |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-15 | No conclusion | 2025-12-15 | |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-12-19 | Belgium | No conclusion | 2025-12-19 |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-03-02 | Belgium | No conclusion | 2026-03-02 |