Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
600
Countries
15
Sites
97
Systemic Lupus Erythematosus
To evaluate the efficacy of nipocalimab compared with placebo on SLE disease activity
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 7 May 2026 → ongoing
- Decision date (initial)
- 2026-05-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Pharmacogenomic, Therapy, Safety, Others, Pharmacodynamic
To evaluate the efficacy of nipocalimab compared with placebo on SLE disease activity
Conditions and MedDRA coding
Systemic Lupus Erythematosus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult participants at the time of informed consent
- Diagnoses of SLE and at least 1 positive autoantibody
- SLEDAI-2K score
- BILAG Score
Exclusion criteria 5
- Any condition for which, participation would not be in the best interest of the participant
- Any clinically significant laboratory abnormality that is not considered appropriate or reasonable for the population under study.
- Comorbidities requiring systemic GCs
- Inflammatory diseases
- Major surgical procedure prior to screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Systemic lupus erythematosus responder index (SRI)-4 composite response at Week 52
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD12057025 · Product
- Active substance
- Nipocalimab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 156 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo subcutaneous without Nipocalimab
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
Janssen Cilag International
- Sponsor organisation
- Janssen Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
Locations
15 EU/EEA countries · 97 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 24 | 8 |
| Czechia | Authorised, recruiting | 15 | 3 |
| Denmark | Authorised, recruiting | 5 | 3 |
| Finland | Authorised, recruiting | 9 | 4 |
| France | Authorised, recruiting | 12 | 6 |
| Germany | Authorised, recruiting | 15 | 6 |
| Greece | Authorised, recruiting | 10 | 4 |
| Hungary | Authorised, recruiting | 35 | 10 |
| Italy | Authorised, recruiting | 20 | 11 |
| Norway | Authorised, recruiting | 8 | 4 |
| Poland | Ongoing, recruiting | 43 | 11 |
| Portugal | Ongoing, recruiting | 11 | 6 |
| Romania | Authorised, recruiting | 38 | 8 |
| Slovakia | Authorised, recruiting | 8 | 3 |
| Spain | Authorised, recruiting | 18 | 10 |
| Rest of world
United States, Thailand, Peru, Canada, Chile, Argentina, Switzerland, Colombia, Taiwan, Serbia, Georgia, Brazil, South Africa, Hong Kong, Turkey, United Kingdom, Australia
|
— | 329 | — |
Investigational sites
Medical Center Hera EOOD
NA, Ulitsa Klisura 20, 1510, Sofiya
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.
Internal Medicine department, Ulitsa Komatevsko Shose 79, 4004, Plovdiv
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Rheumatology Clinic, Ulitsa Urvich 13, 1612, Sofia
Diagnostic-Consultative Center Alexandrovska EOOD
NA, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Military Medical Academy
Rheumatology Department, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofiya
Dkc 1 Ruse EOOD
NA, Nezavisimost Street 2, 7002, Ruse
MBAL Sveta Marina EAD
Rheumatology Clinic, Hristo Smirnenski Str 1, 9010, Varna
Medical Center Medtech Services Ltd.
NA, Bulevard Siedinenie 49, 6304, Haskovo
Revmatologicky Ustav
Revmatologicky ustav, Na Slupi 450/4, Nove Mesto, Prague 2
Fakultni Nemocnice U Sv Anny V Brne
II. interni klinika, Pekarska 53, Stare Brno, Brno-Stred
Revimex pro s.r.o.
Revmatologicka ambulance, Frystatska 168/32, 733 01, Karvina
Aalborg University Hospital
Department of Rheumatology, Hobrovej 18-22, 9000, Aalborg
Rigshospitalet
Centre for Rheumatology and Spine Disease, Blegdamsvej 9, 2100, Copenhagen Oe
Region Sjaelland
Reumatologisk Afdeling, Lykkebaekvej 1, 4600, Koege
HUS-yhtymae
Rheumatology, Haartmaninkatu 4, 00290, Helsinki
Turku University Hospital
Rheumatology, Kiinamyllynkatu 4-8, 20520, Turku
Paeijaet-Haemeen hyvinvointialue
Rheumatology, Keskussairaalankatu 7, 15850, Lahti
Northern Clinical Trial Coordinators Oy
Rheumatology, Lintulammentie 15 B, 90150, Oulu
Assistance Publique Hopitaux De Paris
Internal medicine, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Hospices Civils De Lyon
Internal medicine, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Centre Hospitalier Universitaire De Caen Normandie
Internal medicine and immunology clinic, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Toulouse
Internal medicine and clinical immunology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire Grenoble Alpes
Internal medicine, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Le Mans
Immunology, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
LMU Klinikum Muenchen AöR
Klinik für Rheumatologie/Klinische Forschung, Pettenkoferstrasse 8a, Ludwigsvorstadt-Isarvorstadt, Munich
Medicover GmbH
Rheumatologie, Orleansplatz 3, Au-Haidhausen, Munich
St. Elisabeth Hospitalgesellschaft Niederrhein mbH
Fachklinik für Orthopädie und Rheumatologie, Hauptstrasse 74-76, Lank-Latum, Meerbusch
Centrum für Angewandte Immunologie & Rheumatologie (CAIR)
n/a, Furtwänglerstr. 2/5, 69121, Heidelberg
Universitaetsklinikum Leipzig AöR
Klinik und Poliklinik für Endokrinologie, Nephrologie, Rheumatologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Technische Universitaet Dresden
Klinik und Poliklinik für Dermatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
University General Hospital Of Heraklion
Clinic of Rheumatology and Clinical Immunology, Stavrakia And Voutes, 715 00, Heraklion
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
4th Department of Internal Medicine, Rimini 1, 124 61, Chaidari
General University Hospital Of Larissa
Clinic of Rheumatology and Clinical Immunology, P. O. Box 1425, 411 10, Larissa
Laiko General Hospital Of Athens
Department of Pathophysiology, Agiou Thoma (goudi) 17, 115 27, Athens
Semmelweis University
Department of Rheumatology and Clinical Immunology, Frankel Leo Ut 38-40, Kerulet, Budapest
Obudai Egeszseguegyi Centrum Kft.
NA, Zarda Utca 11-13, 8900, Zalaegerszeg
University Of Debrecen
Klinikai Központ, Belgyógyászati Klinika, C epulet, Nagyerdei Korut 98, 4032, Debrecen
University Of Szeged
Szent-Gyöogyi Albert Klinikai Kozpont, Reumatologiai es Immunologiai Klinika, Kalvaria Sugarut 57, 6725, Szeged
Bekes Varmegyei Koezponti Korhaz
Pandy Kalmas Tagkorhaz, Infectology (Hepatology and Immunology) Department, Semmelweis Utca 1, 5700, Gyula
University Of Pecs
Klinikai Központ, Reumatologiai es Immunologiai Klinika, Akac Utca 1, 7632, Pecs
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
Klinikai Farmakologia, Frankel Leo Ut 17-19, 1027, Budapest II
Vital-Medicina Kft.
NA, Jozsef Attila Utca 17, 8200, Veszprem
Vita Verum Medical Bt.
NA, Fiskalis Ut 43, 8000, Szekesfehervar
Qualiclinic Kft.
NA, Dereglye Utca 5 B, Ep I Em 3, Budapest
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Dipartimento di Reumatologia, Via Santa Sofia 78, 95123, Catania
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
UOC Immunoreumatologia, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Ospedaliera Ordine Mauriziano Di Torino
S.S.D.D.U. Reumatologia, Via Ferdinando Magellano 1, 10128, Turin
Azienda Ospedaliero Universitaria Delle Marche
SOD Clinica Medica, Via Conca 71, 60126, Ancona
Ospedale San Raffaele S.r.l.
Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare, Via Olgettina 60, 20132, Milan
Azienda Sanitaria Universitaria Friuli Centrale
SOC Clinica di Reumatologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Reumatologia, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Integrata Verona
UOC Reumatologia, Piazzale Aristide Stefani 1, 37126, Verona
San Camillo Forlanini Hospital
UOC REUMATOLOGIA, Circonvallazione Gianicolense 87, 00152, Rome
Humanitas Mirasole S.p.A.
Reumatologia E Immunologia Clinica, Via Alessandro Manzoni 56, 20089, Rozzano
Hospital Santa Maria Della Misericordia
Medicina Interna e Specialistica I, SC-Medicina Interna e Scienze Oncologiche, Piazzale Giorgio Menghini 1, 06129, Perugia
Oslo Universitetssykehus HF
Department of Rheumatology, Dermatology and Infectious Diseases, Sognsvannsveien 20, 0372, Oslo
Universitetssykehuset Nord-Norge HF
Department of Rheumatology, Hansine Hansens Veg 67, 9019, Tromsoe
Helse Stavanger HF
Department of Rheumatology, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Helse Bergen HF
Department of Rheumatology, Haukelandbakken 22, 5009, Bergen
Nzoz Bif Med
reumathology, Stefana Zeromskiego 18, 41-902, Bytom
Medicover Integrated Clinical Services Sp. z o.o.
reumathology, Ul Wronia 53 Lok B 10, 00-874, Warsaw
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
reumathology, Ul. Marcelinska 92, 60-324, Poznan
NZOZ Lecznica Mak Med s.c.
reumathology, Ul. Wisniowa 22, 05-830, Nadarzyn
Medicover Integrated Clinical Services Sp. z o.o.
reumathology, Ul. Jana Karola Chodkiewicza 19c, 85-065, Bydgoszcz
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
reumathology, Ul. Glowackiego 8d/2, 67-100, Nowa Sol
Innova Clinic Sp. z o.o.
reumathology, Ul. Mlodziezowa 31 N, 09-100, Plonsk
Provita Sp. z o.o.
reumathology, Ul. Fabryczna 15b, 40-611, Katowice
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
reumathology, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Malopolskie Badania Kliniczne Sp. z o.o.
reumathology, Ul. Pradnicka 12/502, 30-002, Cracow
Rheuma Medicus Sp. z o.o.
reumathology, Ul. Pruszkowska 6, 02-118, Warsaw
Unidade Local De Saude De Gaia/Espinho E.P.E.
Servico de reumatologia, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Unidade Local De Saude De Sao Jose E.P.E.
Serviço de Medicina Interna, Rua Jose Antonio Serrano, 1150-199, Lisbon
Unidade Local De Saude Do Alto Minho E.P.E.
Serviço de Reumatologia, Largo Conde De Bertiandos, 4990-041, Ponte De Lima
Unidade Local De Saude De Santa Maria E.P.E.
Servico de Reumatologia, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local De Saude De Santo Antonio E.P.E.
Servico de Medicina Interna, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude De Almada-Seixal E.P.E.
Servico de Reumatologia, Avenida Torrado Da Silva, 2805-267, Almada
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Rheumatology, Block 1 Staircase C Apartment 2 Room 2, Strada Crisului Nr 1, Brasov
Policlinica CCBR S.R.L.
Rheumatology, Aleea Buchetului 2 Block C2 Sector 3, 030463, Bucharest
Spitalul Clinic Judetean De Urgenta Bihor
Nephrology, Calea Coposu Corneliu Nr 12, 410469, Oradea
Spitalul Clinic Judetean De Urgenta Cluj
Rheumatology, Strada Clinicilor 4-6, 400006, Cluj-Napoca
Hiperdia S.A.
N/A, Soseaua Oltenitei Sector 4 Nr 87-99, 041312, Bucharest
Saint Maria Hospital
Rheumatology and Internal Medicine I, Bulevardul Mihalache Ion 37-39, 011172, Bucharest
Banat Carina Med S.R.L.
N/A, Strada Maresal Alexandru Averescu Nr 37, 300766, Timisoara
Medisof Diagnostic S.R.L.
Rheumatology, Strada Caracal 33, 200347, Craiova
Artromac N.O.
Reumatologicka ambulancia, Toryska 275/1, Zapad, Kosice
Narodny Ustav Reumatickych Chorob
Reumatologická ambulancia a pediatrická reumatologická ambulancia, Nabrezie Ivana Krasku 4782/4, 921 01, Piestany
Medman s.r.o.
Reumatologicka ambulancia, Thurzova 437/15, 036 01, Martin
Complexo Hospitalario Universitario De Santiago
Reumathology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Marques De Valdecilla
Reumathology, Avenida Valdecilla Sn, 39008, Santander
Hospital Clinico Universitario Lozano Blesa
internal medicine, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Quironsalud Infanta Luisa
Reumathology, Calle De San Jacinto 87, 41010, Sevilla
Hospital Universitario Infanta Leonor
Reumathology, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Universitario Juan Ramon Jimenez
reumathology, Ronda Exterior Norte S/n, 21005, Huelva
Hospital De La Santa Creu I Sant Pau
Reumathology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Rio Hortega
internal medicine, Calle Dulzaina 2, 47012, Valladolid
Hospital Universitario De Navarra
internal medicine, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitari Vall D Hebron
Reumathology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 |
|---|---|---|---|---|---|
| Bulgaria | 2026-05-12 | 2026-05-18 | |||
| Czechia | 2026-05-14 | ||||
| Denmark | 2026-05-08 | ||||
| Finland | 2026-05-13 | ||||
| France | 2026-05-18 | ||||
| Germany | 2026-05-12 | ||||
| Greece | 2026-05-19 | ||||
| Hungary | 2026-05-14 | ||||
| Italy | 2026-05-15 | ||||
| Norway | 2026-05-11 | ||||
| Poland | 2026-05-12 | 2026-05-25 | |||
| Portugal | 2026-05-07 | 2026-05-12 | |||
| Romania | 2026-05-11 | ||||
| Slovakia | 2026-05-14 | ||||
| Spain | 2026-05-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 260 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | REDACTED_D1_Protocol_2025-523552-31 | EEA-1 |
| Protocol (for publication) | REDACTED_D4_PF 1_BG_bul_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 1_CZ_cze_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 1_DE_GER_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 1_ES_SPA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 1_FR_FRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 1_GR_GRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 1_HU_HUN_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 1_IT_ITA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 1_Multicountry_ENG_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 1_PT_POR_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 1_RO_RUM_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 1_SK_slo_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 10_Multicountry_ Multilingual_2025-523552-31 | 4 |
| Protocol (for publication) | REDACTED_D4_PF 11_Multicountry_ Multilingual_2025-523552-31 | 2 |
| Protocol (for publication) | REDACTED_D4_PF 2_BG_bul_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 2_CZ_cze_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 2_DE_GER_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 2_ES_SPA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 2_FR_FRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 2_GR_GRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 2_HU_HUN_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 2_IT_ITA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 2_Multicountry_ENG_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 2_PT_POR_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 2_RO_RUM_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 2_SK_slo_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 3_BG_bul_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 3_CZ_cze_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 3_DE_GER_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 3_ES_SPA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 3_FR_FRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 3_GR_GRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 3_HU_HUN_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 3_IT_ITA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 3_Multicountry_ENG_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 3_PT_POR_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 3_RO_RUM_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 3_SK_slo_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 4_BG_bul_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 4_CZ_cze_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 4_DE_GER_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 4_ES_SPA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 4_FR_FRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 4_GR_GRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 4_HU_HUN_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 4_IT_ITA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 4_Multicountry_ENG_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 4_PT_POR_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 4_RO_RUM_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 4_SK_slo_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 5_BG_bul_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 5_CZ_cze_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 5_DE_GER_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 5_ES_SPA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 5_FR_FRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 5_GR_GRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 5_HU_HUN_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 5_IT_ITA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 5_Multicountry_ENG_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 5_PT_POR_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 5_RO_RUM_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 5_SK_slo_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 6_BG_bul_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 6_CZ_cze_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 6_DE_GER_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 6_ES_SPA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 6_FR_FRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 6_GR_GRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 6_HU_HUN_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 6_IT_ITA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 6_Multicountry_ENG_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 6_PT_POR_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 6_RO_RUM_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 6_SK_slo_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 7_BG_bul_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 7_CZ_cze_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 7_DE_GER_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 7_ES_SPA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 7_FR_FRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 7_GR_GRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 7_HU_HUN_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 7_IT_ITA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 7_Multicountry_ENG_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 7_PT_POR_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 7_RO_RUM_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 7_SK_slo_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 8 _Multicountry_Multilingual_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF 9_Multicountry_ Multilingual_2025-523552-31 | 2 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instruction_CZ_cze_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE reporting instruction_SK_slo_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE Text _DE_GER_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE Text _ES_SPA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE Text _GR_GRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE Text _HU_HUN_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE Text _PT_POR_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE Text _RO_RUM_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE Text_FR_FRE_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF AE Text_Multicountry_ENG_2025-523552-31 | 3 |
| Protocol (for publication) | REDACTED_D4_PF PRO AE Text_IT_ITA_2025-523552-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF PRO AE_BG_bul_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements Addendum ClinLife_PL_POL_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_BG_bul_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_CZ_eng_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_DE_ENG_2025-523552-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_DK_ENG_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_ES_ENG_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_FI_FIN_2025-523552-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_FR_FRE_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_GR_ENG_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_HU_ENG_2025-523552-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_IT_ENG_2025-523552-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_NO_ENG_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_PL_POL_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_PT_ENG_2025-523552-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_RO_ENG_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_SK_eng_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Advertisement_FI_FIN_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Brochure_BG_bul_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Brochure_HU_HUN_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Clinlife EC_Notes_HU_HUN_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Clinlife EC_Recruitment_HU_HUN_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Digital Ad_RO_RUM_2025-523552-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Doctor to Patient email_FI_FIN_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Doctor to Patient Email_IT_ITA_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Dr to Patient Email_RO_RUM_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Dr to Patient Letter_DE_GER_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Dr to Patient Letter_PT_POR_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material GARDENIA-SLE EC ClinLife Doc_DE_GER_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material GARDENIA-SLE EC ClinLife Doc_GR_GRE_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material GARDENIA-SLE EC ClinLife Doc_PL_POL_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Brochure_DE_GER_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Brochure_ES_SPA_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Brochure_FI_FIN_2025-523552-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Brochure_FR_FRE_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Brochure_GR_GRE_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Brochure_PL_POL_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Brochure_PT_POR_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Brochure_RO_RUM_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Flyer_FR_FRE_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Flyer_PT_POR_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Poster_DE_GER_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Poster_GR_GRE_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Poster_PL_POL_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Recruitment Poster_RO_RUM_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Poster_FI_FIN_2025-523552-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Poster_HU_HUN_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Recruitment Brochure_IT_ITA_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Recruitment Flyer_IT_ITA_2025-523552-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Dr to Patient Letter_GR_GRE_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_ L1_SIS and ICF Optional Genetic Sample_IT_ITA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_ L1_SIS and ICF Privacy Optional Genetic Sample_IT_ITA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum LTE_IT_ITA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical LTE Addendum 1_FR_FRE_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical v1 Addendum LTE_BG_bul_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical v1 Addendum LTE_BG_eng_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_BG_bul_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_BG_eng_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_CZ_cze_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_HU_HUN_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_IT_ITA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_SK_slo_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum _DE_GER_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum _ES_SPA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum _FI_FIN_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum _GR_GRE_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum _HU_HUN_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum _NO_NOR_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum _PL_POL_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum _PT_POR_2025-523552-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum_CZ_cze_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum_DK_DAN_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum_RO_RUM_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF LTE Addendum_SK_slo_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_DE_GER_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_DK_DAN_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_ES_SPA_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_FI_FIN_2025-523552-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_FR_FRE_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_GR_GRE_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_NO_NOR_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_PL_POL_2025-523552-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_PT_POR_2025-523552-31 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Clinical_RO_RUM_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional compatible research_NO_NOR_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional sample_BG_bul_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional sample_BG_eng_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_CZ_cze_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_DE_GER_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_DK_DAN_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_ES_SPA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_FI_FIN_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_FR_FRE_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_HU_HUN_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_PL_POL_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_PT_POR_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_RO_RUM_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_SK_slo_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Samples_GR_GRE_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Patient Travel Reimbursement_IT_ITA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_RO_RUM_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant partner_BG_bul_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant partner_BG_eng_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_CZ_cze_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_DE_GER_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_SPA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_FI_FIN_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_FR_FRE_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_GR_GRE_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_HU_HUN_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_IT_ITA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_NO_NOR_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PL_POL_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PT_POR_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_SK_slo_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Addendum LTE_IT_ITA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Child Exposed to IP_IT_ITA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Clinical_IT_ITA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy language_CZ_cze_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy language_SK_slo_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Pregnant Partner_IT_ITA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Right to Reject Knowledge_DK_DAN_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Sample storage compatible research_IT_ITA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal _BG_bul_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal _BG_eng_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal _GR_GRE_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_CZ_cze_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_DE_GER_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_SPA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_HU_HUN_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_IT_ITA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PL_POL_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PT_POR_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_RO_RUM_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_SK_slo_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BG_bul_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_CZ_cze_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_DE_GER_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_ES_SPA_2025-523552-31 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_FI_FIN_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_FR_FRE_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_GR_GRE_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_HU_HUN_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_IT_ITA_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_PL_POL_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_PT_POR_2025-523552-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_RO_RUM_2025-523552-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_SK_slo_2025-523552-31 | 1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _ES_SPA_2025-523552-31 | initial |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _GR_GRE_2025-523552-31 | Initial |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _HU_HUN_2025-523552-31 | Initial |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _NO_NOR_2025-523552-31 | 1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _PL_POL_2025-523552-31 | Initial |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _PT_POR_2025-523552-31 | Original |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _RO_RUM_2025-523552-31 | Original |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis _SK_slo_2025-523552-31 | Initial |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BG_bul_2025-523552-31 | initial |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_CZ_cze_2025-523552-31 | Initial |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_FR_FRE_2025-523552-31 | Original |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_IT_ITA_2025-523552-31 | Original |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-14 | Bulgaria | Acceptable with conditions 2026-05-04
|
2026-05-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-12 | Acceptable with conditions 2026-05-04
|
2026-05-12 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-12 | Acceptable with conditions 2026-05-04
|
2026-05-12 |