A study to learn if dapirolizumab pegol is safe and works long-term in people with systemic lupus erythematosus

Start 7 Sep 2021 · Status Ongoing, recruitment ended · 13 EU/EEA countries · 89 sites · Protocol SL0046

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruitment ended

Participants planned 765

Countries 13

Sites 89

Systemic lupus erythematosus (SLE)

Evaluate the long-term safety and tolerability of dapirolizumab pegol (DZP) treatment.

Key facts

Sponsor: UCB Biopharma
Participant type: Pediatric, Patients
Age range: 0-17 years, 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12], Diseases [C] - Immune System Diseases [C20]
Trial duration: 7 Sep 2021 → ongoing
Decision date (initial): 2024-01-24
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: UCB Biopharma SRL

External identifiers

EU CT number: 2023-506368-14-00
EudraCT number: 2019-003409-83
WHO UTN: U1111-1293-7098
ClinicalTrials.gov: NCT04976322

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Safety, Pharmacokinetic, Pharmacodynamic, Others, Efficacy

Evaluate the long-term safety and tolerability of dapirolizumab pegol (DZP) treatment.

Secondary objectives 1

Evaluate the ability of dapirolizumab pegol (DZP) treatment: - to prevent relevant disease flares - to achieve and maintain the treat-to-target goal: low lupus disease activity state (LLDAS) - to maintain long-term clinical response

Conditions and MedDRA coding

Systemic lupus erythematosus (SLE)

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: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

- The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment - The participant completed one of the parent studies within 4 weeks prior to entry to this study

Exclusion criteria 1

- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study. This includes study participants with a life-threatening condition or ongoing malignancies at the start of the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious treatment-emergent adverse events during the study 3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation

Secondary endpoints 7

1. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24
2. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52
3. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104
4. Achievement of LLDAS at ≥50% of all visits
5. Achievement of BICLA response at Week 24
6. Achievement of BICLA response at Week 52
7. Achievement of BICLA response at Week 104

Investigational products

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

Test 1

Dapirolizumab pegol

PRD10656265 · Product

Active substance: Dapirolizumab Pegol
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 24 mg/kg milligram(s)/kilogram
Max total dose: 24 mg/Kg milligram(s)/kilogram
Max treatment duration: 104 Week(s)
Authorisation status: Not Authorised
MA holder: UCB BIOPHARMA SRL
Paediatric formulation: No
Orphan designation: No

Auxiliary 12

—

SCP16873011 · ATC

Route of administration: UNKNOWN USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: C01CA24 — EPINEPHRINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

C02AC · Product

Pharmaceutical form: PHF00245MIG
Route of administration: UNKNOWN USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: C02AC — IMIDAZOLINE RECEPTOR AGONISTS
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

R06A · Product

Pharmaceutical form: -
Route of administration: UNKNOWN USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: R06A — ANTIHISTAMINES FOR SYSTEMIC USE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

M01A · Product

Pharmaceutical form: -
Route of administration: UNKNOWN USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: M01A — ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

N02BG · Product

Pharmaceutical form: PHF00006MIG
Route of administration: UNKNOWN USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: N02BG — OTHER ANALGESICS AND ANTIPYRETICS
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

—

SCP790637 · ATC

Route of administration: UNKNOWN USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: C09AA08 — CILAZAPRIL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

H02AB · Product

Pharmaceutical form: PHF00231MIG
Route of administration: UNKNOWN USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: H02AB — GLUCOCORTICOIDS
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

P01B · Product

Pharmaceutical form: -
Route of administration: UNKNOWN USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: P01B — ANTIMALARIALS
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Anhydrous Caffeine

SCP4358000 · ATC

Active substance: Anhydrous Caffeine
Route of administration: UNKNOWN USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: N02BE01 — PARACETAMOL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

SCP137948 · ATC

Route of administration: UNKNOWN USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: C10AA — HMG COA REDUCTASE INHIBITORS
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

L04A · Product

Pharmaceutical form: -
Route of administration: UNKNOWN USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: L04A — IMMUNOSUPPRESSANTS
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Diphenhydramine Hydrochloride

SCP58627504 · ATC

Active substance: Diphenhydramine Hydrochloride
Route of administration: UNKNOWN USE
Max daily dose: 0 DF dosage form
Max total dose: 0 DF dosage form
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: D04AA32 — DIPHENHYDRAMINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UCB Biopharma

Sponsor organisation: UCB Biopharma
Address: Researchdreef 60
City: Anderlecht
Postcode: 1070
Country: Belgium

Scientific contact point

Organisation: UCB Biopharma
Contact name: UCB Cares

Public contact point

Organisation: UCB Biopharma
Contact name: UCB Cares

Third parties 17

Organisation	City, country	Duties
Pharmaceutical Research Associates Group B.V. ORG-100006268	Assen, Netherlands	Laboratory analysis
DCRI ORL-000003161	Durham, United States	Code 13
Perceptive Informatics Inc. ORG-100013171	Billerica, United States	Interactive response technologies (IRT)
Crisalis LLC ORG-100047297	Oklahoma City, United States	Other
JMAC ORL-000003027	Missouri City, United States	Other
Excelya Greece CRO Single Member S.A. ORG-100009224	Vrilissia, Greece	On site monitoring
Center For Information And Study On Clinical Research Participation Inc. ORG-100044581	Boston, United States	Code 11
Longboat Clinical Limited ORG-100045828	Limerick, Ireland	Other
BioAgilytix Europe GmbH ORG-100016335	Hamburg, Germany	Laboratory analysis
Parexel International (IRL) Limited ORG-100022780	Dublin 8, Ireland	On site monitoring, Code 11, Code 12, Code 13, Other, Other, Code 5, E-data capture, Code 8, Code 9
Intertek ORL-000003028	MANCHESTER, United Kingdom	Laboratory analysis
Clinical Ink Inc. ORG-100042433	Horsham, United States	E-data capture
RWS Life Sciences Inc. ORG-100042348	East Hartford, United States	Other
Syner-G BioPharma Group RTP ORL-000003030	Durham, United States	Code 11
WCG Clinical Inc. ORG-100040730	Princeton, United States	E-data capture
Azenta Germany GmbH ORG-100039257	Griesheim, Germany	Other
Q Squared Solutions Limited ORG-100042527	Reading, United Kingdom	Laboratory analysis

Locations

13 EU/EEA countries · 89 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ongoing, recruiting	10	3
Bulgaria	Ended	9	2
Czechia	Ended	4	1
Denmark	Authorised, recruitment pending	2	3
France	Authorised, recruitment pending	15	2
Germany	Ongoing, recruiting	44	13
Greece	Ongoing, recruiting	11	5
Hungary	Ended	8	5
Italy	Ongoing, recruiting	25	16
Netherlands	Authorised, recruitment pending	5	3
Poland	Ongoing, recruiting	108	17
Romania	Ended	2	1
Spain	Ongoing, recruiting	12	18
Rest of world Chile, United Kingdom, Japan, Peru, Serbia, Taiwan, Colombia, Argentina, Canada, China, Korea, Republic of, Philippines, Mexico, Puerto Rico, United States	—	510	—

Investigational sites

Belgium

3 sites · Ongoing, recruiting

CHU De Liege

#40060:Rhumatologie, Avenue De L'hopital 1, 4000, Liege

Hopital Erasme

#40123:Rhumatologie, Lennikse Baan 808, 1070, Anderlecht

UZ Leuven

#40002:Reumatologie, Herestraat 49, 3000, Leuven

Bulgaria

2 sites · Ended

Diagnostic-Consultative Center Alexandrovska EOOD

#40380, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya

Diagnostic Consultative Center Sveti Georgi EOOD

#40189, Bulevard Vasil Aprilov 15a, 4002, Plovdiv

Czechia

1 site · Ended

Revmatologicky Ustav

#40066, Na Slupi 450/4, Nove Mesto, Prague 2

Denmark

3 sites · Authorised, recruitment pending

Odense University Hospital

#40489:Rheumatology, J B Winsloews Vej 4, 5000, Odense C

Rigshospitalet

#40513:Afd. For Afdeling for Rygkirurgi, Led- og Bindevævssygdomme, Blegdamsvej 9, 2100, Copenhagen Oe

Region Midtjylland

#40562: Department of Rheumatology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

France

2 sites · Authorised, recruitment pending

Centre Hospitalier Universitaire De Montpellier

#40506:Rhumatologie, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5

Centre Hospitalier Le Mans

#40848: Immunologie, 194 Avenue Rubillard, 72037, Le Mans Cedex 9

Germany

13 sites · Ongoing, recruiting

Charite Universitaetsmedizin Berlin KöR

#40480:Med. Kl. mS. Rheumatologie u. Klin. Immunologie, Chariteplatz 1, Mitte, Berlin

Staedtisches Klinikum Dessau

#40322:Hautklinik Und Immunologisches, Auenweg 38, Alten, Dessau-Rosslau

Krankenhaus Porz Am Rhein gGmbH

#40716:Rheumatologie, Urbacher Weg 19, Porz, Cologne

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

#40854:I. Med. Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz

Universitaetsklinikum Jena KöR

#40139:Department of Urology, Am Klinikum 1, Lobeda, Jena

Medicover GmbH

#40815:Medicover MVZ München Ost-Rheumatologie, Orleansplatz 3, Au-Haidhausen, Munich

Universitaetsklinikum Tuebingen AöR

#40402:Medizinische Klinik II - Rheumatologie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

#40356:Rheumatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden

Medical Center - University Of Freiburg

#40072:Klinik für Rheumatologie und Klinische Immunologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau

Universitaetsklinikum Leipzig AöR

#40078:Klinik und Poliklinik für Endokrinologie, Nephrologie, Rheumatologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig

HELIOS Fachklinik Vogelsang-Gommern GmbH

#40715:Rheumatologie, Sophie-Von-Boetticher-Strasse 1, Vogelsang, Gommern

University Hospital Cologne AöR

#40386: Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne

St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr

#40027:Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, Wanne, Herne

Greece

5 sites · Ongoing, recruiting

General University Hospital Of Larissa

#40507:Rheumatology Clinic, P. O. Box 1425, 411 10, Larissa

University General Hospital Of Heraklion

#40377:Rheumatology Clinic, Stavrakia And Voutes, 715 00, Heraklion

University General Hospital Attikon

#40501:4th Department of Internal Medicine, Rimini Street 1, 124 62, Athens

Hippokration Hospital

#40378:2nd Department of Internal Med, Vassilissas Sofias Avenue 114, 115 27, Athens

Laiko General Hospital Of Athens

#40376:1st Department of Propaedeutic, Agiou Thoma (goudi) 17, 115 27, Athens

Hungary

5 sites · Ended

Bekes Varmegyei Koezponti Korhaz

#40413:Infektologia, Hepatologia es I, Semmelweis Utca 1, 5700, Gyula

Vita Verum Medical Bt.

#40499, Fiskalis Ut 43, 8000, Szekesfehervar

University Of Debrecen

#40411:Klinikai Immunológiai Tanszék, Moricz Zsigmond Korut 22, 4032, Debrecen

Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet

#40412:Szent László Kórház Telephely, Infektológiai Osztály, Albert Florian Ut 5-7, 1097, Budapest IX

University Of Szeged

#40031:Reumatologiai es Immunologiai Klinika, Kalvaria Sugarut 57, 6725, Szeged

Italy

16 sites · Ongoing, recruiting

Universita' Campus Bio-medico Di Roma

#40860: UOC di Immureumatologia, Via Alvaro Del Portillo 200, 00128, Rome

Fondazione IRCCS San Gerardo Dei Tintori

#40859: SC Nefrologia, Via Giovanbattista Pergolesi 33, 20900, Monza

Azienda Ospedaliero-Universitaria Policlinico Umberto I

#40675:Reumatologia, Viale Del Policlinico 155, 00161, Rome

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

#40816:S.C. Reumatologia e Immunologia Clinica, Piazzale Spedali Civili 1, 25123, Brescia

University Hospital Of Ferrara

#40472:Reumatologia, Cona, Via Aldo Moro 8, Ferrara

IRCCS Ospedale Policlinico San Martino

#40514:Clinica Reumatologca , Dipartimento di Medicina interna e Specialità Mediche, Viale Benedetto XV 6, 16132, Genoa

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

#40291:U.O. Medicina Generale - Immunologia e > Allergologia Dipartimento di Medicina Interna, Via Francesco Sforza 35, 20122, Milan

Azienda Ospedale-Universita Padova

#40509:Reumatologia, Via Nicolo' Giustiniani 2, 35128, Padova

Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto

#40471:Dipartimento Reumatologia e Scienze Mediche, Unità Operativa Complessa Reumatologia Clinica, Piazza Cardinale Andrea Ferrari 1, 20122, Milan

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

#40148: Reumatologia, Largo Francesco Vito 1, 00168, Rome

Azienda Sanitaria Universitaria Friuli Centrale

#40817:SOC Clinica di Reumatologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine

Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania

#40084:Reumatologia, Viale Azeglio Ciampi Snc, 95121, Catania

Ospedale San Raffaele S.r.l.

#40448:Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare,, Via Olgettina 60, 20132, Milan

Humanitas Mirasole S.p.A.

#40830:Rheumatology and Clinical Immunology, Via Alessandro Manzoni 56, 20089, Rozzano

Azienda Ospedaliero Universitaria Pisana

#40176:U. O. Reumatologia, Via Roma 67, 56126, Pisa

Azienda Ospedaliero Universitaria Di Modena

#40329: Reumatologia, Largo Del Pozzo 71, 41124, Modena

Netherlands

3 sites · Authorised, recruitment pending

Amsterdam UMC Stichting

40838: Rheumatology & Clinical Immunology, De Boelelaan 1117, 1081 HV, Amsterdam

Universitair Medisch Centrum Groningen

40292: Internal Medicine, Hanzeplein 1, 9713 GZ, Groningen

Universiteit Maastricht

40565: Vascular medicine, P Debyelaan 25, 6229 HX, Maastricht

Poland

17 sites · Ongoing, recruiting

Reum Medica Bozena Kowalewska Marek Zawadzki

#40397:Reumatology, Pl. Sw. Macieja 8, 50-244, Wroclaw

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu

#40481: KlinikaReumatologii i Chorob Wewnetrznych, Ul. Borowska 213, 50-556, Wroclaw

Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.

#40821:Twoja Przychodnia PCM, Ul. Marcelinska 92, 60-324, Poznan

Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.

#40502:Reumatology, U2 U4 U5, Ul. Tadeusza Szafrana 5d, Cracow

Klinika Reuma Park Sp. z o.o. S.K.

#40098:Reumatology, Aleja Wilanowska 333, 02-665, Warsaw

Pratia S.A.

#40490:Reumatology, Ul. Pana Tadeusza 2, 30-727, Cracow

Pratia S.A.

#40398:Reumatology, Ul. Dabrowki 13, 40-081, Katowice

Inter Clinic Piotr Adrian Klimiuk

#40482:Reumatology, ul. Warszawska 52, 15-077, Bialystok

Medicover Integrated Clinical Services Sp. z o.o.

#40097: Reumatology, Ul Wronia 53 Lok B 10, 00-874, Warsaw

Medyczne Centrum Hetmanska Piotr Leszczynski

#40044:Reumatology, ul. Hetmanska 55/1, 60-218, Poznan

Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy

#40119:Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz

Prywatna Praktyka Lekarska Prof. dr hab.med. Pawel Hrycaj

#40090:Reumatology, Osiedle Rzeczypospolitej 6 lok. 202, 61-397, Poznan

Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie

#40151:Kliniczny Oddział Reumatologii i Ukladowych Chorob Tkanki Lacznej, Ul. Dr. K. Jaczewskiego 8, 20-954, Lublin

Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher

#40394:Centrum Wsparcia Badan Klinicznych, Ul. Spartanska 1, 02-637, Warsaw

Ortopedyczno-Rehabilitacyjny Szpital Kliniczny Im Wiktora Degi Uniwersytetu Medycznego Im Karola Marcinkowskiego W Poznaniu

#40484:Klinika Reumatologii, Rehabilitacji i Chorob Wewnetrznych, Ul. 28 Czerwca 1956 R. 135/147, 61-544, Poznan

Reumed Sp. z o.o.

#40037: Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda, Ul. Konrada Wallenroda 2f/4, 20-607, Lublin

Provita Sp. z o.o.

#40795: Centrum Medyczne Angelius Provita, Ul. Fabryczna 15b, 40-611, Katowice

Romania

1 site · Ended

Spitalul Clinic Judetean De Urgenta Sf. Apostol Andrei Galati

#40382:Reumatologie, Strada Brailei 177, 800578, Galati

Spain

18 sites · Ongoing, recruiting

Hospital De La Santa Creu I Sant Pau

#40159:Reumatología, Carrer De San Quinti 89, 08041, Barcelona

Hospital Universitario Regional De Malaga

#40341:Reumatología/Immunología, Avenida De Carlos De Haya Sn, 29010, Malaga

Hospital Quironsalud Sagrado Corazon

#40400:Reumatología, Calle De Rafael Salgado 3, 41013, Sevilla

Hospital Universitari Vall D Hebron

#40160:Reumatologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona

Parc Tauli Hospital Universitari

#40101:Servicio de reumatologia, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell

University Clinical Hospital Virgen De La Arrixaca

#40399:Reumatologia, Carretera De Cartagena Sn, El Palmar, Murcia

Complexo Hospitalario Universitario De Vigo

#40099:Reumatología, Estrada Clara Campoamor N 341, 36312, Vigo

Hospital De Merida

#40521:Reumatología, Avenida De Don Antonio Campos Hoyos No 26, 06800, Merida

Complexo Hospitalario Universitario A Coruna

#40045:Reumatologia e Immunologia, Lugar Jubias De Arriba 84, 15006, A Coruna

Hospital Universitario De Badajoz

#40826: Reumatología, Avenida Elvas S/n, 06006, Badajoz

Hospital Universitario Virgen De Valme

#40103:Reumatologia, Avenida Bellavista S/n, 41014, Sevilla

University Hospital Of Canary Islands

#40401:Reumatología, Carretera De La Cuesta Taco S/n, Cuesta La, San Cristobal De La Laguna

Hospital General Universitario De Castellon

#40839: Reumatología, Avenida De Benicasim S/n, 12004, Castello De La Plana

Hospital Universitario Virgen De La Macarena

#40049: Reumatología, Avenida Del Doctor Fedriani 3, 41009, Sevilla

Clinica Gaias Santiago

#40853: Reumatología, Rua Do Pintor Xaime Quesada N 3, 15702, Santiago De Compostela

University Hospital Virgen Del Rocio S.L.

#40106: Reumatología, Avenida De Manuel Siurot S/n, 41013, Sevilla

Futuremeds Spain S.L.

#40857: Medicina Interna, Calle De La Granja 8, 28003, Madrid

Hospital Universitario Araba

#40863: Reumatología, Jose Achotegui Kalea S/N, 01009, Vitoria

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end
Belgium	2022-05-05		2022-05-05
Bulgaria	2021-12-16	2025-05-09	2021-12-16	2023-03-29
Czechia	2022-10-31	2026-02-25	2022-10-31	2024-01-23
Germany	2022-03-31		2022-03-31
Greece	2023-01-03		2023-01-03
Hungary	2022-02-02	2026-02-25	2022-02-02	2024-01-17
Italy	2023-09-12		2023-09-12
Poland	2021-09-07		2021-09-07
Romania	2023-01-18	2025-06-04	2023-01-18	2023-04-26
Spain	2021-10-06		2021-10-06
Denmark
France

Results and documents

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

Documents 252 files

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

Type	Title	Version
Protocol (for publication)	all countries-diary-pcirf-public	1.0
Protocol (for publication)	all countries-quest-C-SSRS Baseline Screening-public	1.0
Protocol (for publication)	all countries-quest-C-SSRS Since Last Visit-public	1.0
Protocol (for publication)	BE-diary-pcirf-fr-BE-public	1.0
Protocol (for publication)	BE-diary-pcirf-nl-BE-public	1.0
Protocol (for publication)	BE-eDiary-fr-BE-public	1.0
Protocol (for publication)	BE-eDiary-nl-BE-public	2.0
Protocol (for publication)	BE-quest-EQ-5D-5L-fr-BE-public	1.0
Protocol (for publication)	BE-quest-EQ-5D-5L-nl-BE-public	1.0
Protocol (for publication)	BE-quest-Fatigue Pro-fr-BE-public	2.0
Protocol (for publication)	BE-quest-Fatigue Pro-nl-BE-public	2.0
Protocol (for publication)	BE-quest-LupusQoL-fr-BE-public	1.0
Protocol (for publication)	BE-quest-LupusQoL-nl-BE-public	1.0
Protocol (for publication)	BE-quest-PHQ-9-fr-BE-public	2.0
Protocol (for publication)	BE-quest-PHQ-9-nl-BE-public	1.0
Protocol (for publication)	BG-CZ-DK-FR-GR-IT-PL-RO-ES-eDiary-public	1.0
Protocol (for publication)	BG-CZ-DK-FR-GR-IT-PL-RO-ES-quest-EQ-5D-5L-public	1.0
Protocol (for publication)	BG-CZ-DK-FR-GR-IT-PL-RO-ES-quest-Fatigue Pro-pubic	2
Protocol (for publication)	BG-CZ-DK-FR-GR-IT-PL-RO-ES-quest-LupusQoL-public	1
Protocol (for publication)	BG-CZ-DK-FR-GR-IT-PL-RO-ES-quest-PHQ-9-public	1.0
Protocol (for publication)	BG-diary-pcirf-bg-BG-public	1.0
Protocol (for publication)	CZ-diary-pcirf-cs-CZ-public	1.0
Protocol (for publication)	CZ-eDiary-cs-CZ-public	2.0
Protocol (for publication)	CZ-quest-EQ-5D-5L-cs-CZ-public	1.0
Protocol (for publication)	CZ-quest-Fatigue Pro-cs-CZ-public	2.0
Protocol (for publication)	CZ-quest-LupusQoL-cs-CZ-public	1.0
Protocol (for publication)	CZ-quest-PHQ-9-cs-CZ-public	1.0
Protocol (for publication)	DE-diary-pcirf-de-DE-public	1.0
Protocol (for publication)	DE-eDiary-de-DE-public	2.0
Protocol (for publication)	DE-quest-EQ-5D-5L-de-DE-public	1.0
Protocol (for publication)	DE-quest-Fatigue Pro-de-DE-public	2.0
Protocol (for publication)	DE-quest-LupusQoL-de-DE-public	1.0
Protocol (for publication)	DE-quest-PHQ-9-de-DE-public	1.0
Protocol (for publication)	DK-diary-pcirf-da-DK-public	1.0
Protocol (for publication)	ES-diary-pcirf-es-ES-public	1.0
Protocol (for publication)	ES-eDiary-es-ES-public	2.0
Protocol (for publication)	ES-quest-EQ-5D-5L-es-ES-public	1.0
Protocol (for publication)	ES-quest-Fatigue Pro-es-ES-public	2.0
Protocol (for publication)	ES-quest-LupusQoL-es-ES-public	1.0
Protocol (for publication)	ES-quest-PHQ-9-es-ES-public	1.0
Protocol (for publication)	FR-diary-pcirf-fr-FR-public	1.0
Protocol (for publication)	FR-eDiary-fr-FR-public	2.0
Protocol (for publication)	FR-quest-EQ-5D-5L-fr-FR-public	1.0
Protocol (for publication)	FR-quest-Fatigue Pro-fr-FR-public	2.0
Protocol (for publication)	FR-quest-LupusQoL-fr-FR-public	1.0
Protocol (for publication)	FR-quest-PHQ-9-fr-FR-public	1.0
Protocol (for publication)	GR-diary-pcirf-el-GR-public	1.0
Protocol (for publication)	GR-eDiary-el-GR-public	2.0
Protocol (for publication)	GR-quest-EQ-5D-5L-el-GR-public	1.0
Protocol (for publication)	GR-quest-Fatigue Pro-el-GR-public	2.0
Protocol (for publication)	GR-quest-LupusQol-el-GR-public	1.0
Protocol (for publication)	GR-quest-PHQ-9-el-GR-public	1.0
Protocol (for publication)	HU-diary-pcirf-hu-HU-public	1.0
Protocol (for publication)	HU-eDiary-hu-HU-public	2.0
Protocol (for publication)	HU-quest-EQ-5D-5L-hu-HU-public	1.0
Protocol (for publication)	HU-quest-Fatigue Pro-hu-HU-public	2.0
Protocol (for publication)	HU-quest-LupusQoL-hu-HU-public	1.0
Protocol (for publication)	HU-quest-PHQ-9-hu-HU-public	1.0
Protocol (for publication)	IT-diary-pcirf-it-IT-public	1.0
Protocol (for publication)	IT-eDiary-it-IT-public	2.0
Protocol (for publication)	IT-quest-EQ-5D-5L-it-IT-public	1.0
Protocol (for publication)	IT-quest-Fatigue Pro-it-IT-public	2.0
Protocol (for publication)	IT-quest-LupusQoL-it-IT-public	1.0
Protocol (for publication)	IT-quest-PHQ-9-it-IT-public	1.0
Protocol (for publication)	PL-diary-pcirf-pl-PL-public	1.0
Protocol (for publication)	RO-diary-pcirf-ro-RO-public	1.0
Protocol (for publication)	RO-eDiary-ro-RO-public	2
Protocol (for publication)	RO-quest-EQ-5D-5L-ro-RO-public	1.0
Protocol (for publication)	RO-quest-Fatigue Pro-ro-RO-public	2.0
Protocol (for publication)	RO-quest-LupusQoL-ro-RO-public	1.0
Protocol (for publication)	RO-quest-PHQ-9-ro-RO-public	1.0
Protocol (for publication)	sl0046-protocol-amend-2.2-el-GR-public	NA
Protocol (for publication)	sl0046-protocol-amend-3-el-GR-public	N/A
Protocol (for publication)	sl0046-protocol-amend-3-public	N/A
Protocol (for publication)	sl0046-protocol-amendment-2-el-gr-public	1
Protocol (for publication)	sl0046-protocol-amendment-2-public	n/a
Protocol (for publication)	sl0046-protocol-amendment-2.2-public	NA
Recruitment arrangements (for publication)	BE-recruitment-study guide-en-BE-public	1.0
Recruitment arrangements (for publication)	BE-recruitment-study guide-fr-BE-public	1.0
Recruitment arrangements (for publication)	BE-recruitment-study guide-nl-BE-public	1.0
Recruitment arrangements (for publication)	BE-recruitment-Study Info Leaflet-fr-BE-public	1.0
Recruitment arrangements (for publication)	BE-recruitment-Study Info Leaflet-nl-BE-public	1.0
Recruitment arrangements (for publication)	BE-recruitment-Study Information Leaflet-en-BE-public	1.0
Recruitment arrangements (for publication)	BGR-Participant St Guide-Bulgarian-SL0046-Public	1.0
Recruitment arrangements (for publication)	BGR-Recr Procedure Des-bg-SL0046-Public	1.0
Recruitment arrangements (for publication)	BGR-Study Info Leaflet-Bulgarian-SL0046 Public	1.0
Recruitment arrangements (for publication)	CZ-recruitment-study guide-cs-CZ-public	1.0
Recruitment arrangements (for publication)	CZ-recruitment-Study Info Leaflet-cs-CZ-public	1.0
Recruitment arrangements (for publication)	HU-recruitment-study guide-hu-HU-public	1.0
Recruitment arrangements (for publication)	HU-recruitment-Study Info Leaflet-hu-HU-public	1.0
Recruitment arrangements (for publication)	K1_sl0046-nl-recr-proc-en-public	1.2
Recruitment arrangements (for publication)	K2_DE-recruitment-study guide-de-DE-public	2.0
Recruitment arrangements (for publication)	K2_DE-recruitment-Study Info Leaflet-de-DE-public	2.0
Recruitment arrangements (for publication)	K2_DNK Participant Study Guide Danish SL0046 Public	2.0
Recruitment arrangements (for publication)	K2_DNK Study Information Leaflet Danish SL0046 Public	2.0
Recruitment arrangements (for publication)	K2_ES-recruitment-study guide-es-ES-public	2.0
Recruitment arrangements (for publication)	K2_ES-recruitment-Study Info Leaflet-es-ES-public	2.0
Recruitment arrangements (for publication)	K2_FR-recruitment-study guide-fr-FR-public	2.0
Recruitment arrangements (for publication)	K2_FR-recruitment-Study Info Leaflet-fr-FR-public	2.0
Recruitment arrangements (for publication)	K2_GR-recruitment-study guide-el-GR-public	2.0
Recruitment arrangements (for publication)	K2_GR-recruitment-Study Info Leaflet-el-GR-public	2.0
Recruitment arrangements (for publication)	K2_IT-recruitment-study guide-it-IT-public	2.0
Recruitment arrangements (for publication)	K2_IT-recruitment-Study Info Leaflet-it-IT-public	2.0
Recruitment arrangements (for publication)	K2_sl0046-pl-recr-studyguide-pl-PL-public	2.0
Recruitment arrangements (for publication)	K2_sl0046-pl-recr-studyinfoleaflet-pl-PL-public	2.0
Recruitment arrangements (for publication)	POL Recr Pr Desc English SL0046 Public	1.0
Recruitment arrangements (for publication)	RO-recruitment-study guide-ro-RO-public	1.0
Recruitment arrangements (for publication)	RO-recruitment-Study-Info-leaflet-ro-RO-public	1.0
Recruitment arrangements (for publication)	sl0046-be-recr-proc-public	1.0
Recruitment arrangements (for publication)	sl0046-de-recr-proc-public	1.0
Recruitment arrangements (for publication)	sl0046-de-recr-proc-public	1.0
Recruitment arrangements (for publication)	sl0046-dk-prelabor-dk-DK-public	1.0
Recruitment arrangements (for publication)	sl0046-fr-icf-recr-proc-en-fr-FR-public	1.0
Recruitment arrangements (for publication)	sl0046-gr-recr-proc-public	1.0
Recruitment arrangements (for publication)	sl0046-pl-recr-proc-en-pl-PL-public	1.0
Subject information and informed consent form (for publication)	ITA CEC Approval Italian SL0046 Public	1.0
Subject information and informed consent form (for publication)	L1_sl0046-de-icf-main-de-DE-public	3.1
Subject information and informed consent form (for publication)	L1_sl0046-nl-icf-main-nl-NL-public	1.1
Subject information and informed consent form (for publication)	L1_sl0046-nl-icf-pp-fu-nl-NL-public	1.1
Subject information and informed consent form (for publication)	sl0046-40189-bg-icf-parpp-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-be-icf-ass-en-BE-public	2.0
Subject information and informed consent form (for publication)	sl0046-be-icf-ass-fr-BE-public	3.0
Subject information and informed consent form (for publication)	sl0046-be-icf-ass-nl-BE-public	3.0
Subject information and informed consent form (for publication)	sl0046-be-icf-asspp-en-BE-public	1.1
Subject information and informed consent form (for publication)	sl0046-be-icf-asspp-fr-BE-public	1.1
Subject information and informed consent form (for publication)	sl0046-be-icf-asspp-nl-BE-public	1.1
Subject information and informed consent form (for publication)	sl0046-be-icf-main-en-BE-public	3.0
Subject information and informed consent form (for publication)	sl0046-be-icf-main-fr-BE-public	4.0
Subject information and informed consent form (for publication)	sl0046-be-icf-main-nl-BE-public	4.0
Subject information and informed consent form (for publication)	sl0046-be-icf-par-en-BE-public	3.0
Subject information and informed consent form (for publication)	sl0046-be-icf-par-fr-BE-public	4.0
Subject information and informed consent form (for publication)	sl0046-be-icf-par-nl-BE-public	4.0
Subject information and informed consent form (for publication)	sl0046-be-icf-parpp-en-BE-public	1.1
Subject information and informed consent form (for publication)	sl0046-be-icf-parpp-fr-BE-public	1.1
Subject information and informed consent form (for publication)	sl0046-be-icf-parpp-nl-BE-public	1.1
Subject information and informed consent form (for publication)	sl0046-be-icf-pp-en-BE-public	1.1
Subject information and informed consent form (for publication)	sl0046-be-icf-pp-fr-BE-public	1.1
Subject information and informed consent form (for publication)	sl0046-be-icf-pp-nl-BE-public	1.1
Subject information and informed consent form (for publication)	sl0046-be-icf-proc-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-40189-icf-assent-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-40189-icf-asspp-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-40189-icf-main-bg-BG-public	2.0
Subject information and informed consent form (for publication)	sl0046-bg-40189-icf-par-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-40189-icf-pp-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-40380-icf-ass-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-40380-icf-asspp-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-40380-icf-main-bg-BG-public	2.0
Subject information and informed consent form (for publication)	sl0046-bg-40380-icf-par-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-40380-icf-parpp-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-40380-icf-pp-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-icf-ass-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-icf-ass-en-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-icf-asspp-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-icf-asspp-en-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-icf-main-bg-BG-public	3.0
Subject information and informed consent form (for publication)	sl0046-bg-icf-main-en-public	3.0
Subject information and informed consent form (for publication)	sl0046-bg-icf-par-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-icf-par-en-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-icf-parpp-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-icf-parpp-en-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-icf-pp-bg-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-bg-icf-pp-en-BG-public	1.0
Subject information and informed consent form (for publication)	sl0046-cz-icf-dp-cz-CZ-public	2.0
Subject information and informed consent form (for publication)	sl0046-cz-icf-main-cz-CZ-public	3.0
Subject information and informed consent form (for publication)	sl0046-cz-icf-mainaep-cz-CZ-public	2.0
Subject information and informed consent form (for publication)	sl0046-cz-icf-pp-cz-CZ-public	1.1
Subject information and informed consent form (for publication)	sl0046-cz-patcard-cz-CZ-public	2.0
Subject information and informed consent form (for publication)	sl0046-de-icf-fr-de-DE-public	1.0
Subject information and informed consent form (for publication)	sl0046-de-icf-pp-de-DE-public	1.1
Subject information and informed consent form (for publication)	sl0046-de-icf-proc-public	1.0
Subject information and informed consent form (for publication)	sl0046-dk-icf-main-da-DK-public	3.0
Subject information and informed consent form (for publication)	sl0046-dk-icf-pp-da-DK-public	1.0
Subject information and informed consent form (for publication)	sl0046-dk-icf-proc-public	1.0
Subject information and informed consent form (for publication)	sl0046-dk-icf-research-da-DK-public	1.0
Subject information and informed consent form (for publication)	sl0046-es-icf-ass-es-ES-public	3.1
Subject information and informed consent form (for publication)	sl0046-es-icf-asspp-es-ES-public	1.0
Subject information and informed consent form (for publication)	sl0046-es-icf-main-es-ES-public	3.1
Subject information and informed consent form (for publication)	sl0046-es-icf-par-es-ES-public	3.1
Subject information and informed consent form (for publication)	sl0046-es-icf-parpp-es-ES-public	1.0
Subject information and informed consent form (for publication)	sl0046-es-icf-pp-es-ES-public	1.0
Subject information and informed consent form (for publication)	sl0046-es-icf-recr-proc-public	1.0
Subject information and informed consent form (for publication)	sl0046-fr-icf-ass-fr-FR-public	3.0
Subject information and informed consent form (for publication)	sl0046-fr-icf-asspp-fr-FR-public	1.0
Subject information and informed consent form (for publication)	sl0046-fr-icf-main-fr-FR-public	3.0
Subject information and informed consent form (for publication)	sl0046-fr-icf-par-fr-FR-public	3.0
Subject information and informed consent form (for publication)	sl0046-fr-icf-parpp-fr-FR-public	1.0
Subject information and informed consent form (for publication)	sl0046-fr-icf-pp-fr-FR-public	1.0
Subject information and informed consent form (for publication)	sl0046-fr-icf-recr-proc-en-fr-FR-public	1.0
Subject information and informed consent form (for publication)	sl0046-gr-icf-asspp-el-GR-public	1.2
Subject information and informed consent form (for publication)	sl0046-gr-icf-asspp-en-GR-public	1.2
Subject information and informed consent form (for publication)	sl0046-gr-icf-main-ass-el-GR-public	3.1
Subject information and informed consent form (for publication)	sl0046-gr-icf-main-ass-en-GR-public	3.1
Subject information and informed consent form (for publication)	sl0046-gr-icf-main-el-GR-public	3.0
Subject information and informed consent form (for publication)	sl0046-gr-icf-main-en-GR-public	3.0
Subject information and informed consent form (for publication)	sl0046-gr-icf-par-el-GR-public	3.0
Subject information and informed consent form (for publication)	sl0046-gr-icf-par-en-GR-public	3.0
Subject information and informed consent form (for publication)	sl0046-gr-icf-parpp-el-GR-public	1.1
Subject information and informed consent form (for publication)	sl0046-gr-icf-parpp-en-GR-public	1.1
Subject information and informed consent form (for publication)	sl0046-gr-icf-pp-el-GR-public	1.1
Subject information and informed consent form (for publication)	sl0046-gr-icf-pp-en-GR-public	1.1
Subject information and informed consent form (for publication)	sl0046-gr-icf-proc-public	1.0
Subject information and informed consent form (for publication)	sl0046-hu-icf-ass-hu-HU-public	2.0
Subject information and informed consent form (for publication)	sl0046-hu-icf-assfr-hu-HU-public	1.0
Subject information and informed consent form (for publication)	sl0046-hu-icf-asspp-hu-HU-public	1.0
Subject information and informed consent form (for publication)	sl0046-hu-icf-fr-hu-HU-public	1.0
Subject information and informed consent form (for publication)	sl0046-hu-icf-jmac-hu-HU-public	1.0
Subject information and informed consent form (for publication)	sl0046-hu-icf-main-hu-HU-public	4.0
Subject information and informed consent form (for publication)	sl0046-hu-icf-par-hu-HU-public	2.0
Subject information and informed consent form (for publication)	sl0046-hu-icf-parfr-hu-HU-public - changed	1.0
Subject information and informed consent form (for publication)	sl0046-hu-icf-parpp-hu-HU-public	1.0
Subject information and informed consent form (for publication)	sl0046-hu-icf-pp-hu-HU-public	1.0
Subject information and informed consent form (for publication)	sl0046-hu-partcard-hu-HU-public	2.0
Subject information and informed consent form (for publication)	sl0046-hu-pis-ass-hu-HU-public	2.0
Subject information and informed consent form (for publication)	sl0046-hu-pis-assfr-hu-HU-public - changed	1.0
Subject information and informed consent form (for publication)	sl0046-hu-pis-asspp-hu-HU-public	1.0
Subject information and informed consent form (for publication)	sl0046-hu-pis-fr-hu-HU-public	1.0
Subject information and informed consent form (for publication)	sl0046-hu-pis-main-hu-HU-public	2.0
Subject information and informed consent form (for publication)	sl0046-hu-pis-par-hu-HU-public	2.0
Subject information and informed consent form (for publication)	sl0046-hu-pis-parfr-hu-HU-public	1.0
Subject information and informed consent form (for publication)	sl0046-hu-pis-parpp-hu-HU-public	1.0
Subject information and informed consent form (for publication)	sl0046-hu-pis-pp-hu-HU-public	1.0
Subject information and informed consent form (for publication)	sl0046-it-icf-ass-it-IT-public	3.1
Subject information and informed consent form (for publication)	sl0046-it-icf-asspp-it-IT-public	1.1
Subject information and informed consent form (for publication)	sl0046-it-icf-main-it-IT-public	3.1
Subject information and informed consent form (for publication)	sl0046-it-icf-par-it-IT-public	3.1
Subject information and informed consent form (for publication)	sl0046-it-icf-parpp-it-IT-public	1.0
Subject information and informed consent form (for publication)	sl0046-it-icf-pd-it-IT-public	2.0
Subject information and informed consent form (for publication)	sl0046-it-icf-pp-it-IT-public	1.1
Subject information and informed consent form (for publication)	sl0046-it-icf-recr-proc-public	1.0
Subject information and informed consent form (for publication)	sl0046-pl-icf-main-pl-PL-public	3.0
Subject information and informed consent form (for publication)	sl0046-pl-icf-par-pl-PL-public	3.0
Subject information and informed consent form (for publication)	sl0046-pl-icf-parpp-pl-PL-public	1.0
Subject information and informed consent form (for publication)	sl0046-pl-icf-pp-pl-PL-public	1.0
Subject information and informed consent form (for publication)	sl0046-pl-icf-proc-en-pl-PL-public	1.0
Subject information and informed consent form (for publication)	sl0046-ro-icf-main-ro-RO-public	3.1
Subject information and informed consent form (for publication)	sl0046-ru-icf-pp-ru-RU-public	1.0
Synopsis of the protocol (for publication)	sl0046-protocol-summary-blank-document-public	1.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-bg-BG	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-cs-CZ	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-da-DK	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-de-BE	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-de-DE	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-el-GR	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-EN	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-es-ES	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-fr-BE	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-fr-FR	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-hu-HU	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-it-IT	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-nl-BE	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-pl-PL	3.0
Synopsis of the protocol (for publication)	SL0046-protocol-summary-public-ro-RO	3.0

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-10-24	Denmark	Acceptable 2023-12-12	2023-12-13
2	SUBSTANTIAL MODIFICATION	SM-1	2024-02-16	Denmark	Acceptable 2024-05-28	2024-05-28
3	NON SUBSTANTIAL MODIFICATION	NSM-1	2024-06-10		Acceptable 2024-05-28	2024-06-10
4	NON SUBSTANTIAL MODIFICATION	NSM-4	2024-06-17		Acceptable 2024-05-28	2024-06-17
5	SUBSTANTIAL MODIFICATION	SM-3	2024-09-18		Acceptable	2024-10-15
6	SUBSTANTIAL MODIFICATION	SM-4	2025-02-21	Denmark	Acceptable 2025-04-22	2025-04-22
7	SUBSEQUENT ADDITION OF MSC	APP-7	2025-07-01		Acceptable 2025-04-22	2025-09-04
8	SUBSTANTIAL MODIFICATION	SM-5	2025-07-04		Acceptable	2025-08-18
9	SUBSTANTIAL MODIFICATION	SM-6	2025-08-12	Denmark	Acceptable	2025-08-27
10	SUBSTANTIAL MODIFICATION	SM-10	2025-08-14		Acceptable	2025-09-23
11	SUBSTANTIAL MODIFICATION	SM-8	2025-09-03		Acceptable	2025-11-17
12	SUBSTANTIAL MODIFICATION	SM-11	2025-09-04		Acceptable	2025-10-20
13	SUBSTANTIAL MODIFICATION	SM-7	2025-09-12		Acceptable	2025-10-27
14	SUBSTANTIAL MODIFICATION	SM-9	2025-09-12		Acceptable	2025-09-29