Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
580
Countries
18
Sites
103
Primary Sjögren’s Disease
To evaluate the efficacy of efgartigimod PH20 SC compared with placebo PH20 SC on systemic disease activity as measured by clinESSDAI.
Key facts
- Sponsor
- Argenx
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 15 Apr 2025 → ongoing
- Decision date (initial)
- 2025-03-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- argenx BV
External identifiers
- EU CT number
- 2024-516609-22-00
- ClinicalTrials.gov
- NCT06684847
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacodynamic, Others, Pharmacokinetic, Pharmacogenomic, Efficacy
To evaluate the efficacy of efgartigimod PH20 SC compared with placebo PH20 SC on systemic disease activity as measured by clinESSDAI.
Secondary objectives 1
- To evaluate the efficacy of efgartigimod PH20 SC compared with placebo PH20 SC on systemic disease activity (clinESSDAI/ESSDAI), on a composite measure (STAR), and on symptom severity (DiSSA, a PRO measure).
Conditions and MedDRA coding
Primary Sjögren’s Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10042846 | Syndrome Sjogren's | 10028395 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Double Blind Treatment Period Participants receive either efgartigimod or placebo (1:1 randomization) for 48 weeks
|
Randomised Controlled | Double | [{"id":181341,"code":4,"name":"Analyst"},{"id":181342,"code":3,"name":"Monitor"},{"id":181340,"code":5,"name":"Carer"},{"id":181343,"code":1,"name":"Subject"},{"id":181339,"code":2,"name":"Investigator"}] | Efgartigimod PH20 SC arm: Participants will receive efgartigimod PH20 SC Placebo PH20 SC arm: Participants will receive placebo PH20 SC |
| 2 | Open Label Treatment Period Participants receive efgartigimod for 48 weeks.
|
Not Applicable | None | Efgartigimod PH20 SC arm: Participants will receive efgartigimod PH20 SC |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
- Meets the following criteria at screening: ACR/EULAR classification criteria 2016 pSjD; clinESSDAI ≥ 6; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)
Exclusion criteria 5
- Secondary (also referred to as associated) Sjögren’s disease, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy).
- Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening.
- Any severe systemic pSjD manifestation that is not adequately controlled at screening or baseline that may put the participant at undue risk based on the investigator’s opinion.
- Use of cyclophosphamide ≤ 24 weeks prior to screening
- Anti-CD20 or anti-CD19 antibody received < 6 months before screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline in clinESSDAI score at week 48
Secondary endpoints 8
- Change from baseline in ESSDAI score at week 48
- Proportion of participants with low disease activity (clinESSDAI < 5) at week 48
- Proportion of responders on STAR (defined as ≥ 5 points) at week 48
- Change from baseline in DiSSA joint pain item at week 48
- Change from baseline in DiSSA total score at week 48
- Change from baseline in DiSSA sicca domain at week 48
- Proportion of participants with MCII (minimal clinically important improvement) in ESSDAI (defined as improvement of ≥ 3 points) at week 48
- Change from baseline in clinESSDAI score at week 24
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Vyvgart 1 000 mg solution for injection in pre-filled syringe
PRD12092966 · Product
- Active substance
- Efgartigimod Alfa
- Substance synonyms
- IMMUNOGLOBULIN G1, ANTI-(FCRN RECEPTOR) (HUMAN MONOCLONAL ARGX-113 FC FRAGMENT), ARGX-113
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 95000 mg milligram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA58 — -
- Marketing authorisation
- EU/1/22/1674/003
- MA holder
- ARGENX BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
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
Argenx
- Sponsor organisation
- Argenx
- Address
- Industriepark-Zwijnaarde 7
- City
- Gent
- Postcode
- 9052
- Country
- Belgium
Scientific contact point
- Organisation
- Argenx
- Contact name
- Vice President Clinical Development
Public contact point
- Organisation
- Argenx
- Contact name
- Chief Scientific Officer
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Sjoegren'S Foundation Inc. ORG-100049042
|
Reston, United States | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Highland Heights, United States | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Interactive response technologies (IRT), Code 5, Data management, Code 8, Code 9 |
| Iqvia Laboratories Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| IQVIA RDS Hellas Single Member S.A. ORG-100048380
|
Chalandri, Greece | On site monitoring, Code 12 |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
Locations
18 EU/EEA countries · 103 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 5 | 1 |
| Belgium | Ongoing, recruitment ended | 11 | 6 |
| Bulgaria | Ongoing, recruitment ended | 8 | 4 |
| Estonia | Ongoing, recruitment ended | 12 | 3 |
| France | Ongoing, recruitment ended | 6 | 5 |
| Germany | Ongoing, recruitment ended | 18 | 5 |
| Greece | Ended | 6 | 5 |
| Hungary | Ongoing, recruitment ended | 15 | 5 |
| Ireland | Ended | 6 | 2 |
| Italy | Ongoing, recruitment ended | 5 | 3 |
| Lithuania | Ongoing, recruitment ended | 20 | 3 |
| Netherlands | Ended | 8 | 2 |
| Poland | Ongoing, recruitment ended | 63 | 33 |
| Portugal | Ongoing, recruitment ended | 6 | 5 |
| Romania | Ongoing, recruitment ended | 18 | 3 |
| Slovakia | Ongoing, recruitment ended | 16 | 5 |
| Spain | Ongoing, recruitment ended | 20 | 12 |
| Sweden | Ongoing, recruitment ended | 5 | 1 |
| Rest of world
Lebanon, Georgia, Philippines, Saudi Arabia, Jordan, Colombia, Korea, Republic of, Peru, Mexico, United Kingdom, Japan, Tunisia, Chile, Serbia, United States, Argentina, China, Israel, Canada, Australia
|
— | 332 | — |
Investigational sites
Universitair Ziekenhuis Gent
Rheumatology, Corneel Heymanslaan 10, 9000, Gent
Reumaclinic
Rheumatology private practice, Jaarbeurslaan 21/22, 3600, Genk
Universitair Ziekenhuis Antwerpen
Immunology, Allergology, Rheumatology, Drie Eikenstraat 655, 2650, Edegem
UZ Leuven
Rheumatology, Herestraat 49, 3000, Leuven
Hopital Erasme
Rheumatology, Lennikse Baan 808, 1070, Anderlecht
CHU Saint Pierre
Rheumatology, Hoogstraat 322, 1000, Brussels
Diagnostic-Consultative Center Alexandrovska EOOD
N/A, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Medical Center Artmed Ltd.
N/A, Ulitsa Mladost 8, 4002, Plovdiv
MBAL Dr. Ivan Seliminski - Sliven AD
Department of Internal Diseases, Bulevard Hristo Botev 1, 8801, Sliven
University Multiprofile Hospital For Active Treatment Pulmed Ltd.
Department of Rheumatology, Ulitsa Perushtitsa 1a, 4002, Plovdiv
Center for Clinical and Basic Research AS
N/A, J. Parna Tn 4, Kesklinna Linnaosa, Tallinn
Innomedica OÜ
N/A, Narva Mnt 7, Kesklinna Linnaosa, Tallinn
MediTrials OÜ
N/A, Moisavahe Tn 34c, 50708, Tartu Linn
Hospital Edouard Herriot
Médecine Interne, 5 Place D Arsonval, 69437, Lyon Cedex 03
Assistance Publique Hopitaux De Paris
Médecine Interne, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Centre Hospitalier Universitaire D Orleans
Ostéodensitométrie - IPROS, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Assistance Publique Hopitaux De Paris
Médecine Interne, 2 Rue Ambroise Pare, 75010, Paris
Hopital Saint Joseph
Service de Médecine Interne, 26 Boulevard De Louvain, 13008, Marseille
Medical Center - University Of Freiburg
Klinik für Rheumatologie und Klinische Immunologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Klinikum der Universitaet Muenchen AöR
Sektion Rheumatologie und klinische Immunologie – Studienambulanz, Pettenkoferstrasse 8a, Ludwigsvorstadt-Isarvorstadt, Munich
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
HRF II - Hamburger Rheuma Forschungszentrum II, Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg
Medizinische Hochschule Hannover
Klinik für Neurologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Tuebingen AöR
Innere Medizin II - Rheumatologie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
General Hospital Of Thessaloniki Papageorgiou
Rheumatology Unit, 1st Clinic of Internal medicine, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
Athens Euroclinic S.A.
Department of Internal Medicine and Autoimmune Diseases, Athanassiadou 7-9, 115 21, Athens
Laiko General Hospital Of Athens
Department of Pathophysiology, Agiou Thoma (goudi) 17, 115 27, Athens
Athens Naval Hospital
Rheumatology Clinic, Dinokratous 70, 115 21, Athens
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
D’ Internal Medicine Clinic, Rimini 1, 124 61, Chaidari
Bekes Varmegyei Koezponti Korhaz
Infektológia és Hepatológia, Semmelweis Utca 1, 5700, Gyula
University Of Pecs
Reumatológiai és Immunológiai Klinika, Akac Utca 1, 7632, Pecs
University Of Debrecen
Belgyógyászati Klinika, C épület, Moricz Zsigmond Korut 22, 4032, Debrecen
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Belgyógyászat - Immunológia, Albert Florian Ut 5-7, 1097, Budapest IX
Vita Verum Medical Bt.
NA, Fiskalis Ut 43, 8000, Szekesfehervar
St Vincent's University Hospital
Rheumatology, Elm Park Merrion Road, D04 T6F4, Dublin 4
Connolly Hospital
Rheumatology, Mill Road, D15 X40D, Dublin 15
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
UOC di Reumatologia e Immunologia Clinica, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero Universitaria Pisana
UO di Reumatologia, Via Roma 67, 56126, Pisa
Universita' Campus Bio-medico Di Roma
UOC Immunoreumatologia, Via Alvaro Del Portillo 200, 00128, Rome
Respublikine Siauliu ligonine VšĮ
Department of Internal Medicine, V. Kudirkos G. 99, Siauliu M. Sav., Siauliai
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Center for Rheumatology, Santariskiu G 2, Vilniaus M. Sav., Vilnius
Inlita UAB
Santaros KTC, Santariskiu G. 5, Vilniaus M. Sav., Vilnius
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Dep of Rheumatology and Clinical Immunology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Universitair Medisch Centrum Groningen
Dep of Rheumatology and Clinical Immunology, Hanzeplein 1, 9713 GZ, Groningen
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Bydgoszcz, Ul. Jana Karola Chodkiewicza 19c, 85-065, Bydgoszcz
Malopolskie Badania Kliniczne Sp. z o.o.
Małopolskie Badania Kliniczne, Ul. Pradnicka 12/502, 30-002, Cracow
Termedia Sp. z o.o.
NSZOZ "Termedica" Centrum Badań Klinicznych, Ul. Boleslawa Chrobrego 101, 60-681, Poznan
REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n.med. Jakub Trefler
N/A, ul. Hetmańska 27/26, 04-305, Warszawa
Futuremeds Sp. z o.o.
FutureMeds Łódź, Ul. Gruszowa 2, 91-363, Lodz
Umed Clinical Trials Sp. z o.o.
N/A, Bud A-2, Ul. Pomorska 251, Lodz
Futuremeds Sp. z o.o.
FutureMeds Gdynia, Ul. Wladyslawa IV 59, 81-384, Gdynia
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak
N/A, Ul. Daleka 32, 05-825, Grodzisk Mazowiecki
Ambulatorium Sp. z o.o.
N/A, Ul. Topolowa 28, 82-300, Elblag
Futuremeds Sp. z o.o.
FutureMeds Wrocław, Ul. Legnicka 16, 53-673, Wroclaw
Mtz Clinical Research Powered By Pratia
N/A, Ul. Gładka 22, 02-172, Warsaw
Futuremeds Sp. z o.o.
Krakowskie Centrum Medyczne, Ul. Mikolaja Kopernika 32, 31-501, Cracow
Clinical Research Center Sp. z o.o. Medic-R sp.k.
N/A, Ul. Feliksa Nowowiejskiego 5, 61-731, Poznan
Klinika Reuma Park Sp. z o.o. S.K.
Centrum Medyczne Reuma Park, Aleja Wilanowska 333, 02-665, Warsaw
Pro Life Medica Sp. z o.o.
Pro Life Medica Sp. z o.o ETG Lublin, Ul. Wladyslawa Kunickiego 26a, 20-412, Lublin
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
N/A, Ul. Tadeusza Szafrana 5d / U2-U5, 30-363, Cracow
Somed Cr Sp. z o.o. sp.k.
Somed CR, Aleja Marszalka Jozefa Pilsudskiego 9, 90-368, Lodz
K2J2 Centrum Medyczne
N/A, ul Gdynska 1/3, 05-200, Wolomin
Lukmed 2 Sp. z o.o.
Lukmed 2 Sp. z o.o. ETG Siedlce, Ul. Mlynarska 16 B, 08-110, Siedlce
Reumed Sp. z o.o.
Zespół Poradni Specjalistycznych, REUMED, Filia nr 1 Wallenroda, Ul. Konrada Wallenroda 2f/4, 20-607, Lublin
K2J2 Sp. z o.o.
Centrum Medyczne K2J2, Ul. Drogowcow 12, 42-202, Czestochowa
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Warszawa, Ul Wronia 53 Lok B 10, 00-874, Warsaw
Centrum Medyczne Intercor Sp. z o.o.
N/A, Ul. Kasztanowa 57, 85-605, Bydgoszcz
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.
Nova Reuma, Ul Prowiantowa 15/4, 15-707, Bialystok
Provita Centrum Medyczne Sp. z o.o.
Provita Profamilia, Ul. Kostromska 66a, 97-300, Piotrkow Trybunalski
Pro Life Medica Sp. z o.o.
ETG Zamość, Ul. Gesia 3, 22-400, Zamosc
Pratia S.A.
Pratia Poznań, Ul. Gryfinska 1, 60-192, Poznan
Pratia S.A.
Centrum Medyczne Pratia Katowice, Ul. Dabrowki 13, 40-081, Katowice
Centrum Medyczne Justmed Sp. z o.o.
Centrum Medyczne JustMed ETG JustMed, Ul. Marymoncka 14/ U1 U2, 01-869, Warsaw
Futuremeds Sp. z o.o.
FutureMeds Targówek, Ul. Sw. Wincentego 93/7, 03-291, Warsaw
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Centrum Wsparcia Badań Klinicznych, Ul. Spartanska 1, 02-637, Warsaw
Pratia S.A.
Centrum Medyczne Pratia Częstochowa, Ul. 3 Maja 16, 42-217, Czestochowa
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Klinika Reumatologii i Układowych Chorob Tkanki Lacznej, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Unidade Local De Saude De Coimbra E.P.E.
Rheumatology, Praceta Professor Mota Pinto, 3004-561, Coimbra
Unidade Local De Saude Do Alto Minho E.P.E.
Rheumatology, Estrada De Santa Luzia, 4904-858, Viana Do Castelo
Hospital Cuf Descobertas S.A.
Rheumatology, Rua Mario Botas 1, 1998-018, Lisbon
Unidade Local De Saude De Gaia/Espinho E.P.E.
Rheumatology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Unidade Local De Saude De Santa Maria E.P.E.
Rheumatology, Avenida Professor Egas Moniz, 1649-035, Lisbon
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
Aqua-Med Consulting S.R.L.
Reumatologie, Sectia Medicala 2, Strada Iorga Nicolae Nr 20, 900612, Constanta
Delta Health Care S.R.L.
Rheumatology, Strada Caramfil G. Nicolae Nr 85a, 014142, Bucharest
Artromac N.O.
rheumatology, Toryska 275/1, Zapad, Kosice
Romjan s.r.o.
rheumatology, Udernicka 1, 851 01, Petrzalka
Albamed s.r.o.
rheumatology, Kuzmanyho Nabrezie 12, 960 01, Zvolen
Narodny Ustav Reumatickych Chorob
rheumatology, Nabrezie Ivana Krasku 4782/4, 921 01, Piestany
Medman s.r.o.
rheumatology, Thurzova 437/15, 036 01, Martin
Hospital Universitario Infanta Leonor
Internal Medicine, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Universitario De Badajoz
Rheumatology, Avenida Elvas S/n, 06006, Badajoz
Hospital Quironsalud Infanta Luisa
Rheumatology, Calle De San Jacinto 87, 41010, Sevilla
Hospital Universitario Virgen De La Macarena
Rheumatology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Araba
Internal Medicine, Jose Achotegui Kalea S/N, 01009, Vitoria
Hospital Universitario Ramon Y Cajal
Rheumatology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitari Vall D Hebron
Rheumatology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinico Universitario De Valencia
Rheumatology, Avenida Blasco Ibanez 17, 46010, Valencia
Clinica Gaias Santiago
Rheumatology, Rua Do Pintor Xaime Quesada N 2-4, 15702, Santiago De Compostela
Sanitas S.A. De Hospitales
Internal Medicine, Passeig De Manuel Girona 33, 08034, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Rheumatology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Complexo Hospitalario Universitario A Coruna
Rheumatology, Lugar Jubias De Arriba 84, 15006, A Coruna
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-04-30 | 2026-03-27 | 2026-01-28 | 2026-03-27 | |
| Belgium | 2025-05-14 | 2025-09-29 | 2026-03-27 | ||
| Bulgaria | 2025-04-28 | 2025-06-04 | 2026-03-27 | ||
| Estonia | 2025-04-24 | 2025-04-28 | 2026-03-27 | ||
| France | 2025-04-29 | 2025-06-11 | 2026-03-27 | ||
| Germany | 2025-05-28 | 2025-06-06 | 2026-03-27 | ||
| Greece | 2025-07-29 | 2026-03-27 | 2025-11-03 | 2026-03-27 | |
| Hungary | 2025-04-29 | 2025-05-22 | 2026-03-27 | ||
| Ireland | 2025-06-06 | 2026-03-27 | |||
| Italy | 2025-06-19 | 2025-11-06 | 2026-03-27 | ||
| Lithuania | 2025-04-17 | 2025-04-23 | 2026-03-27 | ||
| Netherlands | 2025-05-09 | 2026-03-27 | 2025-12-29 | 2026-03-27 | |
| Poland | 2025-04-25 | 2025-05-07 | 2026-03-27 | ||
| Portugal | 2025-08-13 | 2025-10-30 | 2026-03-27 | ||
| Romania | 2025-04-15 | 2025-05-04 | 2026-03-27 | ||
| Slovakia | 2025-04-30 | 2025-06-02 | 2026-03-27 | ||
| Spain | 2025-05-06 | 2025-05-20 | 2026-03-27 | ||
| Sweden | 2025-04-29 | 2025-08-28 | 2026-03-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 335 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-516609-22-00_redacted | 4.0 |
| Protocol (for publication) | D1_Protocol_GR_2024-516609-22-00_redacted | 4.0 |
| Protocol (for publication) | D4_Patient Questionnaire Statement CTIS_2024-516609-22_public | n/a |
| Protocol (for publication) | D5_Study design_Justification of collection of ethnic_2024-516609-22_redacted | n/a |
| Recruitment arrangements (for publication) | K0_ Argenx_UNITY_Cover Letter_Bulgaria_BG_Part II_san | N/A |
| Recruitment arrangements (for publication) | K0_Cover Letter_Bulgaria_SM-5_Part II_red-san | N/A |
| Recruitment arrangements (for publication) | K1_1_ ARGX-113-2306_Patient consent recruitment process form_eng_san | N/A |
| Recruitment arrangements (for publication) | K1_2_ ARGX-113-2306_Patient consent recruitment process form_bg_san | N/A |
| Recruitment arrangements (for publication) | K1_2024-516609-22_Recruitment Arrangements | V2-0FRA1-0 |
| Recruitment arrangements (for publication) | K1_ARGX-113-2306_Patient consent recruitment process form_ITALY | 2.2 |
| Recruitment arrangements (for publication) | K1_ARGX-113-2306_Patient consent recruitment process form_NLD_san | 2.2 |
| Recruitment arrangements (for publication) | K1_Dr-to-Patient Letter_san | V01DEUde01 |
| Recruitment arrangements (for publication) | K1_Online Adv_Social Media_Clin Trial Posts_san | V01DEUde |
| Recruitment arrangements (for publication) | K1_Online Advertisements_Banner Ads | V01HUNhu01 |
| Recruitment arrangements (for publication) | K1_Online Advertisements_Banner Ads_san | V01 DEUde |
| Recruitment arrangements (for publication) | K1_Patient Advocacy Group Letter | V01HUN01 |
| Recruitment arrangements (for publication) | K1_Patient Advocacy Group Letter_san | V01DEUde01 |
| Recruitment arrangements (for publication) | K1_Patient Brochure_red-san | V01 DEUde |
| Recruitment arrangements (for publication) | K1_Patient Brochure_redacted | V01HUNhu01 |
| Recruitment arrangements (for publication) | K1_Patient consent recruitment process form | 2.1 |
| Recruitment arrangements (for publication) | K1_Patient Poster | V01HUNhu01 |
| Recruitment arrangements (for publication) | K1_Patient Poster_san | V01 DEUde |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_san | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | V2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | V2.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Final_IRL_san | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment and Informed consent procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | V1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 1.0 |
| Recruitment arrangements (for publication) | K1_SWE_Recruitment arrangements | V1.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Dr_to_Patient Letter | V01SVK(sk) |
| Recruitment arrangements (for publication) | K2_ SWE_Patient Poster | V01SWE |
| Recruitment arrangements (for publication) | K2_1_ UNITY_Dr-to-Patient Letter_bg | V01BGR(bg) |
| Recruitment arrangements (for publication) | K2_10_UNITY_Patient Pre-screening Website Content_san | V01BGR(bg) |
| Recruitment arrangements (for publication) | K2_11_UNITY_ePR Participant Journey Emails_san | V01BGR(bg) |
| Recruitment arrangements (for publication) | K2_2_ UNITY_Online Advertisements_Banner Ads_bg | V01BGR(bg) |
| Recruitment arrangements (for publication) | K2_2024-516609-22_Recruitment Material_Dr-to-Patient Letter | V01FRAfr02 |
| Recruitment arrangements (for publication) | K2_2024-516609-22_Recruitment Material_Patient Advocacy Group Letter | V01FRAfr01 |
| Recruitment arrangements (for publication) | K2_2024-516609-22_Recruitment Material_Patient Brochure_red | V01FRAfr01 |
| Recruitment arrangements (for publication) | K2_2024-516609-22_Recruitment Material_Patient Poster | V01FRAfr |
| Recruitment arrangements (for publication) | K2_2024-516609-22_Recruitment Material_Physician Referral Brochure_red | V01FRAfr |
| Recruitment arrangements (for publication) | K2_2024-516609-22_Recruitment Material_Physician Referral Letter_red | V01FRAfr02 |
| Recruitment arrangements (for publication) | K2_2024-516609-22_Recruitment Material_Study information slides_red | V01Global |
| Recruitment arrangements (for publication) | K2_2024-516609-22_Recruitment Material_Talking points guide_red | V01Global |
| Recruitment arrangements (for publication) | K2_3_ UNITY_Online Advertisements_Social Media_Clinical Trial Posts_bg | V01BGR(bg) |
| Recruitment arrangements (for publication) | K2_4_ UNITY_Patient Advocacy Group Letter_bg | V01BGR(bg) |
| Recruitment arrangements (for publication) | K2_5_ UNITY_Patient Brochure_bg_red-san | V01BGR(bg) |
| Recruitment arrangements (for publication) | K2_6_ UNITY_Patient Poster_bg | V01BGR(bg) |
| Recruitment arrangements (for publication) | K2_7_ UNITY_Physician Referral Brochure_bg_red-san | V01BGR(bg) |
| Recruitment arrangements (for publication) | K2_8_ UNITY_Physician Referral Letter_bg_red-san | V01BGR(bg) |
| Recruitment arrangements (for publication) | K2_9_ UNITY_Study Information Slides_eng_red-san | V01 |
| Recruitment arrangements (for publication) | K2_ARGX-113-2306_Doctor to Patient Letter_NLD_san | V01NLD02 |
| Recruitment arrangements (for publication) | K2_ARGX-113-2306_Online Advertisements_Banner Ads_NLD_san | V01NLD |
| Recruitment arrangements (for publication) | K2_ARGX-113-2306_Online Advertisements_Social Media_Clinical Trial Posts_NLD_san | V01NLD01 |
| Recruitment arrangements (for publication) | K2_ARGX-113-2306_Participant Journey Emails_NLD | V01NLD(nl) |
| Recruitment arrangements (for publication) | K2_ARGX-113-2306_Patient Advocacy Group Letter_NLD_san | V01NLD02 |
| Recruitment arrangements (for publication) | K2_ARGX-113-2306_Patient Brochure_NLD_red-san | V01NLD01 |
| Recruitment arrangements (for publication) | K2_ARGX-113-2306_Patient Poster_NLD_san | V01NLD |
| Recruitment arrangements (for publication) | K2_ARGX-113-2306_Patient Pre-screening Website Content_NLD | V01NLD(nl) |
| Recruitment arrangements (for publication) | K2_Dr-to-Patient Letter | 01 |
| Recruitment arrangements (for publication) | K2_Patient advertisement_UNITY_Banner Ads | V01 ITA |
| Recruitment arrangements (for publication) | K2_Patient advertisement_UNITY_Dr-to-Patient Letter | V01ITA01 |
| Recruitment arrangements (for publication) | K2_Patient advertisement_UNITY_ePR Participant Journey Emails | V01 ITA |
| Recruitment arrangements (for publication) | K2_Patient advertisement_UNITY_Patient Advocacy Group Letter | V01ITA01 |
| Recruitment arrangements (for publication) | K2_Patient advertisement_UNITY_Patient Brochure_red | V01 ITA |
| Recruitment arrangements (for publication) | K2_Patient advertisement_UNITY_Patient Poster | V01 ITA |
| Recruitment arrangements (for publication) | K2_Patient advertisement_UNITY_Patient Pre-screening Website Content | V01 ITA |
| Recruitment arrangements (for publication) | K2_Patient advertisement_UNITY_Social Media_Clinial Trial Posts | V01 ITA |
| Recruitment arrangements (for publication) | K2_Patient Advocacy Group Letter | 01 |
| Recruitment arrangements (for publication) | K2_Patient Brochure_Redacted | 01 |
| Recruitment arrangements (for publication) | K2_Patient Poster | 01 |
| Recruitment arrangements (for publication) | K2_Physician Referral Brochure_redacted | V01HUNhu01 |
| Recruitment arrangements (for publication) | K2_Physician Referral Letter_redacted | V01HUNhu01 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Advocacy Group Letter | V01SVK(sk) |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Brochure_redacted | V01SVK(sk) |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Poster | V01SVK(sk) |
| Recruitment arrangements (for publication) | K2_Recruitment Material__Patient Brochure_V01 IRL (en)01_redacted | V01 IRL 01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material__Patient Poster_V01 IRL | V01 IRL |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Banner Ads_V01 IRL en | V01 IRL en |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner Advertisement_lt | V01 LTU01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner Advertisements_EN | V01GBR |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner Advertisements_FR | V01BEL |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner Advertisements_NL | V01BEL |
| Recruitment arrangements (for publication) | K2_Recruitment material_Doctor-to-Patient Letter_lt | V01 LTU02 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr to Patient letter_ES | V01ESPes01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Dr to Patient Letter_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Dr-to-Patient Letter_EN | V01ROW(en) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr-to-Patient Letter_EN | V01GBR01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr-to-Patient Letter_et | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr-to-Patient Letter_FR | V01BEL01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr-to-Patient Letter_NL | V01BEL01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Dr-to-Patient Letter_RO | V01ROM(ro) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr-to-Patient Letter_ru | 01 |
| Recruitment arrangements (for publication) | K2_recruitment material_Dr-to-Patient Letter_san | V01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Dr-to-Patient Letter_V01 IRL(en)02 | V01 IRL 02 |
| Recruitment arrangements (for publication) | K2_Recruitment material_DTP Participant Journey Email Communications_lt | V01LTU01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ePR Participant Journey Emails | 1ESP(es) |
| Recruitment arrangements (for publication) | K2_recruitment material_ePR Participant Journey Emails_san | V01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_ePR Participant Journey Emails_san | V01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_GenericDeviceLabel_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Online Advertisements_Banner Ads_ES | V01ESP(es) |
| Recruitment arrangements (for publication) | K2_recruitment material_Online Advertisements_Banner Ads_san | V01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Online Advertisements_Banner Ads_san | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Online Advertisements_Social Media_Clinical Trial Posts_san | V01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Online Advertisements_Social Media_Clinical Trial Posts_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Online Advertisements_Social Media_ES | V01 ESPes |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Only Tables | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Journey Email Commmunications_EN | V01BEL(en) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Journey Email Commmunications_FR | V01BEL(fr) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Journey Email Commmunications_NL | V01BEL(nl) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Advocacy Group Letter_EN | V01ROW(en) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Advocacy Group Letter_EN | V01GBR01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Advocacy Group Letter_ES | V01ESPes01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Advocacy Group Letter_FR | V01BEL01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Advocacy Group Letter_lt | V01 LTU02 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Advocacy Group Letter_NL | V01BEL01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Advocacy Group Letter_RO | V01ROM(ro) |
| Recruitment arrangements (for publication) | K2_recruitment material_Patient Advocacy Group Letter_san | V01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Advocacy Group Letter_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Advocacy Group Letter_V01 IRL | V01 IRL |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Brochure_EN_redacted | V01ROW(en) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_EN_redacted | V01GBR |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_ES_red | V01ESP(es) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_et_redacted | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_FR_redacted | V01BEL |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_lt_redacted | V01 LTU01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_NL_redacted | V01BEL |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Brochure_red-san | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_Patient Brochure_redacted | V01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Brochure_RO_redacted | V01ROM(ro) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_ru_redacted | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Poster_EN | V01ROW(en) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_EN | V01GBR |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient poster_ES | V01ESP(es) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_et | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_FR | V01BEL |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_lt | V01 LTU01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_NL | V01BEL |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Poster_RO | V01ROM(ro) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_ru | 01 |
| Recruitment arrangements (for publication) | K2_recruitment material_Patient Poster_san | V01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Poster_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Pre-screener Website Content_lt | V01LTU02 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Pre-screening Website Content | 1ESP(es) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Pre-screening Website content_EN | V01BEL(en) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Pre-screening Website content_FR | V01BEL(fr) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Pre-screening Website content_NL | V01BEL(nl) |
| Recruitment arrangements (for publication) | K2_recruitment material_Patient Pre-screening Website Content_san | V01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Pre-screening Website Content_san | V01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PFS instruction video screenshots_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_PFS instruction video script_san | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Brochure_EN_redacted | V01GBR |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Brochure_FR_redacted | V01BEL |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Brochure_NL_redacted | V01BEL |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter_EN_redacted | V01GBR01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter_FR_redacted | V01BEL01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter_NL_redacted | V01BEL01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Posts_V01 IRL en | V01 IRL en |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Preparation and Administration Site Staff and Nurse_san | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Advertisements and clinical trial posts for sites_lt | V01LTU01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Hub_Unity_Strategy Supporting Document for Regulatory Submission_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Information Slides_EN_redacted | V01Global |
| Recruitment arrangements (for publication) | K2_Recruitment material_Talking Points Guide_EN_redacted | V01Global |
| Recruitment arrangements (for publication) | K2_Recruitment Material_UNITY_Chart Review Checklist_san-red | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_UNITY_Dr-to-Patient Letter_san | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_UNITY_Eligibility Criteria Booklet_san-red | V01 Global |
| Recruitment arrangements (for publication) | K2_Recruitment Material_UNITY_Investigator Welcome Letter_san | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_UNITY_Mini Protocol Cover_san | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_UNITY_Patient Advocacy Group Letter_san | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_UNITY_Patient Brochure_san-red | V01PRT(pt) |
| Recruitment arrangements (for publication) | K2_Recruitment Material_UNITY_Physician Referral Brochure_san-red | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_UNITY_Physician Referral Letter_san-red | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_UNITY_Study Information Slides_san-red | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Visit_Selection_san | NA |
| Recruitment arrangements (for publication) | K2_SWE_Recruitment material_Banner Advertisement | V01SWE(sv) |
| Recruitment arrangements (for publication) | K2_SWE_Recruitment material_Dr-to-Patient Letter | V01SWE(sv) |
| Recruitment arrangements (for publication) | K2_SWE_Recruitment material_Online Advertisements_Social Media | V01SWE(sv) |
| Recruitment arrangements (for publication) | K2_SWE_Recruitment material_Participant Journey Emails | V01SWE(sv) |
| Recruitment arrangements (for publication) | K2_SWE_Recruitment Material_Patient Advocacy Group Letter | V01SWE(sv) |
| Recruitment arrangements (for publication) | K2_SWE_Recruitment material_Patient Brochure_redacted | V01SWE(sv) |
| Recruitment arrangements (for publication) | K2_SWE_Recruitment material_Patient Pre-screening Website Content | 1 |
| Subject information and informed consent form (for publication) | L1_1_ ARGX-113-2306_Main Master ICF_clean_for Bulgaria_red-san | 4.1 |
| Subject information and informed consent form (for publication) | L1_2_ ARGX-113-2306_Main ICF for Bulgaria_EN_clean_red-san | 1.0 |
| Subject information and informed consent form (for publication) | L1_2024-516609-22_Greenphire Notice | V1-0FRA1-0 |
| Subject information and informed consent form (for publication) | L1_2024-516609-22_lCF_Main_red | V4.1FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-516609-22_lCF_PGx | V1.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2024-516609-22_lCF_Pregnancy | V1.0FRA3.0 |
| Subject information and informed consent form (for publication) | L1_3_ ARGX-113-2306_Bulgarian Main ICF_bg_red-san | V4.1BGR1.0 |
| Subject information and informed consent form (for publication) | L1_ARGX-113-2306_Main ICF_NLD_red-san | V4.1NLD1.0 |
| Subject information and informed consent form (for publication) | L1_ARGX-113-2306_Main ICF_san_red | V4.1ITA1.0 |
| Subject information and informed consent form (for publication) | L1_ARGX-113-2306_Pregnancy ICF_NLD | V1.0NLD4.0 |
| Subject information and informed consent form (for publication) | L1_FSR ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_FSR ICF_red-san | V1.0DEUde1 |
| Subject information and informed consent form (for publication) | L1_Genetic research ICF_red-san | V1.0DEUde2 |
| Subject information and informed consent form (for publication) | L1_Greenphire ICF | V10.1 |
| Subject information and informed consent form (for publication) | L1_Greenphire ICF_red-san | V1.0DEUde1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_red-san | 4.1DE(de)1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_PGx CF | 1.0 |
| Subject information and informed consent form (for publication) | L1_PGx PIS | 1.0 |
| Subject information and informed consent form (for publication) | L1_Pregnancy ICF_clean_san | 4DEU(de)1 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_tc_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_FSR_en_v1_01Oct2024 | V1.0ROM1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_FSR_ro_v1_01Oct2024 | V1.0ROM1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_en_redacted | V4.1ROM1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_ro_redacted | V4.1ROM1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_PGx_en_v1_01Oct2024 | V1.0ROM1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_PGx_ro_v1_01Oct2024 | V1.0ROM1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_PK_en_v2_01Oct2024 | V2.0ROM1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_PK_ro_v2_01Oct2024 | V2.0ROM1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnancy_en | V1.0ROM1.0 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnancy_ro | V1.0ROM1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and FSR ICF | V2.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Greenphire ICF | V1.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Privacy Statement | 4.1SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF FSR_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF FSR_GRC | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire_ENG | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Greenphire_GRC | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ENG_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_et_redacted | V4.1EST2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GRC_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_lt_redacted | V4.1LTU2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN_redacted | 4.1SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ru_redacted | V4.1EST2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PGX_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PGX_GRC | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_ENG | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_GRC | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Main Adult_PL_redacted | V4.1POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FSR | 1.0ESP2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FSR ICF_san | V1.0PRT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FSR_san | V1.0AUT1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Scientific Research_san | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire Consent_san | V1.0AUT1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire_san | IRE_1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_san-red | V4.1PRT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_EN_redacted | V4.1BEL3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_FR_redacted | V4.1BEL3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_NL_redacted | V4.1BEL3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_red | 4.1ESPes1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_red-san | V4.1AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_v1.2_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_v2.0_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PGx | 1ESP(es)3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PGx_san | V1.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pharmacogenomics ICF_san | V1.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pharmacogenomics Research_san | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP_san | V1.0AUT1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy ICF_san | V1.0PRT3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner | V1.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_san | IRE_1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Sponsor statement_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and PGx ICF | V2.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SWE_SIS and ICF_Main ICF_redacted | V4.1SWE1.0 |
| Subject information and informed consent form (for publication) | L2_1_ ARG-113-2306_PP_Global_ICF_clean_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_2_ ARGX-113-2306_PP ICF for Bulgaria_EN_clean_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_2024-516609-22_Patient ID Card | V01FRAfr |
| Subject information and informed consent form (for publication) | L2_3_ ARGX-113-2306_Bulgarian PP ICF_bg_san | V1.0BGR1.0 |
| Subject information and informed consent form (for publication) | L2_ARGX-113-2306_Privacy ICF_Final_ITA_san | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L2_IP Preparation and Administration Log_Participant and Caregiver_hu_san | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bank Transfer FAQ_san | V10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bank Transfer Standard Message_san | V10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Contact Card_san | V10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Reference Guide for Participants_san | V10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Instructions for Use_san | V3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Main Menu Screenshot_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Preparation and Administration for OLE_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Preparation and Administration_san | V3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Hub_R160_Mobile View_san | V1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Hub_Unity_ Setup Participant Instructions_san-red | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Hub_Unity_Participant Tip Sheet_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Training_san | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_UNITY_Employer Letter_san | 01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_UNITY_Patient ID Card_san | 01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_UNITY_Patient Poster_san | V01PRT(pt) |
| Subject information and informed consent form (for publication) | L2_Other subject information material_UNITY_Patient Study Guide_san-red | 01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_UNITY_Visit Reminder Card_san | V01PRT(pt) |
| Subject information and informed consent form (for publication) | L2_SWE_SIS and ICF_Optional Future Scientific Research | V1.0SWE2.0 |
| Subject information and informed consent form (for publication) | L2_SWE_SIS and ICF_Optional Gene Expression Analysis | V1.0SWE2.0 |
| Subject information and informed consent form (for publication) | L2_UNITY ePR Participant Journey Emails_hu_san | 01 |
| Subject information and informed consent form (for publication) | L2_UNITY Patient Pre-screening Website Content_hu_san | 01 |
| Subject information and informed consent form (for publication) | L2_UNITY_Informational Video for Study Hub_hu_redacted_san | 01 |
| Subject information and informed consent form (for publication) | L2_UNITY_Patient Appreciation Items_en_san | 01 |
| Subject information and informed consent form (for publication) | L2_UNITY_Patient ID Card | V01HUNhu01 |
| Subject information and informed consent form (for publication) | L2_UNITY_Sjogrens Awareness_Study Hub Infographic_hu_san | 01 |
| Subject information and informed consent form (for publication) | L2_UNITY_Study Hub Article_Caffeine Alternatives_hu_san | 01 |
| Subject information and informed consent form (for publication) | L2_UNITY_Study Hub Article_Dealing with Stress_hu_san | 01 |
| Subject information and informed consent form (for publication) | L2_UNITY_Study Hub Article_Planning a Vacation_hu_san | 01 |
| Subject information and informed consent form (for publication) | L2_UNITY_Study Hub Article_Self Care_hu_san | 01 |
| Subject information and informed consent form (for publication) | L2_UNITY_Yoga_Meditation_Animation Video_Storyboard_hu_san | 01 |
| Subject information and informed consent form (for publication) | L3_ UNITY_Patient ID Card_BGR bg | V01BGR(bg) |
| Subject information and informed consent form (for publication) | L3_Appendix 1_1_IP Prep and Admin log Participant_Caregiver | 1.0 |
| Subject information and informed consent form (for publication) | L3_Appendix 1_3_IP Prep and Admin log Participant and Caregiver_OLE | V1.0 |
| Subject information and informed consent form (for publication) | L3_Appendix 4_Instructions for Use | 3.0 |
| Subject information and informed consent form (for publication) | L3_ARG-113-2306_FSR ICF_Final_ITA_san | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L3_ARGX-113-2306_Main Menu Screenshot_HU | V1.0 |
| Subject information and informed consent form (for publication) | L3_ARGX-113-2306_Training_HU | V1.0 |
| Subject information and informed consent form (for publication) | L3_Employer Letter | V01HUNhu01 |
| Subject information and informed consent form (for publication) | L3_GenericDeviceLabel_GDL_HUN | V1.0 |
| Subject information and informed consent form (for publication) | L3_List of modified documents_hu_en_san | 1 |
| Subject information and informed consent form (for publication) | L3_Patient Study Guide_redacted | V01HUN01 |
| Subject information and informed consent form (for publication) | L3_Study Hub Unity_ Participant Tip Sheet_HUN | V1.0 |
| Subject information and informed consent form (for publication) | L3_Study Hub_R16_Mobile View | V1.0 |
| Subject information and informed consent form (for publication) | L3_Study Hub_Unity_Setup Participant Instruction_redacted | V1.0 |
| Subject information and informed consent form (for publication) | L3_Visit Reminder Card | V01HUNhu |
| Subject information and informed consent form (for publication) | L4_Bank Transfer FAQ_HUN_Hungarian | V10.0 |
| Subject information and informed consent form (for publication) | L4_Bank Transfer Standard Message HUN | V10.0 |
| Subject information and informed consent form (for publication) | L4_ConneX Travel Contact Card_IC_HUN | V10.0 |
| Subject information and informed consent form (for publication) | L4_ConneX Travel Reference Guide for Participants_HUN | V10.0 |
| Subject information and informed consent form (for publication) | L5_ARGX-113-2306_PGx ICF_Final_ITA_san | V1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L5_Strategy Supporting Document for Regulatory Submission | V1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AU_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE_de_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE_fr_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE_nl_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BG_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GR_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_LT_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PT_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SE_2024-516609-22-00 | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SK_2024-516609-22-00 | 4.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-18 | Estonia | Acceptable 2025-03-24
|
2025-03-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-04 | Estonia | Acceptable 2025-03-24
|
2025-04-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-30 | Acceptable | 2025-05-23 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-08 | Acceptable | 2025-06-06 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-22 | Acceptable | 2025-07-03 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-24 | Acceptable | 2025-07-24 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-05 | Estonia | Acceptable 2025-12-01
|
2025-12-01 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-04-15 | Acceptable | 2026-05-11 |