Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
546
Countries
11
Sites
78
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
The primary objectives of the study are to evaluate the efficacy of BIIB059 compared with placebo in reducing skin disease activity measured by the (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with ac…
Key facts
- Sponsor
- Biogen Idec Research Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 2 Feb 2023 → ongoing
- Decision date (initial)
- 2025-09-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Biogen Idec Research Limited
External identifiers
- EU CT number
- 2023-505634-94-00
- EudraCT number
- 2020-000727-40
- ClinicalTrials.gov
- NCT05531565
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Others, Pharmacodynamic, Pharmacokinetic, Safety
The primary objectives of the study are to evaluate the efficacy of BIIB059 compared with placebo in reducing skin disease activity measured by the (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials.
Secondary objectives 1
- The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].
Conditions and MedDRA coding
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10056509 | Cutaneous lupus erythematosus | 100000004858 |
| 21.1 | PT | 10057903 | Subacute cutaneous lupus erythematosus | 100000004858 |
| 21.1 | PT | 10057929 | Chronic cutaneous lupus erythematosus | 100000004858 |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-504863-17-00 | A Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST LTE) | Biogen Idec Research Limited |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Histologically confirmed (in the past or during the Screening period) diagnosis of CLE with or without systemic manifestations.
- 2. Must have active cutaneous manifestations that meet study criteria.
- 3. Must have a CLASI-A score ≥10.
- 4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.
- 5. NOTE: Other protocol defined Inclusion criteria may apply.
Exclusion criteria 7
- 1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
- 3. Active severe lupus nephritis.
- 4. Active neuropsychiatric SLE.
- 5. Use of intralesional corticosteroids within 1 week prior to Screening and during the study.
- 6. Use of immunosuppressive or disease-modifying treatments for SLE or CLE [via an oral, intravenous (IV), or SC route] that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose.
- 7. NOTE: Other protocol defined Exclusion criteria may apply.
- 2. Diagnosis of mixed connective tissue disease [(within 1 year of signing the informed consent form (ICF)] or any history of overlap syndromes of SLE including concomitant presence with rheumatoid arthritis, dermatomyositis and/or polymyositis, systemic sclerosis, psoriatic arthritis, or any other autoimmune disease that may confound the evaluation of the disease activity or the effect of the investigational product. Exceptions for overlap syndrome of SLE include participants with overlap syndrome of SLE with myositis and secondary Sjögren’s syndrome at screening is permitted provided the participant also meets the criteria for classification as SLE. A past history of mixed connective tissue disease that over time has developed into a diagnosis of SLE is permitted, provided diagnosis of SLE has been present for at least 1 year.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician’s Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1. Time frame: Week 16.
- Part B (ROW): Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response, Defined as ≥ 70% Decrease in CLASI-A Score From Baseline. Time frame: baseline to Week 24.
Secondary endpoints 39
- Part A (US+ROW): Percentage of Participants who Achieve a CLASI-50 Response, Defined as a ≥ 50%Decrease in CLASI-A Score From Baseline Time frame: Weeks 16 and 24.
- Part A (US+ROW): Absolute Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score at Week 52. Time frame: Baseline to Week 52.
- Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in Full Analysis Set (FAS), who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at Baseline. Time frame: Weeks 16 and 24.
- Part B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1, at Week 16 and Week 24, Respectively, for Participants in FAS, who had CLA-IGA-R Erythema Score ≥3and OMC Score ≥3 at Baseline. Time frame: Weeks 16 and 24.
- Part B (US+ROW): Percentage of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score. Time frame: Up to Week 24.
- Part B (US+ROW): Absolute Change in CLASI-D Score. Time frame: Week 52.
- Part B (US+ROW): Percent Change in CLASI-D Score. Time frame: Week 52.
- Part B (US+ROW): Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) Score. Time frame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52.
- Part B (US+ROW): Change From Baseline in Dermatology Life Quality Index (DLQI) Score. Time frame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52.
- Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a CLASI-70 Response, Defined as a ≥ 70% Decrease in CLASI-A Score From Baseline. Time frame: Part A (US+ROW): Weeks 16 and 24; Part B (US): Week 16.
- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1. Time frame: Part A (US+ROW): Week 24; Part B (ROW): Week 24; Part B (US+ROW): Up to Week 24.
- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 or 1 and at Least 1 Level of Improvement From Baseline. Time frame: Part A (US+ROW): Weeks 16 and 24; Part B (US): Week 16; Part B (ROW): Week 24; Part B (US+ROW):Up to Week 24.
- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R OMC Score of 0. Time frame: Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24.
- Parts A and B (US+ROW): Percentage of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score. Time frame: Part A (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24.
- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLA-IGA-R Follicular Activity Score of 0. Time frame: Parts A and B (US+ROW): Weeks 16 and 24; Part B (US+ROW): Up to Week 24.
- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 or 1. Time frame: Up to Week 24.
- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI-A Score of 0 to 3. Time frame: Up to Week 24.
- Parts A and B (US+ROW): Percentage of Participants who Achieve a 70% Reduction in CLASI-A. Time frame: Up to Week 24.
- Parts A and B (US+ROW): Percentage of Participants who Achieve a 50% Reduction in CLASI-A. Time frame: Up to Week 24.
- Parts A and B (US+ROW): Percentage of Participants who Achieve a 7-Point Reduction From Baseline in CLASI-A Score. Time frame: Up to Week 24.
- Parts A and B (US+ROW): Percentage of Participants With a CLASI-70 Response at Week 52 AmongCLASI-70 Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab During the DBPC Treatment Period (TP). Time frame: Week 52.
- Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC TP. Time frame: Week 52.
- Parts A and B(US+ROW):Percentage of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1 Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Responders at Weeks 16and 24, Respectively, who Were Assigned to Receive Litifilimab in DBPC TP. Time frame: Week 52.
- Parts A and B (US+ROW): Percentage of Participants With CLA-IGA-R OMC Score of 0 at Week 52 Among CLA-IGA-R OMC Responders With CLA-IGA-R OMC Score of 0 at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Litifilimab During the DBPC TP. Time frame: Week 52.
- Parts A and B(US+ROW):Percentage of Participants With CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Responders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Litifilimab in DBPC TP. Time frame: Week 52.
- Parts A and B (US+ROW): Percentage of Participants With a CLASI-70 Response at Week 52 AmongCLASI-70 Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP. Time frame: Week 52.
- Parts A and B (US+ROW): Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 at Week 52 Among CLA-IGA-R Erythema Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP. Time frame: Week 52.
- Parts A, B(US+ROW):Percentage of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1Level of Improvement From Baseline at Week 52 Among CLA-IGA-R OMC Nonresponders at Weeks16 and 24, Respectively, who Were Assigned to Receive Placebo in DBPC TP. Time frame: Week 52.
- Parts A and B (US+ROW): Percentage of Participants With a CLA-IGA-R OMC Score of 0 at Week 52Among CLA-IGA-R OMC Nonresponders at Week 16 and Week 24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP. Time frame: Week 52.
- Parts A and B(US+ROW): Percentage of Participants who Achieve CLA-IGA-R Follicular Activity Score of 0 at Week 52 Among CLA-IGA-R Follicular Activity Nonresponders at Weeks 16 and 24,Respectively, who Were Randomly Assigned to Receive Placebo in DBPC TP. Time frame: Week 52.
- Parts A and B (US+ROW): Annualized Mild and Moderate Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rate and Annualized Severe SFI Rate Through Week 24. Time frame: Up to Week 24.
- Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 16. Time frame: Up to Week 16.
- Parts A and B (US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through Week 52. Time frame: Up to Week 52.
- Parts A and B (US+ROW): Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). Time frame: Up to Week 76.
- Percent Change in CLASI-D Score. Time Frame: Baseline to Week 52.
- Part B (US+ROW): Change From Baseline in Numerical Rating Scale (NRS) for Pain in Skin Rash. Time Frame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52.
- Part B (US+ROW): Change From Baseline in NRS for Itch in Skin Rash. Time Frame: Part B (US): Weeks 16 and 52; Part B (ROW): Weeks 24 and 52.
- Parts A and B (US+ROW): Percentage of Participants who Achieve a CLASI 70 Response. Time Frame: Up to Week 24.
- Parts A and B (US+ROW): Number of Participants With Anti-Litifilimab Antibodies in Serum During the Study. Time Frame: Up to Week 76
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10382019 · Product
- Active substance
- Litifilimab
- Pharmaceutical form
- INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BIOGEN IDEC RESEARCH LIMITED
- Paediatric formulation
- No
- Orphan designation
- 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
Biogen Idec Research Limited
- Sponsor organisation
- Biogen Idec Research Limited
- Address
- Innovation House, 70 Norden Road 70 Norden Road
- City
- Maidenhead
- Postcode
- SL6 4AY
- Country
- United Kingdom
Scientific contact point
- Organisation
- Biogen Idec Research Limited
- Contact name
- Clinical Trials Information Desk
Public contact point
- Organisation
- Biogen Idec Research Limited
- Contact name
- Clinical Trials Information Desk
Third parties 20
| Organisation | City, country | Duties |
|---|---|---|
| Crisalis LLC ORG-100047297
|
Oklahoma City, United States | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 11, Code 12, Other, Code 2, Code 5, Data management |
| Publicis Healthcare Communications Group Limited ORG-100044665
|
London, United Kingdom | Other |
| Canfield Scientific Inc. ORG-100042834
|
Parsippany, United States | Other |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Laboratory analysis |
| PPD Global Limited ORG-100007533
|
Cambridge, United Kingdom | Code 8 |
| Clinical Outcomes Solutions Limited ORG-100045524
|
Folkestone, United Kingdom | Other |
| National Medical Services Inc. ORG-100046029
|
Horsham, United States | Laboratory analysis |
| Specialty Laboratories Inc. ORG-100051017
|
Valencia, United States | Laboratory analysis |
| Medical Equipment Supplies And Management Limited ORG-100044212
|
Chorley, United Kingdom | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Signant Health Global LLC ORG-100040604
|
San Francisco, United States | Interactive response technologies (IRT) |
| Labcorp Early Development Laboratories Inc. ORG-100012865
|
Chantilly, United States | Laboratory analysis |
| Cisys Inc. ORG-100046011
|
Raleigh, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Continuum Clinical LLC ORG-100045925
|
Northbrook, United States | Code 11, Other |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
| Inato ORG-100044345
|
Neuilly Sur Seine Cedex, France | Other |
| Quest Diagnostics Nichols Institute ORG-100012789
|
San Juan Capistrano, United States | Laboratory analysis |
Locations
11 EU/EEA countries · 78 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 3 | 4 |
| Bulgaria | Ongoing, recruiting | 18 | 11 |
| France | Ongoing, recruiting | 42 | 10 |
| Germany | Ongoing, recruiting | 42 | 15 |
| Hungary | Ongoing, recruiting | 4 | 3 |
| Italy | Ongoing, recruiting | 40 | 8 |
| Poland | Ongoing, recruiting | 14 | 10 |
| Portugal | Ongoing, recruiting | 6 | 3 |
| Slovakia | Ongoing, recruiting | 8 | 2 |
| Spain | Ongoing, recruiting | 35 | 11 |
| Sweden | Ongoing, recruiting | 5 | 1 |
| Rest of world
Brazil, Puerto Rico, Canada, Colombia, Mexico, Philippines, Argentina, Saudi Arabia, Peru, Korea, Republic of, Chile, United Kingdom, Serbia, United States, Switzerland, Taiwan, Japan, China
|
— | 329 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Dermatology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Leuven
Dermatology, Herestraat 49, 3000, Leuven
Centre hospitalier universitaire de Liege
Dermatology, Avenue De L'Hopital 1, 4000, Liege
Universitair Ziekenhuis Gent
Dermatology, Corneel Heymanslaan 10, 9000, Gent
Dkc Fokus-5 Lzip OOD
Not applicable, Ulitsa Hristo Stanchev 15, 1463, Sofiya
Dkc Fokus-5 Lzip OOD
Not applicable, Ulitsa Hristo Stanchev 15, 1463, Sofiya
Medical Center Medconsult Pleven OOD
Not applicable, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
Diagnostic-Consultative Center Alexandrovska EOOD
Not applicable, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Dkc 1 Ruse EOOD
Not applicable, Nezavisimost Street 2, 7002, Ruse
Specialized Hospital For Active Treatment In Cardiology EAD
Clinic of Dermatology and Venereal Diseases, Ulitsa Vladimir Vazov 91, 5804, Pleven
Military Medical Academy
Department of Rheumatology, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofiya
Diagnostic-Consultative Center Alexandrovska EOOD
Not applicable, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Diagnostics And Consultancy Center Sveti Georgi EOOD
Not applicable, Ulitsa Stefan Stambolov 2, 6304, Haskovo
ASMC IPSMC Skin And Venereal Diseases
Not applicable, Ulitsa Persenk 19, Enter B Floor 1 App 13, Sofiya
Dcc 1 Sevlievo EOOD
Not applicable, Ulitsa Stefan Peshev 147, 5400, Sevlievo
Centre Hospitalier Universitaire De Toulouse
Dermatology, 24 Chemin De Pouvourville, 31400, Toulouse
Assistance Publique Hopitaux De Marseille
Dermatology, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Montpellier
Dermatology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Hospital Edouard Herriot
Dermatology, 5 Place D Arsonval, 69437, Lyon Cedex 03
Hopital Prive D Antony
Dermatology, 1 Rue Velpeau, 92160, Antony
Assistance Publique Hopitaux De Paris
Dermatology, 1 Avenue Claude Vellefaux, 75010, Paris
Hopital Tenon
Dermatology, 4 Rue De La Chine, 75970, Paris Cedex 20
Centre Hospitalier Universitaire De Caen Normandie
Dermatology, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Besancon University Hospital Center
Dermatology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Universitaire De Lille
Dermatology, Rue Michel Polonovski, 59037, Lille Cedex
Universitaetsklinikum Regensburg AöR
Clinic and Policlinic for Dermatology, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Aachen AöR
Studienzentrum d. Med. Fak. der RWTH Aachen CTC-A (E1/F22/Aufzug C2), Pauwelsstrasse 30, 52074, Aachen
Universitaetsklinikum Tuebingen AöR
Clinic and Policlinic for Dermatology, Liebermeisterstrasse 25, Innenstadt, Tuebingen
Charite Universitaetsmedizin Berlin KöR
Klinik für Dermatologie, Allergologie, Venerologie, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Halle (Saale) AöR
Universitätsklinik für Dermatologie und Venerologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
Universitaetsklinikum Duesseldorf AöR
Build:11-81, Flur: 1, Room: 202, Moorenstrasse 5, Bilk, Duesseldorf
Universitaetsklinikum Erlangen AöR
Hautklinik Studienambulanz, 1. Etage, Bauteil D, Zi. 711, Ulmenweg 18, Innenstadt, Erlangen
Klinikum Oldenburg AöR
Universitätsklinik für Dermatologie und Allergologie, Rahel-Straus-Strasse 10, Kreyenbrueck, Oldenburg
Thermalsole und Schwefelbad Bentheim GmbH
Klinisches Studienzentrum, Am Bade 1, 48455, Bad Bentheim
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Studienabteilung, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department of Dermatology and Allergology, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaet Muenster
Klinik für Dermatologie und Venerologie, Von-Esmarch-Strasse 58, Sentrup, Muenster
Klinikum der Ludwig-Maximilians-Universität München
Klinik und Poliklinik fuer Dermatologie und Allergologie, Frauenlobstraße 9–11, Campus Innenstadt, München
Elbe Kliniken Stade-Buxtehude Elbe Klinikum Buxtehude gGmbH
Derma Studien, Am Krankenhaus 1, 21614, Buxtehude
Universitaetsklinikum Wuerzburg AöR
Department of Dermatology, Venereology and Allergology, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
University Of Pecs
Bőr-, Nemikórtani és Onkodermatológiai Klinika, Akac Utca 1, 7632, Pecs
Semmelweis University
Bőr-Nemikórtani és Bőronkológiai Klinika, Maria Utca 41, 1085, Budapest VIII
University Of Szeged
Bőrgyógyászati és Allergológiai Klinika, Koranyi Fasor 6, 6720, Szeged
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Medicina Interna, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento di Medicina Specialistica, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Federico II Di Napoli
UOC di Dermatologia Clinica, Via Sergio Pansini 5, 80131, Naples
Ospedale San Raffaele S.r.l.
U.O. di Medicina Gen. Ind. Immunologico Clinica, Via Olgettina 60, 20132, Milan
IRCCS Ospedale Policlinico San Martino
Clinica Dermatologica, Largo Rosanna Benzi 10, 16132, Genoa
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
U.O.C. Dermatologia, Via Pace 9, 20122, Milan
University Of Florence
Dipartimento di Scienze Dermatologiche, Via Della Pergola 58, 50121, Florence
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Clinica Dermatologica, Largo Agostino Gemelli 8, 00168, Rome
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
N/A, Ul. Ul. Sliczna 13, 50-566, Wroclaw
Royalderm Agnieszka Nawrocka
N/A, ul. K. Kieślowskiego 3b/3, 02-962, Warszawa
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Klinika Dermatologii, Ul. Ulica Nowogrodzka 59, 02-006, Warsaw
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Klinika Dermatologii i Dermatologii Onkologicznej, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
Dermoklinika-Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak
N/A, ul. Aleja T. Kościuszki 93, 90-436, Łódź
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SC
N/A, ulica Zbozowa 2/25, 30-002, Krakow
MT Medic Specjalistyczna Praktyka Lekarska Tomas Stapiński
N/A, Ul. Korczyńska 43, 38-400, Krosno
MICS Centrum Medyczne Warszawa
N/A, ul. Wronia 53 lok. b10, 00-874, Warszawa
Dermedic Jacek Zdybski
N/A, Ul. Klonowa 107/L7, 38-400, Kielce
Promed P.Lach R.Glowacki Sp. j.
N/A, Ul. Olszanska 5g, 31-513, Cracow
Unidade Local De Saude De Coimbra E.P.E.
Dermatology, Praceta Professor Mota Pinto, 3004-561, Coimbra
Unidade Local De Saude De Santo Antonio E.P.E.
Dermatology, Largo Professor Abel Salazar, 4050-011, Porto
Hospital Cuf Descobertas S.A.
Dermatology, Rua Mario Botas 1, 1998-018, Lisbon
Narodny Ustav Reumatickych Chorob
Reumatologicka ambulancia, Nabrezie Ivana Krasku 4782/4, 921 01, Piestany
Artromac N.O.
Reumatologicka ambulancia, Toryska 275/1, Zapad, Kosice
Hospital Germans Trias I Pujol
Dermatology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario Puerta De Hierro De Majadahonda
Dermatology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitario Fundacion Alcorcon
Dermatology, Calle Budapest 1, 28022, Madrid
University Hospital Virgen Del Rocio S.L.
Dermatology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital General Universitario Reina Sofia
Dermatology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Rio Hortega
Internal medicine, Calle Dulzaina 2, 47012, Valladolid
Hospital Del Mar
Dermatology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitari Vall D Hebron
Raumatology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital De La Santa Creu I Sant Pau
Dermatology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Complexo Hospitalario Universitario A Coruna
Rheumatology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital General Universitario De Castellon
Rheumatology, Avenida De Benicasim S/n, 12004, Castello De La Plana
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-12-18 | 2025-12-18 | |||
| Bulgaria | 2023-03-24 | 2023-03-24 | |||
| France | 2023-03-29 | 2023-03-29 | |||
| Germany | 2023-08-09 | 2023-08-09 | |||
| Hungary | 2023-08-03 | 2023-08-03 | |||
| Italy | 2023-06-27 | 2023-06-27 | |||
| Poland | 2023-05-25 | 2023-05-25 | |||
| Portugal | 2024-06-05 | 2024-06-05 | |||
| Slovakia | 2023-07-03 | 2023-07-03 | |||
| Spain | 2023-04-11 | 2023-04-11 | |||
| Sweden | 2023-02-02 | 2023-02-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 291 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Clarification letter_2023-505634-94-00_red | 4.3 |
| Protocol (for publication) | D1_Protocol_2023-505634-94-00_red_san | 4.3 |
| Protocol (for publication) | D4_Patien facing documents_IFP_DE_de_red-san | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_IFP_BG_bul_red_san | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_IFP_EN_red_san | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_IFP_ES_es_red | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_IFP_FRA_fr_red_san | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_IFP_HUN_hu_red_san | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_IFP_IT_it_red_san | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_IFP_POL_PL_red_san | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_IFP_PT_PT_red_san | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_IFP_SK_Sk_san-red | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_IFP_SWE_SE_red | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_questionnaires_red_san | N-A |
| Protocol (for publication) | D4_Patient facing documents_questionnaires_SGA-Skin-BL_POL_PL | 2 |
| Protocol (for publication) | D4_Patient facing documents_questionnaires_SGA-Skin-FU_POL_PL | 2 |
| Recruitment arrangements (for publication) | K0_230LE301_Cover letter_NSM-1_san | N/A |
| Recruitment arrangements (for publication) | K0_Blank page for CTIS for publication_placeholder_redacted | 1.0 |
| Recruitment arrangements (for publication) | K0_Blank page for publication | N/A |
| Recruitment arrangements (for publication) | K1_ 2023-505634-94_Recruitment Arrangement | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment and Informed Consent Procedure_san | 1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment and Informed Consent Procedure_V1-0 | V1.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_230LE301_EU CTR consent_recruitment_ statement_BG_san | N/A |
| Recruitment arrangements (for publication) | K1_EU CTR consent_recruitment_ statement_EN_san | N/A |
| Recruitment arrangements (for publication) | K1_Principles of Recruitment_san | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure | V1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_san | V2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PT_san | V1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment and Informed Consent Procedure_clean_san | V1.1 |
| Recruitment arrangements (for publication) | K1_Referral Fact Card_hu_redacted_san | 3 |
| Recruitment arrangements (for publication) | K1_Referral Letter_hu_redacted_san | 3 |
| Recruitment arrangements (for publication) | K2_2023-505634-94_Flyer_FRA_Red-San | 1 |
| Recruitment arrangements (for publication) | K2_Amethyst Clinic Poster8_V1_08Dec2022_san_red | 1 |
| Recruitment arrangements (for publication) | K2_Amethyst Retention items_V3_June 2023_san | 3 |
| Recruitment arrangements (for publication) | K2_Amethyst_Patient database letter_V1_15Sep2022_san_red | 1 |
| Recruitment arrangements (for publication) | K2_Amethyst_Patient information brochure_red | V2 |
| Recruitment arrangements (for publication) | K2_Clinical Trials Booklet 1-0_15Sep2022_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Clinical Trials Booklet_BG | 1 |
| Recruitment arrangements (for publication) | K2_Concomitant therapy factsheet-patients | V2 |
| Recruitment arrangements (for publication) | K2_Other Investigator material_Inclusion-exclusion cards_red-san | 3 |
| Recruitment arrangements (for publication) | K2_Other Investigator material_Investigator welcome letter_Blank page for publication | 1 |
| Recruitment arrangements (for publication) | K2_Other Investigator material_questionnaires_red-san | N/A |
| Recruitment arrangements (for publication) | K2_Other Investigator material_Referral Fact Card_red-san | 3 |
| Recruitment arrangements (for publication) | K2_Other Investigator material_Referral Letter_red-san | 3 |
| Recruitment arrangements (for publication) | K2_Other Investigator material_Schedules of assessments_Blank page for publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Other material_Site Kit Box_Blank page for publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitmat_Clinical Trials Booklet_san | V1.2 |
| Recruitment arrangements (for publication) | K2_RecruitMat_Participant Flyer_red_san | V2.0 |
| Recruitment arrangements (for publication) | K2_RecruitMat_Patient Folder_Generic | 1 |
| Recruitment arrangements (for publication) | K2_RecruitMat_Patient information brochure_red_san | 2 |
| Recruitment arrangements (for publication) | K2_RecruitMat_Study Flyer_red_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materia _Referral Letter_red | V3 |
| Recruitment arrangements (for publication) | K2_Recruitment material _Referral Fact Card_red | V3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_20221006 Clinical Trials Booklet_PL_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinic Poster_fr_red | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinic Poster_nl_red | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinic Poster_red_san | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinic Poster8_Red_San | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinic Posters 1-6_san_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinic Posters 7-8_san_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trial Participation_RAL_Slovak-Slovakia_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trials Booklet_fr_clean_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trials Booklet_nl_clean_san | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trials Booklet_Red_San | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trials Booklet_san | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trials Booklet_Slovak-Slovakia_v1-0_13Sep2022_san | 1-0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Concomitant therapy factsheet_clean_san_redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Flier_BG_red | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Flier_PL_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Database Letter_fr_red | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Database Letter_nl_red | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Folder_PL_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Folder_SE_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient information brochure_fr_red | V2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient information brochure_nl_red | V2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Information Brochure_PL_redacted_san | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient information brochure_red_san | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient information brochure_Red_San | V2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient information brochure_Slovak-Slovakia_san-red | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Fact Card_BG_red | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Fact Card_Clean_san_redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Fact Card_fr_red | V3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Fact Card_nl_red | V3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Fact Card_Slovak-Slovakia_san_red | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter_BG_red | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter_fr_red | V3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter_nl_red | V3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter_Slovak-Slovakia_san_red | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Retention items_san-red | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Flyer_fr_red | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Flyer_nl_red | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Flyer_PL_redacted_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Flyer_red_san | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Flyer_Red_San | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study visit guide_Slovak-Slovakia_san-red | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Worsening Symptoms Reminder_fr_clean_san | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Worsening Symptoms Reminder_nl_clean_san | V1 |
| Recruitment arrangements (for publication) | K2_Recruitment principals_Spain_28Feb2022_san | NA |
| Recruitment arrangements (for publication) | K3_2023-505634-94_Brochure_FRA_Red-San | 2.1 |
| Recruitment arrangements (for publication) | K4_2023-505634-94_Study Information Slides_FRA_San | NA |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Main Privacy_clean_Red_san | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF PP_red_san | V2.1ITA2.0 |
| Subject information and informed consent form (for publication) | L1_1_1_1_SIS and ICF Global Main_red_san | 8.0 |
| Subject information and informed consent form (for publication) | L1_1_2_SIS and ICF Bulgaria Main_red_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_1_3_SIS and ICF Bulgaria_Main ICF_red_san | V8.0BGR1.0 |
| Subject information and informed consent form (for publication) | L1_2_1_SIS and ICF Global Optional 1_red_san | 2.1 |
| Subject information and informed consent form (for publication) | L1_2_2_SIS and ICF Bulgaria Optional 1_red_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_2_3_SIS and ICF Bulgaria Optional 1_red_san | V2.1BGR1.0 |
| Subject information and informed consent form (for publication) | L1_2023-505634-94_SIS and ICF Main_FRA_Red-San | V8.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_230LE301_QI ICF_Optional_red_san | 2.0DEUde1 |
| Subject information and informed consent form (for publication) | L1_3_1_SIS and ICF Global Optional 2_red_san | 2.1 |
| Subject information and informed consent form (for publication) | L1_3_2_SIS and ICF Bulgaria Optional 2_red_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_3_3_SIS and ICF Bulgaria Optional 2_red_san | V2.1BGR1.0 |
| Subject information and informed consent form (for publication) | L1_4_1_SIS and ICF Global Optional FSR_red_san | 2.1 |
| Subject information and informed consent form (for publication) | L1_4_2_SIS and ICF Bulgaria Optional FSR_red_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_4_3_SIS and ICF Bulgaria Optional FSR_red_san | V2.1BGR1.0 |
| Subject information and informed consent form (for publication) | L1_5_1_SIS and Global ICF PP_red_san | 2.1 |
| Subject information and informed consent form (for publication) | L1_5_2_SIS and Bulgaria ICF PP_red_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_5_3_SIS and Bulgaria ICF PP_red_san | V2.1BGR1.0 |
| Subject information and informed consent form (for publication) | L1_6_0_1_SIS and ICF Master Optional 3_red_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_6_0_2_SIS and ICF Bulgaria Optional 3_red_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_6_0_3_SIS and ICF Bulgaria Optional 3_red_san | V1.0BGR1.0 |
| Subject information and informed consent form (for publication) | L1_6_1_1_SIS and ICF Master Optional 3_red_san | 2.0 |
| Subject information and informed consent form (for publication) | L1_6_1_2_SIS and ICF Bulgaria Optional 3_red_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_6_1_3_SIS and ICF Bulgaria Optional 3_red_san | V2.0BGR1.0 |
| Subject information and informed consent form (for publication) | L1_FSR ICF_red_san | V2_0DEU1_0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional ICF_red | V2.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_red_san | 8.0DEde3.0 |
| Subject information and informed consent form (for publication) | L1_OptGenetic CF_HUN_Clean_redacted_san | 2.1 |
| Subject information and informed consent form (for publication) | L1_OptGenetic PIS_HUN_Clean_redacted_san | 2.1 |
| Subject information and informed consent form (for publication) | L1_Optional ICF 1_red_san | V2_0DEU1_0 |
| Subject information and informed consent form (for publication) | L1_PFU ICF_red_san | V2_0DEU1_0 |
| Subject information and informed consent form (for publication) | L1_SIS and CF FSR_HUN_Clean_san | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and CF Main_HUN_Clean_san | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and CF PP_HUN_Clean_san | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF HIV_Red_San | V1.0ITA3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_red_san | V8.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_red_san | V8.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_red_san | V8.0SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_red_san | V8.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_red_san | V8.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 1_PL_red_san | V2.1POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional 1_red_san | V2.1PRT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 1_red_san | V2.1ESP1.0 |
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| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 2_PL_redacted_san | V2.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 2_red_san | 2.0PRT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 2_red_san | V2.1ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional 3_PL_red_san | V2.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional FSR_red_san | V2.1POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_3600_red_san | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_Clean_red_san | V2.1SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_red_san | V2.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_red_san | V2.1PRT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Addendum for Personal Data protection_san_red | 7.2SVK2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Main ICF_en_red | V8.0BEL2.0 |
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| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Main ICF_nl_red | V8.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Main ICF_san_red | 8.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FSR ICF_Adult_san_red | 2.1SVK2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional 1_ICF_Adult_san_red | 2.1SVK2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional 2 ICF_Adult_san_red | 2.1SVK2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Use of Images ICF_redacted | V2.1SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PGX ICF_san_clean_redacted | V2.1SWE1.0 |
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| Subject information and informed consent form (for publication) | L1_Use of Images ICF_red_san | 2.1DEde3.0 |
| Subject information and informed consent form (for publication) | L2_2023-505634-94_SIS and ICF Optional 2_FRA_Red-San | V2.1FRA1.0 |
| Subject information and informed consent form (for publication) | L2_3D Secure Terms of Use | 10 |
| Subject information and informed consent form (for publication) | L2_3D Secure Terms of Use_hun_san | 10.0 |
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| Subject information and informed consent form (for publication) | L2_ClinCard_Generic_Image | V10.0 |
| Subject information and informed consent form (for publication) | L2_ClinCard_Privacy Policy_hun_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Concomitant therapy factsheet_patients_hun_redacted_san | 2 |
| Subject information and informed consent form (for publication) | L2_Device Label_san | 1 |
| Subject information and informed consent form (for publication) | L2_EU Dispute Form_hun_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire ClinCard Msg Templates - ROW_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire ClinCard Travel Ref Guide for Subjects_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire SAF_EU_ClinCard_ConneX_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire Service Agreement Form_V1-0_01Apr2020 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire Travel Contact Card_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire_ClinCard_Card_Carrier_EU_san | 10.1 |
| Subject information and informed consent form (for publication) | L2_Greenphire_ClinCard_Cardholder_FAQ_san | 11.0 |
| Subject information and informed consent form (for publication) | L2_Greenphire_Fee_Schedule_san | 10.1 |
| Subject information and informed consent form (for publication) | L2_i2c EU Dispute Form | V10.0 |
| Subject information and informed consent form (for publication) | L2_KYC | V10.0 |
| Subject information and informed consent form (for publication) | L2_KYC_hun_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_KYC_Identity_Verification_for_ClinCard | V3.1b |
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| Subject information and informed consent form (for publication) | L2_Other infomation materials_Greenphire ClinCard Msg Templates_BG_san | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other information materials_Amethyst Retention items_san | v3 |
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| Subject information and informed consent form (for publication) | L2_Other information materials_Greenphire EU Generic ClinCard_san | 3.0 |
| Subject information and informed consent form (for publication) | L2_other information materials_Greenphire Fee Schedule_BG_san | N/A |
| Subject information and informed consent form (for publication) | L2_Other information materials_Greenphire Service Agreement Form_BG_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other information materials_Greenphire_ClinCard_Card_Carrier_BG_san | V2 |
| Subject information and informed consent form (for publication) | L2_Other information materials_Greenphire_ClinCard_Cardholder_BG_san | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other information materials_Patient Folder_san | V1 |
| Subject information and informed consent form (for publication) | L2_Other information materials_Skin Photography fact sheet_Bulgarian_redacted | V1 |
| Subject information and informed consent form (for publication) | L2_Other information materials_Subject ID card_Bulgarian_san | V1 |
| Subject information and informed consent form (for publication) | L2_Other subject info material_Concomitant therapy factsheet_red-san | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject info material_Skin Photography fact sheet_red_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject info material_Study visit guide_red-san | 3.1 |
| Subject information and informed consent form (for publication) | L2_Other subject info material_Subject ID Card_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject info material_Thank you card_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject info material_Worsening Symptoms Reminder_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Patient database letter_San | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Amethyst Retention items_Red_San | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Sweden Travel Contact Card_redacted | V1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Sweden Travel Ref Guide for Subjects_redacted | V1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Device label_san-red | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Letter_Red_San | V04 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Card Carrier_redacted | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Cardholder FAQ EU_redacted | V3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Msg Templates | V6.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Msg Templates_ROW_Slovak_san | 6-0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Travel Ref Guide_Subjects_Slovak_san-red | 5-0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire EU Generic ClinCard Template | V3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire EU Generic ClinCard_san-red | 3-0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Fee Schedule | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Service Agreement Form_Red_San | v1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Service Agreement Form_redacted | V1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Service Agreement Form_Slovak_san-red | 1-0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Service Agreement_fr_san | v1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Service Agreement_nl_san | v1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire Travel Contact Card_Slovak_san-red | 2-0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Card_Carrier_EU_Slovak_san-red | 2-0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Cardholder_FAQ_EU_Slovak_san-red | 3-0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_Fee_Schedule_Slovak_san | 4-0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Folder_Generic_San | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Folder_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Skin Photography fact sheet_PL_redacted_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Skin Photography fact sheet_Red_San | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Skin Photography fact sheet_SE_red | V1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Skin Photography fact sheet_Slovak_san-red | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study visit guide_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject ID card | V1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject ID card_ SK-Slovak_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject ID Card_PL_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject ID card_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank you card_Red_San | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Worsening Symptoms Reminder | V1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Worsening Symptoms Reminder_PL_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Worsening Symptoms Reminder_Red_San | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject material_Patient Folder_san | 1 |
| Subject information and informed consent form (for publication) | L2_OtherSubInfo_GreenphireServAgreem_EU_ClinCardConneX | 1 |
| Subject information and informed consent form (for publication) | L2_OtherSubInfo_Patient database letter_red_san | 1 |
| Subject information and informed consent form (for publication) | L2_OtherSubInfo_Skin Photo fact sheet_red_san | 1 |
| Subject information and informed consent form (for publication) | L2_OtherSubInfo_Study visit guide_red_san | 3 |
| Subject information and informed consent form (for publication) | L2_Paper and Electronic Clarification_san | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Folder_Generic_san | 1 |
| Subject information and informed consent form (for publication) | L2_Patient ID Card_san | 01 |
| Subject information and informed consent form (for publication) | L2_Retention items_san | 1 |
| Subject information and informed consent form (for publication) | L2_Signant_ClinicalTrialParticipation_RAL_san | 1 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF FSR_HUN_Clean_redacted_san | 2.1 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF Main_HUN_Clean_redacted_san | 8.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF PP_HUN_Clean_redacted_san | 2.1 |
| Subject information and informed consent form (for publication) | L2_Skin Photography Fact Sheet_redacted_san | 1 |
| Subject information and informed consent form (for publication) | L2_Study visit guide_hun_redacted_san | 3 |
| Subject information and informed consent form (for publication) | L2_Template - Greenphire EU Generic ClinCard_san | 10.0 |
| Subject information and informed consent form (for publication) | L3_2023-505634-94_SIS and ICF Optional 1_FRA_Red-San | V2.1FRA1.0 |
| Subject information and informed consent form (for publication) | L3_List of submitted documents_en | 1 |
| Subject information and informed consent form (for publication) | L3_List of submitted documents_hu | 1 |
| Subject information and informed consent form (for publication) | L4_2023-505634-94_SIS and ICF PP_FRA_Red-San | V2.1FRA1.0 |
| Subject information and informed consent form (for publication) | L5_2023-505634-94_Study visit guide_FRA_Red-San | 3 |
| Subject information and informed consent form (for publication) | L6_2023-505634-94_Patient Folder_FRA_San | 1 |
| Subject information and informed consent form (for publication) | L7_2023-505634-94_Patient Card_FRA_San | 1 |
| Subject information and informed consent form (for publication) | L8_2023-505634-94_Concomitant therapy factsheet_FRA_Red_San | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BG_2023-505634-94-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_DE_full_2023-505634-94-00_red | 4.3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EN_2023-505634-94-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2023-505634-94-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2023-505634-94-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_HU_2023-505634-94-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_HU_full_2023-505634-94-00_red | 4.3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2023-505634-94-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_full_2023-505634-94-00_red | 4.3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2023-505634-94-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PT_2023-505634-94-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PT_full_2023-505634-94-00_red | 4.3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SE_2023-505634-94-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SK_2023-505634-94-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SK_full _2023-505634-94-00_red | 4.3 |
Application history
25 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-14 | Slovakia | Acceptable 2024-03-19
|
2024-03-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-07 | Acceptable 2024-03-19
|
2024-06-07 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-10 | Acceptable | 2024-07-25 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-15 | Acceptable | 2024-10-21 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-21 | Slovakia | 2024-10-21 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-18 | Acceptable | 2025-01-22 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-22 | Acceptable | 2025-01-14 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-02-28 | Slovakia | Acceptable 2025-06-09
|
2025-06-10 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-06-17 | Slovakia | Acceptable 2025-06-09
|
2025-06-17 |
| 10 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-06-25 | Acceptable | 2025-07-29 | |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2025-07-01 | Acceptable 2025-06-09
|
2025-09-08 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-07-02 | Acceptable | 2025-07-23 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-07-10 | Acceptable | 2025-08-19 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-07-15 | Acceptable | 2025-08-25 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-07-16 | Acceptable | 2025-07-25 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-07-17 | Acceptable | 2025-09-15 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-07-25 | Acceptable | 2025-10-27 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-07-25 | Acceptable | 2025-10-06 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-07-30 | Acceptable | 2025-09-12 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-17 | 2025-07-31 | Slovakia | Acceptable | 2025-09-18 |
| 21 | SUBSTANTIAL MODIFICATION | SM-18 | 2025-10-24 | Acceptable | 2025-12-03 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-19 | 2025-10-30 | Acceptable | 2026-01-19 | |
| 23 | SUBSTANTIAL MODIFICATION | SM-20 | 2025-12-09 | Acceptable | 2026-02-02 | |
| 24 | SUBSTANTIAL MODIFICATION | SM-21 | 2026-01-28 | Acceptable | 2026-03-16 | |
| 25 | SUBSTANTIAL MODIFICATION | SM-22 | 2026-03-04 | Acceptable | 2026-03-25 |