Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
1,560
Countries
16
Sites
148
psoriatic arthritis (PsA)
To evaluate long-term safety and tolerability of sonelokimab in participants with PsA
Key facts
- Sponsor
- MoonLake Immunotherapeutics AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2026-03-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- MoonLake Immunotherapeutics AG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To evaluate long-term safety and tolerability of sonelokimab in participants with PsA
Secondary objectives 1
- To describe the long-term efficacy of sonelokimab in participants with PsA
Conditions and MedDRA coding
psoriatic arthritis (PsA)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10037160 | Psoriatic arthritis | 10028395 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-520564-17-00 | A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa | MoonLake Immunotherapeutics AG |
| 2024-516213-20-00 | A Phase 3, parallel-group, randomized, double-blind, 3-arm, placebo-controlled, multicenter study to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years and over with active psoriatic arthritis who are naive to biologic DMARDs | MoonLake Immunotherapeutics AG |
| 2024-516219-25-00 | A Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm, to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years and over with active psoriatic arthritis and previous inadequate response or intolerance to tumor necrosis factor-α inhibitors | MoonLake Immunotherapeutics AG |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- 1. Participants who, in the opinion of the investigator, are expected to benefit from participation in this OLE study.
- 2. Participants who have received the second to last and/or last dose, as planned in the parental study, and have completed the end-of-treatment (EOT) visit (Week 52) of the parental study.
- 3. Participants must have received their last dose of study treatment in the parental study no more than 8 weeks (but ideally 4 weeks) before the first dose in this OLE study.
- 4. Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential (WONCBP) or (if childbearing potential [WOCBP]) must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. WOCBP must have a negative urine pregnancy test in the week prior to the first administration of treatment in this OLE study (Week 0). Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment. NOTE: These precautions for contraception in WOCBP are required for 21 weeks after the last dose of study treatment in the parental study M1095-PsA-302, in case of study drug discontinuations occurring during the first 9 weeks of OLE. Additional precautions in WOCBP may also be required due to the use of any other concomitant medications.
- 5. Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for at least 8 weeks after the last dose of study treatment, unless surgically sterile. Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.
- 6. Participants are considered reliable and capable of adhering to the protocol, visit schedule, and medication intake, according to the judgment of the investigator.
- 7. Participants are able to understand and provide signed informed consent, per local regulations and guidelines.
Exclusion criteria 5
- 1. Participants who met any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
- 2. Participants who have ongoing or planned use of one or more of the prohibited PsA or non-PsA treatments specified in this protocol.
- 3. Participants who plan to participate in another interventional study for a drug or device during this study.
- 4. Participants who were unblinded during the parental study.
- 5. Participant noncompliance to the parental study (significant violation of protocol requirements or any other instances as per investigator’s judgement).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 6
- Treatment-emergent adverse events (TEAEs)
- Serious adverse events (SAEs)
- TEAEs leading to study withdrawal
- Adverse events of special interest (AESIs)
- Vital signs, and electrocardiogram (ECG) results
- Abnormal laboratory parameters (hematology, clinical chemistry)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10271601 · Product
- Active substance
- Sonelokimab
- Pharmaceutical form
- INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 120.00 mg milligram(s)
- Max total dose
- 1320.00 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MOONLAKE IMMUNOTHERAPEUTICS AG
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
MoonLake Immunotherapeutics AG
- Sponsor organisation
- MoonLake Immunotherapeutics AG
- Address
- Dorfstrasse 29
- City
- Zug
- Postcode
- 6300
- Country
- Switzerland
Scientific contact point
- Organisation
- MoonLake Immunotherapeutics AG
- Contact name
- Clinical Trial Information Point
Public contact point
- Organisation
- MoonLake Immunotherapeutics AG
- Contact name
- Clinical Trial Information Point
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Veramed Limited ORG-100048461
|
Twickenham, United Kingdom | Code 10 |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | Other |
Locations
16 EU/EEA countries · 148 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 48 | 13 |
| Croatia | Authorised, recruitment pending | 5 | 2 |
| Czechia | Authorised, recruitment pending | 67 | 11 |
| Estonia | Authorised, recruitment pending | 50 | 3 |
| Finland | Authorised, recruitment pending | 3 | 1 |
| France | Authorised, recruitment pending | 11 | 11 |
| Germany | Authorised, recruitment pending | 47 | 10 |
| Greece | Authorised, recruitment pending | 5 | 3 |
| Hungary | Authorised, recruitment pending | 62 | 12 |
| Latvia | Authorised, recruitment pending | 28 | 2 |
| Lithuania | Authorised, recruitment pending | 11 | 4 |
| Poland | Authorised, recruitment pending | 500 | 46 |
| Portugal | Authorised, recruitment pending | 6 | 6 |
| Romania | Authorised, recruitment pending | 25 | 5 |
| Slovakia | Authorised, recruitment pending | 35 | 4 |
| Spain | Authorised, recruitment pending | 45 | 15 |
| Rest of world
Argentina, Chile, United Kingdom, Mexico, Canada, Georgia, United States, Serbia, Colombia
|
— | 612 | — |
Investigational sites
Medical Center Teodora EOOD
Not applicable, Ulitsa Mutkurova 101, 7000, Ruse
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Clinic of Rheumatology, Zapaden District, Sofia Str 64, Plovdiv
Medical Center Artmed Ltd.
Not applicable, Ulitsa Mladost 8, 4002, Plovdiv
Medical Center Exacta Medica OOD
Not applicable, Ulitsa Hristo Yasenov 13, 5803, Pleven
Mbal Lyulin EAD
Department of Rheumatology, Lyulin 6, Ulitsa D-R Petir Dertliev 81, Sofiya
Acibadem City Clinic Diagnostic And Consultation Center Ltd.
Not applicable, Bulevard Tsarigradsko Shose 66a, 1784, Sofia
University Multiprofile Hospital For Active Treatment Pulmed Ltd.
Department of Rheumatology, Ulitsa Perushtitsa 1a, 4002, Plovdiv
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Clinic of Rheumatology, Bulevard Vasil Aprilov 15a, 4002, Plovdiv
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.
Department of Internal Diseases, Ulitsa Komatevsko Shose 79, 4004, Plovdiv
Dkc Fokus-5 Lzip OOD
Not applicable, Ulitsa Hristo Stanchev 15, 1463, Sofiya
Meditsinski Tsentar-N.I Pirogov EOOD
Not applicable, Bulevard Gen Totleben 21, 1606, Sofiya
Medical Center Zara-Med EOOD
Not applicable, Ulitsa Orfey 4, 6003, Stara Zagora
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.
Department of Internal Diseases, Ulitsa Komatevsko Shose 79, 4004, Plovdiv
Clinical Hospital Centre Rijeka
Zavod za reumatologiju i kliničku imunologiju, Kresimirova 42, 51000, Rijeka
Medicinski centar Kuna Peric d.o.o.
Fizikalna medicina i rehabilitacija, Ulica Crvenog Kriza 35, Zagreb, Grad Zagreb
MUDr. Zuzana Štejfová, Revmatologická ambulance
N/A, Táborská 325/57, 140 00, Praha 4
PV Medical Services s.r.o.
Revmatologická ambulance, Stefanikova 477, 760 01, Zlin
Chirurgie Studenka s.r.o.
N/A, Nam. Republiky 653, 742 13, Butovice
Revmatologie s.r.o.
N/A, Halasovo Namesti 597/1, Lesna, Brno-Sever
Fakultni Thomayerova nemocnice
Klinika revmatologie a rehabilitace 3. LF UK a FTN, Vídeňská 800, 140 59, Praha 4 - Krč
Rheuma s.r.o.
N/A, Sady 28. Rijna 682/5, 690 02, Breclav
Vesalion s.r.o.
N/A, Bozdechova 619/6, Moravska Ostrava, Moravska Ostrava A Privoz
Praglandia s.r.o.
N/A, Nadrazni 3368/30a, Smichov, Prague
Revmatologicky Ustav
N/A, Na Slupi 450/4, Nove Mesto, Prague 2
Affidea Praha s.r.o.
N/A, Sustova 1930/2, Chodov, Prague 11
Fakultni Nemocnice Motol A Homolka
Oddělení revmatologie dětí a dospělých, V Uvalu 84/1, Motol, Prague
MediTrials OÜ
NA, Moisavahe Tn 34c, 50708, Tartu Linn
North Estonia Medical Centre Foundation
NA, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn
Innomedica OÜ
NA, Narva Mnt 7, Kesklinna Linnaosa, Tallinn
Centre Hospitalier Universitaire Rouen
Service de rhumatologie, 1 Rue De Germont, Bp 96031, Rouen Cedex
Assistance Publique Hopitaux De Paris
Service de rhumatologie, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Universitaire De Saint Etienne
Service de rhumatologie, St Priest En Jarez, 25 Boulevard Pasteur, St Etienne Cedex 2
Centre Hospitalier Universitaire De Toulouse
Service de rhumatologie, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Centre Hospitalier Universitaire De Montpellier
Unité clinique thérapeutique des maladies ostéo-articulaires, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
Centre Hospitalier De Narbonne
Service de rhumatologie, Bd Dr Lacroix, Bp 824, Narbonne Cedex
Centre Hospitalier Universitaire Grenoble Alpes
Service de rhumatologie, Av De Kimberley, Bp 185, Echirolles
Centre Hospitalier Universitaire De Nice
Alpes-Maritimes, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Jean Rougier
Service de rhumatologie, 52 Place Antonin Bergon, Bp 50269, Cahors
Centre Hospitalier Regional Universitaire De Tours
Service de rhumatologie, Avenue De La Republique, 37170, Chambray Les Tours
Ass Hospitaliere Protestante De Lyon
Service de rhumatologie, 3 Chemin Du Penthod, 69300, Caluire Et Cuire
Rheumatologische Schwerpunktpraxis
Rheumatologische Schwerpunktpraxis, Bundesallee 104-105, Friedenau, Berlin
Universitaetsklinikum Erlangen AöR
Klinikum Erlangen der FAU Erlangen-Nuernberg, Medizinische Klinik 3 - Rheumotolge und Immunologie, Ulmenweg 18, Innenstadt, Erlangen
LMU Klinikum Muenchen AöR
Klinikum der Universität München Innenstadt Medizinische Klinik und Poliklinik, IVRheumatologie, Pettenkoferstrasse 8a, Ludwigsvorstadt-Isarvorstadt, Munich
Medicover GmbH
Medicover GmbH, Medicover München Ost MVZ, Orleansplatz 3, Au-Haidhausen, Munich
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, Wanne, Herne
Praxis für Rheumatologie, Gastroenterologie und Innere Medizin
Private Practice - Dr. Herbert Kellner, Romanstraße 9, 80639, München
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Dr. Andrea Everding GmbH GbR, HRF II - Hamburger Rheuma Forschungszentrum II, Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg
Immanuel-Krankenhaus GmbH
ImmanuelKrankenhaus GmbH, Rheumatologie und Klinische Immunologie, Lindenberger Weg 19, Buch, Berlin
Thermalsole und Schwefelbad Bentheim GmbH
Fachklinik Bad Bentheim, Am Bade 1, 48455, Bad Bentheim
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Fraunhofer-Institute for Translational Medicine and Pharmacology ITMP, Theodor-Stern-Kai 7, Sachsenhausen, Frankfurt Am Main
Athens Naval Hospital
Rheumatology Clinic, Dinokratous 70, 115 21, Athens
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
4th Department of Internal medicine, Rheumatology and Clinical Immunology, Rimini 1, 124 61, Chaidari
University General Hospital Of Heraklion
Clinic of Rheumatology and Clinical Immunology, Stavrakia And Voutes, 715 00, Heraklion
University Of Debrecen
Reumatológiai és Immunológiai Klinika, Moricz Zsigmond Korut 22, 4032, Debrecen
Revita Kft.
NA, Margit Korut 50-52 Fszt. 9, Kerulet, Budapest II
Obudai Egeszseguegyi Centrum Kft.
NA, Lajos Utca 74-76, 1036, Budapest III
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
Reumatológiai Centrum, Frankel Leo Ut 17-19, 1027, Budapest II
Complex Rendelo Med Zrt.
NA, Seregelyesi Ut 92, 8000, Szekesfehervar
Vasarhelyi Sarkanyfu Kft.
Porcika Klinika, Nagy Sandor Utca 11, 6800, Hodmezovasarhely
Vital-Medicina Kft.
NA, Jozsef Attila Utca 17, 8200, Veszprem
Qualiclinic Kft.
NA, Dereglye Utca 5 B, Ep I Em 3, Budapest
Kistarcsai Flor Ferenc Korhaz
Reumatológiai és Fizikoterápiás Osztály, Semmelweis Ter 1, 2143, Kistarcsa
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Reumatológiai Osztály, Szent Istvan Utca 68, 4400, Nyiregyhaza
Bekes Varmegyei Koezponti Korhaz
Reumatológiai Osztály, Semmelweis Utca 1, 5700, Gyula
Je-Med Bt.
NA, Kossuth Lajos Utca 9, 6300, Kalocsa
Rigas 1. slimnica SIA
Clinic for Dermatology and Sexually Transmitted Diseases, Bruninieku Iela 5, LV-1001, Riga
M & M centrs SIA
NA, Gaujas Iela 11, 6, Adazi Pagasts
Respublikine Siauliu ligonine VšĮ
Department of internal medicine, V. Kudirkos G. 99, Siauliu M. Sav., Siauliai
Viesoji Įstaiga Centro Poliklinika
Department of Rheumatology, Pylimo G. 3, Vilniaus M. Sav., Vilnius
Klaipedos universiteto ligonine VšĮ
Department of Rheumatology, Liepojos G. 41, Klaipedos M. Sav., Klaipeda
Kaunas city polyclinic Public institution
Department of Rheumatology, Pramones Pr. 31, Kauno M. Sav., Kovno
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia NCM, Ul. Glowackiego 8d/2, 67-100, Nowa Sol
Rcmed Oddzial Sochaczew
N/A, Aleja 600-Lecia 45, 96-500, Sochaczew
Klinika Reuma Park Sp. z o.o. S.K.
Centrum Medyczne Reuma Park, Aleja Wilanowska 333, 02-665, Warsaw
Wsd Medi Clinical Sp. z o.o.
WSD MEDI, Aleja Jana Rodowicza Anody 22 Lok U 4, 02-786, Warsaw
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Centrum Kliniczno - Badawcze J.Brzezicki, B.Górnikiewicz-Brzezicka Lekarze Spółka Partnerska, Ul. Studzienna 35-36/a, 82-300, Elblag
Centrum Medyczne Oporow
N/A, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
Wromedica I Bielicka A Strzalkowska s.c.
Wromedica, Ul. Adama Mickiewicza 91, 51-685, Wroclaw
Silmedic Sp. z o.o.
Silmedic Sp. z o.o. Oddział w Katowicach, Ul. Gen. Wladyslawa Sikorskiego 30 Lok 70, 40-282, Katowice
Futuremeds Sp. z o.o.
FutureMeds Gdynia, Ul. Wladyslawa IV 59, 81-384, Gdynia
Termedia Sp. z o.o.
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ ZESPÓŁ PORADNI SPECJALISTYCZNYCH "TERMEDICA", Ul. Boleslawa Chrobrego 101, 60-681, Poznan
Dc-Med Michal Kowalski sp.k.
DC-MED SK, Ul. Dworcowa 5, 58-100, Swidnica
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.
Nova Reuma, Ul Prowiantowa 15/4, 15-707, Bialystok
NZOZ Lecznica Mak Med s.c.
NZOZ Lecznica MAK-MED s.c., Ul. Wisniowa 22, 05-830, Nadarzyn
Rheuma Medicus Sp. z o.o.
Rheuma Medicus, Ul. Pruszkowska 6, 02-118, Warsaw
Somed Cr Sp. z o.o. sp.k.
Somed CR, Aleja Marszalka Jozefa Pilsudskiego 9, 90-368, Lodz
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Toruń, Ul. Stefana Batorego 18-22, 87-100, Torun
Reumedika Sp. z o.o.
REUMEDIKA BADANIA I ROZWÓJ, Ul. Wejherowska 16, 60-446, Poznan
Futuremeds Sp. z o.o.
FutureMeds Wrocław, Ul. Legnicka 16, 53-673, Wroclaw
Ai Centrum Medyczne Sp. z o.o.
AI CENTRUM MEDYCZNE, Ul. Swietojanska 1, 61-113, Poznan
Etg Zamosc Sp. z o.o.
ETG Zamość Poradnie Specjalistyczne, Ul. Gesia 3, 22-400, Zamosc
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ BIF-MED S.C. A. Wawiernia,M. Roykiewicz,R. Roykiewicz
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ BIF-MED S.C., Ul. Stefana Żeromskiego 18, 41-902, Bytom
K2J2 Katarzyna Viktoria Jachimowska
Centrum Medyczne K2J2, Ul. Drogowców 12, 42-202, Częstochowa
Unica Cr Sp. z o.o.
NSZOZ UNICA CR, Ul. Parkowa 9, 62-069, Dabrowka
Clinicmed Daniluk Nowak Sp. k.
ClinicMed, Ul. Stoleczna 7/200, 15-879, Bialystok
K2J2 Katarzyna Viktoria Jachimowska
Centrum Medyczne K2J2, ul. Gdyńska 1/3, 05-200, Wołomin
Futuremeds Sp. z o.o.
Futuremeds Targówek, Ul. Sw. Wincentego 93 Lok. 5/6 7, 03-291, Warsaw
Reumed Sp. z o.o.
Zespół Poradni Specjalistycznych REUMED WALLENRODA Filia nr 1, Ul. Konrada Wallenroda 2f/4, 20-607, Lublin
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Bydgoszcz, Ul. Jana Karola Chodkiewicza 19c, 85-065, Bydgoszcz
Futuremeds Sp. z o.o.
FutureMeds Kraków, Ul. Mikolaja Kopernika 32, 31-501, Cracow
Etg Warszawa Sp. z o.o.
ETG Warszawa, Ul. Wynalazek 4, 02-677, Warsaw
ETG Lublin Sp. z o.o.
ETG Lublin, Ul. Wladyslawa Kunickiego 26a, 20-412, Lublin
Lukmed 2 Sp. z o.o.
ETG Siedlce, Ul. Mlynarska 16 B, 08-110, Siedlce
Medyczne Centrum Hetmańska
N/A, Ul. Hetmańska 55/1, 60-218, Poznań
Malopolskie Centrum Kliniczne
N/A, Ul. Balicka 12a/5b, 30-149, Cracow
ETG Lublin Sp. z o.o.
ETG Dębica, Ul. Czarnieckiego 5, 39-200, Debica
REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler
N/A, ul. Hetmanska 27 lok. U26, 04-305, Warszawa
Med Polonia Sp. z o.o.
Przychodnia MED-POLONIA, Obornicka 262, 60-693, Poznan
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Szpital Uniwersytecki Nr 2 im Biziela, Klinika Reumatologii i Układowych Chorób Tkanki Łącznej, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Malopolskie Badania Kliniczne Sp. z o.o.
Małopolskie Badania Kliniczne, Ul. Pradnicka 12/502, 30-002, Cracow
Futuremeds Sp. z o.o.
Futuremeds Łódź, Ul. Gruszowa 2, 91-363, Lodz
Prywatna Praktyka Lekarska Prof Dr Hab Med Pawel Hrycaj
N/A, Os. Rzeczypospolitej 6/202, 61-397, Poznan
Centrum Medyczne Justmed Sp. z o.o.
Centrum Medyczne JustMed, Ul. Marymoncka 14/ U1 U2, 01-869, Warsaw
Ambulatorium Sp. z o.o.
Ambulatorium Przychodnie Medyczne, Ul. Topolowa 28, 82-300, Elblag
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia PCM, Ul. Marcelinska 92, 60-324, Poznan
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Etyka Ośrodek Badań Klinicznych, Ul. 1 Maja 13 C, 10-117, Olsztyn
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Warszawa, Ul Wronia 53 Lok B 10, 00-874, Warsaw
Clinica Medico Cirurgica de Santa Tecla, SA – Hospital Lusiadas Braga
Rheumatology, Rua Dr. Francisco Duarte, 4715-017, Braga
Unidade Local De Saude Do Alto Minho E.P.E.
Rheumatology, Largo Conde De Bertiandos, 4990-041, Ponte De Lima
Instituto Portugues De Reumatologia
Rheumatology, Rua Da Beneficencia Nr 7, 1050-034, Lisbon
Lusiadas S.A.
Rheumatology, Rua Abilio Mendes 12, 1500-458, Lisbon
Unidade Local De Saude De Santa Maria E.P.E.
Rheumatology, Avenida Professor Egas Moniz, 1649-035, Lisbon
CCAB Centro Clinico Academico Braga Associacao
Rheumatology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Hiperdia S.A.
N/A, Soseaua Oltenitei Sector 4 Nr 87-99, 041312, Bucharest
Policlinica CCBR S.R.L.
N/A, Aleea Buchetului 2 Block C2 Sector 3, 030463, Bucharest
Centrul De Kinetoterapie Si Masaj Banat S.R.L.
Medical Recovery, Rheumatology, Elisabeta Rizea Street 5, 300650, Timisoara
Spitalul Clinic Dr. I. Cantacuzino
Internal Medicine I, Strada Movila Ion 5-7, 020475, Bucharest
Saint Maria Hospital
Rheumatology and Internal Medicine I, Bulevardul Mihalache Ion 37-39, 011172, Bucharest
Artromac N.O.
Reumatologická ambulancia, Toryska 275/1, Zapad, Kosice
Reumamed Poprad s.r.o.
Reumatologická ambulancia, Rovna 5614/19, Spisska Sobota, Poprad
Medman s.r.o.
Reumatologická ambulancia, Thurzova 437/15, 036 01, Martin
Reumex s.r.o.
Reumatologická ambulancia, Zeleznicna 686/23, 979 01, Rimavska Sobota
Parc Tauli Hospital Universitari
Rheumatology, Parc Del Tauli 1, 08208, Sabadell
Futuremeds Spain S.L.
Rheumatology, Calle De La Granja 8, 28003, Madrid
Hospital Universitario Virgen De La Macarena
Rheumatology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Quironsalud Infanta Luisa
Rheumatology, Calle De San Jacinto 87, 41010, Sevilla
Hospital Universitario La Paz
Rheumatology, Paseo De La Castellana 261, 28046, Madrid
Hospital General Universitario De Castellon
Rheumatology, Avenida De Benicasim S/n, 12004, Castello De La Plana
University Hospital Virgen Del Rocio S.L.
Rheumatology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Clinica Gaias Santiago
Rheumatology, Rua Do Pintor Xaime Quesada N 2-4, 15702, Santiago De Compostela
Complexo Hospitalario Universitario De Santiago
Rheumatology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Quironsalud Sagrado Corazon
Rheumatology, Calle De Rafael Salgado 3, 41013, Sevilla
Consorcio Hospital General Universitario De Valencia
Rheumatology, Avenida Tres Cruces 2, 46014, Valencia
Accellacare Espana S.L.
Rheumatology, Calle Del Marques De La Valdavia 103 Bajo Local, 28100, Alcobendas
Complexo Hospitalario Universitario A Coruna
Rheumatology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Regional De Malaga
Rheumatology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario Basurto
Rheumatology, Montevideo Etorbidea 16-18, 48013, Bilbao
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 92 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-522471-28-00_Greek_redacted | 2.1 EU |
| Protocol (for publication) | D1_Protocol_2025-522471-28-00_redacted | 2.1 EU |
| Recruitment arrangements (for publication) | K1_BG_Recruitment Procedure_Bulgarian | 1.0 |
| Recruitment arrangements (for publication) | K1_CZ_Recruitment Procedure_Bilingual | 1-0 |
| Recruitment arrangements (for publication) | K1_DE_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_EE_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_EL_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_ES_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_FI_Recruitment Procedure_Finnish | 1.1 |
| Recruitment arrangements (for publication) | K1_FR_Recruitment Procedure_Bilingual | 1.0 |
| Recruitment arrangements (for publication) | K1_HR_Recruitment Procedure Template | 1.0 |
| Recruitment arrangements (for publication) | K1_HU_Recruitment Procedure_Recruit-ICF Process | 1.0 |
| Recruitment arrangements (for publication) | K1_LT_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_LV_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_PL_Recruitment Procedure_Polish | 1.1 |
| Recruitment arrangements (for publication) | K1_PT_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_RO_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_SK_Recruitment Procedure | 1.1 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main_Bulgarian_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Main_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Pregnant Partner_Bulgarian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_BG_SIS-ICF_Pregnant Partner_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Data Privacy_Czech_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Greenphire_Czech | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Main_Czech_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_CZ_SIS-ICF_Pregnant Partner_Czech_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Greenphire_German | 1.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Main_German_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Pregnancy_German_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_EE_SIS-ICF_Main_Estonian_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1_EE_SIS-ICF_Main_Russian_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1_EE_SIS-ICF_Pregnant Partner_Estonian_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_EE_SIS-ICF_Pregnant Partner_Russian_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Main_Greek_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_EL_SIS-ICF_Pregnant Partner_Greek_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS ICF_Main_Spanish_redacted | 1.4 |
| Subject information and informed consent form (for publication) | L1_ES_SIS ICF_Preg Partner_spanish_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Adults_Finnish_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_FI_SIS-ICF_Pregnant Partner_Finnish_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Greenphire_French_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main_French_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Pregnant Partner_French_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_HR_SIS-ICF_Greenphire_Croatian | 1.0 |
| Subject information and informed consent form (for publication) | L1_HR_SIS-ICF_Main_Croatian_redacted | 1.4 |
| Subject information and informed consent form (for publication) | L1_HR_SIS-ICF_Pregnant Participant_Croatian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_HR_SIS-ICF_Pregnant Partner_Croatian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Main_Hungarian_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_HU_SIS-ICF_Pregnant Partner_Hungarian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_LT_SIS ICF_Main_Lithuanian_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1_LT_SIS ICF_Pregnant Partner_Lithuanian_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_LV_SIS-ICF_Main_Latvian_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_LV_SIS-ICF_Main_Russian_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_LV_SIS-ICF_Pregnant Partner_Latvian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_LV_SIS-ICF_Pregnant Partner_Russian_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Main_Polish_redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1_PL_SIS-ICF_Pregnancy Data Collection_Polish_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Main_Portuguese_redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_PT_SIS-ICF_Pregnancy_Portuguese_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Main_Romanian_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnant Partner_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_RO_SIS-ICF_Pregnant Partner_Romanian_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SK_SIS-ICF_Main_Slovak_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SK_SIS-ICF_Pregnant Partner_Slovak_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SK_SIS-ICF_Privacy_Slovak_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_HU_Other Subject Material_List of Submitted Documents_bilingual_redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00_Bulgarian | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00_Croatian | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00_Czech | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00_Estonian | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00_French | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00_Greek | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00_Hungarian | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00_Latvian | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00_Lithuanian | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00_Polish | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00_Portuguese | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00_Romanian | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Summary_2025-522471-28-00_Slovak | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522471-28-00_Bulgarian_redacted | 2.1 EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522471-28-00_Croatian_redacted | 2.1 EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522471-28-00_Czech_redacted | 2.1 EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522471-28-00_French_redacted | 2.1 EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522471-28-00_Greek_redacted | 2.1 EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522471-28-00_Hungarian_redacted | 2.1 EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522471-28-00_Latvian_redacted | 2.1 EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522471-28-00_Lithuanian_redacted | 2.1 EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522471-28-00_Portuguese_redacted | 2.1 EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522471-28-00_redacted | 2.1 EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522471-28-00_Slovak_redacted | 2.1 EU |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522471-28-00_Spanish_redacted | 2.1 EU |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-31 | Finland | Acceptable 2026-02-25
|
2026-02-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-09 | Acceptable 2026-02-25
|
2026-03-09 |