Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
166
Countries
13
Sites
76
Active, refractory systemic lupus erythematosus (SLE), and active, refractory lupus nephritis (LN)
To evaluate the efficacy of rapcabtagene autoleucel at a target dose of CAR-positive viable T cells as a single infusion with respect to complete renal response (CRR) at Week 52 after rapcabtagene autoleucel infusion. To demonstrate the superiority of rapcabtagene autoleucel at a target dose of CAR-positive viable…
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 11 Dec 2024 → ongoing
- Decision date (initial)
- 2025-03-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Novartis Pharma AG
External identifiers
- EU CT number
- 2023-510150-17-00
- WHO UTN
- U1111-1309-0426
- ClinicalTrials.gov
- NCT06581198
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate the efficacy of rapcabtagene autoleucel at a target dose of CAR-positive viable T cells as a single infusion with respect to complete renal response (CRR) at Week 52 after rapcabtagene autoleucel infusion.
To demonstrate the superiority of rapcabtagene autoleucel at a target dose of CAR-positive viable T cells as a single infusion.
To evaluate the efficacy of rapcabtagene autoleucel at a target dose of CAR-positive viable T cells as a single infusion with respect to DORIS at Week 24 after rapcabtagene autoleucel infusion.
To evaluate the efficacy of rapcabtagene autoleucel at a target dose of CAR-positive viable T cells as a single infusion with respect to DORIS at Week 52 after rapcabtagene autoleucel infusion.
Secondary objectives 5
- To assess the efficacy of rapcabtagene autoleucel in terms of DORIS (Definition Of Remission In Systemic Lupus Erythematosus) remission, low disease status, absence of flares, requirement for glucocorticoids, and absence of antinuclear antibodies up to Week 52.
- To assess the overall safety and tolerability of rapcabtagene autoleucel in the LN population
- To demonstrate the superiority of rapcabtagene autoleucel in terms of complete renal response, low disease status, absence of flares, requirement for glucocorticoids, and absence of antinuclear antibodies up to Week 52.
- To assess the overall safety and tolerability of rapcabtagene autoleucel
- To evaluate whether patients who received rapcabtagene autoleucel and who achieve remission at Week 52 continue to remain in remission at later timepoints.
Conditions and MedDRA coding
Active, refractory systemic lupus erythematosus (SLE), and active, refractory lupus nephritis (LN)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
| 21.1 | PT | 10025140 | Lupus nephritis | 100000004857 |
Regulatory references
- Scientific advice from competent authorities
- Paul-Ehrlich-Institut
- Plan to share IPD
- Yes
- IPD plan description
- Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Signed informed consent must be obtained prior to participation in the study.
- Men and women with SLE, aged ≥18 years and ≤75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE.
- Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer (on HEp-2 cells or an equivalent positive test), or anti-dsDNA (above the ULN); or anti-Sm (above the ULN) as determined by a central laboratory.
- Active lupus nephritis without signs of significant chronicity as defined by: retest during screening of any of the lab assessments for inclusion is permitted with an Investigator’s justification. Active SLE with non-renal significant organ involvement as defined by: BILAG-2004 disease activity level (Isenberg et al 2005, Yee et al 2006, Yee et al 2010, Isenberg et al 2011) in at least 1 of the following: • BILAG-2004 Level A disease in ≥ 1 organ system within the past 3 months with at least BILAG B in the same organ system at screening • BILAG-2004 Level B disease in ≥ 2 organ systems at screening
- points (Gladman et al 2002, Touma et al 2011), excluding points attributed to “fever”, “lupus headache”, "alopecia", and “organic brain syndrome.
Exclusion criteria 6
- Any acute, severe lupus related-flare at and during screening that needs immediate treatment other than pulse GCs and/or makes the immunosuppressive washout impossible and, thus, makes the participant ineligible for CD19 CAR-T therapy.
- Inadequate organ function during screening.
- History of, or current ECG or cardiac abnormalities indicating significant risk of safety for participants.
- Human immunodeficiency virus (HIV) positivity at screening.
- Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV).:
- Evidence of active or latent tuberculosis (TB) infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Complete renal response (CRR) at Week 52.
- Achieving DORIS defined as meeting the criteria of the Definition Of Remission In Systemic Lupus Erythematosus (DORIS) at Week 52 defined as in Section 8.3.1
- DORIS is defined as meeting the criteria of the Definition Of Remission In Systemic Lupus Erythematosus (DORIS): • Clinical SLEDAI-2K of 0 at the respective timepoint AND • Achieving a Physician Global Assessment (PhGA) score of < 0.5 at that timepoint AND • Stable immunomodulatory/immunosuppressive treatment
Secondary endpoints 9
- DORIS at Week 52
- Number of weeks where Lupus Low Disease Activity Score (LLDAS) was achieved until Week 52
- Absence of flaring (i.e., 1 new BILAG2004 A or 2 new BILAG2004 B flares) through Week 52
- Annualized cumulative corticosteroids dose until Week 52
- Negative serological status at Week 52
- FACIT-Fatigue score change from baseline to Week 52
- Achieving DORIS at Week 52 and continuing to remain in remission as per the DORIS criteria.
- Safety parameters including vital signs, adverse events, laboratory parameters and ECG evaluation
- Complete renal response (CRR) at Week 52
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10998958 · Product
- Active substance
- Rapcabtagene Autoleucel
- Substance synonyms
- AUTOLOGOUS T CELLS TRANSDUCED WITH LENTIVIRAL VECTOR CONTAINING A CHIMERIC ANTIGEN RECEPTOR DIRECTED AGAINST CD19, CONTAINING PRESERVED PUTATIVE T STEM CELLS, YTB323
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 Other
- Max total dose
- 00 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVARTIS PHARMA AG
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 9
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- HARD CAPSULES
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
SUB31127 · Substance
- Active substance
- Voclosporin
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 g gram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
SUB10797MIG · Substance
- Active substance
- Tacrolimus
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 g gram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
SUB09098MIG · Substance
- Active substance
- Mycophenolic Acid
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
SUB25607 · Substance
- Active substance
- Belimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- UNKNOWN USE
- Max daily dose
- 00 mg/Kg milligram(s)/kilogram
- Max total dose
- 00 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
SUB12570MIG · Substance
- Active substance
- Rituximab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/23/2816
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
SUB12570MIG · Substance
- Active substance
- Rituximab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 260 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/23/2816
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
SUB05647MIG · Substance
- Active substance
- Azathioprine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/14/1335
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
Auxiliary 3
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
SUB20313 · Substance
- Active substance
- Tocilizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
SUB13897MIG · Substance
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 00 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Third parties 22
| Organisation | City, country | Duties |
|---|---|---|
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Almac Diagnostic Services Limited ORG-100040447
|
Craigavon, United Kingdom (Northern Ireland) | Other, Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Boston, United States | Other, Laboratory analysis |
| Navigate Biopharma Services Inc. ORG-100032721
|
Carlsbad, United States | Other, Laboratory analysis |
| EPL Pathology Archives LLC ORG-100042096
|
Leesburg, United States | Other |
| Clinigma ApS ORG-100044615
|
Copenhagen K, Denmark | Other |
| Publicis Healthcare Communications Group Limited ORG-100044665
|
London, United Kingdom | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| SGS France ORG-100011566
|
St Benoit, France | Other, Laboratory analysis |
| Somalogic Operating Co. Inc. ORG-100042788
|
Boulder, United States | Other, Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Interactive response technologies (IRT) |
| Clinical Ink Inc. ORG-100042433
|
Winston Salem, United States | Other |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Code 12 |
| Veeda Clinical Research Limited ORG-100012827
|
Ahmedabad, India | Other, Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Eurofins Genomics Europe AgriGenomics Products & Services A/S ORG-100044656
|
Aarhus N, Denmark | Other |
| Mag. Andreas Raffeiner GmbH ORG-100043223
|
Walding, Austria | Code 8 |
Locations
13 EU/EEA countries · 76 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 4 | 3 |
| Czechia | Ongoing, recruiting | 7 | 3 |
| Denmark | Ongoing, recruiting | 2 | 1 |
| France | Ongoing, recruiting | 11 | 24 |
| Germany | Ongoing, recruiting | 19 | 11 |
| Hungary | Ongoing, recruiting | 4 | 2 |
| Italy | Ongoing, recruiting | 12 | 9 |
| Netherlands | Ongoing, recruiting | 8 | 4 |
| Norway | Ongoing, recruiting | 3 | 1 |
| Poland | Authorised, recruitment pending | 3 | 4 |
| Romania | Ongoing, recruiting | 2 | 1 |
| Spain | Ongoing, recruiting | 15 | 12 |
| Sweden | Ongoing, recruiting | 3 | 1 |
| Rest of world
Switzerland, Korea, Republic of, United States, Israel, United Kingdom, Mexico, Taiwan, Singapore, Argentina, Brazil, Canada, Japan, Australia, Saudi Arabia
|
— | 73 | — |
Investigational sites
Medizinische Universitaet Innsbruck
1806:Department of Internal Medicine, Clinical Division of Internal Medicine II, Anichstrasse 35, 6020, Innsbruck
Medical University Of Graz
1801: Department of Rheumatology, Neue Stiftingtalstrasse 6, 8010, Graz
Medical University of Vienna
1804: Department of Rheumatology, Waehringer Guertel 18-20, Alsergrund, Vienna
University Hospital Olomouc
1702: Nephrology, Zdravotniku 248/7, 779 00, Olomouc
Vseobecna Fakultni Nemocnice V Praze
1703: Nephrology, U Nemocnice 499/2, Nove Mesto, Prague
Revmatologicky Ustav
1701: Rheumatology, Na Slupi 450/4, Nove Mesto, Prague 2
Aarhus University Hospital
2101: Afdeling for Nyresygdomme, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Assistance Publique Hopitaux De Paris
1009: Medecine Interne, 149 Rue De Sevres, 75015, Paris
Centre Hospitalier Universitaire De Bordeaux
1002: Nephrologie – Transplanation – Dialyse - Apherese, 1 Rue Jean Burguet, 33000, Bordeaux
Les Hopitaux Universitaires De Strasbourg
1004: Service de Medecine Interne et immunologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Rennes
1005: Medecine Interne, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Nantes
1008: Nephrologie et Immunologie Clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Assistance Publique Hopitaux De Paris
1009: Medecine Interne, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Assistance Publique Hopitaux De Paris
1010: Medecine Interne, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
CHRU De Nancy
1007: Medecine Interne et Immunologie Clinique, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Centre Hospitalier Universitaire De Toulouse
1006: Nephrologie et transplantation d’organes, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Bordeaux
1002: Nephrologie – Transplanation – Dialyse - Apherese, Avenue De Magellan, 33600, Pessac
Institut Universitaire Du Cancer Toulouse-Oncopole
1006: Nephrologie et transplantation d’organes, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Paoli Calmettes
1011: Nephrologie et transplantation rénale, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Regional De Marseille
1011: Nephrologie et transplantation rénale, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Regional De Marseille
1011: Nephrologie et transplantation rénale, 147 Boulevard Baille, 13005, Marseille
Assistance Publique Hopitaux De Paris
1001: Medecine Interne 2, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Centre Hospitalier Universitaire De Rennes
1005: Medecine Interne, 16 Boulevard De Bulgarie, Bp 90349, Rennes
Centre Hospitalier Universitaire De Nantes
1008: Nephrologie et Immunologie Clinique, 38 Boulevard Jean Monnet, 44000, Nantes
Les Hopitaux Universitaires De Strasbourg
1004: Service de Medecine Interne et immunologie, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire De Lille
1003: Medecine Interne, 1 Place De Verdun, 59000, Lille
Centre Hospitalier Universitaire De Bordeaux
1002: Nephrologie – Transplanation – Dialyse - Apherese, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Universitaire De Montpellier
1012: Rhumatologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
University Hospital Of Clermont-Ferrand
1013: Medecine Interne, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
University Hospital Of Clermont-Ferrand
1013: Medecine Interne, 58 Rue Montalembert, 63000, Clermont-Ferrand
Centre Hospitalier Universitaire De Montpellier
1012: Rhumatologie, 371 Avenue Du Doyen Gaston Giraud, 34091, Montpellier Cedex 5
Universitaetsklinikum Essen AöR
1101: Klinik fuer Infektiologie, Hufelandstrasse 55, Holsterhausen, Essen
Klinikum Nuernberg
1105: Klinikum fuer Innere Medizin 5, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Universitaetsklinikum Jena KöR
1103: Klinik für Innere Medizin III, Rheumatologie/Osteologie, Am Klinikum 1, Lobeda, Jena
University Hospital Cologne AöR
1104:Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Robert Bosch Krankenhaus GmbH
1112:Klinik fuer Allgemeine Innere Medizin und Nephrologie, Auerbachstrasse 110, Bad Cannstatt, Stuttgart
Universitaetsklinikum Bonn AöR
1109: Medizinische Klinik und Poliklinik III, Venusberg-Campus 1, Venusberg, Bonn
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
1102: Fraunhofer Institute For Translational Medicine And Pharmacology ITMP, Theodor-Stern-Kai 7, Sachsenhausen, Frankfurt Am Main
Universitaetsklinikum Ulm AöR
1106: Zentrum fuer Innere Medizin, Innere Medizin III, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Schleswig-Holstein AöR
1115:Klinik für Rheumatologie, Ratzeburger Allee 160, 23538, Luebeck
Universitaetsklinikum Leipzig AöR
1111: Klinik und Poliklinik fuer Endokrinologie,Nephrologie, Rheumatologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
1107: I. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Semmelweis University
2001: Department of Rheumatology and Immunology, Frankel Leo Ut 38-40, Kerulet, Budapest
University Of Debrecen
2002: Department of Internal Medicine, Nagyerdei Korut 98, 4032, Debrecen
Azienda Sanitaria Locale Di Pescara
1206: U.O. di Reumatologia Dipartimento Medico, Via Renato Paolini 47, 65124, Pescara
Azienda Ospedaliero Universitaria Pisana
1202: U.O. Reumatologia, Via Roma 67, 56126, Pisa
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
1210:U.O. Medicina Generale, Immunologia ed Allergologia, Via Pace 9, 20122, Milan
Fondazione IRCCS Policlinico San Matteo
1209: S.C. Reumatologia, Viale Camillo Golgi 19, 27100, Pavia
Ospedale San Raffaele S.r.l.
1201: U.O. di Immunologia, Reumatologia, Allergologia e Malattie Rare, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
1211: S.C. Nefrologia, Via Venezia 16, 15121, Alexandria
Azienda Ospedaliero Universitaria Delle Marche
1203: S.O.D. Clinica Medica, Via Conca 71, 60126, Ancona
Humanitas Mirasole S.p.A.
1204: U.O. Reumatologia, Via Alessandro Manzoni 56, 20089, Rozzano
IRCCS Ospedale Policlinico San Martino
1207: U.O. di Medicina Interna e Immunologia Dip. di Medicina Interna - DIMI, Viale Benedetto XV 6, 16132, Genoa
Radboud universitair medisch centrum / RADBOUDUMC
1304: Nephrology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Universitair Medisch Centrum Groningen
1303: Rheumatology, Hanzeplein 1, 9713 GZ, Groningen
Leids Universitair Medisch Centrum (LUMC)
1301: Hematology, Albinusdreef 2, 2333 ZA, Leiden
Universitair Medisch Centrum Utrecht
1302: Rheumatology and Clinical immunology, Heidelberglaan 100, 3584 CX, Utrecht
Oslo University Hospital HF
2401: Department of rheumatology dermatology, and infectious disease, Sognsvannsveien 20, 0372, Oslo
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
2501:Klinika Nefrologii, Hipertensjologii, Transplantologii i Chorób Wewnętrznych, Ul. Pomorska Nr 251, 92-213, Lodz
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
2501:Oddział Hematologii, Transplantologii i Chorób Wewnętrznych - Klinika Hematologii, Ul. Pabianicka 62, 93-513, Lodz
Uniwersytecki Szpital Kliniczny W Poznaniu
2502: Oddział Kliniczny Nefrologii, Transplantologii i Chorób Wewnętrznych, Ul. Stanislawa Przybyszewskiego 49, 60-355, Poznan
Uniwersytecki Szpital Kliniczny W Poznaniu
2502:Katedra i Klinika Hematologii i Transplantacji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Hospital Universitario Marques De Valdecilla
1406: Reumatología, Avenida Valdecilla Sn, 39008, Santander
Clinica Universidad De Navarra
1411: Nefrología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitari Vall D Hebron
1402: Reumatología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Complexo Hospitalario Universitario De Santiago
1403: Reumatología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Clinica Universidad De Navarra
1411: Nefrología, Pio XII Etorbidea 36, 31008, Pamplona
Bellvitge University Hospital
1401: Reumatología, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Hospital Universitario Y Politecnico La Fe
1409: Reumatología, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario 12 De Octubre
1405: Reumatología, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital General Universitario Gregorio Maranon
1404: Reumatología, Calle Del Doctor Esquerdo 46, 28007, Madrid
Complexo Hospitalario Universitario De Vigo
1410: Reumatologia, Estrada Clara Campoamor N 341, 36312, Vigo
Hospital Universitario De Salamanca
1408: Reumatología, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Reina Sofia
1407: Reumatología, Avenida Menendez Pidal S/n, 14004, Cordoba
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-11-11 | 2025-11-11 | |||
| Czechia | 2025-07-08 | 2025-07-08 | |||
| Denmark | 2026-01-29 | 2026-01-29 | |||
| France | 2025-05-08 | 2025-05-08 | |||
| Germany | 2024-12-11 | 2024-12-11 | |||
| Hungary | 2026-01-30 | 2026-01-30 | |||
| Italy | 2025-05-20 | 2025-05-20 | |||
| Netherlands | 2025-09-16 | 2025-09-16 | |||
| Norway | 2025-12-03 | 2025-12-03 | |||
| Romania | 2025-10-15 | 2025-10-15 | |||
| Spain | 2025-05-07 | 2025-05-07 | |||
| Sweden | 2026-04-23 | 2026-04-23 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-IT-0001
- Member state
- Italy
- Publication date
- 2025-09-10
- Type
- 1
- Reason
- 6
- Reverted date
- 2025-09-10
- Immediate action required
- Yes
- Notes
- Reverted (2025-09-10)
- Justification
- Dear Applicant,
Considering the expiration of the three-year mandate of the members of the National Ethics Committee (CEN) for clinical trials relating to advanced therapies (“ATMP”) and of the National Ethics Committee (CEN) for clinical trials in the pediatric field, appointed by Decree of the Minister of Health - 2 March 2022;
Considering the fact that, due to the expiration of the mandate of the members of the aforementioned National Ethics Committee (CEN), for the procedure in subject the assessment of the aspects relating to Part II of the evaluation report pursuant to art. 7 of the aforementioned Regulation (EU) No. 536/2014 has not been carried out, and as a result there is no conclusion of Part II for the EU CT 2023-510150-17-00 procedure (AIFA authorization provision n° 098416);
In compliance with CHAPTER XIII (SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS) of Regulation 536/2014 with specific reference to Article 77 (Corrective measures to be taken by Member States):
1. Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
(a) revoke the authorisation of a clinical trial;
(b) suspend a clinical trial;
(c) require the sponsor to modify any aspect of the clinical trial.
A corrective measure is applied suspending the trial. This corrective measure is only applicable to Italy.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 186 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol - Signature Page_2023-510150-17-00_1_English_Red | v02-EEA.01 |
| Protocol (for publication) | D1_Protocol_2023-510150-17-00_1_English_Red | v02-EEA.01 |
| Protocol (for publication) | D4_Patient-facing document - PRO_1_English_Note to Assessor_NonRed | 06Jun2024 |
| Protocol (for publication) | D4_Patient-facing document - PRO_6_English_Note to Assessor_NonRed | 06Jun2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_AT_English_NonRed | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_CZ_NonRed | V2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DE_English_NonRed | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DK_English_NonRed | v3 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_ES_Spanish_NonRed | 09Feb2026 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_FR_NonRed | 02 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_HU_English_NonRed | v1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_IT_English_NonRed | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_NL_English_NonRed | v01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_NO_English_NonRed | v.03 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_PL_Polish_NonRed | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_RO_Romanian_NonRed | v2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_SE_Swedish_NonRed | 2 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_1_DE_German_NonRed | 1.2 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_1_DK_Danish_Red | 1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_1_ES_Spanish_Red | 1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_1_IT_Italian_Red | 1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_2_DE_German_NonRed | 2.0 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_2_DK_Danish_Red | 1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_2_ES_Spanish_NonRed | 1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_2_FR_Red | 1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_2_IT_Italian_NonRed | 1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_3_DK_Danish_NonRed | 1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_3_ES_Spanish_Red | 1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_3_FR_NonRed | 1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_3_IT_Italian_Red | 1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_4_FR_Red | 1 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_5_FR_French_Red | 01 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_6_FR_French_Red | 01 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_7_FR_French_Red | 01 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_8_FR_French_Red | 02 |
| Recruitment arrangements (for publication) | K2_Advertisements - Country_9_FR_French_Red | 01 |
| Subject information and informed consent form (for publication) | L1_ICF Main ICF Study Treatment_1_HU_Hungarian_Red | v02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Additional Biomarkers_1_DE_German_Red | v02.03.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_AT_English_NonRed | 02.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_AT_German_NonRed | 02.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_CZ_Czech_NonRed | V02.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_DE_German_NonRed | v02.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_DK_Danish_NonRed | V02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_ES_Spanish_NonRed | v02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_FR_French_Red | 02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_HU_Hungarian_NonRed | v02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_IT_Italian_NonRed | 02.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_NL_Dutch_NonRed | v02010102 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_NO_Norwegian_NonRed | v.02.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_PL_Polish_NonRed | 02.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_RO_Romanian_Red | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_SE _Swedish_Red | 02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_AT_German_Red | 02.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_CZ_Czech_NonRed | V02.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_DE_German_NonRed | v02.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_ES_Spanish_NonRed | v02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_HU_Hungarian_NonRed | v02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_IT_Italian_NonRed | 02.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_NL_Dutch_NonRed | v02010102 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_PL_Polish_NonRed | 02.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_RO_Romanian_Red | v02.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_AT_German_Red | 02.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_CZ_Czech_Red | V02.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_DE_German_Red | v02.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_ES_Spanish_Red | v02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_FR_French_Red | 02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_HU_Hungarian_Red | v02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_NL_Dutch_Red | V02010100 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_NO_Norwegian_Red | v02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_PL_Polish_Red | 02.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_RO_Romanian_Red | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_SE_Swedish_Red | 02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_2_CZ_Czech_Red | V02.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_AT_English_Red | 02.03.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_AT_German_Red | 02.03.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_CZ_Czech_Red | V02.03.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DE_German_Red | v02.03.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DK_Danish_Red | V02.03.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_ES_Spanish_Red | v02.03.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_FR_French_Red | 02.03.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_HU_Hungarian_Red | v02.03.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_IT_Italian_Red | 02.03.06 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_NL_Dutch_Red | v02030402 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_NO_Norwegian_Red | v02.03.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PL_Polish_Red | 02.03.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_RO_Romanian_Red | v02.03.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_SE_Swedish_Red | v02.03.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_CZ_Czech_Red | V02.03.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_FR_French_Red | v01.02.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_SE_Swedish_Red | 02.03.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_3_FR_French_Red | 02.03.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_3_SE_Swedish_Red | 02.03.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_CZ_Czech_Red | V02.03.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_DK_Danish_Red | V02.03.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_2_CZ_Czech_NonRed | V1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_3_CZ_Czech_Red | V01.02.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_4_CZ_Czech_Red | V02.03.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional_1_IT_Italian_Red | 02.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnancy Follow up Parent Legal Guardian_1_FR_French_Red | 02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Research_1_AT_English_Red | 02.02.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Research_1_AT_German_Red | 02.02.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Research_1_CZ_Czech_Red | V02.02.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Research_1_ES_Spanish_Red | v02.02.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Research_1_HU_Hungarian_Red | v02.02.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Research_1_IT_Italian_Red | 02.02.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Research_1_PL_Polish_Red | 02.02.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Research_1_RO_Romanian_Red | v02.02.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Research_1_SE_Swedish_Red | 02.02.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Research_2_CZ_Czech_Red | V02.02.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Research_2_HU_Hungarian_Red | v02.02.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_CZ_Czech_Red | V02.03.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_2_CZ_Czech_Red | V02.03.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Study Treatment _1_DK_Danish_Red | V02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Study Treatment _1_NL_Dutch_Red | V02010100 |
| Subject information and informed consent form (for publication) | L1_ICF - Study Treatment _1_NO_Norwegian_Red | v02.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Study Treatment _1_SE_Swedish_Red | 02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Study Treatment_1_AT_English_Red | 02.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Study Treatment_1_AT_German_Red | 02.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Study Treatment_1_CZ_Czech_Red | V02.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Study Treatment_1_ES_Spanish_Red | v02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Study Treatment_1_FR_French_Red | 02.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Study Treatment_1_IT_Italian_Red | 02.01.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Study Treatment_1_PL_Polish_Red | 02.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Study treatment_1_RO_Romanian_Red | v02.01.02 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents Part II_1_CZ_English_NonRed | 09Oct2025 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents Part II_2_HU_Red | 11DEC2025 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents_1_HU_Red | v1 |
| Subject information and informed consent form (for publication) | L1_Patient Card_1_Czech_NonRed | 24Jan2024 |
| Subject information and informed consent form (for publication) | L1_Patient Card_1_German_NonRed | 05Dec2012 |
| Subject information and informed consent form (for publication) | L1_Patient Card_1_HU_Hungarian_Red | v2.0 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_AT_German_Red | 1.0 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_CZ_Red | V1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_DE_Red | 1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_HU_Red | v1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_NO_Norwegian_Red | 12Feb2025 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_PL_Polish_Red | v.1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_RO_Romanian_NonRed | v1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_SE_Swedish_Red | 1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_AT_German_Red | V1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_CZ_Red | V1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_DE_Red | 1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_HU_NonRed | v1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_NO_Norwegian_Red | 12Feb2025 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_PL_Polish_Red | v.1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_RO_Romanian_Red | v1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_SE_Swedish_NonRed | 1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_AT_German_Red | V1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_CZ_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_DE_NonRed | 1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_HU_Red | v1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_NO_Norwegian_NonRed | 12Feb2025 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_PL_Polish_NonRed | v.1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_RO_Romanian_Red | v1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_SE_Swedish_Red | 1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_4_AT_German_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_4_DE_German_Red | 4.0 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_5_AT_German_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_6_AT_German_NonRed | V1 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_DE_English_NonRed | 01 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_ES_Spanish_NonRed | 18Sep2025 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_HU_English_NonRed | v1.0 |
| Subject information and informed consent form (for publication) | L2_Subject Info Sheet or Other Info_1_NL_Dutch_Red | 1 |
| Subject information and informed consent form (for publication) | L2_Subject Info Sheet or Other Info_2_NL_Dutch_NonRed | 1 |
| Subject information and informed consent form (for publication) | L2_Subject Info Sheet or Other Info_3_NL_Dutch_Red | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Azathioprine_English_NonRed | 26Mar2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Belimumab_English_NonRed | 20Jan2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Cyclophosphamide_English_NonRed | 06Apr2021 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Envarsus_English_NonRed | 11Apr2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Mycophenolate mofetil_English_NonRed | 17Feb2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Mycophenolic acid_English_NonRed | 23Jan2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Rituximab_English_NonRed | 03Apr2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Tacrolimus_English_NonRed | 27Feb2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Voclosporin_English_NonRed | 27Nov2024 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-510150-17-00_1_Czech_NonRed | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-510150-17-00_1_Dutch_NonRed | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-510150-17-00_1_English_NonRed | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-510150-17-00_1_French_NonRed | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-510150-17-00_1_Hungarian_NonRed | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-510150-17-00_1_Italian_NonRed | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-510150-17-00_1_Norwegian_NonRed | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-510150-17-00_1_Romanian_NonRed | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-510150-17-00_1_Spanish_NonRed | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-510150-17-00_1_Swedish_NonRed | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Technical Language_2023-510150-17-00_1_Czech_Red | V3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Technical Language_2023-510150-17-00_1_German_Red | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Technical Language_2023-510150-17-00_1_Hungarian_Red | v02.02 |
Application history
17 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-12 | Germany | Acceptable 2024-09-30
|
2024-09-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-04 | Germany | Acceptable 2024-09-30
|
2024-11-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-04 | Acceptable | 2025-01-22 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-05 | Acceptable | 2024-12-02 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-13 | Acceptable | 2025-02-13 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-11-22 | 2025-02-26 | ||
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2024-11-22 | Acceptable 2024-09-30
|
2025-02-10 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2024-11-26 | Acceptable 2024-09-30
|
2025-03-03 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2024-11-26 | Acceptable 2024-09-30
|
2025-02-03 | |
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2024-11-28 | Acceptable 2024-09-30
|
2025-02-27 | |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2024-11-29 | Acceptable 2024-09-30
|
2025-03-10 | |
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2024-11-29 | Acceptable 2024-09-30
|
2025-02-20 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-17 | Germany | Acceptable 2025-07-28
|
2025-07-28 |
| 14 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-22 | Germany | Acceptable 2026-02-09
|
2026-02-09 |
| 15 | SUBSEQUENT ADDITION OF MSC | APP-15 | 2026-02-18 | Acceptable 2026-02-09
|
2026-05-11 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-18 | Acceptable | 2026-03-12 | |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-18 | Acceptable | 2026-05-18 |