Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
406
Countries
17
Sites
69
Giant cell arteritis (GCA)
The primary objective is to demonstrate that the efficacy of secukinumab 300 mg s.c. in combination with a 26-week glucocorticoid (GC) taper regimen is superior to placebo in combination with a 52-week GC taper regimen in participants with GCA based on sustained remission at Week 52.
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
- 6 Oct 2021 → 18 Feb 2026
- Decision date (initial)
- 2024-07-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Novartis Pharma AG
External identifiers
- EU CT number
- 2024-510744-31-00
- EudraCT number
- 2020-004809-31
- ClinicalTrials.gov
- NCT04930094
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
The primary objective is to demonstrate that the efficacy of secukinumab 300 mg s.c. in combination with a 26-week glucocorticoid (GC) taper regimen is superior to placebo in combination with a 52-week GC taper regimen in participants with GCA based on sustained remission at Week 52.
Secondary objectives 8
- To demonstrate that the efficacy of secukinumab 300 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week GC taper regimen, in participants with GCA, based on cumulative GC dose through Week 52.
- To demonstrate that the efficacy of secukinumab 150 mg s.c. in combination with a 26-week (GC) taper regimen is superior to placebo in combination with a 52-week GC taper regimen in participants with GCA based on sustained remission at Week 52.
- To demonstrate that the efficacy of secukinumab 150 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week GC taper regimen, in participants with GCA, based on cumulative GC dose through Week 52.
- To demonstrate that the effect on participant’s QoL of secukinumab 300 mg or 150 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week GC taper regimen, in participants with GCA based on change of Short Form Health Survey 36 (SF-36) score [Physical Component Summary (PCS)] at Week 52
- To demonstrate that the effect of secukinumab 300 mg or 150 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week GC taper regimen, in participants with GCA based on Glucocorticoid Toxicity Index (GTI) at Week 52.
- To demonstrate that the effect on participant’s QoL of secukinumab 300 mg or 150 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week GC taper regimen, in participants with GCA based on change in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) score at Week 52.
- To evaluate the safety and tolerability of secukinumab
- To demonstrate that the efficacy of secukinumab 300 mg or 150 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week GC taper regimen in participants with GCA based on time to first use of Escape Treatment or Rescue Treatment due to GCA through Week 52.
Conditions and MedDRA coding
Giant cell arteritis (GCA)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10018250 | Giant cell arteritis | 10047065 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration
- 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 8
- Signed informed consent must be obtained prior to participation in the study.
- Patient must be able to understand and communicate with the investigator and comply with the requirements of the study.
- Male or non-pregnant, non-lactating female patients at least 50 years of age.
- Diagnosis of GCA based on meeting all of the following criteria: Age at onset of disease ≥ 50 years. Unequivocal cranial symptoms of GCA (e.g., new-onset localized headache, scalp or temporal artery tenderness, permanent or temporary ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication), and/or unequivocal symptoms of polymyalgia rheumatica (PMR) (defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness) and/or symptoms of limb ischemia (claudication). TAB revealing features of GCA and/or cross-sectional imaging study such as ultrasound (e.g., cranial or axillary), MRI/MRA, CTA, or PET-CT with evidence of vasculitis.
- Active disease as defined by meeting both of the following within 6 weeks of BSL (see Section 8.1 for details) Presence of signs or symptoms attributed to active GCA and not related to prior damage (e.g., visual loss that occurred prior to 6 weeks before BSL without new findings occurring within 6 weeks of BSL) Elevated ESR ≥ 30 mm/hr or CRP ≥ 10 mg/L attributed to active GCA or active GCA on TAB or on imaging study.
- Patients to meet definition of new-onset GCA or relapsing GCA: Definition of new-onset GCA*: GCA that is diagnosed within 6 weeks of BSL visit Definition relapsing GCA*: GCA diagnosed > 6 weeks before BSL visit and Following institution of an appropriate treatment course for GCA, participant has experienced recurrence of active symptoms or signs of disease after resolution. * The 6-week timeframe is to be calculated from the date of suspected GCA diagnosis. Suspected diagnosis is defined as date when GC therapy was initiated.
- Patients’ current GCA episode should be treatable with a dose of prednisone (or equivalent) designed to adequately achieve disease control in accordance with international guidelines. If this is not possible due to concerns regarding GC toxicity, the patient should not be enrolled. It must be medically appropriate for the patient to receive prednisone (or equivalent) 20 mg-60 mg daily (or equivalent) at BSL.
- Patients taking MTX (≤ 25 mg/week) are allowed to continue their medication provided they have taken it for at least 2 months and are on a stable dose for at least 4 weeks prior to randomization and if they are on stable folic acid treatment before randomization.
Exclusion criteria 21
- Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor.
- Any other systemic biologics (e.g., denosumab, TNFα inhibitors) within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL, or anticipated use of a biologic prior to EOS.
- Active infections during the last 2 weeks prior to randomization.
- Patients treated with any cell-depleting therapies.
- Previous participation in a clinical trial where the outcome of treatment with the GCA drug is unknown. This does not include trials where the treatment for GCA was GCs, MTX, leflunomide or azathioprine
- Active inflammatory bowel disease or other ongoing inflammatory diseases other than GCA that might confound the evaluation of the benefit of secukinumab therapy, including uveitis at screening or randomization.
- Patients who have been treated with inhibitors directly targeting IL-1, or IL-1 receptor, IL-12 and IL-23, or abatacept within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL.
- Treatment with tocilizumab, other IL-6/IL6-R inhibitor or JAK inhibitor within 12 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL, or if patient did not respond to or experienced a relapse during treatment any time before BSL.
- Any treatment received for GCA where patient did not respond to treatment or experienced a relapse while on that treatment any time before BSL. This also includes patients who were treated in a clinical trial for GCA. Patients who failed on treatment with GCs, MTX, leflunomide and/or azathioprine may be included.
- Confirmed diagnosis of any primary form of systemic vasculitis, other than GCA.
- History of hypersensitivity or contraindication to any of the study treatments or its excipients or to drugs in similar chemical classes
- Active ongoing diseases which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for treatment with immunomodulatory therapy.
- History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by a positive QuantiFERON TB- Gold Plus test. Patients with a positive test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. If the test result is indeterminate, the investigator may repeat the test once or may proceed directly to perform the work-up for TB as per local procedure. If presence of latent tuberculosis is established then treatment according to local country guidelines must be initiated prior to randomization.
- Patients treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to BSL.
- Patients treated (i.e., systemic therapy) with cyclophosphamide or hydroxychloroquine within 6 months prior to BSL or tacrolimus, everolimus, cyclosporine A, azathioprine, sulfasalazine, mycophenolate mofetil within 4 weeks prior to BSL
- Use of other investigational drugs within 5 half-lives of enrollment or within 30 days (e.g., small molecules) or until the expected pharmacodynamic effect has returned to BSL (e.g., biologics), whichever is longer); BSL or longer if required by local regulations
- Patients treated with leflunomide within 8 weeks of BSL unless a cholestyramine washout has been performed in which case the patient must be treated within 4 weeks of BSL. Patients treated with an alkylating agent within 5 years prior to BSL, unless specified in other exclusion criteria.
- Major ischemic event (e.g., myocardial infarction, stroke, etc.) or transient ischemic attack (TIA) (except ischemia-related vision loss), related or unrelated to GCA, within 12 weeks of screening.
- BSL Patients requiring chronic (i.e., not occasional “prn”) high potency opioid analgesics for pain management.
- Patients requiring or anticipated to require systemic chronic glucocorticoid therapy or pulses of glucocorticoids for reasons other than GCA (e.g., COPD, asthma, planned surgery) at screening or randomization.
- Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to BSL, or planned or anticipated potential need for live vaccination during study participation until 12 weeks after last study treatment administration.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Sustained remission at Week 52 as per definition of sustained remission in the protocol.
Secondary endpoints 8
- Time to clinical failure as measured in days through Week 52 per definition of clinical failure in the protocol.
- Cumulative GC dose through Week 52
- Sustained remission at Week 52
- Time to clinical failure as measured in days through Week 52
- Change in SF-36 score (PCS) at Week 52
- Change in Glucocorticoid Toxicity Index (GTI) as measured by the Aggregate Improvement Score (AIS) at Week 52
- Change in FACIT-Fatigue score at Week 52
- Safety and tolerability demonstrated by assessing: Adverse events (AEs) and serious adverse events (SAEs) (incidence, severity, and relationship to study drug) Changes in laboratory measures and vital signs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 3325 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-encapsulation, study specific packaging and labeling
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 3325 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-encapsulation, study specific packaging and labeling
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 3325 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-encapsulation, study specific packaging and labeling
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 3325 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-encapsulation, study specific packaging and labeling
SUB33242 · Substance
- Active substance
- Secukinumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 14000 mg milligram(s)
- Max treatment duration
- 276 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Different secondary packaging site used in comparison to authorized product.
SUB33242 · Substance
- Active substance
- Secukinumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 14000 mg milligram(s)
- Max treatment duration
- 276 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Different secondary packaging site used in comparison to authorized product.
Placebo 3
Placebo to AIN457 150mg/1mL solution for injection in pre-filled syringe
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
Placebo to AIN457 300mg/2mL solution for injection in pre-filled syringe
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
Placebo to Prednisone 1 mg, 2.5mg, 5mg, 20mg hard gelatin capsule with tablet content
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
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 24
| Organisation | City, country | Duties |
|---|---|---|
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis, Code 5, Code 8 |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Code 12 |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Code 5, E-data capture |
| Oribalt Riga SIA ORG-100012153
|
Marupe, Latvia | Other |
| Mag. Andreas Raffeiner GmbH ORG-100043223
|
Walding, Austria | Code 8 |
| Icon Clinical Research LLC ORG-100039864
|
Rochester, United States | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Interactive response technologies (IRT), Code 5, Data management |
| Q Squared Solutions LLC ORG-100043195
|
Durham, United States | Laboratory analysis, Code 5, Code 8 |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Abf Pharmaceutical Services GmbH ORG-100014752
|
Vienna, Austria | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring |
| S & D Pharma Logistics BG EOOD ORG-100017521
|
Sofia, Bulgaria | Other |
| Creapharm Clinical Supplies ORG-100020131
|
Reims, France | Other |
| Statmed Sp. z o.o. ORG-100047187
|
Golkow, Poland | Other |
| Sopharma AD ORG-100001020
|
Sofia, Bulgaria | Other |
| Freja Transport & Logistics AS ORG-100018845
|
Frogner, Norway | Other |
| Eco-Abc Sp. z o. o. ORG-100046253
|
Belchatow, Poland | Other |
| Phardis S.r.l. ORG-100019559
|
Calvenzano, Italy | Other |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | On site monitoring |
| ApoEx AB ORG-100021830
|
Stockholm, Sweden | Code 14 |
| Specific Pharma A/S ORG-100015041
|
Copenhagen Sv, Denmark | Other |
| Qualitymetric Incorporated LLC ORG-100044132
|
Johnston, United States | Other |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring |
Locations
17 EU/EEA countries · 69 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 7 | 2 |
| Belgium | Ended | 23 | 2 |
| Bulgaria | Ended | 5 | 2 |
| Czechia | Ended | 8 | 4 |
| Denmark | Ended | 13 | 3 |
| Estonia | Ended | 5 | 2 |
| Finland | Ended | 5 | 4 |
| France | Ended | 50 | 11 |
| Germany | Ended | 32 | 9 |
| Greece | Ended | 1 | 1 |
| Hungary | Ended | 11 | 4 |
| Italy | Ended | 10 | 6 |
| Norway | Ended | 5 | 2 |
| Poland | Ended | 2 | 2 |
| Portugal | Ended | 9 | 2 |
| Spain | Ended | 56 | 11 |
| Sweden | Ended | 1 | 2 |
| Rest of world
Brazil, United Kingdom, Chile, Guatemala, Switzerland, Canada, Australia, Israel, Turkey, Argentina, New Zealand, United States
|
— | 163 | — |
Investigational sites
Medizinische Universitaet Innsbruck
#1201: Inner Med II, Anichstrasse 35, 6020, Innsbruck
Medical University Of Graz
#1200: Dep. Rheumatology, Neue Stiftingtalstrasse 6, 8010, Graz
Centre hospitalier universitaire de Liege
#1301: Reumatologie, Avenue De L'hopital 1, 4000, Liege
UZ Leuven
#1300: Reumatologie, Herestraat 49, 3000, Leuven
University Multiprofile Hospital For Active Treatment Kaspela EOOD
#3101: Clinic of Rheumatology, Zapaden District, Sofia Str 64, Plovdiv
University Multiprofessional Hospital For Active Treatment Plovdiv AD
#3102: Department of Rheumatology, Bulevard Bilgariya 234, 4003, Plovdiv
Revmatologicky Ustav
#3205:Revmatologie, Na Slupi 450/4, Nove Mesto, Prague 2
Medical Plus s.r.o.
#3202:Revmatologie, Obchodni 1507, 686 01, Uherske Hradiste
Fakultni Nemocnice Brno
#3201:Revmatologicka ambulance, Jihlavska 340/20, Bohunice, Brno
Affidea Praha s.r.o.
#3204:Revmatologie, Sustova 1930/2, Chodov, Prague 11
Esbjerg Og Grindsted Sygehus
#1600:Gigt og Bindevæv Ambulatorium E3, Finsensgade 35, 6700, Esbjerg
Lillebaelt Hospital
#1603:Reumatologisk Afsnit - Intern Medicin, Beriderbakken 4, 7100, Vejle
Aarhus Universitetshospital
#1601:Led- og Bindevævssygdomme, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
MediTrials OÜ
#3701: Private Clini, Moisavahe Tn 34c, 50708, Tartu Linn
East Tallinn Central Hospital
#3700: Rheumatology Department, Parnu Mnt 104, Kesklinna Linnaosa, Tallinn
Paeijaet-Haemeen hyvinvointialue
#3303:Department of Internal Medicine, Rheumatology Unit, Keskussairaalankatu 7, 15850, Lahti
Satucon Oy
#3301: General Practice, Kirkkokatu 1 6th Floor, 70100, Kuopio
Turku University Hospital
#3300:Centre for Rheumatology and Clinical Immunology, Kiinamyllynkatu 4-8, 20520, Turku
HUS-Yhtymae
#3302:The Rheumatology Unit, Haartmaninkatu 4, 00290, Helsinki
Centre Hospitalier Et Universitaire De Limoges
#1710:Rhumatology, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Hopital Huriez
#1712:Rhumatology, 1 Place De Verdun, 59045, Lille Cedex
Centre Hospitalier Le Mans
#1704:Rhumatology, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Hopital Saint Joseph
#1711:Rhumatology, 26 Boulevard De Louvain, 13008, Marseille
Centre Hospitalier Regional Et Universitaire De Brest
#1700:Rhumatology, Boulevard Tanguy Prigent, 29200, Brest
Assistance Publique Hopitaux De Paris
#1709:Rhumatology, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Universitaire De Toulouse
#1713:Rhumatology, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Centre Hospitalier Universitaire De Dijon
#1708:Rhumatology, 2 Boulevard Mal De Lattre De Tassigny, 21000, Dijon
Les Hopitaux Universitaires De Strasbourg
#1702:Rhumatology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Assistance Publique Hopitaux De Paris
#1701:Rhumatology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Universitaire De Nantes
#1707:Rhumatology, 1 Place Alexis Ricordeau, 44000, Nantes
Staedtisches Klinikum Dresden
#1809:1. Medizinische Klinik, Friedrichstrasse 41, Friedrichstadt, Dresden
Universitaetsklinikum Bonn AöR
#1806:Medizinische Klinik und Poliklinik III, Venusberg-Campus 1, Venusberg, Bonn
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
#1801:Rheumazentrum Ruhrgebiet, Claudiusstrasse 45, Wanne, Herne
Medical Center - University Of Freiburg
#1800:Klinik für Rheumatologie und Klinische Immunologie, Innere Medizin, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
#1802:Rheumatologie, medizinische Klinik III, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Erlangen AöR
#1805:Medizinische Klinik 3, Rheumatologie Immunologie, Ulmenweg 18, Innenstadt, Erlangen
Immanuel-Krankenhaus GmbH
#1807:Rheumaklinik Berlin-Buch, Lindenberger Weg 19, Buch, Berlin
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
#1803:Medizinische Klinik A, Bremserstrasse 79, Friesenheim, Ludwigshafen Am Rhein
Universitaetsklinikum Wuerzburg AöR
#1808:Zentrum Innere Medizin, Medizinische Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Hippokration Hospital
#4100: 2nd Internal Medicine Clinic, Vassilissas Sofias Avenue 114, 115 27, Athens
University Of Szeged
3402: Reumatologiai es Imunologiai K, Kalvaria Sugarut 57, 6725, Szeged
University Of Debrecen
3401: Belgyogyaszati Klinika, Moricz Zsigmond Korut 22, 4032, Debrecen
Semmelweis University
3403: Varosmajori Sziv es Ergyogy K, Varosmajor Utca 68, Kerulet, Budapest XII
University Of Pecs
3400: Reumatologiai es Immunologiai Klin, Akac Utca 1, 7632, Pecs
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
#2006:Rheumatology and Clinical Immunology, Piazzale Spedali Civili 1, 25123, Brescia
Careggi University Hospital
#2004:S.O.D. Internal Interdisciplinary Medicine, University of Firenze, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Fondazione IRCCS Policlinico San Matteo
#2009:UOC Rheumatology, Viale Camillo Golgi 19, 27100, Pavia
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
#2008:Deparment of UOC di Immunoreumatologia, Via Alvaro Del Portillo N 200, 00128, Rome
Ospedale San Raffaele S.r.l.
#2001:Unit of Immunology Rheumatology, Allergy and Rare Diseases (UnIRAR), Via Olgettina 60, 20132, Milan
Universita' Degli Studi Di Ferrara
#2005:UOC Reumatologia Az Ospedaliero-Universitaria S.Anna-Ferrara, Via Aldo Moro 8, 44124, Ferrara
Martina Hansens Hospital AS
#3600: Revmatologisk klinikk, Doenskiveien 8, 1346, Gjettum
Sykehuset Østfold HF, Moss
#3602: Revmatologisk klinikk, Peer Gynts vei 78, 1535, Moss
Malopolskie Badania Kliniczne Sp. z o.o.
#2200, Ul. Pradnicka 12/502, 30-002, Cracow
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
#2201: Klinika Reumatologii i Układowych Chorób Tkanki Łącznej, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Unidade Local De Saude Do Alto Minho E.P.E.
#2302: Serviço Reumatologia, Largo Conde De Bertiandos, 4990-041, Ponte De Lima
Unidade Local De Saude De Santa Maria E.P.E.
#2300: Serviço Reumatologia, Avenida Professor Egas Moniz, 1649-035, Lisbon
Hospital Universitario La Paz
#2604: Reumatología, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Basurto
#2602: Reumatología, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital Universitario Marques De Valdecilla
#2608: Reumatología, Avenida Valdecilla Sn, 39008, Santander
Hospital De La Santa Creu I Sant Pau
#2606: Reumatología, Carrer De San Quinti 89, 08041, Barcelona
Hospital Germans Trias I Pujol
#2610: Reumatología, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario De Navarra
#2607: Reumatología, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Clinic De Barcelona
#2600: Reumatología, Calle Villarroel 170, 08036, Barcelona
Complexo Hospitalario Universitario De Santiago
#2605: Reumatología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Y Politecnico La Fe
#2603: Reumatología, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital General Universitario Gregorio Maranon
#2609: Reumatología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Parc Tauli Hospital Universitari
#2601: Reumatología, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Region Skane Kristianstad Central Hospital
#2700: Reumatologimottagning, J A Hedlunds Vag 5, Kristianstads Heliga Trefaldighet, Kristianstad
Region Skane Skanes Universitetssjukhus
#2701: Reumatologens mottagning, Jan Waldenstroms Gata 16 Plan 5, Malmo St Johannes, Malmo
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 | 2023-05-24 | 2023-05-24 | 2024-04-15 | ||
| Belgium | 2022-04-13 | 2022-04-13 | 2024-04-15 | ||
| Bulgaria | 2022-02-23 | 2022-02-23 | 2024-04-15 | ||
| Czechia | 2023-01-31 | 2023-01-31 | 2024-04-15 | ||
| Denmark | 2023-05-15 | 2023-05-15 | 2024-04-15 | ||
| Estonia | 2022-05-19 | 2022-05-19 | 2024-04-15 | ||
| Finland | 2022-02-23 | 2022-02-23 | 2024-04-15 | ||
| France | 2021-11-16 | 2021-11-16 | 2024-04-15 | ||
| Germany | 2021-12-02 | 2021-12-02 | 2024-04-15 | ||
| Greece | 2023-10-30 | 2023-10-30 | 2024-04-15 | ||
| Hungary | 2021-10-28 | 2021-10-28 | 2024-04-15 | ||
| Italy | 2022-02-28 | 2022-02-28 | 2024-04-15 | ||
| Norway | 2023-01-02 | 2023-01-02 | 2024-04-15 | ||
| Poland | 2021-10-21 | 2025-09-23 | 2021-10-21 | 2024-04-15 | |
| Portugal | 2021-12-07 | 2021-12-07 | 2024-04-15 | ||
| Spain | 2021-10-06 | 2021-12-07 | 2024-04-15 | ||
| Sweden | 2024-02-13 | 2024-02-13 | 2024-04-15 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 17 · Art. 38 CTR
Temporary halt TH-100661
- Halt date
- 2025-09-18
- Member states concerned
- Germany
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100671
- Halt date
- 2025-09-18
- Member states concerned
- Norway
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100660
- Halt date
- 2025-09-18
- Member states concerned
- France
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100663
- Halt date
- 2025-09-18
- Member states concerned
- Greece
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100673
- Halt date
- 2025-09-18
- Member states concerned
- Poland
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100664
- Halt date
- 2025-09-18
- Member states concerned
- Hungary
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100667
- Halt date
- 2025-09-18
- Member states concerned
- Italy
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100670
- Halt date
- 2025-09-18
- Member states concerned
- Sweden
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100658
- Halt date
- 2025-09-18
- Member states concerned
- Finland
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100614
- Halt date
- 2025-09-18
- Member states concerned
- Belgium
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100669
- Halt date
- 2025-09-18
- Member states concerned
- Spain
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100668
- Halt date
- 2025-09-18
- Member states concerned
- Portugal
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100657
- Halt date
- 2025-09-18
- Member states concerned
- Estonia
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100616
- Halt date
- 2025-09-18
- Member states concerned
- Czechia
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100615
- Halt date
- 2025-09-18
- Member states concerned
- Bulgaria
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100618
- Halt date
- 2025-09-18
- Member states concerned
- Denmark
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-100607
- Halt date
- 2025-09-18
- Member states concerned
- Austria
- Publication date
- 2025-10-03
- Reason
- Sponsor decision
- Explanation
- The primary endpoint of sustained remission at Week 52 did not demonstrate superiority over placebo + 52-week glucocorticoid taper. There were no safety findings that contributed to the decision to halt the study.
- Follow-up measures
- Inform participants that they should not administer any further study treatment. Patients should be transitioned to standard of care therapy.
Schedule an end of treatment (EOT) visit for each participant to be completed 4 weeks after the last dose of study treatment
Schedule an end of study (EOS) visit for each participant to be completed 12 weeks after the last dose of study treatment
If the Investigator determines that a patient is deriving clinical benefit from the current treatment and requires additional time to transition the patient to standard of care therapy, one additional scheduled dose may be administered beyond the early termination date. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 119 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_2024-510744-31-00_1_English_Red | v04 |
| Protocol (for publication) | D1_Protocol_1_Red | 16Sep2021 |
| Protocol (for publication) | D1_Protocol_2024-510744-31-00_1_English_Red | v04 |
| Protocol (for publication) | D1_Protocol_2024-510744-31-00_1_Greek_Red | v04 |
| Protocol (for publication) | D4_Patient-facing document - PRO_1_English_Red | 29Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_AT_English_Note to Assesor_NonRed | 16Oct2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_BE_English_Red | 20May2021 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_BG_English_Note to Assesor_NonRed | 00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DE_English_NonRed | 23Jul2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_EE_English_Note to Assesor_NonRed | 07Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_ES_English_NonRed | 07Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_FI_English_Note to assessor_NonRed | 12Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_FR_English_Note to Assessor_NonRed | V01 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_GR_English_Red | v1.0 |
| 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_NO_English_NonRed | 06Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_NO_English_Note to assessor_NonRed | 06Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_PL_English_Note to Assesor_NonRed | 07Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_PT_English_Note to Assesor_NonRed | 15Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_SE_Swedish_NonRed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Site_1_CZ_English_Note to Assesor_NonRed | 11Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitments arrangements_Transition Replacement | V5.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Additional Biomarkers_1_DE_German_Red | V03.02.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_AT_German_NonRed | 01.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BG_Bulgarian_NonRed | 01.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BG_English_NonRed | 01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_CZ_Czech_NonRed | 01.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_DE_German_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_DK_Danish_NonRed | v01.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_EE_English_NonRed | 01.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_EE_Estonian_NonRed | 01.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_EE_Russian_NonRed | 01.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_ES_Spanish_NonRed | v01.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_FI_Finnish_NonRed | 01.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_FR_French_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_HU_Hungarian_NonRed | v01.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_NO_Norwegian_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_PL_Polish_NonRed | v02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_PT_Portuguese_NonRed | 02.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_SE_Swedish_NonRed | 01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_2_HU_Hungarian_NonRed | v01.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_AT_German_NonRed | 01.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_BG_Bulgarian_NonRed | 01.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_BG_English_NonRed | 01 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_EE_English_NonRed | 01.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_EE_Estonian_NonRed | 01.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_EE_Russian_NonRed | 01.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_ES_Spanish_NonRed | v01.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_HU_Hungarian_Red | v01.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_PL_Polish_NonRed | v02 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_1_SE_Swedish_NonRed | 01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Genetics_2_HU_Hungarian_NonRed | v01.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Addendum - Adult_1_FR_French_NonRed | V03.04.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_AT_German_NonRed | 02.02.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_Dutch_Red | V03.04.08 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_English_Red | V03.04.08 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_French_Red | V03.04.08 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BG_Bulgarian_Red | 03.04.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BG_English_Red | 03.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_CZ_Czech_Red | 03.04.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DE_German_Red | V03.04.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DK_Danish_Red | v03.04.06 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_EE_English_Red | v03.04.10 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_EE_Estonian_Red | v03.04.10 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_EE_Russian_Red | v03.04.10 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_ES_Spanish_Red | v03.04.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_FI_Finnish_Red | 03.04.09 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_FR_French_NonRed | V02.02.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_GR_Greek_Red | v03.04.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_HU_Hungarian_Red | v03.04.06 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_IT_Italian_Red | 03.04.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_NO_Norwegian_Red | 03.04.06 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PL_Polish_Red | v06 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PT_Portuguese_Red | V06.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_SE_Swedish_Red | 03.04.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_AT_German_Red | 03.04.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_FR_French_Red_Addendum | V03.03.06 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_HU_Hungarian_NonRed | v02.02.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_SE_Swedish_Red | 01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_CZ_Czech_Red | v01.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_NO_Norwegian_Red | 03.03.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_SE_Swedish_Red | 01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_2_CZ_Czech_Red | v01.01.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional1_1_IT_Italian_NonRed | 01.00.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Pregnancy Follow up Parent Legal Guardian_1_FR_French_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Qualification of Machines_1_EE_English_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Qualification of Machines_1_EE_Estonian_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Research_1_IT_Italian_Red | 01.00.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_CZ_Czech_NonRed | v03.03.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_ES_Spanish_NonRed | v3 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_2_ES_Spanish_NonRed | v3 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent-Patient_1_PL_Polish_NonRed | v02 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents_1_HU_NonRed | 26Feb2025 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents_2_HU_NonRed | 21May2025 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_AT_German_Red | 3 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_CZ_NonRed | 0.2 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_IT_Italian_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_AT_German_Red | v5 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_BE_English_Red | 1.0 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_ES_Spanish_NonRed | 1.0 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_GR_English_Red | v1.0 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_PT_English_NonRed | 11Nov2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference Label_1_Cosentyx_English_NonRed | 03Sep2019 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference Label_1_Prednisone_English_NonRed | 06Dec2024 |
| Synopsis of the protocol (for publication) | D1_Protocol - Protocol Summary in Technical Language_2024-510744-31-00_1_Czech_Red | v3 |
| Synopsis of the protocol (for publication) | D1_Protocol - Protocol Summary in Technical Language_2024-510744-31-00_1_Dutch_Red | v04 |
| Synopsis of the protocol (for publication) | D1_Protocol - Protocol Summary in Technical Language_2024-510744-31-00_1_French_Red | v05 |
| Synopsis of the protocol (for publication) | D1_Protocol - Protocol Summary in Technical Language_2024-510744-31-00_1_German_Red | v04 |
| Synopsis of the protocol (for publication) | D1_Protocol - Protocol Summary in Technical Language_2024-510744-31-00_1_Greek_Red | v04 |
| Synopsis of the protocol (for publication) | D1_Protocol - Protocol Summary in Technical Language_2024-510744-31-00_1_Italian_Red | 04.05 |
| Synopsis of the protocol (for publication) | D1_Protocol - Protocol Summary in Technical Language_2024-510744-31-00_1_Portugese_Red | v05.00 |
| Synopsis of the protocol (for publication) | D1_Protocol - Protocol Summary in Technical Language_2024-510744-31-00_2_German_Red | v04 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-510744-31-00_1_Bulgarian_Red | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-510744-31-00_1_French_Red | v00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-510744-31-00_1_Hungarian_Red | v03.02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-510744-31-00_1_Norwegian_Red | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-510744-31-00_1_Spanish_Red | v00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-510744-31-00_1_Swedish_Red | 00 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | Germany | Acceptable with conditions 2024-07-17
|
2024-07-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-20 | Germany | Acceptable 2025-04-14
|
2025-04-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-05 | Germany | Acceptable 2025-09-12
|
2025-09-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-15 | Acceptable | 2025-11-11 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-22 | Germany | Acceptable | 2025-12-11 |