Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
139
Countries
4
Sites
15
This study is designed to accept patients with varied disease origins, depending on the parent protocol
To evaluate long term safety data, i.e. SAEs and AEs
Key facts
- Sponsor
- Novartis Pharma Services AG
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Jul 2015 → ongoing
- Decision date (initial)
- 2024-09-17
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Novartis Pharma Services AG, Switzerland
External identifiers
- EU CT number
- 2024-515283-31-00
- EudraCT number
- 2014-003527-22
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others
To evaluate long term safety data, i.e. SAEs and AEs
Secondary objectives 1
- To evaluate clinical benefit as assessed by the investigator
Conditions and MedDRA coding
This study is designed to accept patients with varied disease origins, depending on the parent protocol
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10054658 | Thalassemia | 10010331 |
| 27.0 | PT | 10066261 | Chronic graft versus host disease | 100000004870 |
| 21.0 | LLT | 10074692 | Post essential thrombocythaemia myelofibrosis | 10029104 |
| 20.1 | PT | 10066263 | Acute graft versus host disease in liver | 100000004870 |
| 21.0 | LLT | 10074690 | Post essential thrombocythemia myelofibrosis | 10029104 |
| 27.0 | PT | 10066260 | Acute graft versus host disease | 100000004870 |
| 27.0 | PT | 10066264 | Acute graft versus host disease in intestine | 100000004870 |
| 20.1 | PT | 10072159 | Chronic graft versus host disease in skin | 100000004870 |
| 27.0 | PT | 10066262 | Acute graft versus host disease in skin | 100000004870 |
| 21.1 | LLT | 10074691 | Post polycythaemia vera myelofibrosis | 10029104 |
| 20.1 | PT | 10072160 | Chronic graft versus host disease in liver | 100000004870 |
| 20.1 | PT | 10072158 | Chronic graft versus host disease in intestine | 100000004870 |
| 21.0 | LLT | 10074689 | Post polycythemia vera myelofibrosis | 10029104 |
| 21.1 | LLT | 10036061 | Polycythemia vera | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patient is currently enrolled in a Novartis-sponsored GDD or GMA study or Incyte-sponsored study (where Incyte can delegate the sponsorship to a preferred CRO, if applicable) and are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, or combinations of ruxolitinib and siremadlin, or ruxolitinib and rineterkib and fulfilled all the requirements of the parent protocol. Please refer to the list of parent studies in Appendix 2.
- Patient is currently benefitting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, or combinations of ruxolitinib and siremadlin or ruxolitinib and rineterkib as determined by the investigator.
Exclusion criteria 2
- Patient has been permanently discontinued from study treatment in parent study due to any reason.
- Patient’s indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib with panobinostat, or ruxolitinib and siremadlin or ruxolitinib and rineterkib (if the patient is receiving combination treatment in the parent study).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Frequency and severity of SAEs/AEs
Secondary endpoints 3
- Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits
- Frequency and severity of AEs / SAEs
- Proportion of patients with clinical benefit and assessed by the investigators at scheduled visits
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 17
PRD11250573 · Product
- Active substance
- Siremadlin
- Substance synonyms
- HDM201, HDM 201, (6S)-PYRROLO(3,4-D)IMIDAZOL-4(1H)-ONE, 5-(5-CHLORO-1,2-DIHYDRO-1-METHYL-2-OXO-3-PYRIDINYL)-6-(4-CHLOROPHENYL)-2-(2,4-DIMETHOXY-5-PYRIMIDINYL)-5,6-DIHYDRO-1-(1-METHYLETHYL)
- Pharmaceutical form
- HARD CAPSULES
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 1600 mg milligram(s)
- Max treatment duration
- 40 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVARTIS PHARMA AG
- Paediatric formulation
- No
- Orphan designation
- No
PRD11250584 · Product
- Active substance
- Siremadlin
- Substance synonyms
- HDM201, HDM 201, (6S)-PYRROLO(3,4-D)IMIDAZOL-4(1H)-ONE, 5-(5-CHLORO-1,2-DIHYDRO-1-METHYL-2-OXO-3-PYRIDINYL)-6-(4-CHLOROPHENYL)-2-(2,4-DIMETHOXY-5-PYRIMIDINYL)-5,6-DIHYDRO-1-(1-METHYLETHYL)
- Pharmaceutical form
- HARD CAPSULES
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 1600 mg milligram(s)
- Max treatment duration
- 40 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVARTIS PHARMA AG
- Paediatric formulation
- No
- Orphan designation
- No
PRD10392572 · Product
- Active substance
- Panobinostat
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 2700 mg milligram(s)
- Max treatment duration
- 90 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XH03 — -
- Marketing authorisation
- EU/1/15/1023/006
- MA holder
- PHARMAAND GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/12/1063
- Modified vs. Marketing Authorisation
- No
PRD10392435 · Product
- Active substance
- Panobinostat
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 2700 mg milligram(s)
- Max treatment duration
- 90 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XH03 — -
- Marketing authorisation
- EU/1/15/1023/001
- MA holder
- PHARMAAND GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/12/1063
- Modified vs. Marketing Authorisation
- No
PRD2387736 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 150 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/014
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- for countries receiving INC424 tablets via clinical supplies (only Poland), the clinical supplies are packaged in bottles, while the commercial presentation is in blisters For countries sourcing from commercial stocks, no modification
PRD868096 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 150 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/009
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- for countries receiving INC424 tablets via clinical supplies (only Poland), the clinical supplies are packaged in bottles, while the commercial presentation is in blisters For countries sourcing from commercial stocks, no modification
PRD868102 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 150 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/006
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- for countries receiving INC424 tables via clinical supplies (only Poland), the clinical supplies are packaged in bottles, while the commercial presentation is in blisters For countries sourcing from commercial stocks, no modification
PRD868094 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 150 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/007
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- for countries receiving INC424 tablets via clinical supplies (only Poland), the clinical supplies are packaged in bottles, while the commercial presentation is in blisters For countries sourcing from commercial stocks, no modification
SUB32273 · Substance
- Active substance
- Ruxolitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 150 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- for countries receiving INC424 tables via clinical supplies (only Poland), the clinical supplies are packaged in bottles, while the commercial presentation is in blisters For countries sourcing from commercial stocks, no modification
PRD2387738 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 150 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/016
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- for countries receiving INC424 tablets via clinical supplies (only Poland), the clinical supplies are packaged in bottles, while the commercial presentation is in blisters For countries sourcing from commercial stocks, no modification
PRD868099 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 150 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/012
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- for countries receiving INC424 tablets via clinical supplies (only Poland), the clinical supplies are packaged in bottles, while the commercial presentation is in blisters For countries sourcing from commercial stocks, no modification
PRD868098 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 150 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/011
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- for countries receiving INC424 tablets via clinical supplies (only Poland), the clinical supplies are packaged in bottles, while the commercial presentation is in blisters For countries sourcing from commercial stocks, no modification
PRD868097 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 150 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/010
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- for countries receiving INC424 tablets via clinical supplies (only Poland), the clinical supplies are packaged in bottles, while the commercial presentation is in blisters For countries sourcing from commercial stocks, no modification
PRD2387737 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 150 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/015
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- for countries receiving INC424 tablets via clinical supplies (only Poland), the clinical supplies are packaged in bottles, while the commercial presentation is in blisters For countries sourcing from commercial stocks, no modification
PRD868095 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 150 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/008
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- for countries receiving INC424 tablets via clinical supplies (only Poland), the clinical supplies are packaged in bottles, while the commercial presentation is in blisters For countries sourcing from commercial stocks, no modification
PRD868100 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 150 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/004
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- for countries receiving INC424 tablets via clinical supplies (only Poland), the clinical supplies are packaged in bottles, while the commercial presentation is in blisters For countries sourcing from commercial stocks, no modification
PRD868101 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 150 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- for countries receiving INC424 tablets via clinical supplies (only Poland), the clinical supplies are packaged in bottles, while the commercial presentation is in blisters For countries sourcing from commercial stocks, no modification
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma Services AG
- Sponsor organisation
- Novartis Pharma Services 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 7
| Organisation | City, country | Duties |
|---|---|---|
| Opis S.r.l. ORG-100011127
|
Desio, Italy | Other |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Code 12 |
| Mipharm S.p.A. ORG-100000724
|
Milan, Italy | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Phardis S.r.l. ORG-100019559
|
Calvenzano, Italy | Other |
Locations
4 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 5 | 4 |
| Italy | Ongoing, recruitment ended | 19 | 5 |
| Poland | Ongoing, recruitment ended | 4 | 2 |
| Sweden | Ongoing, recruitment ended | 5 | 4 |
| Rest of world
India, Turkey, Thailand, Chile, Argentina, Saudi Arabia, Taiwan, Jordan, Korea, Republic of, Japan, Lebanon, Canada, Australia, South Africa, Mexico, China, Brazil, Russian Federation, Israel, Switzerland
|
— | 106 | — |
Investigational sites
Universitaetsklinikum Magdeburg AöR
2006: Klinik für Hämatologie und Onkologie, Leipziger Strasse 44, 39120, Magdeburg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
2005: III. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Jena KöR
2009: Klinik für Innere Medizin II Abteilung Hämatologie und Internistische Onkologie, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Aachen AöR
2001: Medizinische Klinik VI, Pauwelsstrasse 30, 52074, Aachen
Careggi University Hospital
3001: Dipartimento di Medicina Sperimentale e Clinica S.O.D.C. di Ematologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
3015: U.S.D. Trapianto Midollo Adulti, Piazzale Spedali Civili 1, 25123, Brescia
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
3004: U.O.C. Ematologia, Viale Europa, 89133, Reggio Calabria
Casa Sollievo Della Sofferenza
3023: S.S.D. di Ematologia e Terapie Cellulari, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Fondazione IRCCS Policlinico San Matteo
3007: S.C. Ematologia 1 Dipartimento Oncologia, Viale Camillo Golgi 19, 27100, Pavia
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
2401: Klinika Hematologii, Terapii Komórkowych i Chorób Wewnetrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
2402: Klinika Transplantacji Szpiku i Onkohematologii, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Region Skane Skanes Universitetssjukhus
9503: VO Hematologi, Kliniska forskningsenheten, 221 85 Lund, Entregatan 7, 222 42, Lund
NU Hospital Group-Vastra Gotalandsregionen
9501: Uddevalla Hospital, Hematologmottagningen, 54180 Uddevalla, Larketorpsvagen, 461 85, Trollhattan
Karolinska University Hospital
9502: Hematologiskt Centrum, Halsovagen, Flemingsberg, Huddinge
Region Norrbotten
9504: Hematologisk dagvård, Medicinkliniken, Sunderby sjukhus, 97180 Luleå, Robertsviksgatan 7, Lulea Domkyrkofors., Lulea
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 |
|---|---|---|---|---|---|
| Germany | 2015-11-17 | 2015-11-17 | 2024-08-28 | ||
| Italy | 2015-07-30 | 2015-07-30 | 2024-08-28 | ||
| Poland | 2022-02-18 | 2022-02-18 | 2024-08-28 | ||
| Sweden | 2017-10-10 | 2017-10-10 | 2024-08-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 33 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_2024-515283-31-00_1_English_Red | V07 |
| Protocol (for publication) | D1_Protocol_2024-515283-31-00 _1_English_Red | V07 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DE_English | 15.10.2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_IT_English_Note to Assessor_NonRed | 26Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_PL_Polish_NonRed | 05Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_SE_Swedish_NonRed | 1 |
| Subject information and informed consent form (for publication) | L1_ICF - Adolescent Assent_1_IT_Italy_NonRed | v05.03.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Child Assent_1_IT_Italy_NonRed | v05.02.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_DE_German_NonRed | v06.03.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_IT_Italy_NonRed | 06.03.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_PL_Polish_NonRed | 06.03.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_SE_Swedish_NonRed | 06.03.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_DE_German_NonRed | v06.03.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_IT_Italy_NonRed | 06.03.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_PL_Polish_NonRed | 06.03.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_DE_German_NonRed | v06.03.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_IT_Italy_NonRed | 06.03.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_PL_Polish_NonRed | 06.03.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_SE_Swedish_NonRed | 06.03.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DE_German_NonRed | v06.08.10 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_IT_Italy_NonRed | 06.08.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PL_Polish_NonRed | 06.08.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_SE_Swedish_NonRed | 06.08.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_DE_German_NonRed | v05.07.08 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_1_IT_Italy_NonRed | v05.04.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_PL_Polish_NonRed | 01 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_IT_Italy_NonRed | 05.00.01 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_IT_Italy_NonRed | v05.00 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_DE_English_NonRed | V01 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_LBH589_English_NonRed | 17Jul2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_1_INC424_English_NonRed | 04Nov2024 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-515283-31-00_1_Italian_NonRed | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2024-515283-31-00_1_Swedish_NonRed | 00 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-09 | Sweden | Acceptable with conditions 2024-09-11
|
2024-09-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-20 | Sweden | Acceptable 2025-03-31
|
2025-03-31 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-20 | Sweden | Acceptable 2025-03-31
|
2025-05-20 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-14 | Sweden | Acceptable 2025-03-31
|
2025-07-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-25 | Sweden | Acceptable 2025-09-04
|
2025-09-05 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-09 | Sweden | Acceptable 2025-09-04
|
2025-12-09 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-20 | Sweden | Acceptable | 2026-04-21 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-05-08 | Acceptable | 2026-05-08 |