Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
122
Countries
7
Sites
22
Acute Myeloid Leukemia in First Remission
Part I (Dose Confirmation): To determine the RPTD of venetoclax in combination with AZA as maintenance therapy in subjects with AML who have achieved CR or CRi with conventional induction and consolidation chemotherapy Part III (Dose Finding): To determine the RPTD of venetoclax in combination with oral AZA as maintena…
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Jun 2020 → 18 Feb 2026
- Decision date (initial)
- 2024-02-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2023-507221-42-00
- EudraCT number
- 2019-002217-19
- ClinicalTrials.gov
- NCT04102020
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety
Part I (Dose Confirmation): To determine the RPTD of venetoclax in combination with AZA as maintenance therapy in subjects with AML who have achieved CR or CRi with conventional induction and consolidation chemotherapy
Part III (Dose Finding): To determine the RPTD of venetoclax in combination with oral AZA as maintenance therapy in subjects with AML who have achieved CR or CRi with conventional induction and consolidation chemotherapy.
Part III (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol.
Secondary objectives 2
- Part 3 (Dose Finding) To characterize the safety, efficacy, pharmacokinetic (PK), and toxicity profiles of venetoclax in combination with oral AZA as maintenance therapy in subjects with AML who have achieved CR or CRi with conventional induction and consolidation chemotherapy.
- Part 3 (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol.
Conditions and MedDRA coding
Acute Myeloid Leukemia in First Remission
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10000881 | Acute myeloid leukaemia (in remission) | 100000004864 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Part 1: Dose Confirmation For Part 1, the dose-confirmation cohort will enroll at least 20 subjects to receive venetoclax + AZA at the following dose levels: venetoclax 400 mg once daily (QD; Days 1 –28) for each 28-day cycle up to 24 cycles and AZA 50 mg/m2 SC or IV, QD for 5 days beginning on Cycle 1, Day 1 (Days 1 –5) of each 28-day cycle up to 6 cycles.
When at least 20 subjects have been treated for at least 28 days, an aggregate review of the toxicity data will be made by the sponsor. If fewer than 20% of the subjects experience DLTs during Cycle 1, the RPTD will have been established. However, if 20% or more have DLTs during Cycle 1, an additional cohort of approximately 20 subjects will be treated with a reduced dose of AZA (36 mg/m2 , QD for 5 days) without dose modification of venetoclax (400 mg, QD) for 28 days. If 20% or more of these additional subjects experience DLTs during Cycle 1, a subsequent cohort of approximately 20 subjects may be treated with a reduced dose of AZA and/or reduced dosing duration per cycle of venetoclax.
The recommended dose of venetoclax in combination with AZA will be such that fewer than 20% of subjects experienced a DLT during Cycle 1 in Part 1.
Subjects are considered to have completed the study treatment once they complete 24 treatment cycles. Subjects with controlled disease, who have not experienced a DLT, and who have tolerable side effects may continue to receive study drug for up to 48 cycles or until relapse, unacceptable toxicity occurs, or until the study closes. The investigator may discontinue a subject from the study as deemed appropriate.
As of 26 August 2021, 66 subjects were enrolled in Part 1 (Dose Confirmation).
|
2 | None | ||
| 2 | Part 3: Dose Finding Part 3 (Dose Finding) will follow a Bayesian optimal interval (BOIN) design to guide dose-escalation and de-escalation decisions based on the cumulative number of subjects experiencing a DLT at the current dose level. Table 2 of the protocol gives the dose levels of venetoclax in combination with oral AZA to be explored. Venetoclax and oral AZA may be administered for up to 24 cycles.
In the dose-escalation portion, each dose level will initially enroll at least 6 DLT-evaluable subjects. The first cohort of subjects will be assigned to receive dose Level 1 (venetoclax [400 mg] QD on Days 1 to 21 in combination with oral AZA [200 mg] QD on Days 1 to 14 of each 28-day cycle) with dose escalation or de-escalation for the subsequent cohort of subjects guided by a BOIN design. Table 3 of the protocol gives the BOIN dose-escalation decision rule for a target toxicity rate of 20% and optimal interval of (16.9%, 25.1%).
Approximately 12 subjects will be assigned to receive the preliminary RPTD identified during dose escalation.
The safety expansion portion will enroll at least 12 additional subjects to receive venetoclax in combination with oral AZA at the preliminary RPTD identified from dose-escalation portion of Part 3.
Subjects will be assessed for potential evidence of AML relapse through medical history, physical examination, and hematological laboratory review as detailed in the Operations Manual Section 3.14.
Subjects with controlled disease who have not experienced a DLT and who have tolerable side effects may continue to receive study drugs for 24 cycles or until relapse or unacceptable toxicity occurs. The investigator may discontinue a subject from the study as deemed appropriate.
Subjects who discontinue study drug but have not had an event of documented relapse will return for post-treatment follow-up visits. Subjects in Part 3 (Dose Finding) will return for post-treatment follow-up visits every 3 months (± 28 days) for 1 year and then every 6 months (± 28 days) thereafter starting from study drug discontinuation until documented relapse or the study ends, whichever occurs first. After relapse, survival information will be collected (e.g., via telephone calls and/or clinical visits) every 3 months (± 28 days) or more frequently at the sponsor's discretion for up to 2 years after relapse or until the sponsor's decision to stop follow-up.
As of 08 September 2022, 46 subjects were enrolled in Part 3 (Dose Finding).
|
2 | None |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration
- Plan to share IPD
- Yes
- IPD plan description
- AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Subject must be ≥18 years old, have newly diagnosed AML with intermediate or poor risk cytogenetics, have confirmation of CR or CRi following completion of intensive Induction and Consolidation chemotherapies; subject should be within one of the following time windows: have achieved first CR or CRi (after induction) within 120 days of the first dose of study drug (Cycle 1 Day 1) or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies until enrollment (Cycle 1 Day 1), and have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- The key laboratory requirements are as follows: Subject must meet the following laboratory parameters, per laboratory reference range within the screening period prior to study drug administration: - creatinine clearance ≥30 mL/minute; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection; - bilirubin < 3.0 × upper limit of normal (ULN) (adequate liver function) for Parts 1 or bilirubin < 2.0 × ULN for Part 3; - absolute neutrophil count ≥1,500/μL; - platelets ≥100,000/μL.
Exclusion criteria 3
- History of APL.
- History of active central nervous system involvement with AML.
- History of autologous stem cell transplantation for AML.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Part I: The primary endpoint is dose-limiting toxicities of venetoclax in combination with AZA
- Part III (Dose Finding): The primary endpoint is DLTs of venetoclax in combination with oral AZA
- Part III (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol.
Secondary endpoints 1
- Part 3 (Randomization): Not applicable; Part 3 (Randomization) was removed from Version 6.0 of this protocol.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD2186234 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 403200 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD2186236 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 403200 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD2186235 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 403200 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD9836740 · Product
- Active substance
- Azacitidine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 67200 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD9836742 · Product
- Active substance
- Azacitidine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 100800 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
SUB05624MIG · Substance
- Active substance
- Azacitidine
- Pharmaceutical form
- POWDER FOR SUSPENSION FOR INJECTION
- Route of administration
- INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 12000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Other |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
Locations
7 EU/EEA countries · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 14 | 3 |
| France | Ended | 3 | 3 |
| Germany | Ended | 2 | 1 |
| Greece | Ended | 8 | 4 |
| Hungary | Ended | 6 | 3 |
| Italy | Ended | 3 | 3 |
| Spain | Ended | 5 | 5 |
| Rest of world
Russian Federation, United Kingdom, Japan, Canada, United States, Australia, Taiwan, Turkey, China
|
— | 81 | — |
Investigational sites
Fakultni Nemocnice Ostrava
N/A, 17. Listopadu 1790/5, 708 00, Poruba
Institute Of Hematology And Blood Transfusion
N/A, U Nemocnice 2094/1, Nove Mesto, Prague 2
Fakultni Nemocnice Brno
N/A, Jihlavska 340/20, Bohunice, Brno
Centre Hospitalier De La Cote Basque
N/A, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Institut Gustave Roussy
N/A, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Nice
N/A, 151 Route De Saint Antoine, 06200, Nice
University General Hospital Of Alexandroupoli
Hematology, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
Laiko General Hospital Of Athens
Hematology, Sevastoupoleos 16, 115 26, Athens
Evaggelismos Hospital
Haematology-Lymphomas Department and BMT Unit, Ipsiladou 45-47, 106 76, Athens
University General Hospital Attikon
Department of Internal Medicine - Propaedeutic, Hematology Unit, Rimini Street 1, 124 62, Athens
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
N/A, Szent Istvan Utca 68, 4400, Nyiregyhaza
Somogy Varmegyei Kaposi Mor Oktato Korhaz
N/A, Tallian Gyula Utca 20-32, 7400, Kaposvar
University Of Debrecen
Belgyogyaszati Klinika Hematologiai Tanszek, Nagyerdei Korut 98, 4032, Debrecen
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
N/A, Corso Bramante 88, 10126, Turin
ASST Grande Ospedale Metropolitano Niguarda
N/A, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
N/A, Via Filippo Corridoni 11, 60123, Ancona
Hospital Universitario Virgen De La Victoria
Hematology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital De La Santa Creu I Sant Pau
N/A, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
NA, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario 12 De Octubre
N/A, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Ramon Y Cajal
N/A, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
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 |
|---|---|---|---|---|---|
| Czechia | 2020-06-03 | 2026-01-22 | 2020-06-23 | 2022-08-29 | |
| France | 2021-09-22 | 2026-01-21 | 2021-10-01 | 2022-08-29 | |
| Germany | 2020-10-30 | 2026-01-28 | 2021-06-16 | 2022-08-29 | |
| Greece | 2020-07-01 | 2026-02-04 | 2020-07-20 | 2022-08-04 | |
| Hungary | 2020-06-11 | 2026-02-05 | 2020-10-22 | 2022-04-28 | |
| Italy | 2020-06-15 | 2026-02-11 | 2022-02-21 | 2022-08-29 | |
| Spain | 2020-07-07 | 2026-02-05 | 2020-12-15 | 2023-03-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 70 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m19708-protocol-admin-change_EL-GR_Redacted | 1 |
| Protocol (for publication) | D1_m19708-protocol-admin-change_redacted | 1 |
| Protocol (for publication) | D1_m19708-protocol-redacted | 8 |
| Protocol (for publication) | D1_m19708-protocol-redacted-EL-EL | 8 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 2 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | K1_M19-708 CZ_Recruitment and ICF Procedures_blank document | 2 |
| Recruitment arrangements (for publication) | K1_M19-708 EU CTR Blank Document_Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | K1_M19-708 GR_Recruitment and ICF Procedures_blank document | 1.0 |
| Recruitment arrangements (for publication) | K1_M19-708 HU_EU CTR Blank Document_Recruitment and ICF Procedures | 2 |
| Recruitment arrangements (for publication) | K1_M19-708 IT_Recruitment and ICF Procedures_blank document | 1 |
| Recruitment arrangements (for publication) | K1_M19-708_ES_Recruitment and ICF Procedures_Blank_public | 1 |
| Subject information and informed consent form (for publication) | L1 M19-708 FR Addendum ICF_Public | 1 |
| Subject information and informed consent form (for publication) | L1 M19-708_CZ GDPR_public | 2 |
| Subject information and informed consent form (for publication) | L1 M19-708_CZ ICF Main PART 3 TC | 6 |
| Subject information and informed consent form (for publication) | L1 M19-708_CZ ICF Main PART 3_public | 6 |
| Subject information and informed consent form (for publication) | L1 M19-708_CZ ICF Main_PART 1 public | 8 |
| Subject information and informed consent form (for publication) | L1 M19-708_CZ ICF Main_PART 1 TC | 8 |
| Subject information and informed consent form (for publication) | L1 M19-708_CZ ICF Optional TC | 3 |
| Subject information and informed consent form (for publication) | L1 M19-708_CZ ICF Optional_public | 3 |
| Subject information and informed consent form (for publication) | L1 M19-708_CZ PPA_v2_4Jun2024 TC | 2 |
| Subject information and informed consent form (for publication) | L1 M19-708_CZ PPA2 public | 2 |
| Subject information and informed consent form (for publication) | L1_M19-708 GR - ICF Submission Informed Consent Main- Public | 8.0 |
| Subject information and informed consent form (for publication) | L1_M19-708 HU PIS and ICF Main_Public redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_M19-708 IT - 213946 ICF PregPart IRB Approved Public | 02Aug2023 |
| Subject information and informed consent form (for publication) | L1_M19-708 IT_ICF Main_Clean_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_M19-708 IT_ICF Optional PG_Clean_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_M19-708_DE_ICF Main_German_public | 7 |
| Subject information and informed consent form (for publication) | L1_M19-708_ES_ICF Main_public | 8.0 |
| Subject information and informed consent form (for publication) | L1_M19-708_ES_ICF Pregnant partner_public | 3.0 |
| Subject information and informed consent form (for publication) | M19-708 CZ - ICF Main Country Sample Czech_1_Public | 5.0 |
| Subject information and informed consent form (for publication) | M19-708 CZ - ICF Main Country Sample Czech_2_Public | 7.0 |
| Subject information and informed consent form (for publication) | M19-708 CZ - ICF Main Country Sample Czech_3_Public | 7.0 |
| Subject information and informed consent form (for publication) | M19-708 CZ - ICF Main Country Sample Czech_Public | 5.0 |
| Subject information and informed consent form (for publication) | M19-708 CZ - ICF Submission Informed Consent Main Czech_3_Public | 7.0 |
| Subject information and informed consent form (for publication) | M19-708 CZ - ICF Submission Informed Consent Main Czech_4_Public | 7.0 |
| Subject information and informed consent form (for publication) | M19-708 CZ - ICF Submission Informed Consent Main Czech_Public | 5.0 |
| Subject information and informed consent form (for publication) | M19-708 CZ - ICF Submission Informed Consent PharmacoGenetic Czech_Public | 2.0 |
| Subject information and informed consent form (for publication) | M19-708 CZ - ICF Submission Informed Consent Pregnant Partner Czech - Public | 3.0 |
| Subject information and informed consent form (for publication) | M19-708 CZ - Informed Consent - Public | 4.0 |
| Subject information and informed consent form (for publication) | M19-708 CZ - ICF Submission Informed Consent Main Czech_1_Public | 5.0 |
| Subject information and informed consent form (for publication) | M19-708 DE - Informed Consent - Public | 1.1 |
| Subject information and informed consent form (for publication) | M19-708 ES - Informed Consent - Public | 1 |
| Subject information and informed consent form (for publication) | M19-708 FR - ICF Addend IRB Approved French - Public | 2 |
| Subject information and informed consent form (for publication) | M19-708 FR - ICF Main IRB Approved French - Public | 6.0 |
| Subject information and informed consent form (for publication) | M19-708 FR - Informed Consent Pregnant Partner - Public | 3.0 |
| Subject information and informed consent form (for publication) | M19-708 GR - ICF Other IRB Approved Greek - Public | 2 |
| Subject information and informed consent form (for publication) | M19-708 GR - Informed Consent - Public | 1 |
| Subject information and informed consent form (for publication) | M19-708 HU - ICF Main IRB Approved Hungarian_Public | 8.0 |
| Subject information and informed consent form (for publication) | M19-708 HU - Optional Genetic ICF_Public | 1.0 |
| Subject information and informed consent form (for publication) | M19-708 HU - Optional Genetic PIS_Public Redacted | 1 |
| Subject information and informed consent form (for publication) | M19-708 HU - PIS Main IRB Approved Hungarian_Public Redacted | 8.0 |
| Subject information and informed consent form (for publication) | M19-708 HU - Pregnant Partner ICF_Public | 1.1 |
| Subject information and informed consent form (for publication) | M19-708 HU - Pregnant Partner PIS_Public | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC-Vidaza-25mgml-pow for sus for inj | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC-Vidaza-25mgml-pow for sus for inj-redlines | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | onureg-epar-product-information_en_Public | 1 |
| Synopsis of the protocol (for publication) | D1_m19708-protocol synops-is-FR-FR-redlines | 8 |
| Synopsis of the protocol (for publication) | D1_m19708-protocol synopsis | 8 |
| Synopsis of the protocol (for publication) | D1_m19708-protocol synopsis-CS-CZ | 8 |
| Synopsis of the protocol (for publication) | D1_m19708-protocol synopsis-CS-CZ-redlines | 8 |
| Synopsis of the protocol (for publication) | D1_m19708-protocol synopsis-EL-EL | 8 |
| Synopsis of the protocol (for publication) | D1_m19708-protocol synopsis-EL-EL-redlines | 8 |
| Synopsis of the protocol (for publication) | D1_m19708-protocol synopsis-ES-ES | 8 |
| Synopsis of the protocol (for publication) | D1_m19708-protocol synopsis-ES-ES-redlines | 8 |
| Synopsis of the protocol (for publication) | D1_m19708-protocol synopsis-FR-FR | 8 |
| Synopsis of the protocol (for publication) | D1_m19708-protocol synopsis-HU-HU | 8 |
| Synopsis of the protocol (for publication) | D1_m19708-protocol synopsis-HU-HU-redlines | 8 |
| Synopsis of the protocol (for publication) | D1_m19708-protocol synopsis-IT-IT | 8 |
| Synopsis of the protocol (for publication) | D1_m19708-protocol synopsis-IT-IT-redlines | 8 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-18 | Germany | Acceptable 2024-02-06
|
2024-02-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-07 | Germany | Acceptable 2024-11-11
|
2024-11-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-31 | Germany | Acceptable 2025-05-26
|
2025-05-26 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-15 | Acceptable 2025-05-26
|
2025-12-15 |