Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
370
Countries
3
Sites
15
Relapsed or Refractory B-Cell Malignancies
- To evaluate safety and tolerability of and identify the recommended dose(s) for expansion (RDFE[s]) for BGB-16673 combination treatments in patients with selected relapsed/refractory (R/R) B-cell malignancies (Part 1a) - To characterize the safety and tolerability of BGB-16673 combination treatments at the RDFE(s) …
Key facts
- Sponsor
- BeOne Medicines AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516234-35-00
- ClinicalTrials.gov
- NCT06634589
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Dose response, Pharmacodynamic, Therapy, Safety, Pharmacokinetic
- To evaluate safety and tolerability of and identify the recommended dose(s) for expansion (RDFE[s]) for BGB-16673 combination treatments in patients with selected relapsed/refractory (R/R) B-cell malignancies (Part 1a)
- To characterize the safety and tolerability of BGB-16673 combination treatments at the RDFE(s) and RP2D(s) in patients with selected B-cell malignancies (Part 1b)
Secondary objectives 3
- To assess the preliminary antitumor activity of BGB-16673 combination treatments at the RDFE(s) and RP2D(s) in patients with selected B-cell malignancies (Part 1a, part 1b)
- To assess the pharmacokinetics (PK) for BGB-16673 and other study drugs in combination treatments (Part 1a, part 1b)
- To assess undetectable minimal residual disease (uMRD) in patients with CLL/SLL during and after treatment with BGB-16673 and sonrotoclax (Part 1b, sub-study 1 only)
Conditions and MedDRA coding
Relapsed or Refractory B-Cell Malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10085127 | Follicular lymphoma stage III | 100000004864 |
| 27.0 | PT | 10085125 | Follicular lymphoma stage II | 100000004864 |
| 21.1 | LLT | 10008977 | Chronic lymphocytic leukemia recurrent | 10029104 |
| 21.0 | PT | 10012821 | Diffuse large B-cell lymphoma recurrent | 100000004864 |
| 21.1 | PT | 10077533 | Marginal zone lymphoma recurrent | 100000004864 |
| 21.0 | PT | 10026800 | Mantle cell lymphoma recurrent | 100000004864 |
| 21.1 | PT | 10026801 | Mantle cell lymphoma refractory | 100000004864 |
| 21.1 | LLT | 10008978 | Chronic lymphocytic leukemia refractory | 10029104 |
| 27.1 | PT | 10047804 | Waldenstrom´s macroglobulinaemia recurrent | 100000004864 |
| 27.1 | PT | 10047805 | Waldenstrom´s macroglobulinaemia refractory | 100000004864 |
| 20.0 | PT | 10058728 | Richter's syndrome | 100000004864 |
| 27.0 | PT | 10085123 | Follicular lymphoma stage I | 100000004864 |
| 20.0 | PT | 10077534 | Marginal zone lymphoma refractory | 100000004864 |
| 21.0 | PT | 10012822 | Diffuse large B-cell lymphoma refractory | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF
- Confirmed diagnosis of a R/R B-cell malignancy
- Protocol-defined measurable disease
- Stable Eastern Cooperative Oncology Group Performance Status of 0 to 1
- Adequate organ function
- Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, or 90 days after the last dose of sonrotoclax, 3 months after the last dose of mosunetuzumab or tocilizumab, 18 months after pretreatment with obinutuzumab, 2 months after the last dose of glofitamab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment
- Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, 90 days after the last dose of sonrotoclax, 3 months after the last dose of mosunetuzumab or tocilizumab, 18 months after pretreatment with obinutuzumab, 2 months after the last dose of glofitamab
- Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min (Sub-studies 1, 3 and 4)
- Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression (Sub-study 2)
- Adequate renal function as indicated by eGFR of ≥ 30 mL/min (Sub-study 2)
Exclusion criteria 11
- Treatment-naive B-cell malignancies, except for patients in Substudy 1 Cohorts 5 and 6.
- Unable to comply with the requirements of the protocol
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively
- Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening
- Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent (Sub-studies 1 and 2)
- Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of BGB-16673, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab
- Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception for participants who relapsed ≥ 24 months after completion of a full course of a prior Bcl-2 inhibitor containing regimen) (Sub-study 1)
- Participants who discontinued prior zanubrutinib treatment due to intolerance (Sub-study 2)
- Prior exposure to a CD20 x CD3 T-cell engager antibody treatment (Sub-studies 3 and 4)
- All participants with a prior allogeneic stem cell transplant (Sub-studies 3 and 4)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Number of patients with dose-limiting toxicities (Part 1a)
- Number of patients with treatment-emergent adverse events (Part 1a, part 1b)
- Number of patients with treatment-related adverse events (Part 1a, part 1b)
- Number of patients with serious adverse events (Part 1a, part 1b)
Secondary endpoints 7
- Overall response rate (ORR) as assessed by the investigator (Part 1a, part 1b)
- Duration of response (DOR) (Part 1a, part 1b)
- Time-to-response (TTR) (Part 1a, part 1b)
- Derived PK parameters of BGB-16673 (Part 1a)
- Plasma concentration data (Part 1a, part 1b)
- Number of patients with complete response/complete response with incomplete count recovery (CR/CRi) who achieve uMRD status with < 10^(-4) sensitivity in peripheral blood and/or bone marrow (Part 1b, sub-study 1 only)
- Derived PK parameters of sonrotoclax (Part 1a, sub-study 1 only)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 13
PRD9581694 · Product
- Active substance
- Mosunetuzumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD9581693 · Product
- Active substance
- Mosunetuzumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD4470763 · Product
- Active substance
- Zanubrutinib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- BEIGENE
- Paediatric formulation
- No
- Orphan designation
- No
Columvi 10 mg concentrate for solution for infusion
PRD10561235 · Product
- Active substance
- Glofitamab
- Substance synonyms
- ANTI-CD20/CD3 BISPECIFIC MONOCLONAL ANTIBODY RO7082859, RO-7082859, RG-6026, RO7082859
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- NOTASSIGN — -
- Marketing authorisation
- EU/1/23/1742/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2497
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labeling and secondary packaging for use in this clinical trial
Columvi 10 mg concentrate for solution for infusion
PRD10561233 · Product
- Active substance
- Glofitamab
- Substance synonyms
- ANTI-CD20/CD3 BISPECIFIC MONOCLONAL ANTIBODY RO7082859, RO-7082859, RG-6026, RO7082859
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- NOTASSIGN — -
- Marketing authorisation
- EU/1/23/1742/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2497
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labeling and secondary packaging for use in this clinical trial
Columvi 10 mg concentrate for solution for infusion
PRD10561234 · Product
- Active substance
- Glofitamab
- Substance synonyms
- ANTI-CD20/CD3 BISPECIFIC MONOCLONAL ANTIBODY RO7082859, RO-7082859, RG-6026, RO7082859
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- NOTASSIGN — -
- Marketing authorisation
- EU/1/23/1742/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2497
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labeling and secondary packaging for use in this clinical trial
Columvi 10 mg concentrate for solution for infusion
PRD10561232 · Product
- Active substance
- Glofitamab
- Substance synonyms
- ANTI-CD20/CD3 BISPECIFIC MONOCLONAL ANTIBODY RO7082859, RO-7082859, RG-6026, RO7082859
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- NOTASSIGN — -
- Marketing authorisation
- EU/1/23/1742/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2497
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labeling and secondary packaging for use in this clinical trial
PRD9450025 · Product
- Active substance
- N-4-1R4R-4-HYDROXY-4-METHYLCYCLOHEXYLMETHYLAMINO-3- NITROBENZENE-1-SULFONYL-4-2-2S-2-2-PROPAN-2-YLPHENYLPYRROLIDIN1-YL-7-AZASPIRO35NONAN-7-YL-2-1H-PYRROLO23-BPYRIDIN-5- Yl)Oxy]Benzamide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- BEIGENE
- Paediatric formulation
- No
- Orphan designation
- No
PRD9450022 · Product
- Active substance
- N-4-1R4R-4-HYDROXY-4-METHYLCYCLOHEXYLMETHYLAMINO-3- NITROBENZENE-1-SULFONYL-4-2-2S-2-2-PROPAN-2-YLPHENYLPYRROLIDIN1-YL-7-AZASPIRO35NONAN-7-YL-2-1H-PYRROLO23-BPYRIDIN-5- Yl)Oxy]Benzamide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- BEIGENE
- Paediatric formulation
- No
- Orphan designation
- No
PRD9450023 · Product
- Active substance
- N-4-1R4R-4-HYDROXY-4-METHYLCYCLOHEXYLMETHYLAMINO-3- NITROBENZENE-1-SULFONYL-4-2-2S-2-2-PROPAN-2-YLPHENYLPYRROLIDIN1-YL-7-AZASPIRO35NONAN-7-YL-2-1H-PYRROLO23-BPYRIDIN-5- Yl)Oxy]Benzamide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- BEIGENE
- Paediatric formulation
- No
- Orphan designation
- No
PRD9450024 · Product
- Active substance
- N-4-1R4R-4-HYDROXY-4-METHYLCYCLOHEXYLMETHYLAMINO-3- NITROBENZENE-1-SULFONYL-4-2-2S-2-2-PROPAN-2-YLPHENYLPYRROLIDIN1-YL-7-AZASPIRO35NONAN-7-YL-2-1H-PYRROLO23-BPYRIDIN-5- Yl)Oxy]Benzamide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- BEIGENE
- Paediatric formulation
- No
- Orphan designation
- No
PRD10290213 · Product
- Active substance
- BGB-16673
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- BEIGENE
- Paediatric formulation
- No
- Orphan designation
- No
PRD10290214 · Product
- Active substance
- BGB-16673
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- BEIGENE
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 4
Gazyvaro 1,000 mg concentrate for solution for infusion.
PRD1753415 · Product
- Active substance
- Obinutuzumab
- Substance synonyms
- RO5072759, AFUTUZUMAB, RO-5072759, RG-7159, GA-101, RO 5072759
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FA03 — -
- Marketing authorisation
- EU/1/14/937/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/15/1504
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labeling and secondary packaging for use in this clinical trial
Gazyvaro 1,000 mg concentrate for solution for infusion.
PRD2159366 · Product
- Active substance
- Obinutuzumab
- Substance synonyms
- RO5072759, AFUTUZUMAB, RO-5072759, RG-7159, GA-101, RO 5072759
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FA03 — -
- Marketing authorisation
- EU/1/14/937/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/15/1504
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labeling and secondary packaging for use in this clinical trial
Gazyvaro 1,000 mg concentrate for solution for infusion.
PRD2159925 · Product
- Active substance
- Obinutuzumab
- Substance synonyms
- RO5072759, AFUTUZUMAB, RO-5072759, RG-7159, GA-101, RO 5072759
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FA03 — -
- Marketing authorisation
- EU/1/14/937/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/15/1504
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labeling and secondary packaging for use in this clinical trial
Gazyvaro 1,000 mg concentrate for solution for infusion.
PRD2154738 · Product
- Active substance
- Obinutuzumab
- Substance synonyms
- RO5072759, AFUTUZUMAB, RO-5072759, RG-7159, GA-101, RO 5072759
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FA03 — -
- Marketing authorisation
- EU/1/14/937/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/15/1504
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Labeling and secondary packaging for use in this clinical trial
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
BeOne Medicines AG
- Sponsor organisation
- BeOne Medicines AG
- Address
- Aeschengraben 27
- City
- Basel
- Postcode
- 4051
- Country
- Switzerland
Scientific contact point
- Organisation
- BeOne Medicines AG
- Contact name
- BeOne Medical Officer
Public contact point
- Organisation
- BeOne Medicines AG
- Contact name
- BeOne Medical Officer
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| Wuxi Biologics (Shanghai) Co. Ltd. ORG-100020899
|
Shanghai, China | Laboratory analysis |
| Iqvia Laboratories Limited ORG-100042527
|
Livingston, United Kingdom | Laboratory analysis |
| Komtur Polska Sp. z o.o. ORG-100036131
|
Warsaw, Poland | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Laboratory analysis |
| WCG Clinical Inc. ORG-100040730
|
Los Angeles, United States | Other |
| Ledger Run Inc. ORG-100047359
|
Belvedere Tiburon, United States | Other |
Locations
3 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 30 | 5 |
| Italy | Ongoing, recruiting | 33 | 5 |
| Poland | Ongoing, recruiting | 36 | 5 |
| Rest of world
New Zealand, Brazil, United States, China, Australia
|
— | 271 | — |
Investigational sites
Universitaetsklinikum Schleswig-Holstein AöR
Medical Department II, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaetsklinikum Jena KöR
Hämatologie und internistische Onkologie, Am Klinikum 1, Lobeda, Jena
Technische Universitaet Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Ulm AöR
Comprehensive Cancer Center Ulm, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Tuebingen AöR
Medizinische Klinik, Innere Medizin II, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Centro Ricerche Cliniche Di Verona S.r.l.
Hematology Unit, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
ASST Grande Ospedale Metropolitano Niguarda
S.C. Ematologia e UTMO, Piazza Dell'ospedale Maggiore 3, 20162, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Ematologia Oncologica e Trapianto di Cellule Staminali, Via Mariano Semmola 52, 80131, Naples
Humanitas Mirasole S.p.A.
Experimental Therapeutics Unit and Lymphoma Unit, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
U.O.C. Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Układu Chłonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Szpital Wojewodzki W Opolu Sp. z o.o.
Oddział Kliniczny Hematologii, Onkologii Hematologicznej i Chorób Wewnętrznych, Ul. Katowicka 64, 45-061, Opole
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Klinika Hematoonkologii i Transplantacji Szpiku, Ul. Stanislawa Staszica 11, 20-081, Lublin
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku, Al. Wojska Polskiego 37, 10-228, Olsztyn
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 | 2025-11-12 | 2025-12-01 | |||
| Italy | 2025-10-28 | 2025-12-09 | |||
| Poland | 2025-10-15 | 2025-10-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 54 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Master Protocol_2024-516234-35-00 Redacted | 2.0/EU-1 |
| Protocol (for publication) | D1_Sub Protocol 1_2024-516234-35-00 Redacted | 2.0/EU-2 |
| Protocol (for publication) | D1_Sub Protocol 2_2024-516234-35-00 Redacted | 2.0/EU-1 |
| Protocol (for publication) | D1_Sub Protocol 3_2024-516234-35-00 Redacted | 3.0/EU-1 |
| Protocol (for publication) | D1_Sub Protocol 4_2024-516234-35-00 Redacted | 3.0/EU-2 |
| Recruitment arrangements (for publication) | K1_IT_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Substudy 1_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Substudy 2_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Substudy 3_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Substudy 4_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biomarker Research_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Storage and Future Research | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Main ICF_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Master Main ICF_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biomarker ICF_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biomarker ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biomarker Research_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research ICF_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Storage and Future Research_Clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Patient Discontinuation_Clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study-Level Substudy 1 ICF_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study-Level Substudy 2 ICF_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study-Level Substudy 3 ICF_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study-Level Substudy 4 ICF_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study-Level Substudy 4 ICF_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Substudy 1_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Substudy 2_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Substudy 3_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Substudy 4_Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Master Protocol synopsis DE 2024-516234-35-00_redacted | PA2.0/EU-1 |
| Synopsis of the protocol (for publication) | D1_Master Protocol synopsis IT 2024-516234-35-00_redacted | PA2.0/EU-1 |
| Synopsis of the protocol (for publication) | D1_Master Protocol synopsis PL 2024-516234-35-00_redacted | PA2.0/EU-1 |
| Synopsis of the protocol (for publication) | D1_Substudy 1 Protocol synopsis DE 2024-516234-35-00_redacted | PA2.0/EU-2 |
| Synopsis of the protocol (for publication) | D1_Substudy 1 Protocol synopsis IT 2024-516234-35-00_redacted | PA2.0/EU-2 |
| Synopsis of the protocol (for publication) | D1_Substudy 1 Protocol synopsis PL 2024-516234-35-00_redacted | PA2.0/EU-2 |
| Synopsis of the protocol (for publication) | D1_Substudy 2 Protocol synopsis DE 2024-516234-35-00_redacted | PA2.0/EU-1 |
| Synopsis of the protocol (for publication) | D1_Substudy 2 Protocol synopsis IT 2024-516234-35-00_redacted | PA2.0/EU-1 |
| Synopsis of the protocol (for publication) | D1_Substudy 2 Protocol synopsis PL 2024-516234-35-00_redacted | PA2.0/EU-1 |
| Synopsis of the protocol (for publication) | D1_Substudy 3 Protocol synopsis DE 2024-516234-35-00_redacted | PA3.0/EU-1 |
| Synopsis of the protocol (for publication) | D1_Substudy 3 Protocol synopsis IT 2024-516234-35-00_redacted | PA3.0/EU-1 |
| Synopsis of the protocol (for publication) | D1_Substudy 3 Protocol synopsis PL 2024-516234-35-00_redacted | PA3.0/EU-1 |
| Synopsis of the protocol (for publication) | D1_Substudy 4 Protocol synopsis DE 2024-516234-35-00_redacted | PA3.0/EU-2 |
| Synopsis of the protocol (for publication) | D1_Substudy 4 Protocol synopsis IT 2024-516234-35-00_redacted | PA3.0/EU-2 |
| Synopsis of the protocol (for publication) | D1_Substudy 4 Protocol synopsis PL 2024-516234-35-00_redacted | PA3.0/EU-2 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-29 | Italy | Acceptable 2025-09-22
|
2025-09-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-07 | Italy | Acceptable 2025-10-28
|
2025-10-29 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-11 | Italy | Acceptable 2025-10-28
|
2025-12-11 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-14 | Italy | Acceptable 2025-10-28
|
2026-01-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-06 | Italy | Acceptable 2026-04-21
|
2026-04-23 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-29 | Italy | Acceptable 2026-04-21
|
2026-04-29 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-05-05 | Acceptable 2026-04-21
|
2026-05-05 |