Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
275
Countries
13
Sites
36
Intermediate or High-risk Primary or Secondary Myelofibrosis
- Nuvisertib Monotherapy (Arm 1) - Phase 1: To identify the recommended Phase 2 dose (RP2D) of Nuvisertib monotherapy. - Nuvisertib Monotherapy (Arm 1) - Phase 1: To determine the overall safety of Nuvisertib monotherapy.(Note: this objective is secondary in Phase 2) - Nuvisertib Monotherapy (Arm 1) - Phase 2: To as…
Key facts
- Sponsor
- Sumitomo Pharma America Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Oct 2023 → ongoing
- Decision date (initial)
- 2025-12-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Sumitomo Pharma America, Inc.
External identifiers
- EU CT number
- 2022-502597-16-00
- WHO UTN
- U1111-1284-6703
- ClinicalTrials.gov
- NCT04176198
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Efficacy, Pharmacokinetic, Safety
- Nuvisertib Monotherapy (Arm 1) - Phase 1: To identify the recommended Phase 2 dose (RP2D) of Nuvisertib monotherapy.
- Nuvisertib Monotherapy (Arm 1) - Phase 1: To determine the overall safety of Nuvisertib monotherapy.(Note: this objective is secondary in Phase 2)
- Nuvisertib Monotherapy (Arm 1) - Phase 2: To assess any preliminary clinical activity of Nuvisertib monotherapy.
- Nuvisertib + Momelotinib (Arm 3) – Phase 1: To identify the recommended Phase 2 dose (RP2D) of Nuvisertib when administered in combination with momelotinib.
- Nuvisertib + Momelotinib (Arm 3) – Phase 1: To determine the overall safety of Nuvisertib and momelotinib combination.(Note: this objective is secondary in Phase 2)
- Nuvisertib + Momelotinib (Arm 3) – Phase 2: To assess any preliminary clinical activity of Nuvisertib and momelotinib combination.
Secondary objectives 5
- Nuvisertib Monotherapy (Arm 1) - Phase 1 and 2: To assess any preliminary clinical activity of Nuvisertib monotherapy.
- Nuvisertib Monotherapy (Arm 1) - Phase 1 and 2: To determine the cardiac safety of Nuvisertib.
- Nuvisertib Monotherapy (Arm 1) - Phase 1 and 2: To establish the pharmacokinetic (PK) profile of orally administered Nuvisertib monotherapy.
- Nuvisertib + Momelotinib (Arm 3) – Phase 1 and 2: To assess any preliminary clinical activity of Nuvisertib and momelotinib combination.
- Nuvisertib + Momelotinib (Arm 3) – Phase 1 and 2: To establish the pharmacokinetic (PK) profile of Nuvisertib and momelotinib at steady state when administered concomitantly.
Conditions and MedDRA coding
Intermediate or High-risk Primary or Secondary Myelofibrosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10028537 | Myelofibrosis | 100000004864 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Dose Escalation/Dose Optimization Nuvisertib Monotherapy (Arm 1) will be administered to patients who have been previously treated with JAK inhibitors (intolerant, resistant, refractory or lost response to a JAK inhibitor) or are ineligible to receive a JAK inhibitor as determined by the investigator in accordance with the local product labels. Escalation of the Nuvisertib dose will be guided by the BLRM method along with EWOC principle to control the risk of exposing patients to toxic doses. Approximately 21 to 50 patients are planned to be enrolled. into the dose escalation portion of the study. If an alternative condition (ie, dosing regimen, fed condition, etc) is explored, approximately 9 to 15 additional patients may be enrolled per condition during dose escalation. Each dose level is expected to be investigated with 1 to 6 DLT-evaluable patients per dose escalation cohort, as determined by the BLRM model. Enrichment of cohorts with additional patients may occur for dose optimization and selection of the Nuvisertib RP2D(s)
Arm 2: is not being evaluated in all regions or at all sites.
Arm 3 will evaluate Nuvisertib administered in combination with momelotinib in patients with MF and anemia, and once the RP2D(s) have been identified, will assess the potential clinical activity of Nuvisertib administered together with momelotinib. During dose escalation, it is anticipated that approximately 4 cohorts of up to 6 patients each will be opened to evaluate escalating Nuvisertib dose levels administered in combination with momelotinib. Additional cohorts may be added due to the adaptive nature of the dose escalation. If an alternative condition (ie, dosing regimen, fed condition, etc) is explored, approximately 9 to 15 additional patients may be enrolled per condition during dose escalation. Enrichment of cohorts with additional patients may occur for dose optimization and selection of the Nuvisertib RP2D(s). During dose escalation, PK samples will be collected to model PK parameters at steady state.
Both for Arm 1 and Arm 3, an SRC consisting of Principal Investigators from the sites and Sponsor representative will provide safety oversight of the patients, determine DLTs, and guide escalation and dose decisions through scheduled safety meetings and review of patient level and totality of the data.
|
Not Applicable | None | Arm 1: Nuvisertib Monotherapy.: Nuvisertib escalating doses. Arm 3: Nuvisertib + Momelotinib.: Nuvisertib escalating doses + Momelotinib. |
|
| 2 | Dose Expansion Nuvisertib Monotherapy (Arm 1): At the end of dose escalation, the Sponsor, in consultation with investigators, will determine the RP2D(s) of Nuvisertib monotherapy based on the review of safety, clinical activity, PK, and biomarker data collected during the study. Afterward, expansion cohort(s) will enroll approximately 20 to 40 patients to evaluate preliminary clinical activity and safety of Nuvisertib monotherapy.
Nuvisertib + Momelotinib (Arm 3): Once dose escalation is complete and the RP2D(s) for Nuvisertib have been identified, dose expansion will commence. Patients will receive momelotinib plus Nuvisertib at the RP2D. Bayesian monitoring will be utilized to continuously assess the posterior probability of achieving SVR35 and SVR25 after 10 patients are enrolled and data from the model will be used to determine whether to continue or stop enrollment before reaching 40 patients.
|
Not Applicable | None | Arm 1: Nuvisertib (RP2D).: Nuvisertib at RP2D. Arm 3: Nuvisertib (RP2D) + Momelotinib.: Nuvisertib at RP2D + Momelotinib. |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-508018-41-00 | Extended Access of Momelotinib for Subjects with Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ETMF) | Glaxosmithkline Research & Development Limited |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 25
- Arm 1: Adult (≥18 years of age).
- Arm 1: Previously treated with an approved JAK inhibitor(s) and is intolerant, resistant, refractory or has lost response to an approved the JAK inhibitor(s), or is ineligible to be treated with an approved JAK inhibitor as determined by the Investigator in accordance with the local product labels. Note: “Intolerant” is considered as requiring a transfusion of ≥ 4 units of red blood cells in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma for ruxolitinib and fedratinib; Grade ≥2 peripheral neuropathy for momelotinib.
- Arm 1: Fulfills the following laboratory parameters: a. Platelet count ≥ 25 × 10^9 /L without the assistance of growth factors or platelet transfusions; b. Absolute neutrophil count (ANC) ≥ 1 × 10^9 /L without the assistance of granulocyte growth factors.
- Arm 1: Peripheral blood blast count < 5%.
- Arm 1: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Arm 1: Life expectancy ≥ 6 months.
- Arm 1: Adequate renal function, as determined by clinical laboratory tests: serum creatinine ≤ 1.5 x upper limit of normal (ULN), or calculated creatinine clearance ≥ 30 mL/min (using Cockcroft-Gault formula).
- Arm 1: Adequate hepatic function: ALT and AST ≤ 3 × ULN, (ALT and AST ≤ 5 × ULN, if liver involvement secondary to MF); direct bilirubin ≤ 2 × ULN; and coagulation function: PT and PTT ≤ 1.5 × ULN; INR ≤ 1.2 × ULN (INR < 2.5 × ULN permitted if on chronic anticoagulant therapy).
- Arm 3: Previously treated with an approved JAK inhibitor (except momelotinib) for PMF or Post-PV/ET MF for ≥ 12 weeks, or ≥ 4 weeks if JAK inhibitor therapy was complicated by a transfusion requirement of ≥ 4 units of red blood cells in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma.
- Arm 3: Fulfills the following clinical laboratory parameters: a. Anemic, defined as Hb <10 g/dL; b. Platelet count ≥ 50 × 109 /L (without the assistance of growth factors or platelet transfusions); c. ANC ≥ 1 × 10^9 /L without the assistance of granulocyte growth factors; d. Peripheral blood blast count < 5% at screening; e. Adequate renal function, as determined by clinical laboratory tests: serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 30 mL/min (using Cockcroft-Gault formula); f. Adequate hepatic function: ALT and AST ≤ 3 × ULN (ALT and AST ≤ 5 × ULN if there is liver involvement secondary to MF); direct bilirubin ≤ 2 × ULN; g. Adequate coagulation function: PT and PTT ≤ 1.5 × ULN; INR ≤ 1.2 × ULN (INR < 2.5 × ULN permitted if on chronic anticoagulant therapy).
- Arm 3: Splenomegaly, defined as spleen volume of ≥ 450 cm3 by MRI/CT scan within 2 weeks prior to Cycle 1 Day 1.
- Arm 1: Capable of providing signed informed consent as described in Section 10.1.3 of the study protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Arm 3: At least 2 symptoms measurable with each score of ≥ 3 or a total average score of ≥ 10 per MFSAF v4.0.
- Arm 3: ECOG performance status ≤ 1.
- Arm 3: Life expectancy ≥ 6 months.
- Arm 3: Non-fertile or agree to use an adequate method of contraception.
- Arm 3: Capable of providing signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Arm 3: Able to swallow orally administered medication.
- Arm 1: Non-fertile or agrees to use an adequate method of contraception.
- Arm 1: Splenomegaly, defined as spleen volume of ≥ 450 cm3 by magnetic resonance Imaging (MRI) or computerized tomography (CT) scan, within 2 weeks prior to Cycle 1 Day 1.
- Arm 1: Dose Escalation: at least 2 symptoms measurable (score ≥ 1) using the MFSAF v4.0. Dose Expansion: at least 2 symptoms measurable with each score of ≥ 3 or a total average score of ≥ 10 per MFSAF v4.0.
- Arm 1: Able to swallow orally administered medication.
- Arm 3: Confirmed pathological diagnosis of PMF or post-PV-MF/post ET-MF as per WHO diagnostic criteria (Section 10.2.4), and intermediate or high-risk primary or secondary MF based on the DIPSS.
- Arm 1: Confirmed pathological diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera (PV)-MF/post-ET-MF as per World Health Organization (WHO) diagnostic criteria, and intermediate or high-risk primary or secondary MF based on the Dynamic International Prognostic Scoring System (DIPSS).
- Arm 3: Adult (≥18 years of age).
Exclusion criteria 38
- Arm 1: Received previous systemic antineoplastic therapy or any experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1. Notes: In patients with ongoing JAK inhibitor therapy, ie, ruxolitinib, at screening, JAK inhibitor therapy must be tapered over a period of at least 1 week. Patients on a low dose of ruxolitinib (eg, 5 mg QD) may have a reduced taper period or no taper. Hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1.
- Arm 1: Systemic steroid therapy (>10 mg/day prednisone or equivalent) within 1 week prior to the first dose of study treatment (Note: topical, inhaled, nasal, and ophthalmic steroids are not prohibited).
- Arm 1: Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding.
- Arm 1: Major surgery within 4 weeks prior to first dose of either study drug and/or have not recovered adequately from complications of any surgical intervention prior to first dose.
- Arm 1: Pregnant (as evidenced by a positive serum or urine pregnancy test) or is breastfeeding.
- Arm 3: Received previous systemic antineoplastic therapy or any experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1. Notes: - Prior treatment with momelotinib is not allowed; - Prior treatment with Nuvisertib is not allowed; - In patients with ongoing JAK inhibitor therapy, ie, ruxolitinib, at screening, JAK inhibitor therapy must be tapered over a period of at least 1 week. Patients on a low dose of ruxolitinib (eg, 5 mg QD) may have a reduced taper period or no taper; - Hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1.
- Arm 3: Received systemic steroid therapy (>10 mg daily prednisone or equivalent) within 1 week prior to Cycle 1 Day 1. Note: Topical, inhaled, nasal, and ophthalmic steroids are not prohibited.
- Arm 3: Currently receiving treatment with a prohibited medication that cannot be discontinued at least 1 week prior to Cycle 1 Day 1.
- Arm 3: Known allergic reactions or sensitivity to Nuvisertib, momelotinib, or any structurally similar drug, or to any component of the formulations of either study intervention.
- Arm 3: Splenic irradiation within 6 months prior to screening or prior splenectomy.
- Arm 3: Prior allogenic stem cell transplant within the last 6 months. Note: Patients who have relapsed after 6 months post-transplant and do not have active GVHD are eligible.
- Arm 1: Prior or concurrent malignancy whose natural history or treatment would have a significant potential to interfere with the safety or efficacy assessments of the investigational regimen.
- Arm 1: Splenic irradiation within 6 months prior to screening or prior splenectomy.
- Arm 1: Prior allogeneic stem cell transplant within the last 6 months. Note: Patients who have relapsed after 6 months post-transplant and do not have active graft versus host disease (GVHD) are eligible.
- Arm 1: Eligible for allogeneic bone marrow or stem cell transplantation. Note: Patients who are willing to undergo transplantation, or for whom a suitable donor is not available are considered transplant ineligible.
- Arm 1: Currently receiving treatment with a prohibited medication that cannot be discontinued at least 1 week prior to Cycle 1 Day 1.
- Arm 1: Unresolved Grade ≥ 2 non-hematological toxicity related to prior treatment (however, stable Grade 2 exceptions may be permitted if discussed in advance with the Sponsor).
- Arm 1: History of symptomatic congestive heart failure or myocardial infarction, or uncontrolled arrhythmia within the 6 months prior to Cycle 1 Day 1; left ventricular ejection fraction (LVEF) < 45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1.
- Arm 1: Corrected QT interval (using Fridericia's correction formula; QTcF) of > 470.
- Arm 3: Eligible for allogeneic bone marrow or stem cell transplantation. Note: Patients who are not willing to undergo transplantation or for whom a suitable donor is not available are considered as transplant ineligible.
- Arm 3: Major surgery within 4 weeks prior to Cycle 1 Day 1 and/or have not recovered adequately from complications of any surgical intervention prior to first dose.
- Arm 3: Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic antimicrobial within 14 days prior to Cycle 1 Day 1.
- Arm 1: Known history of chronic liver disease (eg, portal hypertension or any of its complications, cirrhosis, Child-Pugh C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson’s disease, etc). Note: Abnormal liver morphology at baseline imaging may require additional testing, as needed.
- Arm 3: Chronic active or acute viral hepatitis A, B, or C infection (testing for hepatitis B and C are required).
- Arm 3: Known history of chronic liver disease (eg, portal hypertension or any of its complications, cirrhosis, Child-Pugh C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson’s disease, etc) Note: Abnormal liver morphology at baseline imaging may require additional testing, as needed.
- Arm 3: Unresolved Grade ≥ 2 non-hematological adverse events related to prior treatment (stable Grade 2 conditions may be permitted in consultation with the Sponsor).
- Arm 3: Presence of Grade ≥ 2 peripheral neuropathy.
- Arm 3: History of myocardial infarction or symptomatic congestive heart failure or uncontrolled arrhythmia within 6 months prior to Cycle 1 Day 1; LVEF < 45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1.
- Arm 3: Corrected QTcF of > 470 msec.
- Arm 3: Prior or concurrent malignancy whose natural history or treatment has a significant potential to interfere with the safety or efficacy assessment of the study intervention.
- Arm 3: History of a medical condition or GI tract surgery that could impair absorption or could result in short bowel syndrome with diarrhea.
- Arm 3: Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding.
- Arm 3: Pregnant (as evidenced by a positive serum or urine pregnancy test) or is breastfeeding.
- Arm 1: Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic antimicrobial within 14 days prior to Cycle 1 Day 1.
- Arm 1: Chronic active or acute viral hepatitis A, B, or C infection (testing for hepatitis B and C are required).
- Arm 1: Currently receiving any other investigational agent.
- Arm 1: Exhibited allergic reactions or sensitivity to Nuvisertib, or any structurally similar compound, biological agent, or to any component of the formulation.
- Arm 1: Medical condition or gastrointestinal (GI) tract surgery that could impair absorption or result in short bowel syndrome with diarrhea.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 6
- Nuvisertib Monotherapy (Arm 1) - Phase 1: Dose-limiting toxicity (DLT) at escalated doses of Nuvisertib.
- Nuvisertib Monotherapy (Arm 1) - Phase 1: Adverse events (AEs) as characterized by type, frequency, severity, seriousness, and relationship to study drugs. (Note: This endopoint is secondary in Phase 2)
- Nuvisertib Monotherapy (Arm 1) - Phase 2: Spleen volume response: ≥35% spleen volume reduction (SVR35) at any time.
- Nuvisertib + Momelotinib (Arm 3) – Phase 1: Dose-limiting toxicity (DLT) at escalated doses of Nuvisertib when administered in combination with momelotinib.
- Nuvisertib + Momelotinib (Arm 3) – Phase 1: Adverse events (AEs) as characterized by type, frequency, severity, seriousness, and relationship to study drugs. [Note: This endpoint is secondary in Phase 2]
- Nuvisertib + Momelotinib (Arm 3) – Phase 2: Spleen volume response: ≥35% spleen volume reduction (SVR35) at any time.
Secondary endpoints 11
- Nuvisertib Monotherapy (Arm 1) - Phase 1 and 2: Spleen volume response: - ≥ 25% spleen volume reduction [SVR25] at any time; - Duration of spleen volume response.
- Nuvisertib Monotherapy (Arm 1) - Phase 1 and 2: Total symptom score response assessed by MFSAF v4.0; - ≥ 50% improvement in total symptom score (TSS50) at Week 24; - Duration of TSS50 over time during the study; - Absolute TSS change from baseline at Week 24.
- Nuvisertib Monotherapy (Arm 1) - Phase 1 and 2: Patient Global Impression of Change (PGIC) at Week 24 and at any time.
- Nuvisertib Monotherapy (Arm 1) - Phase 1 and 2: Response evaluation per the revised IWG-MRT criteria: Complete remission (CR), partial remission (PR), clinical improvement (CI), stable disease (SD), and progressive disease (PD).
- Nuvisertib Monotherapy (Arm 1) - Phase 1 and 2: QT interval changes.
- Nuvisertib Monotherapy (Arm 1) - Phase 1 and 2: PK parameters of Nuvisertib: Cmax, tmax, AUC, t½, and others as data permits.
- Nuvisertib + Momelotinib (Arm 3) – Phase 1 and 2: Spleen volume response: - ≥25% spleen volume reduction [SVR25] at any time; - Duration of spleen volume response.
- Nuvisertib + Momelotinib (Arm 3) – Phase 1 and 2: Total symptom score response assessed by MFSAF v4.0: - ≥ 50% improvement in total symptom score (TSS50) at Week 24; - Duration of TSS50 over time during the study; - Absolute TSS change from baseline at Week 24.
- Nuvisertib + Momelotinib (Arm 3) – Phase 1 and 2: Patient Global Impression of Change (PGIC) at Week 24 and at any time.
- Nuvisertib + Momelotinib (Arm 3) – Phase 1 and 2: Response evaluation per the revised IWG-MRT criteria: - Complete remission (CR), partial remission (PR), clinical improvement (CI), stable disease (SD), and progressive disease (PD).
- Nuvisertib + Momelotinib (Arm 3) – Phase 1 and 2: PK parameters of TP-3654 and momelotinib: Cmax, tmax, AUC, t½ and others as data permits.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
Momelotinib Dihydrochloride Monohydrate
PRD11032121 · Product
- Active substance
- Momelotinib Dihydrochloride Monohydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/11/887
Momelotinib Dihydrochloride Monohydrate
PRD11032047 · Product
- Active substance
- Momelotinib Dihydrochloride Monohydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/11/887
Momelotinib Dihydrochloride Monohydrate
PRD11032087 · Product
- Active substance
- Momelotinib Dihydrochloride Monohydrate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/11/887
PRD12374901 · Product
- Active substance
- Nuvisertib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- SUMITOMO PHARMA AMERICA INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD11462588 · Product
- Active substance
- Nuvisertib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- SUMITOMO PHARMA AMERICA INC
- Paediatric formulation
- No
- Orphan designation
- No
PRD10214886 · Product
- Active substance
- Nuvisertib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- SUMITOMO PHARMA AMERICA INC
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sumitomo Pharma America Inc.
- Sponsor organisation
- Sumitomo Pharma America Inc.
- Address
- 84 Waterford Drive
- City
- Marlborough
- Postcode
- 01752-7010
- Country
- United States
Scientific contact point
- Organisation
- Sumitomo Pharma America Inc.
- Contact name
- Clinical Development
Public contact point
- Organisation
- Sumitomo Pharma America Inc.
- Contact name
- Clinical Development
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 11, Code 12, Code 13, Other, Code 2, Code 5, E-data capture, Code 8 |
| Inotiv Inc. ORG-100012772
|
West Lafayette, United States | Laboratory analysis |
| Rules Based Medicine Inc. ORG-100043610
|
Austin, United States | Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| PPD Development LP ORG-100011560
|
Wilmington, United States | Other, Code 8 |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Tempus Labs Inc. ORG-100044006
|
Chicago, United States | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management, E-data capture |
| The DPO Centre ORL-000009205
|
London, United Kingdom | Other |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
Locations
13 EU/EEA countries · 36 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 2 | 1 |
| Belgium | Ongoing, recruiting | 7 | 4 |
| Bulgaria | Authorised, recruitment pending | 2 | 1 |
| Czechia | Authorised, recruitment pending | 2 | 1 |
| Denmark | Authorised, recruitment pending | 2 | 1 |
| France | Ongoing, recruiting | 19 | 8 |
| Germany | Authorised, recruitment pending | 2 | 2 |
| Hungary | Authorised, recruitment pending | 2 | 1 |
| Italy | Ongoing, recruiting | 25 | 11 |
| Netherlands | Authorised, recruitment pending | 2 | 1 |
| Poland | Authorised, recruitment pending | 2 | 1 |
| Romania | Authorised, recruitment pending | 2 | 1 |
| Spain | Authorised, recruiting | 2 | 3 |
| Rest of world
Australia, Canada, United States, Japan, United Kingdom
|
— | 204 | — |
Investigational sites
Medical University Of Graz
AT001A: Department of Internal Medicine, Neue Stiftingtalstrasse 6, 8010, Graz
Universitair Ziekenhuis Gent
BE015A: Hematologie, t.a.v. Katrien De Grove, Studies Hematologie – Route 1456, Corneel Heymanslaan 10, 9000, Gent
Centre hospitalier universitaire de Liege
BE002A: Ophtalmologie, Avenue De L'Hopital 1, 4000, Liege
Het Ziekenhuisnetwerk Antwerpen
BE017A: medical oncology, Lange Beeldekensstraat 267, 2060, Antwerp
UZ Leuven
BE005A: Oncologie, Herestraat 49, 3000, Leuven
Dr. Pencho Georgiev Ambulatory For Individual Practice For Medical Aid For Clinical Hematology EOOD
BG008A, Ulitsa Perushtitsa 13b 2nd Floor, 4002, Plovdiv
Fakultni Nemocnice Brno
CZ007A: Int. hemat. a onkol. klinika, Jihlavska 340/20, Bohunice, Brno
Hospices Civils De Lyon
FR034A Hématologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire Amiens Picardie
FR024A Hématologie clinique et thérapie cellulaire, 1 Rond Point Du Professeur Christian Cabrol, 80054, Amiens
Centre Hospitalier Universitaire D'Angers
FR035A Hématologie, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Poitiers
FR004A: Hématologie oncologie et thérapie cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Hopital Saint Louis
FR030A Hémato-Oncologie et projets translationnels CAR-T Cells, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Nimes
FR029A Hematologie clinique, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Institut Gustave Roussy
FR012A Département d'hématologiemédecine Oncologique, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Nice
FR031A Service de médecine interne, 151 Route De Saint Antoine, 06200, Nice
Martin-Luther-Universitaet Halle-Wittenberg
DE050A: Hämatologie,Onkologie Und Imm, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Universitaetsklinikum Schleswig-Holstein AöR
DE052A: Klinik fuer Haematologie und Onkologie, Ratzeburger Allee 160, 23538, Luebeck
University Of Debrecen
HU007A: Belgyógyászati klinika, Hematológia, Nagyerdei Korut 98, 4032, Debrecen
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L.
Dipartimento di Oncologia ed Ematologia Clinica e Sperimentale, Via Piero Maroncelli 40, 47014, Meldola
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
IT052A: Unità Operativa Complessa di Ematologia, Viale Luigi Borri N 57, 21100, Varese
Fondazione IRCCS San Gerardo Dei Tintori
IT028A: UO Ematologia Adulti, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
IT022A: S.C. di Ematologia, Corso Bramante 88, 10126, Turin
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
IT053A: SC Ematologia, Via Francesco Sforza 35, 20122, Milan
Azienda Ospedaliero-Universitaria Maggiore Della Carita
IT039A: SCDU Ematologia, Corso Giuseppe Mazzini 18, 28100, Novara
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
IT027A: UO di Ematologia con TMO, Via Santa Sofia 78, 95123, Catania
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
IT054A: U.S.D. TMO per Adulti Dipartimento di Scienze Cliniche e Sperimentali Università di Brescia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
IT061A: SCDU Ematologia, Via Venezia 16, 15121, Alexandria
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
IT007A: UOC Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Centro Di Riferimento Oncologico Di Aviano
IT060A: "SOSD Oncoematologia Trapianti Emopoietici e Terapie Cellulari", Via Franco Gallini 2, 33081, Aviano
Academisch Ziekenhuis Maastricht
NL010A: Medical Oncology, P Debyelaan 25, 6229 HX, Maastricht
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
PL019A: Centrum Innowacyjnych Terapii, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Institut Catala D'oncologia
ES001A: Hematología, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario De Salamanca
ES046A: Hematología, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Y Politecnico La Fe
ES044A: Hematología, Avenida Fernando Abril Martorell 106, 46026, Valencia
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 |
|---|---|---|---|---|---|
| Belgium | 2024-03-11 | 2024-03-14 | |||
| France | 2023-11-23 | 2024-02-08 | |||
| Italy | 2023-10-27 | 2024-01-02 | |||
| Spain | 2026-04-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 134 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | CT03 03 03 01 BBI-TP-3654-102 Patient Mat MFSAFv4_BE_DE Public | 4.0 |
| Protocol (for publication) | CT03 03 03 01 BBI-TP-3654-102 Patient Mat MFSAFv4_BE_FR Public | 4.0 |
| Protocol (for publication) | CT03 03 03 01 BBI-TP-3654-102 Patient Mat MFSAFv4_BE_NL Public | 4.0 |
| Protocol (for publication) | CT03 03 03 01 BBI-TP-3654-102 Patient Mat MFSAFv4_EN US Public | 4.0 |
| Protocol (for publication) | CT03 03 03 01 BBI-TP-3654-102 Patient Mat MFSAFv4_FR_FR Public | 4.0 |
| Protocol (for publication) | CT03 03 03 01 BBI-TP-3654-102 Patient Mat MFSAFv4_IT_IT Public | 4.0 |
| Protocol (for publication) | CT03 03 03 01 BBI-TP-3654-102 Patient Mat PGIC_BE_DE Public | 1.0 |
| Protocol (for publication) | CT03 03 03 01 BBI-TP-3654-102 Patient Mat PGIC_BE_FR Public | 1.0 |
| Protocol (for publication) | CT03 03 03 01 BBI-TP-3654-102 Patient Mat PGIC_BE_NL Public | 1.0 |
| Protocol (for publication) | CT03 03 03 01 BBI-TP-3654-102 Patient Mat PGIC_EN US Public | 1.0 |
| Protocol (for publication) | CT03 03 03 01 BBI-TP-3654-102 Patient Mat PGIC_FR_FR Public | 1.0 |
| Protocol (for publication) | CT03 03 03 01 BBI-TP-3654-102 Patient Mat PGIC_IT_IT Public | 1.0 |
| Protocol (for publication) | CT03 03 03 01 BBI-TP-3654-102 Protocol Amend EU_SOC English Public | 6.2.1.1 |
| Protocol (for publication) | CT03 03 03 01 TP-3654-102-prot-amend-PSP-Public | 6.2.1.1 |
| Protocol (for publication) | D1_BBI-TP-3654-102-prot-amend-Public | 8.2.1 |
| Protocol (for publication) | D4_MFSAF Questionnaire_ES-ES_Public | 4.0 |
| Protocol (for publication) | D4_MFSAF Questionnaire_HU_HU_Public | 4.0 |
| Protocol (for publication) | D4_MFSAFv4 Questionnaire_AT_DE_Public | 4.0 |
| Protocol (for publication) | D4_MFSAFv4 Questionnaire_DE_DE_Public | 4.0 |
| Protocol (for publication) | D4_PGIC Questionnaire_AT-DE_Public | 1.0 |
| Protocol (for publication) | D4_PGIC Questionnaire_DE-DE_Public | 1.0 |
| Protocol (for publication) | D4_PGIC Questionnaire_ES-ES_Public | 1.0 |
| Protocol (for publication) | D4_PGIC Questionnaire_HU_HU_Public | 1.0 |
| Protocol (for publication) | D4_QoL and GI Effects Questionnaire_AT_DE_Public | 1.0 |
| Protocol (for publication) | D4_QoL and GI Effects Questionnaire_BE_DE_Public | 0.0 |
| Protocol (for publication) | D4_QoL and GI Effects Questionnaire_BE_FR_Public | 0.0 |
| Protocol (for publication) | D4_QoL and GI Effects Questionnaire_BE_NL_Public | 0.0 |
| Protocol (for publication) | D4_QoL and GI Effects Questionnaire_DE_DE_Public | 1.0 |
| Protocol (for publication) | D4_QoL and GI Effects Questionnaire_EN Public | 0.0 |
| Protocol (for publication) | D4_QoL and GI Effects Questionnaire_ES_ES_Public | 1.0 |
| Protocol (for publication) | D4_QoL and GI Effects Questionnaire_FR_FR_Public | 0.0 |
| Protocol (for publication) | D4_QoL and GI Effects Questionnaire_HU_HU_Public | 1.0 |
| Protocol (for publication) | D4_QoL and GI Effects Questionnaire_IT_IT_Public | 0.0 |
| Recruitment arrangements (for publication) | K1_AUT Recruitment Procedure Description English BBI-TP-3654-102 Public | 3.0 |
| Recruitment arrangements (for publication) | K1_BEL Recruitment and Informed Consent Procedure English BBI-TP-3654-102 Public | 6.0 |
| Recruitment arrangements (for publication) | K1_BGR Recruitment Procedure Description Bulgarian BBI-TP-3654-102 Public | 3.1 |
| Recruitment arrangements (for publication) | K1_CZE Country ICF Procedure CZ-EN BBI-TP-3654-102 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_DEU Recruitment Procedure Description English BBI-TP-3654-102 Public | 3.0 |
| Recruitment arrangements (for publication) | K1_DNK Recruitment Procedure Description English BBI-TP-3654-102 Public | 1.1 |
| Recruitment arrangements (for publication) | K1_ESP Recruitment Procedure Description English BBI-TP-3654-102 Public | 3.0 |
| Recruitment arrangements (for publication) | K1_FRA Recruitment Procedure Description French English BBI-TP-3654-102 Public | 5.0 |
| Recruitment arrangements (for publication) | K1_HUN Recruitment Other File Note English BBI-TP-3654-102 | 1.0 |
| Recruitment arrangements (for publication) | K1_ITA Recruitment Procedure Description English BBI-TP-3654-102 Public | 4.0 |
| Recruitment arrangements (for publication) | K1_NLD Recruitment Procedure Description English BBI-TP-3654-102 Public | 3.0 |
| Recruitment arrangements (for publication) | K1_POL Recruitment Procedure Description Polish BBI-TP-3654-102 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_ROU Country ICF Procedure English BBI-TP-3654-102 | 1.0 |
| Recruitment arrangements (for publication) | K2_BEL Recruitment Brochure Dutch BBI-TP-3654-102 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_BEL Recruitment Brochure French BBI-TP-3654-102 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_BEL Recruitment Other Video Script Dutch-English BBI-TP-3654-102 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_BEL Recruitment Other Video Script French-English BBI-TP-3654-102 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_FRA Recruitment Brochure French BBI-TP-3654-102 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_FRA Recruitment Other Video script FR-EN BBI-TP-3654-102 Public | 1.0 |
| Recruitment arrangements (for publication) | K2_ITA Recruitment Brochure Italian BBI-TP-3654-102 Public | 2.0 |
| Recruitment arrangements (for publication) | K2_ITA Recruitment Other Video script English Italian BBI-TP-3654-102 Public | 2.0 |
| Subject information and informed consent form (for publication) | BEL Country ICF Main French BBI-TP-3654-102 Public | 3.0 |
| Subject information and informed consent form (for publication) | BEL Country ICF Other Pregnant Partner Dutch BBI-TP-3654-102 Public | 3.0 |
| Subject information and informed consent form (for publication) | BEL Country ICF Other Pregnant Partner English BBI-TP-3654-102 Public | 3.0 |
| Subject information and informed consent form (for publication) | BEL Country ICF Other Pregnant Partner French BBI-TP-3654-102 Public | 3.0 |
| Subject information and informed consent form (for publication) | BEL Country ICF Procedure English BBI-TP-3654-102 Public | 1.0 |
| Subject information and informed consent form (for publication) | FRA Country ICF Other Adult French TC BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | FRA ICF Main Adult French TC BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | FRA ICF Other Adult French BBI-TP-3654-102 Public | 3.2 |
| Subject information and informed consent form (for publication) | ITA Country ICF Main Italian BBI-TP-3654-102 Public TC | 3.0 |
| Subject information and informed consent form (for publication) | ITA Country ICF Other Pregnancy Italian BBI-TP-3654-102 Public | 3.0 |
| Subject information and informed consent form (for publication) | ITA Other Information Given to Subjects Italian BBI-TP-3654-102 Public | 1 |
| Subject information and informed consent form (for publication) | L1_AUT Country ICF - Genetic Research German BBI-TP-3654-102 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_AUT Country ICF - Pregnant Form German BBI-TP-3654-102 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_AUT Country ICF Main Arm 1 German BBI-TP-3654-102 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_AUT Country ICF Main Arm 3 German BBI-TP-3654-102 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Arm 1 Dutch BBI-TP-3654-102 Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Arm 1 English BBI-TP-3654-102 Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Arm 1 French BBI-TP-3654-102 Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Arm 3 Dutch BBI-TP-3654-102 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Arm 3 English BBI-TP-3654-102 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Arm 3 French BBI-TP-3654-102 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_BGR Country ICF - Pregnant Form Adult Bulgarian BBI-TP-3654-102 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_BGR Country ICF - Pregnant Form Adult English BBI-TP-3654-102 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_BGR Country ICF Main Adult Arm 1 Bulgarian BBI-TP-3654-102 Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_BGR Country ICF Main Adult Arm 1 English BBI-TP-3654-102 Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_BGR Country ICF Main Adult Arm 3 Bulgarian BBI-TP-3654-102 Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_BGR Country ICF Main Adult Arm 3 English BBI-TP-3654-102 Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF - Data Protection Adult Czech BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF - Pregnant Form Adult Czech BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF - Research Adult Future Czech BBI-TP-3654-102 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Main Adult Arm 1 Czech BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Main Adult Arm 3 Czech BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF - Biobank German BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF - Pregnant Form German BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Main Arm 1 German BBI-TP-3654-102 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Main Arm 3 German BBI-TP-3654-102 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_DNK Country ICF - Pregnant Form Danish BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_DNK Country ICF - Research Danish BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_DNK Country ICF Main Arm 1 Danish BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_DNK Country ICF Main Arm 3 Danish BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF - Pregnant Form Adult Spanish BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Adult Arm 1 Spanish BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Adult Arm 3 Spanish BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Main Arm 3 French BBI-TP-3654-102 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_FRA ICF Main Adult Arm 1 French BBI-TP-3654-102 Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF - Genetic ICF Hungarian BBI-TP-3654-102 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF - Genetic Information Sheet Hungarian BBI-TP-3654-102 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF - Pregnant Form Pregnant Partner Hungarian BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Main Arm 1 Hungarian BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Main Arm 3 Hungarian BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_HUN Form Genetic Statement BBI-TP-3654-102 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HUN Subject Participation Card Hungarian BBI-TP-3654-102 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Data Protection Italian BBI-TP-3654-102 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Main Adult Arm 1 Italian BBI-TP-3654-102 Public | 8.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Main ARM 3 Italian BBI-TP-3654-102 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Research Adult Italian BBI-TP-3654-102 Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF - Pregnant Form Dutch BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Main Arm 1 Dutch BBI-TP-3654-102 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Main Arm 3 Dutch BBI-TP-3654-102 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF - Pregnant Form Adult Polish BBI-TP-3654-102 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Main Adult Arm 1 Polish BBI-TP-3654-102 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Main Adult Arm 3 Polish BBI-TP-3654-102 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ROU Country ICF - Other Pregnancy Romanian BBI-TP-3654-102 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ROU Country ICF Main Arm 3 Romanian BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ROU Country ICF Main Arm 1 Romanian BBI-TP-3654-102 Public | 1.1 |
| Subject information and informed consent form (for publication) | L2_AUT Subject Materials Other Contact Data Form English BBI-TP-3654-102 Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_DNK Subject Materials Other Leaflet Danish BBI-TP-3654-102 Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_HUN Form List of Documents BBI-TP-3654-102 | 1.0 |
| Synopsis of the protocol (for publication) | D1_BBI-TP-3654-102 Protocol Synopsis_Amend_ BE-NL Public | 8.2 |
| Synopsis of the protocol (for publication) | D1_BBI-TP-3654-102 Protocol Synopsis_Amend_AT-DE_Public | 8.2 |
| Synopsis of the protocol (for publication) | D1_BBI-TP-3654-102 Protocol Synopsis_Amend_BE_DE Public | 8.2 |
| Synopsis of the protocol (for publication) | D1_BBI-TP-3654-102 Protocol Synopsis_Amend_BE_FR Public | 8.2 |
| Synopsis of the protocol (for publication) | D1_BBI-TP-3654-102 Protocol Synopsis_Amend_BG-BG_Public | 8.2 |
| Synopsis of the protocol (for publication) | D1_BBI-TP-3654-102 Protocol Synopsis_Amend_EN Public | 8.2 |
| Synopsis of the protocol (for publication) | D1_BBI-TP-3654-102 Protocol Synopsis_Amend_ES-ES_Public | 8.2 |
| Synopsis of the protocol (for publication) | D1_BBI-TP-3654-102 Protocol Synopsis_Amend_FR_FR Public | 8.2 |
| Synopsis of the protocol (for publication) | D1_BBI-TP-3654-102 Protocol Synopsis_Amend_HU-HU_Public | 8.2 |
| Synopsis of the protocol (for publication) | D1_BBI-TP-3654-102 Protocol Synopsis_Amend_IT_IT Public | 8.2 |
| Synopsis of the protocol (for publication) | D1_BBI-TP-3654-102 Protocol Synopsis_Amend_NL-NL_Public | 8.2 |
| Synopsis of the protocol (for publication) | D1_BBI-TP-3654-102 Protocol Synopsis_Amend_PL-PL Public | 8.2 |
Application history
20 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-21 | Belgium | Acceptable with conditions 2023-07-04
|
2023-07-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-28 | Belgium | Acceptable with conditions 2023-07-04
|
2023-08-28 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-03-01 | Belgium | Acceptable with conditions 2023-07-04
|
2024-03-01 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-03-20 | Acceptable with conditions | 2024-06-07 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-03-20 | Acceptable with conditions | 2024-05-02 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-03-20 | Belgium | Acceptable with conditions | 2024-06-05 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-07-26 | Belgium | Acceptable 2024-10-07
|
2024-10-07 |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-01-17 | Belgium | Acceptable 2025-04-18
|
2025-04-18 |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-05-16 | Belgium | Acceptable 2025-08-12
|
2025-08-12 |
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2025-09-30 | Acceptable 2025-08-12
|
2026-01-08 | |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2025-09-30 | Acceptable 2025-08-12
|
2025-11-19 | |
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2025-09-30 | Acceptable 2025-08-12
|
2026-01-02 | |
| 13 | SUBSEQUENT ADDITION OF MSC | APP-13 | 2025-09-30 | Acceptable 2025-08-12
|
2025-12-22 | |
| 14 | SUBSEQUENT ADDITION OF MSC | APP-14 | 2025-10-01 | Acceptable 2025-08-12
|
2026-01-12 | |
| 15 | SUBSEQUENT ADDITION OF MSC | APP-15 | 2025-10-02 | 2025-12-08 | ||
| 16 | SUBSEQUENT ADDITION OF MSC | APP-16 | 2025-10-02 | Acceptable 2025-08-12
|
2025-12-10 | |
| 17 | SUBSEQUENT ADDITION OF MSC | APP-17 | 2025-10-02 | 2026-01-04 | ||
| 18 | SUBSEQUENT ADDITION OF MSC | APP-18 | 2025-10-03 | 2025-12-22 | ||
| 19 | SUBSEQUENT ADDITION OF MSC | APP-19 | 2025-10-03 | Acceptable 2025-08-12
|
2026-01-05 | |
| 20 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-10 | Belgium | Acceptable 2025-08-12
|
2026-03-10 |