Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
247
Countries
1
Sites
4
Myeloproliferative Neoplasms (Essential Thrombocythemia, Polycythemia Vera and Myelofibrosis)
To evaluate the safety and tolerability of bomedemstat
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Jun 2024 → ongoing
- Decision date (initial)
- 2024-04-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2023-506996-89-00
- WHO UTN
- U1111-1294-8621
- ClinicalTrials.gov
- NCT06351631
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety
To evaluate the safety and tolerability of bomedemstat
Secondary objectives 6
- To evaluate duration of clinicohematologic response (DOCHR) for participants with essential thrombocythemia (ET) or polycythemia vera (PV)
- To evaluate duration of hematologic remission (DOHR) for participants with ET or PV
- To evaluate the incidence of disease progression for participants with ET or PV
- To evaluate the incidence of disease progression for participants with myelofibrosis (MF)
- To evaluate the incidence of thrombotic events for participants with MF, ET, or PV
- To evaluate the incidence of major hemorrhagic events for participants with MF, ET, or PV
Conditions and MedDRA coding
Myeloproliferative Neoplasms (Essential Thrombocythemia, Polycythemia Vera and Myelofibrosis)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10036061 | Polycythemia vera | 10029104 |
| 21.0 | LLT | 10015494 | Essential thrombocythemia | 10029104 |
| 20.0 | PT | 10028537 | Myelofibrosis | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- From a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck & Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready.
- Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator
- ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator
- Is not currently on a dose hold
- Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat
Exclusion criteria 3
- Has received prohibited concomitant medications
- Ongoing or planned participation in another investigational study
- Has noncompliance in prior bomedemstat study receiving <90% of assigned doses excluding suspensions or holds as assigned by the investigator.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Percentage of participants with one or more adverse events (AEs)
- Percentage of participants who discontinued study treatment due to an AE
Secondary endpoints 6
- For participants with ET or PV: Duration of clinicohematologic response
- For participants with ET or PV: Duration of hematologic remission
- For participants with ET or PV: Transformation to MF or myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML)
- For participants with MF: Worsening of splenomegaly or transformation to MDS/AML
- For participants with MF, ET, or PV: Thrombotic events
- For participants with MF, ET, or PV: Major hemorrhagic events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD10914816 · Product
- Active substance
- Bomedemstat
- Substance synonyms
- MK-3543, N-[(2S)-5-{[(1R,2S)-2-(4-FLUOROPHENYL)CYCLOPROPYL]AMINO}-1-(4-METHYLPIPERAZIN-1-YL)-1-OXOPENTAN-2-YL]-4-(1H-1,2,3-TRIAZOL-1-YL)BENZAMIDE, IMG-7289
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2451
PRD10818118 · Product
- Active substance
- Bomedemstat
- Substance synonyms
- MK-3543, N-[(2S)-5-{[(1R,2S)-2-(4-FLUOROPHENYL)CYCLOPROPYL]AMINO}-1-(4-METHYLPIPERAZIN-1-YL)-1-OXOPENTAN-2-YL]-4-(1H-1,2,3-TRIAZOL-1-YL)BENZAMIDE, IMG-7289
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2451
PRD10818117 · Product
- Active substance
- Bomedemstat
- Substance synonyms
- MK-3543, N-[(2S)-5-{[(1R,2S)-2-(4-FLUOROPHENYL)CYCLOPROPYL]AMINO}-1-(4-METHYLPIPERAZIN-1-YL)-1-OXOPENTAN-2-YL]-4-(1H-1,2,3-TRIAZOL-1-YL)BENZAMIDE, IMG-7289
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2451
PRD10818116 · Product
- Active substance
- Bomedemstat
- Substance synonyms
- MK-3543, N-[(2S)-5-{[(1R,2S)-2-(4-FLUOROPHENYL)CYCLOPROPYL]AMINO}-1-(4-METHYLPIPERAZIN-1-YL)-1-OXOPENTAN-2-YL]-4-(1H-1,2,3-TRIAZOL-1-YL)BENZAMIDE, IMG-7289
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 00 % (V/V) percent volume/volume
- Max total dose
- 00 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2451
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jonas Jutzi
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jonas Jutzi
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Interactive response technologies (IRT) |
| The Doctors Laboratory Limited ORG-100012670
|
London, United Kingdom | Laboratory analysis |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 25 | 4 |
| Rest of world
Canada, China, Hong Kong, Argentina, New Zealand, Japan, Chile, Australia, United States, Mexico, Taiwan, Turkey, Colombia, United Kingdom, Korea, Republic of, Israel
|
— | 222 | — |
Investigational sites
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
SCDU Ematologia, Via Venezia 16, 15121, Alexandria
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UO Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Careggi University Hospital
Ematologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
S.C. Ematologia Trial Unit, Viale Luigi Borri 57, 21100, Varese
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 |
|---|---|---|---|---|---|
| Italy | 2024-06-13 | 2024-07-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Clarification Letter_EN_for pub | 19MAR2024 |
| Protocol (for publication) | D1_Protocol_2023-506996-89_EN_SM04_for pub | AM02R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_for pub | 06DEC2023 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_SM04_for pub | AM02v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_for pub | 06DEC2023 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_for pub | 06DEC2023 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-506996-89_EN_SM04_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-506996-89_ITA_IT_SM04_for pub | 2.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-19 | Italy | Acceptable 2024-04-15
|
2024-04-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-06 | Italy | Acceptable 2024-06-26
|
2024-06-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-12 | Italy | Acceptable 2025-02-03
|
2025-02-06 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-21 | Italy | Acceptable 2025-02-03
|
2025-02-21 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-30 | Italy | Acceptable 2025-10-07
|
2025-10-09 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-24 | Italy | Acceptable 2026-01-15
|
2026-01-21 |