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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06351631




Registration number
NCT06351631
Ethics application status
Date submitted
2/04/2024
Date registered
8/04/2024
Date last updated
27/06/2024

Titles & IDs
Public title
A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
Scientific title
A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study
Secondary ID [1] 0 0
2023-506996-89
Secondary ID [2] 0 0
3543-017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thrombocythemia, Essential 0 0
Primary Myelofibrosis 0 0
Myelofibrosis 0 0
Post-polycythemia Vera Myelofibrosis 0 0
Post-essential Thrombocythemia Myelofibrosis 0 0
Polycythemia Vera 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bomedemstat

Experimental: Bomedemstat - Participants will receive oral capsules of bomedemstat once daily for up to 10 years, with the starting dose as the same dose that the participant was on at the time of transition from the feeder study.


Treatment: Drugs: Bomedemstat
10, 15, 20, and 50 mg oral capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with one or more adverse events (AEs)
Timepoint [1] 0 0
Up to ~10 years
Primary outcome [2] 0 0
Percentage of participants who discontinued study treatment due to an AE
Timepoint [2] 0 0
Up to ~10 years
Secondary outcome [1] 0 0
For participants with ET or PV: Duration of clinicohematologic response
Timepoint [1] 0 0
Up to ~10 years
Secondary outcome [2] 0 0
For participants with ET or PV: Duration of hematologic remission
Timepoint [2] 0 0
Up to ~10 years
Secondary outcome [3] 0 0
For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML
Timepoint [3] 0 0
Up to ~10 years
Secondary outcome [4] 0 0
For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML
Timepoint [4] 0 0
Up to ~10 years
Secondary outcome [5] 0 0
For participants with MF, ET, or PV: Percentage of participants with thrombotic events
Timepoint [5] 0 0
Up to ~10 years
Secondary outcome [6] 0 0
For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events
Timepoint [6] 0 0
Up to ~10 years
Secondary outcome [7] 0 0
For participants with MF, ET, or PV: Event-Free Survival (EFS)
Timepoint [7] 0 0
Up to ~10 years

Eligibility
Key inclusion criteria
* Is 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
* Be able to initiate study intervention on Day 1 of the extension study (ie, not currently on a dose hold)
* Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/12/2034
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002) - Southport
Recruitment hospital [2] 0 0
Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000) - Adelaide
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Toscana
Country [2] 0 0
Italy
State/province [2] 0 0
Alessandria
Country [3] 0 0
Italy
State/province [3] 0 0
Bologna
Country [4] 0 0
Italy
State/province [4] 0 0
Varese
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:

* Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;
* Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission.

No hypothesis testing will be conducted in this study.
Trial website
https://clinicaltrials.gov/study/NCT06351631
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp and Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@merck.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06351631