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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05223920




Registration number
NCT05223920
Ethics application status
Date submitted
31/08/2021
Date registered
4/02/2022

Titles & IDs
Public title
Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005)
Scientific title
A Multi-Center, Open Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Patients With Myeloproliferative Neoplasms (MPNs) Enrolled in a Prior Bomedemstat Clinical Study
Secondary ID [1] 0 0
MK-3543-005
Secondary ID [2] 0 0
IMG-7289-CTP-202
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
Condition category
Condition code
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
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

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

Experimental: Bomedemstat - Participants will receive bomedemstat daily for 169 days with additional treatment continuing in participants deriving clinical benefit.


Treatment: Drugs: Bomedemstat
Capsule (oral)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants who Experience an Adverse Event (AE)
Timepoint [1] 0 0
Up to approximately 3 years
Primary outcome [2] 0 0
Number of Participants who Experience a Serious Adverse Event (SAE)
Timepoint [2] 0 0
Up to approximately 3 years
Primary outcome [3] 0 0
Number of Participants with Clinically Significant Change from Baseline in One or More Vital Signs
Timepoint [3] 0 0
Baseline and up to approximately 3 years
Primary outcome [4] 0 0
Number of Participants with Clinically Significant Changes from Baseline in One or More Laboratory Parameters
Timepoint [4] 0 0
Baseline and up to approximately 3 years
Primary outcome [5] 0 0
Myelofibrosis (MF) Participants Only: Change from Baseline in Spleen Volume
Timepoint [5] 0 0
Baseline and up to approximately 3 years
Primary outcome [6] 0 0
Essential Thrombocythemia (ET) Participants Only: Change from Baseline in Platelet Counts
Timepoint [6] 0 0
Baseline and up to approximately 3 years

Eligibility
Key inclusion criteria
1. Completed at least one Treatment Period (TP) in a prior bomedemstat MPN protocol (such as, but not limited to, IMG-7289-CTP-102 or IMG-7289-CTP-201).
2. In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ongoing participation in another investigational study (except observational studies).
2. A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted).
3. Current use of a prohibited medication (e.g., romiplostim).
4. Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's safety, ability to give informed consent, or comply with the trial protocol.
5. Females who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
6. Women of childbearing potential (WOCBP) and fertile men unwilling to agree to use an approved method of contraception from time of enrollment until 14 days after last bomedemstat dose.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2024
Sample size
Target
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [3] 0 0
Gold Coast Hospital and Health Service - Southport
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
Germany
State/province [6] 0 0
Essen
Country [7] 0 0
Hong Kong
State/province [7] 0 0
Hong Kong
Country [8] 0 0
Italy
State/province [8] 0 0
VA
Country [9] 0 0
Italy
State/province [9] 0 0
Alessandria
Country [10] 0 0
Italy
State/province [10] 0 0
Firenze
Country [11] 0 0
Italy
State/province [11] 0 0
Pavia
Country [12] 0 0
New Zealand
State/province [12] 0 0
Aukland
Country [13] 0 0
United Kingdom
State/province [13] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05223920