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Epigenetic Modulator

Bomedemstat for Blood Disorders

Phase 3
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~10 years
Awards & highlights

Summary

"This trial aims to continue monitoring participants who have been taking bomedemstat for a while to gather information on its long-term safety and effectiveness. Participants must have been using bomedemstat for at

Who is the study for?
This trial is for people with certain blood disorders like Polycythemia, Essential Thrombocythemia, or Myelofibrosis who have been part of previous bomedemstat studies. They must be able to take oral medication and have shown benefits from at least 6 months of prior treatment with bomedemstat.
What is being tested?
The study tests the long-term safety and effectiveness of a drug called Bomedemstat in patients who've previously responded well to it. It's an extension study without hypothesis testing, meaning they're not trying to prove a specific theory but rather gather more data.
What are the potential side effects?
Specific side effects are not listed here, but generally, participants will be monitored for any adverse reactions since this is a safety and efficacy study. Side effects could range from mild to severe depending on individual responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take pills and follow home dosing instructions.
Select...
I am part of a bomedemstat study by Imago Biosciences or MSD, approved for MK-3543-017.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of participants who discontinued study treatment due to an AE
Percentage of participants with one or more adverse events (AEs)
Secondary study objectives
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: Percentage of participants with transformation to MF or MDS/AML
+4 more

Side effects data

From 2022 Phase 1 & 2 trial • 90 Patients • NCT03136185
55%
Thrombocytopenia
36%
Contusion
27%
Dysgeusia
27%
Oedema peripheral
27%
Arthralgia
27%
Nausea
27%
Back pain
27%
Depression
27%
Anaemia
27%
Constipation
27%
Hypocalcaemia
18%
Palpitations
18%
Pruritus
18%
Fatigue
18%
Hyperuricaemia
18%
Insomnia
18%
Lymphopenia
18%
Cough
18%
Fall
18%
Dyspnoea
18%
Asthenia
18%
Abdominal pain
18%
Muscular weakness
18%
Pain in extremity
18%
Dizziness
18%
Blood uric acid increased
18%
Decreased appetite
18%
Hyponatraemia
18%
Diarrhoea
18%
Alopecia
18%
Activated partial thromboplastin time prolonged
18%
Hypertension
18%
International normalised ratio increased
18%
Dry mouth
18%
Urine abnormality
9%
Sinus tachycardia
9%
Eye oedema
9%
Gout
9%
Musculoskeletal chest pain
9%
Neuralgia
9%
Neck pain
9%
Blood thyroid stimulating hormone increased
9%
Flank pain
9%
Balance disorder
9%
Hypophosphataemia
9%
Blood bilirubin increased
9%
Blood magnesium decreased
9%
Drooling
9%
Urinary incontinence
9%
Petechiae
9%
Aortic arteriosclerosis
9%
Cellulitis
9%
Hypotension
9%
Stress cardiomyopathy
9%
Lacrimation increased
9%
Chest pain
9%
Traumatic haematoma
9%
Blood albumin decreased
9%
Vulvovaginal pruritus
9%
Nail disorder
9%
Neutropenia
9%
Abdominal distension
9%
Sepsis
9%
Blood lactate dehydrogenase increased
9%
Confusional state
9%
Non-cardiac chest pain
9%
Pneumonitis
9%
Vomiting
9%
Blood creatinine increased
9%
Haematoma
9%
Pyrexia
9%
Anal pruritus
9%
Wound secretion
9%
Heart rate irregular
9%
Catathrenia
9%
Dysphagia
9%
Leukopenia
9%
Hyperglycaemia
9%
Bone pain
9%
Dry skin
9%
Rash
9%
Breast pain
9%
Pelvic pain
9%
Skin ulcer
9%
Eczema
9%
Pallor
9%
Disturbance in attention
9%
Headache
9%
Pleural effusion
9%
Rash maculo-papular
9%
Cachexia
9%
Stomatitis
9%
Myocardial ischaemia
9%
Flatulence
9%
Hypokalaemia
9%
Epistaxis
9%
Early satiety
9%
Splenic infarction
9%
Abdominal pain upper
9%
Calcium ionised decreased
9%
Hyperactive pharyngeal reflex
9%
Hyperhidrosis
9%
Blood alkaline phosphatase increased
9%
Myalgia
9%
Mouth haemorrhage
9%
Abdominal wall haematoma
9%
Hypervolaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ph 2b PPV-MF: Bomedemstat 0.6 mg/kg/d
Ph 1/2a PMF: Bomedemstat 0.25 mg/kg/d
Ph 1/2a PPV-MF: Bomedemstat 0.25 mg/kg/d
Ph 1/2a PET-MF: Bomedemstat 0.25 mg/kg/d
Ph 2b PMF: Bomedemstat 0.5 mg/kg/d
Ph 2b PPV-MF: Bomedemstat 0.5 mg/kg/d
Ph 2b PET-MF: Bomedemstat 0.5 mg/kg/d
Ph 2b PMF: Bomedemstat 0.6 mg/kg/d
Ph 2b PET-MF: Bomedemstat 0.6 mg/kg/d

Trial Design

1Treatment groups
Experimental Treatment
Group I: BomedemstatExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Bomedemstat
2017
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,583 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp and Dohme LLC
2,834 Previous Clinical Trials
8,079,380 Total Patients Enrolled
~267 spots leftby Dec 2034
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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