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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

No Placebo-Only Group

Pivotal Trial

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

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I can take pills and follow home dosing instructions.

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I am part of a bomedemstat study by Imago Biosciences or MSD, approved for MK-3543-017.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~10 years

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%

Arthralgia

27%

Dysgeusia

27%

Back pain

27%

Nausea

27%

Anaemia

27%

Depression

27%

Constipation

27%

Oedema peripheral

27%

Hypocalcaemia

18%

Activated partial thromboplastin time prolonged

18%

Muscular weakness

18%

Palpitations

18%

Dyspnoea

18%

Hyperuricaemia

18%

Fatigue

18%

Hyponatraemia

18%

Cough

18%

Fall

18%

Lymphopenia

18%

Blood uric acid increased

18%

Pruritus

18%

Insomnia

18%

Dizziness

18%

Abdominal pain

18%

Diarrhoea

18%

Alopecia

18%

Pain in extremity

18%

Asthenia

18%

Decreased appetite

18%

Hypertension

18%

International normalised ratio increased

18%

Dry mouth

18%

Urine abnormality

Flank pain

Drooling

Dysphagia

Skin ulcer

Confusional state

Hypotension

Headache

Neck pain

Blood bilirubin increased

Blood magnesium decreased

Chest pain

Wound secretion

Petechiae

Hyperglycaemia

Non-cardiac chest pain

Cellulitis

Stress cardiomyopathy

Myalgia

Balance disorder

Sinus tachycardia

Sepsis

Musculoskeletal chest pain

Blood lactate dehydrogenase increased

Eye oedema

Blood creatinine increased

Splenic infarction

Epistaxis

Vomiting

Catathrenia

Traumatic haematoma

Leukopenia

Rash

Hypokalaemia

Breast pain

Pelvic pain

Anal pruritus

Myocardial ischaemia

Hypophosphataemia

Mouth haemorrhage

Blood albumin decreased

Urinary incontinence

Vulvovaginal pruritus

Pneumonitis

Pallor

Disturbance in attention

Hyperhidrosis

Eczema

Abdominal distension

Bone pain

Hyperactive pharyngeal reflex

Heart rate irregular

Cachexia

Nail disorder

Stomatitis

Neuralgia

Pyrexia

Abdominal pain upper

Rash maculo-papular

Haematoma

Neutropenia

Early satiety

Calcium ionised decreased

Gout

Dry skin

Pleural effusion

Lacrimation increased

Flatulence

Aortic arteriosclerosis

Blood alkaline phosphatase increased

Blood thyroid stimulating hormone increased

Abdominal wall haematoma

Hypervolaemia

100%

80%

60%

40%

20%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

2021

Completed Phase 2

~250

0 / 2Eligibility criteria met