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LSD1 Inhibitor

Bomedemstat for Polycythemia Vera

Phase 2
Waitlist Available
Research Sponsored by Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at designated time points on day 1, day 15 and at investigators choice of one of any regularly scheduled study visit from week 4 (day 29) to week 8 (day 57)
Awards & highlights

Study Summary

This trial studies an oral drug to treat a blood disorder. It will look at safety and how it affects the body.

Who is the study for?
This trial is for people with Polycythemia Vera who haven't responded well to at least one standard treatment. They should have a certain level of platelets and white blood cells, expect to live more than 36 weeks, and meet specific diagnostic criteria. Those with severe physical limitations, unresolved side effects from past treatments, certain infections or bleeding risks, pregnant or breastfeeding women, or on prohibited meds can't join.Check my eligibility
What is being tested?
The study tests Bomedemstat (MK-3543), an oral drug that targets LSD1 enzymes in patients with Polycythemia Vera. The goal is to see if it's safe and can manage the disease by reducing blood counts, improving symptoms, and shrinking enlarged spleens within 36 weeks.See study design
What are the potential side effects?
While the exact side effects are not listed here, typical reactions may include issues related to digestion due to oral intake of medication; potential impact on blood counts since it targets hematologic response; fatigue as commonly seen in such treatments; and possibly liver enzyme changes given its metabolic pathway.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at designated time points on day 1, day 15 and at investigators choice of one of any regularly scheduled study visit from week 4 (day 29) to week 8 (day 57)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at designated time points on day 1, day 15 and at investigators choice of one of any regularly scheduled study visit from week 4 (day 29) to week 8 (day 57) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants who discontinued study intervention due to AEs
Number of participants with adverse events (AEs)
Number of participants with change from baseline of hematocrit to <45% without phlebotomy at Week 36
Secondary outcome measures
Area under the curve 0-24 (AUC 0-24) of bomedemstat
Duration of platelet count ≤ 450 x 10^9/L in participants at Week 36
Duration of reduction of hematocrit to <45% without phlebotomy
+12 more

Side effects data

From 2018 Phase 1 & 2 trial • 45 Patients • NCT02842827
100%
Diarrhoea
50%
Epistaxis
50%
Hypotension
50%
Hypophosphataemia
50%
Nausea
50%
Hypokalaemia
50%
Conjunctivitis
25%
Pyrexia
25%
Hypomagnesaemia
25%
Confusional state
25%
Acute pulmonary oedema
25%
Vomiting
25%
Dyspnoea
25%
Cellulitis
25%
Lower respiratory tract infection bacterial
25%
Pneumonia
25%
Anaemia
25%
Thrombocytopenia
25%
Conjunctival hyperaemia
25%
Eye haemorrhage
25%
Eye pain
25%
Eye swelling
25%
Gastrooesophageal reflux disease
25%
Chest pain
25%
Pain
25%
Thirst
25%
Subcutaneous haematoma
25%
Decreased appetite
25%
Fluid overload
25%
Hypoglycaemia
25%
Arthralgia
25%
Depressed level of consciousness
25%
Dysgeusia
25%
Multiple organ dysfunction syndrome
25%
Hypoxia
25%
Tachypnoea
25%
Skin lesion
25%
Otitis externa
25%
Lower respiratory tract infection fungal
25%
Hypertension
25%
Oedema
25%
Hordeolum
25%
Haematuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 3x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day
Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day
Cohort 1a: Bomedemstat 0.75 mg/kg/Day
Cohort 1b: Bomedemstat 1.5 mg/kg/Day
Cohort 1c: Bomedemstat 3 mg/kg/Day
Cohort 1d: Bomedemstat 6 mg/kg/Day
Cohort 1x3: Bomedemstat 3 mg/kg/Day Orally Plus Tretinoin 45 mg/m^2/Day
Cohort 1x6: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day

Trial Design

1Treatment groups
Experimental Treatment
Group I: bomedemstatExperimental Treatment1 Intervention
Participants will receive bomedemstat daily for 36 weeks and may qualify for additional treatment thereafter if deriving clinical benefit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bomedemstat
2016
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Imago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)Lead Sponsor
9 Previous Clinical Trials
393 Total Patients Enrolled
2 Trials studying Polycythemia Vera
114 Patients Enrolled for Polycythemia Vera
Imago BioSciences,Inc.Lead Sponsor
9 Previous Clinical Trials
393 Total Patients Enrolled
2 Trials studying Polycythemia Vera
114 Patients Enrolled for Polycythemia Vera
Hugh Rienhoff, MDStudy DirectorImago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New Jersey USA)
2 Previous Clinical Trials
153 Total Patients Enrolled

Media Library

bomedemstat (LSD1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05558696 — Phase 2
Polycythemia Vera Research Study Groups: bomedemstat
Polycythemia Vera Clinical Trial 2023: bomedemstat Highlights & Side Effects. Trial Name: NCT05558696 — Phase 2
bomedemstat (LSD1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05558696 — Phase 2
~10 spots leftby Mar 2025
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