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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 weeks3 visits
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)
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)
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 moreSide effects data
From 2018 Phase 1 & 2 trial • 45 Patients • NCT0284282788%
Diarrhoea
63%
Vomiting
63%
Oedema peripheral
63%
Nausea
50%
Febrile neutropenia
38%
Pyrexia
38%
Thrombocytopenia
38%
Fatigue
38%
Fall
38%
Decreased appetite
38%
Hypokalaemia
38%
Dry skin
38%
Petechiae
25%
Hypophosphataemia
25%
Epistaxis
25%
Abdominal pain
25%
Blood blister
25%
Pneumonia
25%
Syncope
25%
Anaemia
25%
Constipation
25%
Mouth haemorrhage
25%
Stomatitis
25%
Dysgeusia
25%
Pleural effusion
25%
Headache
25%
Alopecia
25%
Hypocalcaemia
25%
Skin exfoliation
25%
Rhinorrhoea
13%
Rash maculo-papular
13%
Atrial fibrillation
13%
Gout
13%
Inguinal mass
13%
Transfusion reaction
13%
Confusional state
13%
Acute pulmonary oedema
13%
Swelling face
13%
Lower respiratory tract infection
13%
Conjunctival haemorrhage
13%
Rectal haemorrhage
13%
Injection site swelling
13%
Cellulitis
13%
Oral candidiasis
13%
Staphylococcal bacteraemia
13%
Urinary tract infection
13%
Muscle spasms
13%
Agitation
13%
Cough
13%
Skin ulcer
13%
Splinter haemorrhages
13%
Extremity necrosis
13%
Painful respiration
13%
Bacterial sepsis
13%
Clostridium difficile colitis
13%
Enterococcal bacteraemia
13%
Folliculitis
13%
Klebsiella sepsis
13%
Lymph node pain
13%
Neutropenia
13%
Ear discomfort
13%
Dry mouth
13%
Dyspepsia
13%
Enteritis
13%
Gingival bleeding
13%
Haemorrhoids
13%
Mouth ulceration
13%
Palatal ulcer
13%
Tongue discomfort
13%
Tongue ulceration
13%
Catheter site erythema
13%
Catheter site haematoma
13%
Catheter site swelling
13%
Local swelling
13%
Oedema
13%
Pain
13%
Hepatomegaly
13%
Acute haemorrhagic conjunctivitis
13%
Escherichia bacteraemia
13%
Contusion
13%
Genital injury
13%
Laceration
13%
Radiation skin injury
13%
Subcutaneous haematoma
13%
International normalised ratio increased
13%
Liver function test abnormal
13%
Electrolyte imbalance
13%
Fluid overload
13%
Hypomagnesaemia
13%
Back pain
13%
Onycholysis
13%
Pruritus
13%
Pain in extremity
13%
Tenosynovitis
13%
Dyskinesia
13%
Lethargy
13%
Dyspnoea
13%
Nasal ulcer
13%
Sinus congestion
13%
Atrial flutter
13%
Dermatitis acneiform
13%
Oral mucosa haematoma
13%
Skin lesion
13%
Toothache
13%
Herpes simplex oesophagitis
13%
Nasal mucosal erosion
13%
Hypotension
13%
Gastrointestinal haemorrhage
13%
Umbilical hernia
13%
Non-cardiac chest pain
13%
Oral herpes
13%
Lower respiratory tract infection fungal
13%
Inspiratory capacity decreased
13%
Ageusia
13%
Rales
13%
Decubitus ulcer
13%
Diverticulitis
13%
Localised infection
13%
Thrombophlebitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 4x: Bomedemstat 6 mg/kg/Day Plus Tretinoin 45 mg/m^2/Day
Cohort 3x: 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
424 Total Patients Enrolled
2 Trials studying Polycythemia Vera
114 Patients Enrolled for Polycythemia Vera
Imago BioSciences,Inc.Lead Sponsor
9 Previous Clinical Trials
424 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bone marrow fibrosis is minimal.I have HIV or active Hepatitis B/C.I have tried at least one standard treatment to lower my blood volume without success.I stopped my previous cancer treatment 2 weeks ago, or 4 weeks ago if it was interferon.I have an ongoing infection that isn't under control.I need considerable assistance and am unable to care for myself.I have a condition that increases my risk of bleeding.My side effects from previous treatments are mild or gone.I have been diagnosed with Polycythemia Vera according to WHO standards.You are expected to live for at least 36 more weeks.
Research Study Groups:
This trial has the following groups:- Group 1: bomedemstat
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has bomedemstat received endorsement from the Federal Drug Administration?
"Taking into consideration the Phase 2 status of bomedemstat, our team at Power assigned it a safety rating of two due to limited data supporting efficacy."
Answered by AI
What is the aggregate amount of individuals involved in this research?
"Affirmative. Information accessed from clinicaltrials.gov attests that this research protocol, which was first unveiled on February 1st 2023, is currently inviting participants to join the study. A total of 20 volunteers are expected to be recruited from a single medical centre."
Answered by AI
Is participation in this clinical trial currently available for persons seeking treatment?
"According to the listing on clinicaltrials.gov, this investigation is currently accepting volunteers; initial posting was February 1st 2023 with the most recent update being made on February 3rd of that same year."
Answered by AI
What is the ultimate objective of this research endeavor?
"Within the 14-day period assessed, this clinical trial is primarily assessing the percentage of patients that experience a decrease in hematocrit. Supporting data will be collected to evaluate the duration of this change, spleen volume reduction and Cmax with sparse blood sampling for bomedemstat pharmacokinetics."
Answered by AI
Who else is applying?
What site did they apply to?
Duke University Medical Center ( Site 0016)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I have a JAK2 gene that isn't working. I currently take 1500 mg of Hydroxyurea.
PatientReceived 2+ prior treatments
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