Recruiting PHASE3 Thrombocythemia, Essential

Tests treatment safety and results for Thrombocythemia, Essential

Official title A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

ClinicalTrials.gov ID: NCT06351631

What this study is testing

What is Bomedemstat?

Bomedemstat is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for thrombocythemia, essential.

Also referred to as MK-3543, IMG-7289.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria: Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat; Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \& Co., Inc.) or MSD, and established by the Sponsor as...
  • Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and...
  • ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must...
  • Is not currently on a dose hold
  • Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat

You likely can't join if

  • Has received prohibited concomitant medications
  • Ongoing or planned participation in another investigational study
  • Has noncompliance in prior bomedemstat study receiving \<90% of assigned doses excluding suspensions or holds as assigned by the investigator

The study team makes the final eligibility decision.

Where it's taking place

  • Ann Arbor, Michigan, United States
  • Durham, North Carolina, United States
  • Columbus, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Camperdown, New South Wales, Australia
  • St Leonards, New South Wales, Australia
  • Buderim, Queensland, Australia
  • Southport, Queensland, Australia
  • Adelaide, South Australia, Australia
  • Clayton, Victoria, Australia
  • Hksar, Hong Kong
  • Florence, Tuscany, Italy
  • Alessandria, Italy
  • Bologna, Italy
  • Varese, Italy
  • Auckland, New Zealand
  • London, Hammersmith and Fulham, United Kingdom
  • Boston, Lincolnshire, United Kingdom
  • London, London, City of, United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Ann Arbor, Michigan, United States; Durham, North Carolina, United States; Columbus, Ohio, United States; Pittsburgh, Pennsylvania, United States; Camperdown, New South Wales, Australia; St Leonards, New South Wales, Australia and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.