A clinical study of bomedemstat for people in a prior bomedemstat study

Phase 1

Recruiting

• Conditions: Myeloproliferative Neoplasms (Essential Thrombocythemia, Polycythemia Vera and Myelofibrosis); MedDRA version: 20.0Level: PTClassification code: 10028537Term: Myelofibrosis Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10036061Term: Polycythemia vera Class: 10029104; MedDRA version: 21.0Level: LLTClassification code: 10015494Term: Essential thrombocythemia Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-506996-89-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

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., Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator, ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator, Be able to initiate study intervention on Day 1 of the extension study (ie, not currently on a dose hold), Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified