A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study

Long-term safety and effectiveness of Bomedemstat for blood disorders

NCT: NCT06351631 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Merck Sharp & Dohme LLC · Started: 2024-05-23 · Est. Completion: 2034-12-04

Plain English Summary

A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017) is a Phase 3 clinical trial sponsored by Merck Sharp & Dohme LLC studying Thrombocythemia, Essential, Primary Myelofibrosis, Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera. This study tests the long-term safety and effectiveness of a drug called Bomedemstat. It is for patients who have already participated in a previous Bomedemstat study and are tolerating the drug well. Participation involves continuing to take Bomedemstat as prescribed and attending regular study visits. The alternative for eligible patients is to stop taking Bomedemstat and potentially seek other treatment options outside of this specific study. The trial aims to enroll 400 participants.

Official Summary

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. No hypothesis testing will be conducted in this study.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients who have previously taken Bomedemstat in specific prior studies (IMG-7289-202/MK-3543-005 or other feeder studies) and are benefiting from it. Patients must have received at least 6 months of Bomedemstat in the IMG-7289-202/MK-3543-005 study or achieved confirmed hematologic remission in other feeder studies. Patients must be able to swallow pills and manage at-home dosing. Patients who have taken prohibited medications, are in other studies, or have not taken at least 90% of their previous Bomedemstat doses (excluding holds) cannot join. This trial is studying Thrombocythemia, Essential, Primary Myelofibrosis, Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how many participants experience side effects and how many have to stop the study drug because of them, giving an idea of the drug's long-term safety profile. The specific primary outcome measures are: Percentage of participants with one or more adverse events (AEs) (Up to ~10 years); Percentage of participants who discontinued study treatment due to an AE (Up to ~10 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial matters because it aims to collect long-term data on Bomedemstat, a drug that may help patients with certain blood disorders who have not found success with other treatments. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Thrombocythemia, Essential, Primary Myelofibrosis, Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera, where improved treatment options are needed.

Investor Insight

This is a Phase 3 extension study for Bomedemstat, indicating positive prior results and a potential path towards broader market approval for treating myeloproliferative neoplasms. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if continuing Bomedemstat in this study is the best option for you compared to other treatments. Be prepared for regular clinic visits to monitor your health and the drug's effects. You will need to take the medication at home as directed and report any side effects promptly. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* 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
* 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
* Is 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

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06351631?

NCT06351631 is a Phase 3 INTERVENTIONAL study titled "A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 400 participants.

What conditions does NCT06351631 study?

This trial investigates treatments for Thrombocythemia, Essential, Primary Myelofibrosis, Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera. The primary condition under study is Thrombocythemia, Essential.

What treatments are being tested in NCT06351631?

The interventions being studied include: Bomedemstat (DRUG). 10, 15, 20, and 50 mg oral capsules

What does Phase 3 mean for NCT06351631?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06351631?

This trial is currently "Recruiting." It started on 2024-05-23. The estimated completion date is 2034-12-04.

Who is sponsoring NCT06351631?

NCT06351631 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06351631?

The trial aims to enroll 400 participants. The trial is currently recruiting and accepting new participants.

How is NCT06351631 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT06351631?

The primary outcome measures are: Percentage of participants with one or more adverse events (AEs) (Up to ~10 years); Percentage of participants who discontinued study treatment due to an AE (Up to ~10 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06351631 being conducted?

This trial is being conducted at 20 sites, including Ann Arbor, Michigan; Durham, North Carolina; Columbus, Ohio; Pittsburgh, Pennsylvania and 16 more sites (United States, Australia, Hong Kong).

Where can I find official information about NCT06351631?

The official record for NCT06351631 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06351631. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06351631 testing in simple terms?

This study tests the long-term safety and effectiveness of a drug called Bomedemstat. It is for patients who have already participated in a previous Bomedemstat study and are tolerating the drug well.

Why is this trial significant?

This trial matters because it aims to collect long-term data on Bomedemstat, a drug that may help patients with certain blood disorders who have not found success with other treatments. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06351631?

The most common risks include side effects from Bomedemstat, which could range from mild to severe. Some participants may need to stop the study drug due to side effects. Long-term use of any medication can have unforeseen effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06351631?

Ask your doctor if continuing Bomedemstat in this study is the best option for you compared to other treatments. Be prepared for regular clinic visits to monitor your health and the drug's effects. You will need to take the medication at home as directed and report any side effects promptly. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06351631 signal from an investment perspective?

This is a Phase 3 extension study for Bomedemstat, indicating positive prior results and a potential path towards broader market approval for treating myeloproliferative neoplasms. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participation involves continuing to take Bomedemstat as prescribed and attending regular study visits. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.