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A Phase 1 Study to Assess STP938 as a Monotherapy in Adults With High Risk Essential Thrombocythaemia

NCT06786234 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-28

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if the drug STP938 works to treat adults with high risk essential thrombocythaemia (ET) who are resistant to, or intolerant of, hydroxycarbamide (also known as hydroxyurea) therapy. The trial will also learn about the safety of STP938. The main questions the trial aims to answer are:

* Does STP938 control platelet counts
* Does STP938 control platelet counts without inducing unwanted side effects

Participants will:

* Take STP938 every day for up to 12 months.
* Visit the clinic once every week for the first month, then every 2 weeks for checkups and tests.
* Complete a questionnaire about symptoms once a month.

Conditions

  • Essential Thrombocythaemia

Interventions

DRUG

STP938

At enrolment all patients will be assigned to a single dose level of STP938 for 4 weeks. After 4 weeks the dose level may be adjusted as needed by the Investigator.

Sponsors & Collaborators

  • Step Pharma, SAS

    lead INDUSTRY

Principal Investigators

  • Maureen Higgins · Step Pharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-18
Primary Completion
2026-05-31
Completion
2027-12-31

Countries

  • France
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06786234 on ClinicalTrials.gov