INCB000928 + Ruxolitinib for Myelofibrosis

(LIMBER Trial)

Recruiting at42 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Incyte Corporation

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called INCB000928, either alone or with ruxolitinib, to see if it is safe and effective. It targets people with Myelofibrosis who need regular blood transfusions or have severe anemia. The goal is to see if the drug can reduce the need for transfusions and improve anemia symptoms.

Research Team

Amanda McBride, MD

Principal Investigator

Incyte Corporation

Eligibility Criteria

This trial is for people with myeloproliferative disorders causing anemia who've had prior treatment with JAK inhibitors, are dependent on blood transfusions, and have a life expectancy over 6 months. They must not be pregnant or fathering children and should not have received certain other treatments recently.

Inclusion Criteria

Life expectancy greater than 6 months

I have been treated with JAK inhibitors for over 12 weeks and my condition is rated intermediate-2 or high.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I haven't taken any cancer treatments except ruxolitinib for TGB within the last 28 days.

Laboratory Values outside of protocol defined range at screening

I have had or am a candidate for a stem cell transplant.

Treatment Details

Interventions

• INCB000928 (Other)
• ruxolitinib (Other)

Trial Overview The study tests INCB000928 alone or combined with ruxolitinib to assess safety, how the body processes it (PK/PD), and effectiveness in treating symptomatic anemia in myelofibrosis patients. It includes dose-finding phases to determine the best amount of drug to give.

Participant Groups

Group I: Treatment Group C (TGC) Experimental Treatment 2 Interventions

INCB000928 will be administered in combination with ruxolitinib.

Group II: Treatment Group B (TGB) Experimental Treatment 2 Interventions

INCB000928 will be administered in combination with ruxolitinib.

Group III: Treatment Group A (TGA) Experimental Treatment 1 Intervention

INCB000928 will be administered once daily (QD).

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School