← Back to Search

Other

INCB000928 + Ruxolitinib for Myelofibrosis (LIMBER Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with MF who are transfusion-dependent or present with symptomatic anemia as defined
Ineligible to receive or have not responded to available therapies for anemia such as ESAs
Must not have
Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib for TGB only, within 5 half-lives or 28 days before the first dose of study treatment
Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately upto 13 months
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, typical ones may include reactions at the infusion site, fatigue, changes in blood counts or chemistry that could affect organ function. The trial aims to identify all possible side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need regular blood transfusions due to my myelofibrosis.
Select...
I cannot take or have not responded to standard anemia treatments.
Select...
I have been on a stable ruxolitinib treatment for 12 weeks and have a certain level of myelofibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't taken any cancer treatments except ruxolitinib for TGB within the last 28 days.
Select...
I have had or am a candidate for a stem cell transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately upto 13 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately upto 13 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of treatment-related adverse events
Secondary study objectives
AUC
AUC0-t
Anemia Response
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment Group C (TGC)Experimental Treatment2 Interventions
INCB000928 will be administered in combination with ruxolitinib.
Group II: Treatment Group B (TGB)Experimental Treatment2 Interventions
INCB000928 will be administered in combination with ruxolitinib.
Group III: Treatment Group A (TGA)Experimental Treatment1 Intervention
INCB000928 will be administered once daily (QD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB000928
2021
Completed Phase 2
~70
ruxolitinib
2017
Completed Phase 3
~660

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for anemia include erythropoiesis-stimulating agents (ESAs), hypomethylating agents, and red blood cell (RBC) transfusions. ESAs, such as erythropoietin, stimulate the bone marrow to produce more red blood cells, addressing the root cause of anemia by increasing RBC production. Hypomethylating agents, like azacitidine and decitabine, can improve blood counts by modifying the DNA of bone marrow cells, promoting normal cell growth and differentiation. RBC transfusions provide immediate relief by directly increasing the number of red blood cells in circulation. These treatments are crucial for anemia patients as they help alleviate symptoms like fatigue and weakness, improve quality of life, and, in some cases, address the underlying causes of anemia.
Distinguishing anemia and iron deficiency of heart failure: signal for severity of disease or unmet therapeutic need?

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
387 Previous Clinical Trials
63,406 Total Patients Enrolled
4 Trials studying Anemia
60 Patients Enrolled for Anemia
Amanda McBride, MDStudy DirectorIncyte Corporation
Ekatarine Asantiani, MDStudy DirectorIncyte Corporation

Media Library

INCB000928 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04455841 — Phase 1 & 2
Anemia Research Study Groups: Treatment Group C (TGC), Treatment Group A (TGA), Treatment Group B (TGB)
Anemia Clinical Trial 2023: INCB000928 Highlights & Side Effects. Trial Name: NCT04455841 — Phase 1 & 2
INCB000928 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04455841 — Phase 1 & 2
~48 spots leftby Nov 2025