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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately upto 13 months
Awards & highlights

LIMBER Trial Summary

This trial is testing a new drug for people with myelofibrosis who are either transfusion-dependent or have symptomatic anemia. The trial will have two parts: dose escalation (finding the best dose) and expansion (a larger group of people testing the best dose).

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.Check my eligibility
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.See study design
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.

LIMBER Trial 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.

LIMBER Trial 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

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

LIMBER 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 1
~50
ruxolitinib
2017
Completed Phase 3
~600

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
367 Previous Clinical Trials
55,201 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How much recruitment is present for this clinical investigation?

"Affirmative. In accordance with the clinicaltrials.gov records, this clinical trial is currently enrolling participants. Initially posted on March 19th 2021 and recently updated November 15th 2022, 100 patients need to be recruited across 12 sites in total."

Answered by AI

Are there any openings for those interested in participating in this research?

"Verified: clinicaltrials.gov attests that this ongoing trial, published on March 19th 2021 and last edited November 15th 2022, is actively enrolling 100 participants across 12 different medical centres."

Answered by AI

To what extent has this trial been implemented in various healthcare facilities?

"Currently, Usc Norris Comprehensive Cancer Center in Los Angeles, City of Hope Orange County in Irvine and Duke University Medical Center's Department of Hematologic Malignancies and Cellular Therapy in Durham are enrolling patients as well as 12 other research centres."

Answered by AI

Is there any precedent for utilizing INCB000928 in scientific research?

"INCB000928 was first studied in 2002 at the NIH Clinical Center, 9000 Rockville Pike. To date, there have been 91 completed trials and an additional 97 which are actively recruiting patients; many of these studies take place in Los Angeles."

Answered by AI

What is the traditional purpose of INCB000928 consumption?

"INCB000928 is a medication often prescribed for polycythemia vera and other similar conditions, including hydroxyurea-resistant or -intolerant polycytemia and primary myelofibrosis."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Stanford Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders
2021. "INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04455841.
All > Essential Thrombocythemia > Polycythemia Vera
~66 spots leftby Nov 2025
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