MyelofibrosisPhase 2NCT04629508
To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)
A Phase 2 study testing itacitinib in people with Myelofibrosis and Polycythemia Vera, run by Incyte Corporation at 21 sites in 7 countries.
Trial summary
This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Polycythemia Vera, Thrombocythemia
- What is being tested?
- itacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 21 sitesin 7 countries
- Study dates
- 12 Jul 2021to 24 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary MF meeting the 2016 WHO criteria for overt PMF or secondary MF (PPV-MF or PET-MF) meeting the 2008 IWG-MRT criteria.
- At least Intermediate 1 risk MF according to the DIPSS.
- Prior treatment with ruxolitinib and/or fedratinib monotherapy
- Currently receiving ruxolitinib or fedratinib monotherapy for PMF or secondary MF.
- Splenomegaly defined as palpable spleen at least 5 cm below the left costal margin or volume ≥ 450 cm3 on imaging assessed during screening.
- Allogeneic stem cell transplant not planned.
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- Platelet is greater than or equal to 50 × 109/L at screening.
- Ability to comprehend and willingness to sign a written ICF for the study.
- Willingness to avoid pregnancy or fathering children.
Who cannot join
- Prior treatment with a JAK inhibitor other than ruxolitinib or fedratinib
- Record of ≥ 10% myeloid blasts in the peripheral blood (on peripheral blood smear) or bone marrow prior to or at the time of screening
- For participants on ruxolitinib or fedratinib, unable to be tapered from that treatment over the course of 14 days without corticosteroids, hydroxyurea, or other agents
- Treatment with ruxolitinib, fedratinib or other MF-directed therapy (approved or investigational) within 2 weeks of Day 1
- Prior splenectomy or splenic irradiation within 6 months before receiving the first dose of itacitinib
- Unable or unwilling to undergo serial MRI or CT scans for spleen volume measurement
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- Unable or unwilling to complete MFSAF v4.0 diary on a daily basis during the study
- ECOG performance status ≥ 3
- Life expectancy less than 24 weeks
- Not willing to receive RBC or platelet transfusions
- Participants with laboratory values at screening outside of protocol defined ranges
- Significant concurrent, uncontrolled medical condition
- Participants with impaired cardiac function or clinically significant cardiac disease unless approved by medical monitor/sponsor
- History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
- Evidence of HBV or HCV infection or risk of reactivation
- Known HIV infection.
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
United States8 sites
Rcca Md, Llc
Bethesda, Maryland, 20817
New Jersey Hematology Oncology Associates Llc
Brick, New Jersey, 08724-3009
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, 75246-2092
Midamerica Cancer Care
Kansas City, Missouri, 64114
Baptist Cancer Center
Memphis, Tennessee, 38120
Vanderbilt University
Nashville, Tennessee, 37235
Tulane University
New Orleans, Louisiana, 70112
Renovatio Clinical Consultants Llc
Spring, Texas, 77380
Belgium4 sites
Cliniques Universitaires Ucl Saint-Luc
Brussels, 01000
Jessa Ziekenhuis
Hasselt, 03500
AZ DELTA
Roeselare, 08800
Chu Ucl Namur University Hospital Mont-Godinne
Yvoir, 05530
Italy3 sites
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele
Milan, 20132
Aou San Giovanni Di Dio E Ruggi
Salerno, 84131
Treviso Hospital
Treviso, 31100
Germany2 sites
Universitaetsmedizin Greifswald
Greifswald, 17475
Universitatsklinikum Halle (Saale)
Halle, 06120
Spain2 sites
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitari I Politecnic La Fe
Valencia, 46000
Austria1 site
Interne 1 - Hematologie Mit Stammzelltransplantation, Hemostaseologie Und Medizinische Onkologie Ord
Linz, 70376
About this study
Official title: A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy
This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.
- Conditions
- Myelofibrosis, Polycythemia Vera, Thrombocythemia
- Being tested
- itacitinib
- Keywords
- Myelofibrosis, Post-PV Myelofibrosis, Post-ET Myelofibrosis, LIMBER, LIMBER-213, MF, Myeloproliferative Neoplasms
- Medical subject headings
- Primary Myelofibrosis, Polycythemia Vera, Thrombocytosis, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
itacitinibDrug
Also called INCB039110
itacitinb Immediate Release (IR) will be dosed orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| Part 1 : Dose Escalation of itacitinib | Experimental | Participants will be dosed at different dose levels with a maximum of up to 9 participants per dose level. Receives: Drug: itacitinib |
| Part 2 : Dose Expansion of itacitinib | Experimental | Participants will be dosed at the recommended Phase 2 dose (RP2D) identified in Part 1. Receives: Drug: itacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Measured: up to 724 days
Part 1: Number of Participants With Any Grade 3 or Higher TEAE
A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Measured: up to 724 days
Part 2: Splenic Response Rate (SRR) at Week 24
SRR was defined as the percentage of participants who had a reduction in spleen volume (by imaging) of at least 35% when compared with Baseline.
Measured: Baseline; Week 24
Secondary outcomes (5)
Part 2: Number of Participants With Any TEAE
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Measured: up to at least 24 weeks
Part 2: Number of Participants With Any Grade 3 or Higher TEAE
A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Measured: up to at least 24 weeks
Part 2: Total Symptom Score (TSS) Response Rate at Week 24
TSS response was defined as the percentage of participants who achieved at least 50% reduction in TSS over the 28 days immediately before the end of Week 24 compared with the 7 days immediately before the initiation of itacitinib immediate release (aseline).B
Measured: Baseline; Week 24
Part 2: Mean Change (From Day 1 Versus Week 12 and Week 24) in the 5 Multi-item Functional Scale Scores and the Multi-item Global Health Status Scale Score (EORTC QLQ-C30)
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was to be used to assess the improvement in quality of life.
Measured: Baseline; Weeks 12 and 24
Part 2: Percentage of Participants Categorized as Improved on the Week 24 Patient Global Impression of Change (PGIC)
The PGIC consists of a single question pertaining to a participant's overall status since the start of the study. The questionnaire gives participants 7 options to describe their overall status including: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse.
Measured: Baseline; Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start12 Jul 2021
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629508
- Sponsor's protocol ID
- INCB 39110-213/LIMBER-213
- Other IDs
- 2020-003123-42
- Status last verified
- Aug 2025
- First submitted
- 10 Nov 2020
- Last updated
- 2 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy
- ClinicalTrials.gov ID
- NCT04629508
- Acronym / sponsor ID
- INCB 39110-213/LIMBER-213
- Conditions
- Myelofibrosis, Polycythemia Vera, Thrombocythemia
- Keywords
- Myelofibrosis, Post-PV Myelofibrosis, Post-ET Myelofibrosis, LIMBER, LIMBER-213, MF, Myeloproliferative Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 : Dose Escalation of itacitinib | Experimental | Drug: itacitinibParticipants will be dosed at different dose levels with a maximum of up to 9 participants per dose level. |
| Part 2 : Dose Expansion of itacitinib | Experimental | Drug: itacitinibParticipants will be dosed at the recommended Phase 2 dose (RP2D) identified in Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of primary MF meeting the 2016 WHO criteria for overt PMF or secondary MF (PPV-MF or PET-MF) meeting the 2008 IWG-MRT criteria.
- At least Intermediate 1 risk MF according to the DIPSS.
- Prior treatment with ruxolitinib and/or fedratinib monotherapy
- Currently receiving ruxolitinib or fedratinib monotherapy for PMF or secondary MF.
- Splenomegaly defined as palpable spleen at least 5 cm below the left costal margin or volume ≥ 450 cm3 on imaging assessed during screening.
Key exclusion criteria (17 listed)
- Prior treatment with a JAK inhibitor other than ruxolitinib or fedratinib
- Record of ≥ 10% myeloid blasts in the peripheral blood (on peripheral blood smear) or bone marrow prior to or at the time of screening
- For participants on ruxolitinib or fedratinib, unable to be tapered from that treatment over the course of 14 days without corticosteroids, hydroxyurea, or other agents
- Treatment with ruxolitinib, fedratinib or other MF-directed therapy (approved or investigational) within 2 weeks of Day 1
- Prior splenectomy or splenic irradiation within 6 months before receiving the first dose of itacitinib
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| itacitinibAlso: INCB039110itacitinb Immediate Release (IR) will be dosed orally twice a day | Drug | Part 1 : Dose Escalation of itacitinib, Part 2 : Dose Expansion of itacitinib |
Primary outcome
Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to 724 days
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Part 1: Number of Participants With Any Grade 3 or Higher TEAE
Time frame: up to 724 days
A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Part 2: Splenic Response Rate (SRR) at Week 24
Time frame: Baseline; Week 24
SRR was defined as the percentage of participants who had a reduction in spleen volume (by imaging) of at least 35% when compared with Baseline.
5 secondary outcomes
Part 2: Number of Participants With Any TEAE
Time frame: up to at least 24 weeks
Part 2: Number of Participants With Any Grade 3 or Higher TEAE
Time frame: up to at least 24 weeks
Part 2: Total Symptom Score (TSS) Response Rate at Week 24
Time frame: Baseline; Week 24
Part 2: Mean Change (From Day 1 Versus Week 12 and Week 24) in the 5 Multi-item Functional Scale Scores and the Multi-item Global Health Status Scale Score (EORTC QLQ-C30)
Time frame: Baseline; Weeks 12 and 24
Part 2: Percentage of Participants Categorized as Improved on the Week 24 Patient Global Impression of Change (PGIC)
Time frame: Baseline; Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing itacitinib in people with Myelofibrosis and Polycythemia Vera, run by Incyte Corporation at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Belgium, Italy, Germany, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) (time frame: up to 724 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.