Trial · NCT04629508
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)
NCT04629508, Phase 2, Completed, Incyte Corporation; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT04629508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04629508
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT04629508
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Myelofibrosis, Polycythemia Vera, Thrombocythemia
- Interventions
- itacitinib
- First posted
- 2020-11-16
- Last updated
- 2025-09-02
- Other registries' IDs
- eudract:2020-003123-42
- Results first posted
- 2024-09-19
- Limitations and caveats
The sponsor terminated study enrollment following an assessment regarding the expected duration of recruitment for the Phase 2 portion of the study combined with the availability of other study options for this patient population.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 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. |
| Primary | Part 1: Number of Participants With Any Grade 3 or Higher TEAE | 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. |
| Primary | Part 2: Splenic Response Rate (SRR) at Week 24 | 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. |
| Secondary | Part 2: Number of Participants With Any TEAE | up to at least 24 weeks | 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. |
| Secondary | Part 2: Number of Participants With Any Grade 3 or Higher TEAE | up to at least 24 weeks | 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. |
| Secondary | Part 2: Total Symptom Score (TSS) Response Rate at Week 24 | Baseline; 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 |
| Secondary | 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) | Baseline; Weeks 12 and 24 | 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. |
| Secondary | Part 2: Percentage of Participants Categorized as Improved on the Week 24 Patient Global Impression of Change (PGIC) | Baseline; Week 24 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 724 days | Safety Evaluable Population: all participants enrolled in the study who received at least 1 dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1: Number of Participants With Any Grade 3 or Higher TEAE | up to 724 days | Safety Evaluable Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2: Splenic Response Rate (SRR) at Week 24 | Baseline; Week 24 | Analysis was not conducted because Part 2 never opened for enrollment. | ||
| SECONDARY | Part 2: Number of Participants With Any TEAE | up to at least 24 weeks | Analysis was not conducted because Part 2 never opened for enrollment. | ||
| SECONDARY | Part 2: Number of Participants With Any Grade 3 or Higher TEAE | up to at least 24 weeks | Analysis was not conducted because Part 2 never opened for enrollment. | ||
| SECONDARY | Part 2: Total Symptom Score (TSS) Response Rate at Week 24 | Baseline; Week 24 | Analysis was not conducted because Part 2 never opened for enrollment. | ||
| SECONDARY | 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) | Baseline; Weeks 12 and 24 | Analysis was not conducted because Part 2 never opened for enrollment. | ||
| SECONDARY | Part 2: Percentage of Participants Categorized as Improved on the Week 24 Patient Global Impression of Change (PGIC) | Baseline; Week 24 | Analysis was not conducted because Part 2 never opened for enrollment. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Itacitinib 300 mg | 4 | Participants | ||
| Part 1: Number of Participants With Any Grade 3 or Higher TEAE | Itacitinib 300 mg | 4 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Itacitinib 300 mg | 4 | |
| Overall Study | COMPLETED | Itacitinib 300 mg | 0 | |
| Overall Study | NOT COMPLETED | Itacitinib 300 mg | 4 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Itacitinib 300 mg | 1 | 4 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Total | 1 | 4 | 2 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Itacitinib 300 mg | 1 | 4 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Total | 1 | 4 | 1 |
| other | Asthenia | General disorders | Itacitinib 300 mg | 1 | 4 | 1 |
| other | Asthenia | General disorders | Total | 1 | 4 | 1 |
| other | Blood bilirubin increased | Investigations | Itacitinib 300 mg | 1 | 4 | 1 |
| other | Blood bilirubin increased | Investigations | Total | 1 | 4 | 1 |
| other | Blood creatinine increased | Investigations | Itacitinib 300 mg | 1 | 4 | 1 |
| other | Blood creatinine increased | Investigations | Total | 1 | 4 | 1 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Itacitinib 300 mg | 2 | 4 |
| Total, all-cause mortality | Total | 2 | 4 |
| Total, other adverse events | Itacitinib 300 mg | 4 | 4 |
| Total, other adverse events | Total | 4 | 4 |
| Total, serious adverse events | Itacitinib 300 mg | 3 | 4 |
| Total, serious adverse events | Total | 3 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Itacitinib 300 mg vs Total: deaths from any cause | Trial comparisons |
| Itacitinib 300 mg vs Total: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04629508
GET https://conductscience.org/api/trials/v1/NCT04629508/events?page=2