Trial · NCT04551066
To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)
NCT04551066, Phase 3, Terminated, Incyte Corporation; results first posted 2024-10-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313). Trials, record NCT04551066. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04551066
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)
- NCT number
- NCT04551066
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 252 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
- Interventions
- parsaclisib, ruxolitinib, placebo
- First posted
- 2020-09-16
- Last updated
- 2025-10-21
- Other registries' IDs
- eudract:2020-003130-21
- Results first posted
- 2024-10-04
- Limitations and caveats
- Due to participants rolling over to another study (NCT02955940), no participants randomized to receive placebo plus ruxolitinib switched to treatment with parsaclisib plus ruxolitinib.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving ≥35% Reduction in Spleen Volume From Baseline to Week 24 as Measured by Magnetic Resonance Imaging [MRI] (or Computed Tomography [CT] Scan in Applicable Participants) | Baseline; Week 24 | Participants had an MRI of the upper and lower abdomen and pelvis to determine the spleen volume. A CT scan was substituted for participants who were not candidates for MRI or when MRI was not readily available. Determination of spleen length below the left costal margin was measured by palpation, using a flexible ruler provided by the sponsor. |
| Secondary | Percentage of Participants Who Had a ≥50% Reduction in Total Symptom Score (TSS) From Baseline to Week 24 as Measured by the Myelofibrosis Symptom Assessment Form v4.0 (MFSAF v4.0) Diary | Baseline; Week 24 | Symptoms of myelofibrosis were assessed using the MFSAF v4.0 diary. The MFSAF v4.0 is composed of 7 individual symptom scores (fatigue, night sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone pain), each collected daily using a 0- (no symptoms) to 10-point (worst imaginable symptoms) scale. The daily TSS (0 to 70) is the sum of the 7 individual symptom scores collected on the same day. Higher TSS indicate more severe symptoms. The TSS was missing if there were any missing individual scores. Observations with missing dates were excluded from the analysis. The Baseline/Week 24 total score was defined as the average of the daily total scores from the last 7 days before the first dose of parsaclisib, placebo, or ruxolitinib/the Week 24 visit. The Baseline/Week 24 total scores was missing if there were ≥4 missing out of the 7 daily total scores. |
| Secondary | Change in TSS From Baseline to Week 24 as Measured by the MFSAF v4.0 Diary | Baseline; Week 24 | Symptoms of myelofibrosis were assessed using the MFSAF v4.0 diary. The MFSAF v4.0 is composed of 7 individual symptom scores (fatigue, night sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone pain), each collected daily using a 0- (no symptoms) to 10-point (worst imaginable symptoms) scale. The daily TSS (0 to 70) is the sum of the 7 individual symptom scores collected on the same day. Higher TSS indicate more severe symptoms. The TSS was missing if there were any missing individual scores. Observations with missing dates were excluded from the analysis. The Baseline/Week 24 total score was defined as the average of the daily total scores from the last 7 days before the first dose of parsaclisib, placebo, or ruxolitinib/the Week 24 visit. The Baseline/Week 24 total scores was missing if there were ≥4 missing out of the 7 daily total scores. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Time to the First ≥50% Reduction in TSS as Measured by the MFSAF v4.0 Diary | Baseline; up to Week 24 | Symptoms of myelofibrosis were assessed using the MFSAF v4.0 diary. The MFSAF v4.0 is composed of 7 individual symptom scores (fatigue, night sweats, itchiness, abdominal discomfort, pain under left ribs, early satiety, bone pain), each collected daily using a 0- (no symptoms) to 10-point (worst imaginable symptoms) scale. The daily TSS (0 to 70) is the sum of the 7 individual symptom scores collected on the same day. Higher TSS indicate more severe symptoms. The TSS was missing if there were any missing individual scores. Observations with missing dates were excluded from the analysis. The Baseline/Week 24 total score was defined as the average of the daily total scores from the last 7 days before the first dose of parsaclisib, placebo, or ruxolitinib/the Week 24 visit. The Baseline/Week 24 total scores was missing if there were ≥4 missing out of the 7 daily total scores. |
| Secondary | Overall Survival | up to 749 days | Overall survival was defined as the interval between the randomization date and the date of death due to any cause. |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 960 days | An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore be 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 is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 to 35 days after the last dose of parsaclisib/matching placebo or ruxolitinib. |
| Secondary | Number of Participants With Any Grade 3 or Higher TEAE | up to 960 days | An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE is defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 to 35 days after the last dose of parsaclisib/matching placebo or ruxolitinib. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated; limiting instrumental activities of daily living (ADL). Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4: life-threatening urgent intervention indicated. Grade 5: death related to AE. |
| Secondary | Time of Onset of a ≥35% Reduction in Spleen Volume | up to 925 days | The time to the first ≥35% reduction in spleen volume is defined as the time from randomization to the first time participants had ≥35% reduction in spleen volume. |
| Secondary | Duration of Maintenance of a ≥35% Reduction in Spleen Volume | up to 925 days | The duration of ≥35% reduction from Baseline in spleen volume was defined as the interval between the first spleen volume measurement that was a ≥35% reduction from Baseline and the date of the first measurement that was no longer a ≥35% reduction from Baseline. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving ≥35% Reduction in Spleen Volume From Baseline to Week 24 as Measured by Magnetic Resonance Imaging [MRI] (or Computed Tomography [CT] Scan in Applicable Participants) | Baseline; Week 24 | Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were defined according to the treatment assignment at randomization regardless of the actual study drug the participant took during their participation. Participants who had both Baseline and Week 24 measurements, or discontinued treatment before 27APR2023, or reached Week 24 before 27APR2023 but were missing Week 24 assessments were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had a ≥50% Reduction in Total Symptom Score (TSS) From Baseline to Week 24 as Measured by the Myelofibrosis Symptom Assessment Form v4.0 (MFSAF v4.0) Diary | Baseline; Week 24 | ITT Population. Participants who had both Baseline and Week 24 measurements, or discontinued treatment before 27APR2023, or reached Week 24 before 27APR2023 but were missing Week 24 assessments were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change in TSS From Baseline to Week 24 as Measured by the MFSAF v4.0 Diary | Baseline; Week 24 | ITT Population. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Time to the First ≥50% Reduction in TSS as Measured by the MFSAF v4.0 Diary | Baseline; up to Week 24 | ITT Population, including censored participants. Censored participants didn't have a response at any time up to the last assessment date. Participants who didn't have a \>=50% reduction in TSS was censored at the time of the last assessment. Participants with a DIPSS risk level of Low Risk Level (0 prognostic points) were excluded from the analysis. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method with log-log transformation. | days | MEDIAN |
| SECONDARY | Overall Survival | up to 749 days | ITT Population | days | MEDIAN |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 960 days | Safety Population: all participants who received at least 1 dose of parsaclisib, placebo, or ruxolitinib. Treatment groups for this population were determined according to the actual treatment the participant received regardless of assigned study drug treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Grade 3 or Higher TEAE | up to 960 days | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time of Onset of a ≥35% Reduction in Spleen Volume | up to 925 days | ITT Population, including censored participants. Censored participants didn't have a response at any time up to the last assessment date. Participants who didn't have a \>=35% reduction in spleen volume were censored at the time of the last assessment. Participants with a DIPSS risk level of Low Risk Level (0 prognostic points) were excluded from the analysis. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method with log-log transformation. | days | MEDIAN |
| SECONDARY | Duration of Maintenance of a ≥35% Reduction in Spleen Volume | up to 925 days | ITT Population. Participants with DIPSS risk level being low risk level (0 prognostic points) have been excluded from the analysis. Only those participants with a ≥35% reduction in spleen volume who then had a loss of ≥35% reduction in spleen volume with a 25% increase from NADIR were analyzed. If the maintenance end date was not observed before the database cutoff, the duration was censored at the last assessment. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants Achieving ≥35% Reduction in Spleen Volume From Baseline to Week 24 as Measured by Magnetic Resonance Imaging [MRI] (or Computed Tomography [CT] Scan in Applicable Participants) | Parsaclisib Plus Ruxolitinib | 52.8 | percentage of participants | ||
Percentage of Participants Achieving ≥35% Reduction in Spleen Volume From Baseline to Week 24 as Measured by Magnetic Resonance Imaging [MRI] (or Computed Tomography [CT] Scan in Applicable Participants) | Placebo Plus Ruxolitinib | 46.7 | percentage of participants | ||
| Percentage of Participants Who Had a ≥50% Reduction in Total Symptom Score (TSS) From Baseline to Week 24 as Measured by the Myelofibrosis Symptom Assessment Form v4.0 (MFSAF v4.0) Diary | Parsaclisib Plus Ruxolitinib | 34.8 | percentage of participants | ||
| Percentage of Participants Who Had a ≥50% Reduction in Total Symptom Score (TSS) From Baseline to Week 24 as Measured by the Myelofibrosis Symptom Assessment Form v4.0 (MFSAF v4.0) Diary | Placebo Plus Ruxolitinib | 38.8 | percentage of participants | ||
| Change in TSS From Baseline to Week 24 as Measured by the MFSAF v4.0 Diary | Parsaclisib Plus Ruxolitinib | Baseline | 19.8 | Standard Deviation 14.29 | scores on a scale |
| Change in TSS From Baseline to Week 24 as Measured by the MFSAF v4.0 Diary | Placebo Plus Ruxolitinib | Baseline | 19.6 | Standard Deviation 13.07 | scores on a scale |
| Change in TSS From Baseline to Week 24 as Measured by the MFSAF v4.0 Diary | Parsaclisib Plus Ruxolitinib | Change from Baseline at Week 24 | -6.6 | Standard Deviation 12.36 | scores on a scale |
| Change in TSS From Baseline to Week 24 as Measured by the MFSAF v4.0 Diary | Placebo Plus Ruxolitinib | Change from Baseline at Week 24 | -6.8 | Standard Deviation 10.74 | scores on a scale |
| Time to the First ≥50% Reduction in TSS as Measured by the MFSAF v4.0 Diary | Parsaclisib Plus Ruxolitinib | 67.0 | 95% Confidence Interval 27.0 to 131.0 | days | |
| Time to the First ≥50% Reduction in TSS as Measured by the MFSAF v4.0 Diary | Placebo Plus Ruxolitinib | 69.0 | 95% Confidence Interval 35.0 to 143.0 | days |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Parsaclisib Plus Ruxolitinib | 125 | |
| Overall Study | STARTED | Placebo Plus Ruxolitinib | 127 | |
| Overall Study | COMPLETED | Parsaclisib Plus Ruxolitinib | 0 | |
| Overall Study | COMPLETED | Placebo Plus Ruxolitinib | 0 | |
| Overall Study | NOT COMPLETED | Parsaclisib Plus Ruxolitinib | 125 | |
| Overall Study | NOT COMPLETED | Placebo Plus Ruxolitinib | 127 |
Source ClinicalTrials.gov
Adverse events172
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 | Abdominal distension | Gastrointestinal disorders | Parsaclisib Plus Ruxolitinib | 0 | 125 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo Plus Ruxolitinib | 7 | 127 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | Parsaclisib Plus Ruxolitinib | 8 | 125 | 10 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo Plus Ruxolitinib | 8 | 127 | 9 |
| other | Alanine aminotransferase increased | Investigations | Parsaclisib Plus Ruxolitinib | 18 | 125 | 29 |
| other | Alanine aminotransferase increased | Investigations | Placebo Plus Ruxolitinib | 11 | 127 | 14 |
| other | Anaemia | Blood and lymphatic system disorders | Parsaclisib Plus Ruxolitinib | 57 | 125 | 70 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Plus Ruxolitinib | 68 | 127 | 94 |
| other | Aspartate aminotransferase increased | Investigations | Parsaclisib Plus Ruxolitinib | 22 | 125 | 38 |
| other | Aspartate aminotransferase increased | Investigations | Placebo Plus Ruxolitinib | 10 | 127 | 12 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Parsaclisib Plus Ruxolitinib | 6 | 125 |
| Total, all-cause mortality | Placebo Plus Ruxolitinib | 3 | 127 |
| Total, other adverse events | Parsaclisib Plus Ruxolitinib | 109 | 125 |
| Total, other adverse events | Placebo Plus Ruxolitinib | 109 | 127 |
| Total, serious adverse events | Parsaclisib Plus Ruxolitinib | 26 | 125 |
| Total, serious adverse events | Placebo Plus Ruxolitinib | 18 | 127 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Parsaclisib Plus Ruxolitinib vs Placebo Plus Ruxolitinib: Number of Participants With Any Grade 3 or Higher TEAE | Trial comparisons |
| Parsaclisib Plus Ruxolitinib vs Placebo Plus Ruxolitinib: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Trial comparisons |
| Parsaclisib Plus Ruxolitinib vs Placebo Plus Ruxolitinib: deaths from any cause | Trial comparisons |
| Parsaclisib Plus Ruxolitinib vs Placebo Plus Ruxolitinib: 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/NCT04551066
GET https://conductscience.org/api/trials/v1/NCT04551066/events?page=2