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Trial record 2 of 9409 for:    REQUIRE

Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)

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ClinicalTrials.gov Identifier: NCT04377620
Recruitment Status : Terminated (Study terminated by sponsor)
First Posted : May 6, 2020
Results First Posted : January 19, 2022
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition COVID-19
Interventions Drug: Placebo
Drug: Ruxolitinib
Enrollment 211
Recruitment Details This study was conducted at 33 study centers in the United States (29) and Russia (4), and 211 participants were enrolled and analyzed for efficacy.; 209 participants were analyzed for safety. Enrollment in this study was stopped early and was not due to safety reasons.
Pre-assignment Details Participants were randomly assigned in a 2:2:1 ratio to receive ruxolitinib 5 mg BID, ruxolitinib 15 mg BID, or placebo for an initial treatment period of 14 days; participants randomly assigned to receive placebo were randomly assigned in a 1:1 ratio to receive placebo matching ruxolitinib 5 mg BID or placebo matching ruxolitinib 15 mg BID. Randomization was stratified by ARDS severity (severe vs mild/moderate at the time of randomization) and investigative site.
Arm/Group Title Ruxolitininb 15mg + Standard of Care Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Period Title: Overall Study
Started 77 87 47
Completed 35 37 11
Not Completed 42 50 36
Reason Not Completed
Death             42             48             36
Withdrawal by Subject             0             2             0
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC) Total
Hide Arm/Group Description Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral. Total of all reporting groups
Overall Number of Baseline Participants 77 87 47 211
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants who were randomized to the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 87 participants 47 participants 211 participants
63.6  (12.92) 63.6  (12.25) 62.5  (13.34) 63.4  (12.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 87 participants 47 participants 211 participants
Female
29
  37.7%
32
  36.8%
13
  27.7%
74
  35.1%
Male
48
  62.3%
55
  63.2%
34
  72.3%
137
  64.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 87 participants 47 participants 211 participants
Hispanic or Latino
21
  27.3%
21
  24.1%
12
  25.5%
54
  25.6%
Not Hispanic or Latino
53
  68.8%
64
  73.6%
34
  72.3%
151
  71.6%
Unknown or Not Reported
3
   3.9%
2
   2.3%
1
   2.1%
6
   2.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 87 participants 47 participants 211 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
2
   4.3%
2
   0.9%
Asian
3
   3.9%
3
   3.4%
1
   2.1%
7
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  11.7%
12
  13.8%
5
  10.6%
26
  12.3%
White
57
  74.0%
61
  70.1%
31
  66.0%
149
  70.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
  10.4%
11
  12.6%
8
  17.0%
27
  12.8%
1.Primary Outcome
Title Percentage of Participants Who Have Died Due to Any Cause
Hide Description To evaluate the 28-day mortality rate of ruxolitinib 5 mg BID + SoC therapy and ruxolitinib 15 mg BID + SoC compared with placebo + SoC therapy, in participants with COVID-19-associated ARDS who require mechanical ventilation.
Time Frame Study start to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description:
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Overall Number of Participants Analyzed 77 85 47
Measure Type: Number
Unit of Measure: Percentage
50.6 52.9 70.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitininb 15mg + Standard of Care (SoC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0292
Comments [Not Specified]
Method Mixed Models Analysis
Comments logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
0.201 to 1.028
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ruxolitinib 5mg + Standard of Care (SoC)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0280
Comments [Not Specified]
Method Mixed Models Analysis
Comments logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.171 to 1.023
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Ventilator Free Days
Hide Description Number of days participant did not require mechanical ventilation
Time Frame Study start to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description:
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Overall Number of Participants Analyzed 77 85 47
Mean (Standard Deviation)
Unit of Measure: Days
6.31  (9.047) 4.92  (8.398) 2.98  (7.228)
3.Secondary Outcome
Title Number of ICU Free Days
Hide Description Number of days participant is out of the ICU
Time Frame Study start to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description:
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Overall Number of Participants Analyzed 77 85 47
Mean (Standard Deviation)
Unit of Measure: Days
4.75  (7.716) 4.00  (7.517) 2.45  (6.362)
4.Secondary Outcome
Title Oxygen Free Days
Hide Description Number of days participant did not receive supplemental oxygen
Time Frame Study start to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description:
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Overall Number of Participants Analyzed 77 85 47
Mean (Standard Deviation)
Unit of Measure: Days
2.66  (6.073) 2.98  (6.745) 1.53  (4.690)
5.Secondary Outcome
Title Vasopressor Free Days
Hide Description Number of days without use of vasopressor therapy
Time Frame Study start to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description:
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Overall Number of Participants Analyzed 77 85 47
Mean (Standard Deviation)
Unit of Measure: Days
8.95  (11.738) 7.53  (10.861) 4.47  (9.322)
6.Secondary Outcome
Title Hospital Free Days
Hide Description Number of days Partcipant is out of the hospital
Time Frame Study start to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description:
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Overall Number of Participants Analyzed 77 85 47
Mean (Standard Deviation)
Unit of Measure: Days
2.09  (4.889) 2.35  (5.259) 1.38  (3.976)
7.Secondary Outcome
Title Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale
Hide Description Participants with at least 2-point improvement at Day 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Time Frame Study start to Days 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description:
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Overall Number of Participants Analyzed 77 87 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Day 15 Number Analyzed 77 participants 85 participants 47 participants
22.1
(13.4 to 33.)
15.3
(8.4 to 24.7)
10.6
(3.5 to 23.1)
Day 29 Number Analyzed 74 participants 83 participants 47 participants
29.7
(19.7 to 41.5)
25.3
(16.4 to 36.0)
17.0
(7.6 to 30.8)
8.Secondary Outcome
Title Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale
Hide Description Participants with at lest 1-point improvement in clinical status at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Time Frame Study start to Days 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description:
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Overall Number of Participants Analyzed 77 87 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Day 15 Number Analyzed 77 participants 85 participants 47 participants
41.6
(30.4 to 53.4)
32.9
(23.1 to 44.0)
21.3
(10.7 to 35.7)
Day 29 Number Analyzed 77 participants 87 participants 47 participants
43.2
(31.8 to 55.3)
32.5
(22.6 to 43.7)
17.0
(7.6 to 30.8)
9.Secondary Outcome
Title Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale
Hide Description TIme to improvement compared to baseline. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Time Frame Study Start to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description:
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Overall Number of Participants Analyzed 50 49 20
Median (95% Confidence Interval)
Unit of Measure: Days
0.91
(0.711 to 0.992)
0.75
(0.614 to 0.867)
0.61
(0.408 to 0.818)
10.Secondary Outcome
Title Percentage of Participants With the COVID-19 Ordinal Scale Reported
Hide Description Clinical status of participant at Day 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Time Frame Study start to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study. Please note that in the 15mg BID arm, 3 participants were missing scale reporting on Day 29. In the 5mg BID, 2 participants were lost to follow-up, and 2 were missing scale reporting.
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description:
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Overall Number of Participants Analyzed 74 83 47
Measure Type: Number
Unit of Measure: Percentage
Score 0 = Uninfected 0 4.6 0
Score 1 = Ambulatory (no limitation of activities) 2.6 0 2.1
Score 2 = Ambulatory (limitation of activities) 16.9 16.1 10.6
Score 3 = Hospitalized/Mild Disease (no oxygen therapy) 0 1.1 0
Score 4 = Hospitalized/Mild Disease (oxygen therapy via mask or nasal prongs) 9.1 1.1 4.3
Score 5 = Hospitalized/Severe Disease (non-invasive ventilation or high-flow oxygen) 3.9 4.6 0.0
Score 6 = Hospitalized/Severe Disease (intubationand mechanical ventilization) 10.4 8.0 2.1
Score 7 = Hospitalized/Severe Disease (ventilation + additional organ support) 2.6 8.0 10.6
Score 8 - Death 50.6 51.7 70.2
11.Secondary Outcome
Title Change in the COVID-19 9-point Ordinal Scale
Hide Description Change in the Clinical status of participant at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Time Frame Study start to Days 15 and 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study. In the 15mg BID arm, 3 participants were missing scale reportingon Day 29. IN the 5mg BID, 2 participants were lost to follow-up, and 2 were missing scale reporting.
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description:
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Overall Number of Participants Analyzed 77 87 47
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Change from Day 1 to Day 15 Number Analyzed 77 participants 85 participants 47 participants
-0.4  (1.80) -0.2  (1.73) 0.6  (1.69)
Change from Day 1 to Day 29 Number Analyzed 74 participants 83 participants 47 participants
-0.5  (2.53) -0.4  (2.57) 0.4  (2.23)
12.Secondary Outcome
Title Change in SOFA Score
Hide Description Sequential Organ Failure Assessment (SOFA) score is a scoring system to determine the extent of a person's organ function or rate of failure. The score is based on 6 different scores, 1 each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).
Time Frame from baseline to Days 3, 5, 8, 11, 15, and 29
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study. Numbers of participants decreased after Day 1 because data was no longer collected if a patient was discharged from ICU and/or deceased.
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description:
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Overall Number of Participants Analyzed 77 87 47
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline - Day 1 Number Analyzed 74 participants 87 participants 46 participants
9.2  (2.35) 9.6  (2.53) 9.4  (2.69)
Day 3 Number Analyzed 76 participants 87 participants 46 participants
-0.1  (2.77) 0.4  (3.14) 2.6  (5.89)
Day 5 Number Analyzed 76 participants 85 participants 47 participants
0.2  (4.27) 0.7  (4.58) 3.3  (6.60)
Day 8 Number Analyzed 69 participants 83 participants 45 participants
1.9  (6.77) 2.0  (6.30) 4.5  (7.87)
Day 11 Number Analyzed 69 participants 79 participants 42 participants
2.5  (7.64) 2.0  (7.02) 6.5  (8.26)
Day 15 Number Analyzed 67 participants 74 participants 40 participants
4.2  (9.24) 4.1  (7.72) 10.3  (7.89)
Day 29 Number Analyzed 52 participants 60 participants 38 participants
10.3  (8.54) 10.4  (7.04) 12.8  (5.41)
13.Secondary Outcome
Title Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events
Hide Description Treatment-emergent AEs are judged as related by the investigator or have a missing causality.
Time Frame Study start to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all participants who received at least 1 dose of ruxolitinib/placebo.
Arm/Group Title Ruxolitininb 15mg + Standard of Care (SoC) Ruxolitinib 5mg + Standard of Care (SoC) Placebo + Standard of Care (SoC)
Hide Arm/Group Description:
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
Overall Number of Participants Analyzed 77 87 45
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment-Emergent Adverse Events (TEAEs)
22
  28.6%
23
  26.4%
11
  24.4%
Serious TEAEs
23
  29.9%
21
  24.1%
11
  24.4%
Time Frame Up to approximately 2 months.
Adverse Event Reporting Description All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
 
Arm/Group Title Ruxolitinib 15 mg BID Ruxolitinib 5 mg BID Placebo Total
Hide Arm/Group Description Ruxolitinib 15 mg BID Ruxolitinib 5 mg BID Placebo Total
All-Cause Mortality
Ruxolitinib 15 mg BID Ruxolitinib 5 mg BID Placebo Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   42/77 (54.55%)      48/87 (55.17%)      36/47 (76.60%)      124/209 (59.33%)    
Hide Serious Adverse Events
Ruxolitinib 15 mg BID Ruxolitinib 5 mg BID Placebo Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/77 (29.87%)      21/87 (24.14%)      11/45 (24.44%)      55/209 (26.32%)    
Blood and lymphatic system disorders         
Anaemia  1  1/77 (1.30%)  1 0/87 (0.00%)  0 1/45 (2.22%)  1 2/209 (0.96%)  2
Thrombocytopenia  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Cardiac disorders         
Atrioventricular block complete  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Bradycardia  1  0/77 (0.00%)  0 0/87 (0.00%)  0 1/45 (2.22%)  1 1/209 (0.48%)  1
Cardio-respiratory arrest  1  0/77 (0.00%)  0 0/87 (0.00%)  0 1/45 (2.22%)  1 1/209 (0.48%)  1
Cardiopulmonary failure  1  1/77 (1.30%)  1 1/87 (1.15%)  1 1/45 (2.22%)  1 3/209 (1.44%)  3
Myocardial infarction  1  0/77 (0.00%)  0 1/87 (1.15%)  1 0/45 (0.00%)  0 1/209 (0.48%)  1
Pulseless electrical activity  1  1/77 (1.30%)  1 0/87 (0.00%)  0 1/45 (2.22%)  1 2/209 (0.96%)  2
Torsade de pointes  1  0/77 (0.00%)  0 1/87 (1.15%)  1 0/45 (0.00%)  0 1/209 (0.48%)  1
Gastrointestinal disorders         
Duodenal ulcer perforation  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Ileus  1  0/77 (0.00%)  0 0/87 (0.00%)  0 1/45 (2.22%)  1 1/209 (0.48%)  1
Intestinal perforation  1  0/77 (0.00%)  0 0/87 (0.00%)  0 1/45 (2.22%)  1 1/209 (0.48%)  1
Lower gastrointestinal haemorrhage  1  0/77 (0.00%)  0 2/87 (2.30%)  2 0/45 (0.00%)  0 2/209 (0.96%)  2
Rectal haemorrhage  1  0/77 (0.00%)  0 1/87 (1.15%)  1 1/45 (2.22%)  1 2/209 (0.96%)  2
Hepatobiliary disorders         
Cholestasis  1  0/77 (0.00%)  0 1/87 (1.15%)  1 0/45 (0.00%)  0 1/209 (0.48%)  1
Infections and infestations         
Aspergillus infection  1  0/77 (0.00%)  0 1/87 (1.15%)  1 0/45 (0.00%)  0 1/209 (0.48%)  1
Fungaemia  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Hepatic infection  1  0/77 (0.00%)  0 1/87 (1.15%)  1 0/45 (0.00%)  0 1/209 (0.48%)  1
Pneumonia  1  2/77 (2.60%)  3 4/87 (4.60%)  4 2/45 (4.44%)  2 8/209 (3.83%)  9
Pneumonia bacterial  1  0/77 (0.00%)  0 0/87 (0.00%)  0 1/45 (2.22%)  1 1/209 (0.48%)  1
Pneumonia pseudomonal  1  0/77 (0.00%)  0 0/87 (0.00%)  0 1/45 (2.22%)  1 1/209 (0.48%)  1
Pneumonia staphylococcal  1  1/77 (1.30%)  1 1/87 (1.15%)  1 0/45 (0.00%)  0 2/209 (0.96%)  2
Sepsis  1  3/77 (3.90%)  3 1/87 (1.15%)  1 0/45 (0.00%)  0 4/209 (1.91%)  4
Staphylococcal bacteraemia  1  0/77 (0.00%)  0 1/87 (1.15%)  1 0/45 (0.00%)  0 1/209 (0.48%)  1
Staphylococcal sepsis  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Streptococcal bacteraemia  1  0/77 (0.00%)  0 0/87 (0.00%)  0 1/45 (2.22%)  1 1/209 (0.48%)  1
Strongyloidiasis  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Urinary tract infection bacterial  1  0/77 (0.00%)  0 0/87 (0.00%)  0 1/45 (2.22%)  1 1/209 (0.48%)  1
Vascular device infection  1  1/77 (1.30%)  1 1/87 (1.15%)  1 0/45 (0.00%)  0 2/209 (0.96%)  2
Injury, poisoning and procedural complications         
Endotracheal intubation complication  1  0/77 (0.00%)  0 1/87 (1.15%)  1 0/45 (0.00%)  0 1/209 (0.48%)  1
Investigations         
Alanine aminotransferase increased  1  3/77 (3.90%)  3 1/87 (1.15%)  1 1/45 (2.22%)  1 5/209 (2.39%)  5
Aspartate aminotransferase increased  1  2/77 (2.60%)  2 1/87 (1.15%)  1 1/45 (2.22%)  1 4/209 (1.91%)  4
Blood alkaline phosphatase increased  1  0/77 (0.00%)  0 2/87 (2.30%)  2 0/45 (0.00%)  0 2/209 (0.96%)  2
Blood creatinine increased  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Oxygen saturation decreased  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Metabolism and nutrition disorders         
Acidosis  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Hyperkalaemia  1  0/77 (0.00%)  0 0/87 (0.00%)  0 1/45 (2.22%)  1 1/209 (0.48%)  1
Hyperphosphataemia  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Nervous system disorders         
Cerebral haemorrhage  1  0/77 (0.00%)  0 2/87 (2.30%)  2 0/45 (0.00%)  0 2/209 (0.96%)  2
Product Issues         
Device dislocation  1  0/77 (0.00%)  0 1/87 (1.15%)  1 0/45 (0.00%)  0 1/209 (0.48%)  1
Renal and urinary disorders         
Acute kidney injury  1  1/77 (1.30%)  1 2/87 (2.30%)  2 0/45 (0.00%)  0 3/209 (1.44%)  3
Haematuria  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Respiratory, thoracic and mediastinal disorders         
Acute respiratory distress syndrome  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Aspiration  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Hypoxia  1  1/77 (1.30%)  1 1/87 (1.15%)  1 3/45 (6.67%)  3 5/209 (2.39%)  5
Pneumothorax  1  3/77 (3.90%)  3 0/87 (0.00%)  0 1/45 (2.22%)  1 4/209 (1.91%)  4
Pulmonary oedema  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Vascular disorders         
Deep vein thrombosis  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
Haematoma  1  0/77 (0.00%)  0 1/87 (1.15%)  1 0/45 (0.00%)  0 1/209 (0.48%)  1
Hypertension  1  2/77 (2.60%)  2 1/87 (1.15%)  1 0/45 (0.00%)  0 3/209 (1.44%)  3
Hypotension  1  1/77 (1.30%)  1 3/87 (3.45%)  4 1/45 (2.22%)  1 5/209 (2.39%)  6
Peripheral arterial occlusive disease  1  0/77 (0.00%)  0 1/87 (1.15%)  1 0/45 (0.00%)  0 1/209 (0.48%)  1
Peripheral ischaemia  1  0/77 (0.00%)  0 2/87 (2.30%)  2 0/45 (0.00%)  0 2/209 (0.96%)  2
Shock  1  1/77 (1.30%)  1 0/87 (0.00%)  0 0/45 (0.00%)  0 1/209 (0.48%)  1
1
Term from vocabulary, MedDRA 22
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ruxolitinib 15 mg BID Ruxolitinib 5 mg BID Placebo Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/77 (45.45%)      46/87 (52.87%)      21/45 (46.67%)      102/209 (48.80%)    
Blood and lymphatic system disorders         
Anaemia  1  12/77 (15.58%)  13 21/87 (24.14%)  23 9/45 (20.00%)  9 42/209 (20.10%)  45
Cardiac disorders         
Atrial fibrillation  1  1/77 (1.30%)  1 5/87 (5.75%)  6 3/45 (6.67%)  3 9/209 (4.31%)  10
Gastrointestinal disorders         
Constipation  1  5/77 (6.49%)  5 4/87 (4.60%)  4 2/45 (4.44%)  2 11/209 (5.26%)  11
Vomiting  1  5/77 (6.49%)  10 4/87 (4.60%)  5 1/45 (2.22%)  1 10/209 (4.78%)  16
General disorders         
Oedema peripheral  1  2/77 (2.60%)  2 5/87 (5.75%)  6 0/45 (0.00%)  0 7/209 (3.35%)  8
Pyrexia  1  2/77 (2.60%)  2 5/87 (5.75%)  7 4/45 (8.89%)  4 11/209 (5.26%)  13
Infections and infestations         
Bacteraemia  1  1/77 (1.30%)  1 5/87 (5.75%)  5 0/45 (0.00%)  0 6/209 (2.87%)  6
Pneumonia staphylococcal  1  5/77 (6.49%)  5 2/87 (2.30%)  2 1/45 (2.22%)  1 8/209 (3.83%)  8
Investigations         
Alanine aminotransferase increased  1  9/77 (11.69%)  9 12/87 (13.79%)  13 5/45 (11.11%)  5 26/209 (12.44%)  27
Aspartate aminotransferase increased  1  10/77 (12.99%)  10 11/87 (12.64%)  12 3/45 (6.67%)  3 24/209 (11.48%)  25
Lymphocyte count decreased  1  3/77 (3.90%)  5 4/87 (4.60%)  7 3/45 (6.67%)  4 10/209 (4.78%)  16
Metabolism and nutrition disorders         
Hyperglycaemia  1  3/77 (3.90%)  4 8/87 (9.20%)  9 1/45 (2.22%)  1 12/209 (5.74%)  14
Hyperkalaemia  1  4/77 (5.19%)  4 3/87 (3.45%)  3 3/45 (6.67%)  3 10/209 (4.78%)  10
Hypermagnesaemia  1  5/77 (6.49%)  7 4/87 (4.60%)  4 1/45 (2.22%)  1 10/209 (4.78%)  12
Hypernatraemia  1  8/77 (10.39%)  13 7/87 (8.05%)  8 7/45 (15.56%)  7 22/209 (10.53%)  28
Hypoalbuminaemia  1  1/77 (1.30%)  1 7/87 (8.05%)  7 4/45 (8.89%)  4 12/209 (5.74%)  12
Hypokalaemia  1  9/77 (11.69%)  11 9/87 (10.34%)  11 4/45 (8.89%)  4 22/209 (10.53%)  26
Hyponatraemia  1  3/77 (3.90%)  4 2/87 (2.30%)  2 3/45 (6.67%)  4 8/209 (3.83%)  10
Hypophosphataemia  1  5/77 (6.49%)  5 6/87 (6.90%)  8 2/45 (4.44%)  2 13/209 (6.22%)  15
Psychiatric disorders         
Anxiety  1  6/77 (7.79%)  6 4/87 (4.60%)  4 1/45 (2.22%)  1 11/209 (5.26%)  11
Skin and subcutaneous tissue disorders         
Decubitus ulcer  1  3/77 (3.90%)  4 4/87 (4.60%)  5 3/45 (6.67%)  4 10/209 (4.78%)  13
Skin ulcer  1  3/77 (3.90%)  4 5/87 (5.75%)  6 3/45 (6.67%)  3 11/209 (5.26%)  13
Vascular disorders         
Hypertension  1  5/77 (6.49%)  5 11/87 (12.64%)  12 5/45 (11.11%)  5 21/209 (10.05%)  22
Hypotension  1  4/77 (5.19%)  5 3/87 (3.45%)  3 2/45 (4.44%)  2 9/209 (4.31%)  10
1
Term from vocabulary, MedDRA 22
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Incyte Corporation
Phone: 1-855-463-3463
EMail: medinfo@incyte.com
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04377620    
Other Study ID Numbers: INCB 18424-369
First Submitted: May 4, 2020
First Posted: May 6, 2020
Results First Submitted: November 17, 2021
Results First Posted: January 19, 2022
Last Update Posted: January 19, 2022