Trial Outcomes & Findings for Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia (NCT NCT05073458)
NCT ID: NCT05073458
Last Updated: 2025-11-03
Results Overview
A durable hemoglobin response was defined as hemoglobin ≥10 grams per deciliter (g/dL) with an increase from Baseline of ≥2 g/dL not attributed to rescue therapy at ≥3 of the 4 available visits at Week 12 and/or later during the 24-week double-blind treatment period.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
13 participants
Primary outcome timeframe
up to Week 24
Results posted on
2025-11-03
Participant Flow
This study was designed to evaluate parsaclisib 2.5 mg QD compared with placebo over a 24-week double-blind treatment period followed by a 24-week open-label treatment period with parsaclisib. Participants could then continue to receive parsaclisib in a long-term extension period.
Participant milestones
| Measure |
Parsaclisib
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
Placebo Followed by Parsaclisib
Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24.
|
|---|---|---|
|
24-week Double-blind Period
STARTED
|
7
|
6
|
|
24-week Double-blind Period
COMPLETED
|
4
|
4
|
|
24-week Double-blind Period
NOT COMPLETED
|
3
|
2
|
|
24-week Open-label Period
STARTED
|
4
|
4
|
|
24-week Open-label Period
COMPLETED
|
2
|
2
|
|
24-week Open-label Period
NOT COMPLETED
|
2
|
2
|
|
Long-term Extension Period (~2 Years)
STARTED
|
2
|
2
|
|
Long-term Extension Period (~2 Years)
COMPLETED
|
2
|
2
|
|
Long-term Extension Period (~2 Years)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Parsaclisib
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
Placebo Followed by Parsaclisib
Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24.
|
|---|---|---|
|
24-week Double-blind Period
Adverse Event
|
1
|
0
|
|
24-week Double-blind Period
Physician Decision
|
1
|
0
|
|
24-week Double-blind Period
Study Terminated by Sponsor
|
1
|
1
|
|
24-week Double-blind Period
Withdrawal by Subject
|
0
|
1
|
|
24-week Open-label Period
Withdrawal by Subject
|
1
|
0
|
|
24-week Open-label Period
Adverse Event
|
1
|
2
|
Baseline Characteristics
Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia
Baseline characteristics by cohort
| Measure |
Parsaclisib
n=7 Participants
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
Placebo Followed by Parsaclisib
n=6 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 14.28 • n=15 Participants
|
57.8 years
STANDARD_DEVIATION 15.54 • n=161 Participants
|
60.23 years
STANDARD_DEVIATION 14.42 • n=100 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=15 Participants
|
6 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
11 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
6 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: up to Week 24Population: Safety Analysis Set: all randomized participants who received at least 1 dose of study drug. Treatment groups were determined according to the actual treatment the participant received on Day 1 regardless of assigned study treatment. Only participants with available data were analyzed.
A durable hemoglobin response was defined as hemoglobin ≥10 grams per deciliter (g/dL) with an increase from Baseline of ≥2 g/dL not attributed to rescue therapy at ≥3 of the 4 available visits at Week 12 and/or later during the 24-week double-blind treatment period.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Placebo
n=4 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Parsaclisib
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|---|
|
Percentage of Participants Attaining a Durable Hemoglobin Response
|
33.3 percentage of participants
|
25.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Safety Analysis Set. Only participants with available data were analyzed.
The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Placebo
n=4 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Parsaclisib
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|---|
|
Percentage of Participants With a ≥3-point Increase From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 24
|
66.7 percentage of participants
|
50.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Safety Analysis Set. Only participants with available data were analyzed,
The 6MWT is used to evaluate submaximal exercise capacity. It is a self-paced measurement of the distance that a participant can quickly walk on a flat, hard surface in a period of 6 minutes.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Placebo
n=2 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Parsaclisib
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|---|
|
Percentage of Participants With a 50 Meter Increase From Baseline to Week 24 in a 6-minute Walk Test (6MWT)
|
0.0 percentage of participants
|
100.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56Population: Safety Analysis Set. Only participants with available data were analyzed.
The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visit 3 occurred 12 weeks after the end of treatment visit.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Placebo
n=4 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Parsaclisib
n=7 Participants
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|---|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Baseline
|
28.5 scores on a scale
Standard Deviation 5.96
|
31.3 scores on a scale
Standard Deviation 5.12
|
31.1 scores on a scale
Standard Deviation 7.78
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at Week 8
|
8.2 scores on a scale
Standard Deviation 5.63
|
—
|
2.4 scores on a scale
Standard Deviation 7.16
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at Week 12
|
7.6 scores on a scale
Standard Deviation 6.58
|
—
|
3.6 scores on a scale
Standard Deviation 8.56
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at Week 16
|
3.8 scores on a scale
Standard Deviation 5.91
|
—
|
6.2 scores on a scale
Standard Deviation 7.36
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at Week 20
|
2.0 scores on a scale
Standard Deviation 9.09
|
—
|
4.5 scores on a scale
Standard Deviation 7.78
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at Week 24
|
3.3 scores on a scale
Standard Deviation 2.63
|
—
|
5.0 scores on a scale
Standard Deviation 5.20
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at End of Treatment, Double-blind Period
|
20.0 scores on a scale
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
-8.0 scores on a scale
Standard Deviation 9.90
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at Week 28
|
—
|
6.5 scores on a scale
Standard Deviation 6.86
|
6.0 scores on a scale
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at Week 32
|
—
|
-9.0 scores on a scale
Standard Deviation 13.89
|
-1.0 scores on a scale
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at Week 40
|
—
|
1.0 scores on a scale
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at Week 48
|
—
|
5.0 scores on a scale
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at End of Treatment, Open-label Period
|
—
|
-2.0 scores on a scale
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
8.0 scores on a scale
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at Week 56
|
—
|
1.0 scores on a scale
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at End of Treatment, Long-term Extension Period
|
—
|
1.0 scores on a scale
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
|
Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Change from Baseline at Follow-up Visit 3
|
—
|
0.0 scores on a scale
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
-1.0 scores on a scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56Population: Safety Analysis Set. Only participants with available data were analyzed,
The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Percentage change from Baseline was calculated as (\[the post-Baseline value minus the Baseline value\]/Baseline value) x 100. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visit 3 occurred 12 weeks after the end of treatment visit.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Placebo
n=4 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Parsaclisib
n=7 Participants
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|---|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Week 8
|
29.6 percentage change
Standard Deviation 21.40
|
—
|
8.2 percentage change
Standard Deviation 21.25
|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Week 12
|
28.1 percentage change
Standard Deviation 26.10
|
—
|
15.30252 percentage change
Standard Deviation 32.05
|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Week 16
|
12.4 percentage change
Standard Deviation 20.21
|
—
|
21.9 percentage change
Standard Deviation 27.65
|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Week 20
|
9.1 percentage change
Standard Deviation 31.07
|
—
|
12.8 percentage change
Standard Deviation 24.79
|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Week 24
|
10.1 percentage change
Standard Deviation 6.71
|
—
|
14.8 percentage change
Standard Deviation 16.97
|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
End of Treatment, Double-blind Period
|
95.2 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
-32.4 percentage change
Standard Deviation 42.62
|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Week 28
|
—
|
22.6 percentage change
Standard Deviation 26.80
|
18.8 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Week 32
|
—
|
-26.9 percentage change
Standard Deviation 40.55
|
-4.8 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Week 40
|
—
|
2.9 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Week 48
|
—
|
14.7 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
End of Treatment, Open-label Period
|
—
|
-5.4 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
25.0 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Week 56
|
—
|
2.9 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
End of Treatment, Long-term Extension Period
|
—
|
2.9 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
|
Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit
Follow-up Visit 3
|
—
|
0.0 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant
|
-5.1 percentage change
Standard Deviation 10.41
|
SECONDARY outcome
Timeframe: Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56Population: Safety Analysis Set. Only participants with available data were analyzed.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visits 1, 2, and 3 occurred 4, 8, and 12 weeks, respectively, after the end of treatment visit.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Placebo
n=4 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Parsaclisib
n=7 Participants
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Baseline
|
86.5 grams per liter
Standard Deviation 15.31
|
85.3 grams per liter
Standard Deviation 12.97
|
98.4 grams per liter
Standard Deviation 21.53
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 2
|
-9.3 grams per liter
Standard Deviation 29.09
|
—
|
8.7 grams per liter
Standard Deviation 11.76
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 4
|
-4.4 grams per liter
Standard Deviation 14.29
|
—
|
14.2 grams per liter
Standard Deviation 13.14
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 6
|
2.7 grams per liter
Standard Deviation 6.38
|
—
|
14.3 grams per liter
Standard Deviation 16.83
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 8
|
12.7 grams per liter
Standard Deviation 14.07
|
—
|
15.0 grams per liter
Standard Deviation 18.95
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 10
|
16.5 grams per liter
Standard Deviation 17.41
|
—
|
16.5 grams per liter
Standard Deviation 16.32
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 12
|
13.8 grams per liter
Standard Deviation 19.69
|
—
|
20.5 grams per liter
Standard Deviation 11.01
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 16
|
19.5 grams per liter
Standard Deviation 15.76
|
—
|
22.4 grams per liter
Standard Deviation 16.41
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 20
|
15.3 grams per liter
Standard Deviation 6.08
|
—
|
7.7 grams per liter
Standard Deviation 1.53
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 24
|
19.5 grams per liter
Standard Deviation 14.80
|
—
|
19.3 grams per liter
Standard Deviation 22.28
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 26
|
—
|
14.0 grams per liter
Standard Deviation 9.60
|
3.0 grams per liter
Standard Deviation 24.33
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 28
|
—
|
18.9 grams per liter
Standard Deviation 19.58
|
8.3 grams per liter
Standard Deviation 26.48
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 32
|
—
|
19.0 grams per liter
Standard Deviation 31.32
|
26.0 grams per liter
Standard Deviation 11.31
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at End of Treatment, Double-blind Period
|
-62.4 grams per liter
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
11.0 grams per liter
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 30
|
—
|
8.1 grams per liter
Standard Deviation 32.67
|
27.0 grams per liter
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 36
|
—
|
22.8 grams per liter
Standard Deviation 18.01
|
18.5 grams per liter
Standard Deviation 13.44
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 40
|
—
|
21.5 grams per liter
Standard Deviation 12.02
|
26.5 grams per liter
Standard Deviation 7.78
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 44
|
—
|
25.0 grams per liter
Standard Deviation 21.21
|
27.5 grams per liter
Standard Deviation 14.85
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 48
|
—
|
22.5 grams per liter
Standard Deviation 21.92
|
32.0 grams per liter
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at End of Treatment, Open-label Period
|
—
|
127.7 grams per liter
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
124.0 grams per liter
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 56
|
—
|
17.5 grams per liter
Standard Deviation 12.02
|
36.0 grams per liter
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Week 64
|
—
|
8.0 grams per liter
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at End of Treatment, Long-term Extension Period
|
—
|
86.0 grams per liter
|
—
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Follow-up Visit 1
|
—
|
40.0 grams per liter
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
11.0 grams per liter
Standard Deviation 7.62
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Follow-up Visit 2
|
—
|
32.0 grams per liter
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
12.5 grams per liter
Standard Deviation 17.52
|
|
Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at Follow-up Visit 3
|
—
|
23.0 grams per liter
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
20.3 grams per liter
Standard Deviation 9.95
|
SECONDARY outcome
Timeframe: Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56Population: Safety Analysis Set. Only participants with available data were analyzed.
Percentage change from Baseline was calculated as (\[the post-Baseline value minus the Baseline value\]/Baseline value) x 100. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visits 1, 2, and 3 occurred 4, 8, and 12 weeks, respectively, after the end of treatment visit.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Placebo
n=4 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Parsaclisib
n=7 Participants
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|---|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 10
|
17.8 percentage change
Standard Deviation 17.44
|
—
|
16.5 percentage change
Standard Deviation 17.59
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 2
|
-12.3 percentage change
Standard Deviation 41.18
|
—
|
8.2 percentage change
Standard Deviation 13.82
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 4
|
-3.5 percentage change
Standard Deviation 16.87
|
—
|
14.2 percentage change
Standard Deviation 13.68
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 6
|
3.4 percentage change
Standard Deviation 7.42
|
—
|
14.2 percentage change
Standard Deviation 18.21
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 8
|
14.0 percentage change
Standard Deviation 14.59
|
—
|
14.3 percentage change
Standard Deviation 19.65
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 12
|
13.6 percentage change
Standard Deviation 21.15
|
—
|
20.7 percentage change
Standard Deviation 12.36
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 16
|
21.7 percentage change
Standard Deviation 16.02
|
—
|
23.2 percentage change
Standard Deviation 17.81
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 20
|
18.5 percentage change
Standard Deviation 9.32
|
—
|
7.6 percentage change
Standard Deviation 2.11
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 24
|
22.7 percentage change
Standard Deviation 15.52
|
—
|
19.4 percentage change
Standard Deviation 22.70
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at End of Treatment, Double-blind Period
|
-87.9 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
12.0 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 26
|
—
|
15.2 percentage change
Standard Deviation 9.34
|
3.4 percentage change
Standard Deviation 24.52
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 28
|
—
|
23.4 percentage change
Standard Deviation 25.16
|
9.7 percentage change
Standard Deviation 27.56
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 30
|
—
|
6.6 percentage change
Standard Deviation 36.17
|
30.0 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 32
|
—
|
23.6 percentage change
Standard Deviation 40.57
|
29.0 percentage change
Standard Deviation 12.41
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 36
|
—
|
29.3 percentage change
Standard Deviation 26.69
|
20.6 percentage change
Standard Deviation 14.85
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 40
|
—
|
29.7 percentage change
Standard Deviation 18.67
|
29.6 percentage change
Standard Deviation 8.46
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 44
|
—
|
34.9 percentage change
Standard Deviation 31.46
|
30.7 percentage change
Standard Deviation 16.35
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 48
|
—
|
31.6 percentage change
Standard Deviation 32.12
|
35.6 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at End of Treatment, Open-label Period
|
—
|
31.7 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
25.3 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 56
|
—
|
24.3 percentage change
Standard Deviation 18.21
|
40.0 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Week 64
|
—
|
10.1 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Change from Baseline at End of Treatment, Long-term Extension Period
|
—
|
8.9 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
—
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Follow-up Visit 1
|
—
|
41.2 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
11.5 percentage change
Standard Deviation 8.19
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Follow-up Visit 2
|
—
|
33.0 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
14.5 percentage change
Standard Deviation 19.47
|
|
Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit
Follow-up Visit 3
|
—
|
23.7 percentage change
Standard Deviation NA
The standard deviation cannot be calculated for a single participant.
|
23.4 percentage change
Standard Deviation 13.52
|
SECONDARY outcome
Timeframe: Week 6 to Week 24; Week 24 to Week 48Population: Safety Analysis Set. Only participants with available data were analyzed. The number of participants analyzed at Weeks 6 to 24 reflects the number of participants who received study drug for at least 43 days. The number of participants analyzed at Weeks 24 to 48 reflects the number of participants who received study drug during the open-label period.
Transfusion was permitted as a rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of warm autoimmune hemolytic anemia (wAIHA).
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Placebo
n=4 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Parsaclisib
n=7 Participants
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|---|
|
Percentage of Participants Who Received Transfusions From Week 6 to Week 24 and From Week 24 to Week 48
Week 6 to Week 24
|
0.0 percentage of participants
|
—
|
42.9 percentage of participants
|
|
Percentage of Participants Who Received Transfusions From Week 6 to Week 24 and From Week 24 to Week 48
Week 24 to Week 48
|
—
|
25.0 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Safety Analysis Set. Only participants with available data were analyzed.
A new or increased dose of corticosteroids (prednisone or equivalent) from the Day 1 dose was permitted as rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Placebo
n=6 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Parsaclisib
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|---|
|
Change From Baseline in Daily Corticosteroid Dose at Week 24
Change from Baseline at Week 24
|
8.1 milligrams
Standard Deviation 14.02
|
-4.8 milligrams
Standard Deviation 10.41
|
—
|
|
Change From Baseline in Daily Corticosteroid Dose at Week 24
Baseline
|
13.3 milligrams
Standard Deviation 5.77
|
20.8 milligrams
Standard Deviation 10.21
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Safety Analysis Set. Only participants with available data were analyzed.
A new or increased dose of corticosteroids (prednisone or equivalent) from the Day 1 dose was permitted as rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA. Percentage change from Baseline was calculated as (\[the post-Baseline value minus the Baseline value\]/Baseline value) x 100.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Placebo
n=5 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Parsaclisib
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|---|
|
Percentage Change From Baseline in Daily Corticosteroid Dose at Week 24
|
81.0 percentage change
Standard Deviation 140.21
|
-22.0 percentage change
Standard Deviation 60.07
|
—
|
SECONDARY outcome
Timeframe: Week 6 to Week 24; Week 24 to Week 48Population: Safety Analysis Set. Only participants with available data were analyzed.
Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Placebo
n=4 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Parsaclisib
n=7 Participants
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|---|
|
Percentage of Participants Who Required Rescue Therapy at Any Visit From Week 6 Through Week 24, and From Week 24 to Week 48
Week 6 to Week 24
|
0.0 percentage of participants
|
—
|
0.0 percentage of participants
|
|
Percentage of Participants Who Required Rescue Therapy at Any Visit From Week 6 Through Week 24, and From Week 24 to Week 48
Week 24 to Week 48
|
—
|
0.0 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: up to 446 daysPopulation: Safety Analysis Set
An adverse event (AE) 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 be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study drug.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Placebo
n=4 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Parsaclisib
n=7 Participants
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
4 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: up to 446 daysPopulation: Safety Analysis Set
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study drug. The severity of AEs were assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. 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.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Placebo
n=4 Participants
Participants received matching placebo QD for 24 weeks during the double-blind treatment period.
|
Parsaclisib
n=7 Participants
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|---|
|
Number of Participants With Any ≥Grade 3 TEAE
|
1 Participants
|
3 Participants
|
6 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Parsaclisib
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=6 participants at risk
Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24.
|
Parsaclisib
n=11 participants at risk
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24.
|
Parsaclisib
n=11 participants at risk
Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
18.2%
2/11 • Number of events 3 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Nervous system disorders
Amnesia
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
General disorders
Asthenia
|
33.3%
2/6 • Number of events 3 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 2 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Renal and urinary disorders
Choluria
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
27.3%
3/11 • Number of events 3 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Vascular disorders
Embolism
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
18.2%
2/11 • Number of events 2 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
18.2%
2/11 • Number of events 3 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Vascular disorders
Hot flush
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
18.2%
2/11 • Number of events 2 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Renal and urinary disorders
Micturition disorder
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Psychiatric disorders
Mood altered
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
18.2%
2/11 • Number of events 2 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
General disorders
Oedema
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
16.7%
1/6 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
0.00%
0/11 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
18.2%
2/11 • Number of events 3 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
9.1%
1/11 • Number of events 1 • up to 446 days
For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER