18 and older, any sex, with Autoimmune Hemolytic Anemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12Primary· Week 6 to Week 12
A complete response was defined as hemoglobin \>12 grams per deciliter (g/dL) not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion.
Group
Value
95% CI
Parsaclisib 1 mg QD
20.0
Parsaclisib 2.5 mg QD
40.0
Percentage of Participants Attaining a Partial Response at Any Visit From Week 6 to Week 12Primary· Week 6 to Week 12
A partial response was defined as hemoglobin 10-12 g/dL or at least a 2 g/dL increase from Baseline not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion.
Group
Value
95% CI
Parsaclisib 1 mg QD
60.0
Parsaclisib 2.5 mg QD
66.7
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)Primary· up to 1638 days
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy, or required changes in the study drug. Anemia and transfusions should not have been reported as AEs unless they represented a clinically meaningful decrease from Baseline in hemoglobin. A
Group
Value
95% CI
Parsaclisib 1 mg QD
10
Parsaclisib 2.5 mg QD
15
Percentage of Participants Attaining a Complete Response During Post-Baseline VisitsSecondary· up to 1638 days
A complete response was defined as hemoglobin \>12 g/dL) not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion.
Week 1
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
6.7
Week 2
Group
Value
95% CI
Parsaclisib 1 mg QD
10.0
Parsaclisib 2.5 mg QD
6.7
Week 4
Group
Value
95% CI
Parsaclisib 1 mg QD
22.2
Parsaclisib 2.5 mg QD
21.4
Week 6
Group
Value
95% CI
Parsaclisib 1 mg QD
22.2
Parsaclisib 2.5 mg QD
28.6
Week 8
Group
Value
95% CI
Parsaclisib 1 mg QD
22.2
Parsaclisib 2.5 mg QD
23.1
Week 10
Group
Value
95% CI
Parsaclisib 1 mg QD
22.2
Parsaclisib 2.5 mg QD
23.1
Week 12
Group
Value
95% CI
Parsaclisib 1 mg QD
22.2
Parsaclisib 2.5 mg QD
42.9
Follow-up Month 1
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
0.0
Percentage of Participants Attaining a Partial Response During Post-Baseline VisitsSecondary· up to 1638 days
A partial response was defined as hemoglobin 10-12 g/dL or at least a 2 g/dL increase from Baseline not attributed to a transfusion effect and the normalization of hemolytic markers. No transfusion effect was defined as \> 1 week since the last transfusion.
Week 1
Group
Value
95% CI
Parsaclisib 1 mg QD
50.0
Parsaclisib 2.5 mg QD
53.3
Week 2
Group
Value
95% CI
Parsaclisib 1 mg QD
50.0
Parsaclisib 2.5 mg QD
66.7
Week 4
Group
Value
95% CI
Parsaclisib 1 mg QD
44.4
Parsaclisib 2.5 mg QD
64.3
Week 6
Group
Value
95% CI
Parsaclisib 1 mg QD
44.4
Parsaclisib 2.5 mg QD
50.0
Week 8
Group
Value
95% CI
Parsaclisib 1 mg QD
55.6
Parsaclisib 2.5 mg QD
61.5
Week 10
Group
Value
95% CI
Parsaclisib 1 mg QD
55.6
Parsaclisib 2.5 mg QD
61.5
Week 12
Group
Value
95% CI
Parsaclisib 1 mg QD
55.6
Parsaclisib 2.5 mg QD
64.3
Follow-up Month 1
Group
Value
95% CI
Parsaclisib 1 mg QD
50.0
Parsaclisib 2.5 mg QD
0.0
Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From BaselineSecondary· up to 1638 days
Hemoglobin levels were assessed throughout the study.
Week 1
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
26.7
Week 2
Group
Value
95% CI
Parsaclisib 1 mg QD
10.0
Parsaclisib 2.5 mg QD
46.7
Week 4
Group
Value
95% CI
Parsaclisib 1 mg QD
22.2
Parsaclisib 2.5 mg QD
42.9
Week 6
Group
Value
95% CI
Parsaclisib 1 mg QD
22.2
Parsaclisib 2.5 mg QD
35.7
Week 8
Group
Value
95% CI
Parsaclisib 1 mg QD
33.3
Parsaclisib 2.5 mg QD
38.5
Week 10
Group
Value
95% CI
Parsaclisib 1 mg QD
22.2
Parsaclisib 2.5 mg QD
46.2
Week 12
Group
Value
95% CI
Parsaclisib 1 mg QD
33.3
Parsaclisib 2.5 mg QD
50.0
Follow-up Month 1
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
0.0
Change From Baseline in HemoglobinSecondary· Baseline; up to 1638 days
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline
Group
Value
95% CI
Parsaclisib 1 mg QD
9.1
± 0.80
Parsaclisib 2.5 mg QD
8.7
± 0.85
Change from Baseline at Week 1
Group
Value
95% CI
Parsaclisib 1 mg QD
0.9
± 0.84
Parsaclisib 2.5 mg QD
1.2
± 1.30
Change from Baseline at Week 2
Group
Value
95% CI
Parsaclisib 1 mg QD
0.6
± 0.96
Parsaclisib 2.5 mg QD
1.5
± 1.75
Change from Baseline at Week 4
Group
Value
95% CI
Parsaclisib 1 mg QD
0.9
± 1.06
Parsaclisib 2.5 mg QD
1.6
± 1.79
Change from Baseline at Week 6
Group
Value
95% CI
Parsaclisib 1 mg QD
1.2
± 0.80
Parsaclisib 2.5 mg QD
1.7
± 1.96
Change from Baseline at Week 8
Group
Value
95% CI
Parsaclisib 1 mg QD
1.2
± 1.14
Parsaclisib 2.5 mg QD
2.0
± 2.07
Change from Baseline at Week 10
Group
Value
95% CI
Parsaclisib 1 mg QD
1.3
± 1.14
Parsaclisib 2.5 mg QD
2.1
± 2.22
Change from Baseline at Week 12
Group
Value
95% CI
Parsaclisib 1 mg QD
1.3
± 1.46
Parsaclisib 2.5 mg QD
2.5
± 2.67
Percentage Change From Baseline in HemoglobinSecondary· Baseline; up to 1638 days
Percentage change from Baseline was calculated as: (\[post-Baseline value minus the Baseline value\] / Baseline value) x 100.
Week 1
Group
Value
95% CI
Parsaclisib 1 mg QD
10.1
± 9.23
Parsaclisib 2.5 mg QD
14.4
± 16.31
Week 2
Group
Value
95% CI
Parsaclisib 1 mg QD
6.0
± 10.26
Parsaclisib 2.5 mg QD
18.5
± 20.71
Week 4
Group
Value
95% CI
Parsaclisib 1 mg QD
9.9
± 10.83
Parsaclisib 2.5 mg QD
19.2
± 20.65
Week 6
Group
Value
95% CI
Parsaclisib 1 mg QD
13.3
± 8.35
Parsaclisib 2.5 mg QD
19.5
± 22.35
Week 8
Group
Value
95% CI
Parsaclisib 1 mg QD
12.7
± 12.16
Parsaclisib 2.5 mg QD
23.4
± 24.57
Week 10
Group
Value
95% CI
Parsaclisib 1 mg QD
14.1
± 11.54
Parsaclisib 2.5 mg QD
25.1
± 26.30
Week 12
Group
Value
95% CI
Parsaclisib 1 mg QD
13.9
± 15.72
Parsaclisib 2.5 mg QD
30.2
± 33.95
Follow-up Month 1
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
± 12.26
Parsaclisib 2.5 mg QD
-4.1
± 7.92
Percentage of Participants Requiring TransfusionsSecondary· Baseline; up to 1638 days
A participant was defined to have required a transfusion if his or her last transfusion was within 7 days of the visit date.
Week 1
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
6.7
Week 2
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
0.0
Week 4
Group
Value
95% CI
Parsaclisib 1 mg QD
22.2
Parsaclisib 2.5 mg QD
0.0
Week 6
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
0.0
Week 8
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
15.4
Week 10
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
7.7
Week 12
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
0.0
Follow-up Month 1
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
0.0
Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect BilirubinSecondary· up to 1638 days
Normalization was determined by the Investigator based on normal ranges for the clinical reference laboratory.
Hemoglobin, Week 1
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
6.7
Hemoglobin, Week 2
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
6.7
Hemoglobin, Week 4
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
14.3
Hemoglobin, Week 6
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
21.4
Hemoglobin, Week 8
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
15.4
Hemoglobin, Week 10
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
15.4
Hemoglobin, Week 12
Group
Value
95% CI
Parsaclisib 1 mg QD
11.1
Parsaclisib 2.5 mg QD
35.7
Hemoglobin, Follow-up Month 1
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
0.0
Percentage of Participants Requiring a Prednisone Dose Change (Increase or Decrease)Secondary· up to 1638 days
Prednisone use was monitored throughout the study.
Week 1, increased
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
6.7
Week 1, decreased
Group
Value
95% CI
Parsaclisib 1 mg QD
20.0
Parsaclisib 2.5 mg QD
6.7
Week 2, increased
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
0.0
Week 2, decreased
Group
Value
95% CI
Parsaclisib 1 mg QD
20.0
Parsaclisib 2.5 mg QD
13.3
Week 4, increased
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
0.0
Week 4, decreased
Group
Value
95% CI
Parsaclisib 1 mg QD
10.0
Parsaclisib 2.5 mg QD
6.7
Week 6, increased
Group
Value
95% CI
Parsaclisib 1 mg QD
0.0
Parsaclisib 2.5 mg QD
0.0
Week 6, decreased
Group
Value
95% CI
Parsaclisib 1 mg QD
10.0
Parsaclisib 2.5 mg QD
6.7
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale ScoresSecondary· Baseline; up to 1638 days
The FACIT-F subscale is a 13-item instrument designed to assess fatigue/tiredness and its impact on daily activities and functioning in a number of chronic diseases. Participants were asked to respond to 13 statements that people with the illness have said are important on the following scale: 0, not at all; 1, a little bit; 2, somewhat; 3, quite a bit; 4, very much. Participants were asked to indicate the response as it applied to the last 7 days. The total fatigue subscale score ranges from 0 to 52; a higher score indicates more severe impact on daily activities and functioning.
Baseline
Group
Value
95% CI
Parsaclisib 1 mg QD
32.6
± 12.80
Parsaclisib 2.5 mg QD
30.1
± 13.88
Week 6
Group
Value
95% CI
Parsaclisib 1 mg QD
6.7
± 12.44
Parsaclisib 2.5 mg QD
8.2
± 9.28
Week 12
Group
Value
95% CI
Parsaclisib 1 mg QD
6.2
± 16.08
Parsaclisib 2.5 mg QD
5.4
± 15.49
Follow-up Month 1
Group
Value
95% CI
Parsaclisib 1 mg QD
2.0
± 2.83
Parsaclisib 2.5 mg QD
2.3
± 10.69
Follow-up Month 2
Group
Value
95% CI
Parsaclisib 1 mg QD
1.5
± 7.78
Parsaclisib 2.5 mg QD
7.0
± 15.56
Follow-up Month 3
Group
Value
95% CI
Parsaclisib 1 mg QD
-2.0
± 21.21
Parsaclisib 2.5 mg QD
13.0
± 14.14
Adverse events — posted to ClinicalTrials.gov
Time frame: up to a maximum of 1638 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Parsaclisib 1 mg QD
Serious: 6/10 (60%)
Deaths: 0/10
Parsaclisib 2.5 mg QD
Serious: 5/15 (33%)
Deaths: 1/15
Serious adverse events (28 terms)
Reaction
System
Parsaclisib 1 mg QD
Parsaclisib 2.5 mg QD
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
COVID-19 pneumonia
Infections and infestations
—
—
Amoebic dysentery
Infections and infestations
—
—
Aortic thrombosis
Vascular disorders
—
—
Atypical mycobacterial infection
Infections and infestations
—
—
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
—
—
Bacterial sepsis
Infections and infestations
—
—
COVID-19
Infections and infestations
—
—
Campylobacter colitis
Infections and infestations
—
—
Cytomegalovirus infection reactivation
Infections and infestations
—
—
Diabetes insipidus
Endocrine disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Enterococcal infection
Infections and infestations
—
—
Fall
Injury, poisoning and procedural complications
—
—
Femur fracture
Injury, poisoning and procedural complications
—
—
Haemolytic anaemia
Blood and lymphatic system disorders
—
—
Hypernatraemia
Metabolism and nutrition disorders
—
—
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
—
—
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Pneumonia
Infections and infestations
—
—
Pseudomonas infection
Infections and infestations
—
—
Psoriasis
Skin and subcutaneous tissue disorders
—
—
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
—
—
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Other adverse events (123 terms — click to expand)
The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07149818 — A Single-arm Phase 2 Prospective Clinical Study of Linprixel in the Treatment of Relapsed/Refractory Autoimmune Hemolyti
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NCT05083208 — PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma
· Phase 1
· terminated
NCT04774068 — Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas
· Phase 1
· completed
NCT04509700 — Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies o
· Phase 2
· active not recruiting
NCT04323956 — Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma
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· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
Last refreshed: 11 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03538041.