Trial · NCT03538041

A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

NCT03538041, Phase 2, Completed, Incyte Corporation; results first posted 2022-09-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia. Trials, record NCT03538041. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03538041

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
NCT number: NCT03538041
Status: Completed
Phases: Phase 2
Enrollment: 25 participants, actual
Lead sponsor: Incyte Corporation
Conditions: Autoimmune Hemolytic Anemia
Interventions: Parsaclisib
First posted: 2018-05-25
Last updated: 2025-07-11
Other registries' IDs: eudract:2017-003652-22
Results first posted: 2022-09-22

Source ClinicalTrials.gov

Registered outcomes26

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12	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.
Primary	Percentage of Participants Attaining a Partial Response at Any Visit From Week 6 to Week 12	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.
Primary	Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	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 TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Secondary	Percentage of Participants Attaining a Complete Response During Post-Baseline Visits	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.
Secondary	Percentage of Participants Attaining a Partial Response During Post-Baseline Visits	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.
Secondary	Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline	up to 1638 days	Hemoglobin levels were assessed throughout the study.
Secondary	Change From Baseline in Hemoglobin	Baseline; up to 1638 days	Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Secondary	Percentage Change From Baseline in Hemoglobin	Baseline; up to 1638 days	Percentage change from Baseline was calculated as: (\[post-Baseline value minus the Baseline value\] / Baseline value) x 100.
Secondary	Percentage of Participants Requiring Transfusions	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.
Secondary	Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin	up to 1638 days	Normalization was determined by the Investigator based on normal ranges for the clinical reference laboratory.

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12	Week 6 to Week 12	Full Analysis Set: all participants who enrolled in the study who received at least 1 dose of study drug	percentage of participants	NUMBER
PRIMARY	Percentage of Participants Attaining a Partial Response at Any Visit From Week 6 to Week 12	Week 6 to Week 12	Full Analysis Set	percentage of participants	NUMBER
PRIMARY	Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	up to 1638 days	Full Analysis Set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants Attaining a Complete Response During Post-Baseline Visits	up to 1638 days	Full Analysis Set. Only participants with available data were analyzed.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Attaining a Partial Response During Post-Baseline Visits	up to 1638 days	Full Analysis Set. Only participants with available data were analyzed.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Attaining a ≥ 2 g/dL Increase in Hemoglobin From Baseline	up to 1638 days	Full Analysis Set. Only participants with available data were analyzed.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Hemoglobin	Baseline; up to 1638 days	Full Analysis Set. Only participants with available data were analyzed.	grams per deciliter (g/dL)	MEAN
SECONDARY	Percentage Change From Baseline in Hemoglobin	Baseline; up to 1638 days	Full Analysis Set. Only participants with available data were analyzed.	percent change	MEAN
SECONDARY	Percentage of Participants Requiring Transfusions	Baseline; up to 1638 days	Full Analysis Set. Only participants with available data were analyzed.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved Normalization of Hemoglobin, Haptoglobin, Lactate Dehydrogenase (LDH), Reticulocyte Count, Total Bilirubin, Direct Bilirubin, and Indirect Bilirubin	up to 1638 days	Full Analysis Set. Only participants with available data were analyzed.	percentage of participants	NUMBER

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group497

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12	Parsaclisib 1 mg QD		20.0	percentage of participants
Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12	Parsaclisib 2.5 mg QD		40.0	percentage of participants
Percentage of Participants Attaining a Partial Response at Any Visit From Week 6 to Week 12	Parsaclisib 1 mg QD		60.0	percentage of participants
Percentage of Participants Attaining a Partial Response at Any Visit From Week 6 to Week 12	Parsaclisib 2.5 mg QD		66.7	percentage of participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	Parsaclisib 1 mg QD		10	Participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	Parsaclisib 2.5 mg QD		15	Participants
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits	Parsaclisib 1 mg QD	Week 1	0.0	percentage of participants
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits	Parsaclisib 2.5 mg QD	Week 1	6.7	percentage of participants
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits	Parsaclisib 1 mg QD	Week 2	10.0	percentage of participants
Percentage of Participants Attaining a Complete Response During Post-Baseline Visits	Parsaclisib 2.5 mg QD	Week 2	6.7	percentage of participants

1 to 10 of 497Source ClinicalTrials.gov

See all 497 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
12-Week Treatment Period	STARTED	Parsaclisib 1 mg QD	10
12-Week Treatment Period	STARTED	Parsaclisib 2.5 mg QD	15
12-Week Treatment Period	COMPLETED	Parsaclisib 1 mg QD	9
12-Week Treatment Period	COMPLETED	Parsaclisib 2.5 mg QD	13
12-Week Treatment Period	NOT COMPLETED	Parsaclisib 1 mg QD	1
12-Week Treatment Period	NOT COMPLETED	Parsaclisib 2.5 mg QD	2
Treatment Extension Period	STARTED	Parsaclisib 1 mg QD	7
Treatment Extension Period	STARTED	Parsaclisib 2.5 mg QD	11
Treatment Extension Period	COMPLETED	Parsaclisib 1 mg QD	0
Treatment Extension Period	COMPLETED	Parsaclisib 2.5 mg QD	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events302

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal distension	Gastrointestinal disorders	Parsaclisib 1 mg QD	0	10	0
other	Abdominal distension	Gastrointestinal disorders	Parsaclisib 2.5 mg QD	1	15	1
other	Abdominal pain	Gastrointestinal disorders	Parsaclisib 1 mg QD	0	10	0
other	Abdominal pain	Gastrointestinal disorders	Parsaclisib 2.5 mg QD	1	15	1
other	Agitation	Psychiatric disorders	Parsaclisib 1 mg QD	0	10	0
other	Agitation	Psychiatric disorders	Parsaclisib 2.5 mg QD	1	15	1
other	Anaemia	Blood and lymphatic system disorders	Parsaclisib 1 mg QD	0	10	0
other	Anaemia	Blood and lymphatic system disorders	Parsaclisib 2.5 mg QD	1	15	1
other	Angina pectoris	Cardiac disorders	Parsaclisib 1 mg QD	1	10	1
other	Angina pectoris	Cardiac disorders	Parsaclisib 2.5 mg QD	0	15	0

1 to 10 of 302Source ClinicalTrials.gov

See all 302 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Parsaclisib 1 mg QD	0	10
Total, all-cause mortality	Parsaclisib 2.5 mg QD	1	15
Total, other adverse events	Parsaclisib 1 mg QD	10	10
Total, other adverse events	Parsaclisib 2.5 mg QD	15	15
Total, serious adverse events	Parsaclisib 1 mg QD	6	10
Total, serious adverse events	Parsaclisib 2.5 mg QD	5	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39435908	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Parsaclisib 1 mg QD vs Parsaclisib 2.5 mg QD: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	Trial comparisons
Parsaclisib 1 mg QD vs Parsaclisib 2.5 mg QD: deaths from any cause	Trial comparisons
Parsaclisib 1 mg QD vs Parsaclisib 2.5 mg QD: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03538041

GET https://conductscience.org/api/trials/v1/NCT03538041/registered?page=2

API reference For AI assistants