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PI3K Inhibitor

Parsaclisib for Autoimmune Hemolytic Anemia

Phase 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions
Eastern Cooperative Oncology Group performance status of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2.5 years
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug for people with autoimmune hemolytic anemia who have decreased hemoglobin and evidence of ongoing hemolysis.

Who is the study for?
This trial is for individuals with autoimmune hemolytic anemia (AIHA) who have tried standard treatments without success, are intolerant to them, or refuse them. Participants should have a certain level of hemoglobin and be in stable condition without severe liver or kidney issues. They must not be pregnant, breastfeeding, or at risk of fathering children.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of parsaclisib, an oral medication for AIHA patients with low hemoglobin levels due to ongoing blood cell destruction that needs medical intervention.See study design
What are the potential side effects?
While specific side effects for parsaclisib in this trial aren't listed here, common ones may include digestive issues, liver enzyme changes, fatigue, rash or other allergic reactions. Each person's experience can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any immune system-related cancers or autoimmune diseases.
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I can take care of myself and am up and about more than half of my waking hours.
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I have been diagnosed with AIHA based on specific blood tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Percentage of Participants Attaining a Complete Response at Any Visit From Week 6 to Week 12
Percentage of Participants Attaining a Partial Response at Any Visit From Week 6 to Week 12
Secondary outcome measures
Change From Baseline in C3 and C4
Change From Baseline in CH50
Change From Baseline in Cold Agglutinin Levels
+21 more

Side effects data

From 2021 Phase 1 & 2 trial • 88 Patients • NCT02018861
63%
Fatigue
50%
Cough
38%
Upper respiratory tract infection
38%
Nausea
25%
Hypertension
25%
Hyperglycaemia
25%
Diarrhoea
25%
Tachycardia
25%
Oral herpes
13%
Alanine aminotransferase increased
13%
Headache
13%
Paraesthesia
13%
Herpes zoster
13%
Hepatic steatosis
13%
Acute kidney injury
13%
Anxiety
13%
Myalgia
13%
Bradycardia
13%
Hypokalaemia
13%
Neuropathy peripheral
13%
Hyperlipidaemia
13%
Pain
13%
Pyrexia
13%
Respiratory tract congestion
13%
Radiculopathy
13%
Neutropenia
13%
Night sweats
13%
Sinusitis
13%
Aspartate aminotransferase increased
13%
Hypophosphataemia
13%
Abdominal distension
13%
Haematuria
13%
Hypotension
13%
Lacrimation increased
13%
Nasal congestion
13%
Neutrophil count decreased
13%
Oedema peripheral
13%
Productive cough
13%
Vertigo
13%
Wound
13%
Abdominal pain
13%
Blood alkaline phosphatase increased
13%
Dyspepsia
13%
Dyspnoea
13%
Malaise
13%
Paranasal sinus discomfort
13%
Renal impairment
13%
Blood creatinine increased
13%
Blood phosphorus increased
13%
Spinal cord compression
13%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Parsaclisib 20 mg + Itacitinib 300 mg
Total
Parsaclisib 30 mg + Itacitinib 300 mg
Parsaclisib 20 mg QD + R-ICE
Parsaclisib 15 mg QD + R-ICE
Parsaclisib 5 mg QD
Parsaclisib 10 mg QD
Parsaclisib 15 mg QD
Parsaclisib 20 mg QD
Parsaclisib 30 mg QD
Parsaclisib 45 mg QD

Trial Design

2Treatment groups
Experimental Treatment
Group I: Parsaclisib 2.5 mg QDExperimental Treatment1 Intervention
Parsaclisib at 2.5 mg QD for 12 weeks followed by extension period.
Group II: Parsaclisib 1 mg QDExperimental Treatment1 Intervention
Parsaclisib at 1 milligram (mg) once daily (QD) for 12 weeks followed by extension period, with a dose-increase option (to 2.5 mg QD) at Week 6 for participants who fulfill dose increase criteria.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Parsaclisib
2018
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,140 Total Patients Enrolled
Kathleen Butler, MDStudy DirectorIncyte Corporation
14 Previous Clinical Trials
1,665 Total Patients Enrolled

Media Library

Parsaclisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03538041 — Phase 2
Autoimmune Hemolytic Anemia Research Study Groups: Parsaclisib 1 mg QD, Parsaclisib 2.5 mg QD
Autoimmune Hemolytic Anemia Clinical Trial 2023: Parsaclisib Highlights & Side Effects. Trial Name: NCT03538041 — Phase 2
Parsaclisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03538041 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedents to the Parsaclisib clinical trials?

"Currently, 17 studies are researching the effects of Parsaclisib. Of those active trials, 3 have entered Phase 3. Concentrated mainly in Knoxville, Tennessee, 953 different sites worldwide are conducting experiments on this pharmaceutical intervention."

Answered by AI

Is this a pioneering endeavor in its field?

"Currently, 17 clinical trials related to Parsaclisib are taking place worldwide in 115 cities across 26 countries. In 2017, the pharmaceuticals company Incyte Corporation initiated a Phase 2 trial involving 161 participants that has since been complemented with 10 additional studies."

Answered by AI

How many individuals is the research team enrolling in this experiment?

"Unfortunately, this trial is not currently seeking new participants. Initially posted on November 21st 2018 and last updated August 26th 2022, it may be worth exploring the 247 other clinical trials actively recruiting for autoimmune hemolytic anemia or the 17 studies utilizing Parsaclisib that are enrolling patients."

Answered by AI

What are the ultimate aims of this research program?

"The principal aim of this 28-week study is to ascertain the rate of partial response in participants between weeks 6 and 12. Secondary objectives include measuring parsaclisib's AUC0-t, noting changes from baseline hemoglobin levels, and determining how many patients had normalization of haptoglobin, LDH, reticulocyte count total bilirubin direct bilirubin, and indirect bilirubin ranges set by the clinical reference laboratory."

Answered by AI

In what localities is this clinical trial currently being conducted?

"This research project is taking place at six locations, such as Weill Medical College of Cornell University in New york, Georgetown University Hospital in Washington and Washington University School of Medicine in Saint Louis. An additional three sites are also participating."

Answered by AI

How detrimental are the consequences of Parsaclisib for patients?

"Although there is some evidence testifying to Parsaclisib's general safety, the drug was still given a score of 2 due to only being in Phase 2 trials and lacking any proof of efficacy."

Answered by AI

Are there any openings in this clinical investigation that participants can enroll in?

"This trial is now closed to prospective patients. It was first posted on November 21st 2018 and the last edit occurred in August 26th 2022. However, there are presently 247 trials recruiting individuals with autoimmune hemolytic anemia, as well as 17 studies looking for participants taking Parsaclisib."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
2018. "A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03538041.
~4 spots leftby Apr 2025
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