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PI3K Inhibitor

Parsaclisib for Autoimmune Hemolytic Anemia (PATHWAY Trial)

Q: Is this the first time this kind of clinical trial has been conducted?

There are currently 17 global trials for parsaclisinib underway in 114 cities and 26 countries. The first parsaclisinib trial began in 2017 and was completed in Phase 2. That trial, sponsored by Incyte Corporation, had 161 participants. Since then, 2693 additional studies have been completed.

Q: To whom does this trial grant access?

medical research is currently underway to find 100 participants, aged 18 to 99, who have anemia and meet the following additional requirements: a diagnosis of primary warm AIHA, a FACIT-F score of ≤ 43, the ability to receive PJP prophylaxis, and more.

Q: Does this research include minors in its data pool?

This trial is open to patients that are under 99 years old and have reached the age of majority.

Q: What are some other examples of research done on parsaclisinib?

The first clinical trials for parsaclisinib were completed in 2017 at Hospital Universitario Ramon Y Cajal. To date, there have been 2693 completed studies, with 17 live studies. The largest number of these active studies are taking place in Knoxville, <a href="https://www.withpower.com/clinical-trials/kentucky">Kentucky</a>.

Q: Are there any open spots in this research project?

That is correct, according to the listing on clinicaltrials.gov this trial is still looking for volunteers. The first posting was on March 15th, 2022 with the most recent update being on October 11th, 2022. They are expecting to have 100 participants at 9 different sites.

Q: In how many different outpatient facilities is this research project being conducted?

At the moment, this trial is open to enrolment from patients at Investigative Site US001 in Knoxville, <a href="https://www.withpower.com/clinical-trials/kentucky">Kentucky</a>, Investigative Site US005 in Los Angeles, <a href="https://www.withpower.com/clinical-trials/california">California</a>, Investigative Site US004 in Whittier, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> as well as 9 other locations.

Phase 3

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

Hemoglobin ≥ 6.5 to < 10 g/dL with symptoms of anemia at screening

Diagnosis of primary warm AIHA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

PATHWAY Trial Summary

This trial will compare the effectiveness and safety of a new drug, parsclisib, to a placebo for treating primary warm autoimmune hemolytic anemia.

Who is the study for?

This trial is for adults with Primary Warm Autoimmune Hemolytic Anemia (wAIHA) who have tried at least one treatment that didn't work or can't tolerate other therapies. They should not be pregnant, planning to get pregnant, or fathering children and must agree to prevent infections. People with recent splenectomy, other AIHA types, significant illnesses, certain cancers in the last 5 years, or chronic infections are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of a drug called Parsaclisib against a placebo in treating wAIHA. Participants will either receive Parsaclisib or a placebo to see if there's an improvement in their condition compared to those not receiving the active drug.See study design

What are the potential side effects?

While specific side effects for parsaclisib aren't listed here, similar medications may cause liver issues, diarrhea, nausea, rash and increase infection risk. The exact side effects will be monitored throughout the trial.

PATHWAY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My hemoglobin is between 6.5 and 10 g/dL, and I feel tired or weak.

Select...

I have been diagnosed with warm autoimmune hemolytic anemia.

PATHWAY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Proportion of participants attaining a durable hemoglobin response

Secondary outcome measures

Change in FACIT-F score

Adrenal Cortex Hormones

Change in hemoglobin

+8 more

PATHWAY Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group A: ParsaclisibExperimental Treatment1 Intervention

Participants will receive parsaclisib for 24 weeks (double-blind period). Participant who completed the double-blind period and tolerating the study treatment upon investigator's opinion will continue into open-label period for an additional 24 weeks. Participants may then continue to receive parsaclisib in a long-term extension period.

Group II: Group B: Placebo followed by ParsaclisibPlacebo Group1 Intervention

Participants will receive placebo for 24 weeks (double-blind period). Participants who completed the double-blind period will receive parsaclisib in the 24 week open-label period. Participants may then continue to receive parsaclisib in a long-term extension period.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

364 Previous Clinical Trials

55,152 Total Patients Enrolled

1 Trials studying Autoimmune Hemolytic Anemia

25 Patients Enrolled for Autoimmune Hemolytic Anemia

Kathleen Butler, MDStudy DirectorIncyte Corporation

14 Previous Clinical Trials

1,677 Total Patients Enrolled

1 Trials studying Autoimmune Hemolytic Anemia

25 Patients Enrolled for Autoimmune Hemolytic Anemia

Media Library

Parsaclisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05073458 — Phase 3

Frequently Asked Questions

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

Is this the first time this kind of clinical trial has been conducted?

"There are currently 17 global trials for parsaclisinib underway in 114 cities and 26 countries. The first parsaclisinib trial began in 2017 and was completed in Phase 2. That trial, sponsored by Incyte Corporation, had 161 participants. Since then, 2693 additional studies have been completed."

Answered by AI

To whom does this trial grant access?

"medical research is currently underway to find 100 participants, aged 18 to 99, who have anemia and meet the following additional requirements: a diagnosis of primary warm AIHA, a FACIT-F score of ≤ 43, the ability to receive PJP prophylaxis, and more."

Answered by AI

Does this research include minors in its data pool?

"This trial is open to patients that are under 99 years old and have reached the age of majority."

Answered by AI

What are some other examples of research done on parsaclisinib?

"The first clinical trials for parsaclisinib were completed in 2017 at Hospital Universitario Ramon Y Cajal. To date, there have been 2693 completed studies, with 17 live studies. The largest number of these active studies are taking place in Knoxville, Kentucky."

Answered by AI

Are there any open spots in this research project?

"That is correct, according to the listing on clinicaltrials.gov this trial is still looking for volunteers. The first posting was on March 15th, 2022 with the most recent update being on October 11th, 2022. They are expecting to have 100 participants at 9 different sites."

Answered by AI

In how many different outpatient facilities is this research project being conducted?

"At the moment, this trial is open to enrolment from patients at Investigative Site US001 in Knoxville, Kentucky, Investigative Site US005 in Los Angeles, California, Investigative Site US004 in Whittier, New york as well as 9 other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia

2022. "Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05073458.

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