A Phase 2, Open-Label Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

Who is this study for? Adult patients with Autoimmune Hemolytic Anemia
What treatments are being studied? Parsaclisib
Status: Completed
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of AIHA based on the presence of hemolytic anemia and serological evidence of anti-erythrocyte antibodies, detectable by the direct antiglobulin test.

• Participants who have disease progression after treatment with standard therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens.

• Hemoglobin 7 to 10 g/dL.

• No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions.

• Eastern Cooperative Oncology Group performance status of 0 to 2.

• Willingness to avoid pregnancy or fathering children.

Locations
United States
Washington, D.c.
Georgetown University Hospital
Washington D.c.
Minnesota
University of Minnesota
Minneapolis
Missouri
Washington University School of Medicine
St Louis
New York
Weill Medical College of Cornell University
New York
Montefiore Medical Center
The Bronx
Tennessee
University Health System Inc., Dba the University of Tn Medical Center
Knoxville
Other Locations
Austria
Allgemeines Krankenhaus Der Stadt Wien
Vienna
France
Centre Hospitalier Universitaire Henri Mondor
Créteil
Centre Hospitalier Regional Universitaire (Chru) de Lille
Lille
Italy
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan
UNIVERSIT� DI NAPOLI FEDERICO II
Napoli
AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARIT� DI NOVARA
Novara
Time Frame
Start Date: 2018-11-21
Completion Date: 2024-04-02
Participants
Target number of participants: 25
Treatments
Experimental: Parsaclisib 1 mg QD
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.
Experimental: Parsaclisib 2.5 mg QD
Parsaclisib at 2.5 mg QD for 12 weeks followed by extension period.
Sponsors
Leads: Incyte Corporation

This content was sourced from clinicaltrials.gov