A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia
Who is this study for? Patients with primary warm autoimmune hemolytic anemia
What treatments are being studied? Parsaclisinib
Status: Terminated
Location: See all (56) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• Diagnosis of primary warm AIHA.
• Participants who have at least 1 unsuccessful prior therapy for warm AIHA or unable to receive or tolerate other therapies.
• Hemoglobin ≥ 6.5 to \< 10 g/dL with symptoms of anemia at screening.
• FACIT-F score ≤ 43 at screening.
• Willingness to avoid pregnancy or fathering children.
• Willingness to receive PJP prophylaxis.
• Further inclusion criteria apply.
Locations
United States
California
Investigative Site US005
Los Angeles
Investigative Site US004
Whittier
Florida
Investigative Site US006
Miami
Indiana
Investigative Site US012
Indianapolis
North Carolina
Investigative Site US003
Greenville
New York
Investigative Site US002
The Bronx
Investigative Site US007
The Bronx
Ohio
Investigative Site US009
Canton
Pennsylvania
Investigative Site US010
Easton
Tennessee
Investigative Site US001
Knoxville
Other Locations
Austria
Investigative Site AT002
Salzburg Cet
Investigative Site AT001
Vienna
Belgium
Investigative Site BE001
La Louvière
Investigative Site BE002
Liège
Canada
Investigative Site CA001
Edmonton
France
Investigative Site FR002
Lille
Investigative Site FR003
Marseille
Investigative Site FR001
Paris
Germany
Investigative Site DE001
Essen
Investigative Site DE002
Ulm
Israel
Investigative Site IL002
Haifa
Investigative Site IL001
Nahariya
Italy
Investigative Site IT003
Florence
Investigative Site IT002
Milan
Investigative Site IT001
Novara
Investigative Site IT004
Pavia
Investigative Site IT006
Rome
Investigative Site IT005
Trieste
Japan
Investigative Site JP008
Fukuoka
Investigative Site JP004
Isehara
Investigative Site JP006
Nagoya
Investigative Site JP002
Okayama
Investigative Site JP009
Okayama
Investigative Site JP010
Osakasayama-shi
Investigative Site JP005
Saitama
Investigative Site JP007
Sendai
Investigative Site JP001
Suita-shi
Investigative Site JP003
Tokyo
Netherlands
Investigative Site NL001
Rotterdam
Poland
Investigative Site PL001
Legnica
Investigative Site PL006
Lodz
Investigative Site PL003
Nowy Sącz
Investigative Site PL005
Opole
Investigative Site PL004
Wałbrzych
Investigative Site PL002
Wroclaw
Spain
Investigative Site ES006
Badalona
Investigative Site ES001
Barcelona
Investigative Site ES003
Madrid
Investigative Site ES005
Murcia
Investigative Site ES004
Tarragona
Investigative Site ES002
Valencia
United Kingdom
Investigative Site GB002
Glasgow
Investigative Site GB006
London
Investigative Site GB003
Norwich
Investigative Site GB004
Plymouth
Investigative Site GB005
Reading
Time Frame
Start Date: 2022-03-15
Completion Date: 2024-04-29
Participants
Target number of participants: 13
Treatments
Experimental: Group A: Parsaclisib
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.
Placebo_comparator: Group B: Placebo followed by Parsaclisib
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.
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation