Phase
Condition
Lupus
Immune (Idiopathic) Thrombocytopenic Purpura (Itp)
Anemia
Treatment
povetacicept
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Indication-specific Criteria
Immune Thrombocytopenia (ITP)
- Documented persistent or chronic primary ITP of at least 12 weeks durationfrom diagnosis to Cycle 1 Day 1
- History of failure or relapse to at least 2 treatment regimens for ITP
- History of exposure to a TPO-RA unless otherwise contraindicated orunavailable
- Documented history of platelets <30 × 10^9/L
- Warm Autoimmune Hemolytic Anemia (wAIHA)
- Diagnosis of primary wAIHA of at least 12 weeks duration documented with acurrent or prior positive direct antiglobulin test (DAT) for anti-IgG (±C3d)
- Documented history of anemia with hemoglobin ≤10 g/dL
- At least one of the following: (i) haptoglobin < lower limit of normal (LLN) (ii) indirect bilirubin > upper limit of normal (ULN) (iii) lactatedehydrogenase>ULN
- History of failure or relapse to at least 2 treatment regimens for wAIHA
- Cold Agglutinin Disease (CAD)
- Diagnosis of primary CAD of at least 12 weeks duration with all of thefollowing: (i) chronic hemolysis (ii) polyspecific DAT positive (iii)monospecific DAT strongly positive for C3d (iv) cold agglutinin titer ≥64at 4°C (v) IgG DAT ≤1+ (vi) no overt malignant disease
- Documented history of anemia with hemoglobin ≤10 g/dL
- Evidence of hemolysis during screening: (i) indirect bilirubin >ULN and (ii) lactate dehydrogenase>ULN or haptoglobin <LLN
- History of failure or relapse to at least 1 treatment regimen for CAD
- (All indications) If receiving protocol-specified standard-of-care medications,doses must be stable for protocol-specified durations
Exclusion
Key Exclusion Criteria:
Secondary AIHA, CAD, or ITP
Treatment with any of the following within the noted period prior to study entry
rituximab: <12 weeks
IVIg: <4 weeks
sutimlimab, any use after initiation of screening is exclusionary
plasmapheresis, plasma exchange, or double-filtration plasmapheresis: <8 weeks
transfusions with blood, blood products or other rescue medications: <2 weeks
splenectomy: <12 weeks
other immunomodulatory or investigational agents, except for investigationalagents for COVID-19 that have been granted emergency use authorization orapproved by the applicable national health authority: <5 half-lives andrequires agreement of the Medical Monitor
Recent serious or ongoing infection; risk or history of serious infection
Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Investigational Site (410)
Box Hill, 3128
AustraliaActive - Recruiting
Investigational Site (519)
Concord, 2139
AustraliaActive - Recruiting
Investigational Site (517)
Douglas, 4814
AustraliaCompleted
Investigational Site (413)
Liverpool, 2170
AustraliaActive - Recruiting
Investigational Site (407)
West Perth, 6005
AustraliaActive - Recruiting
Investigational Site (409)
Westmead, 2145
AustraliaActive - Recruiting
Investigational Site (434)
Vienna, 1090
AustriaActive - Recruiting
Investigational Site (406)
Greenfield Park, J4V2H1
CanadaActive - Recruiting
Investigational Site (403)
Hamilton, L8S 4K1
CanadaActive - Recruiting
Investigational Site (444)
Toronto, M5B 1W8
CanadaActive - Recruiting
Investigational Site (438)
Essen, 45147
GermanyActive - Recruiting
Investigational Site (432)
Meldola, 47014
ItalyActive - Recruiting
Investigational Site (428)
Milan, 20122
ItalyActive - Recruiting
Investigational Site (431)
Novara, 28100
ItalySite Not Available
Investigational Site (443)
Trieste, 34128
ItalySite Not Available
Investigational Site (433)
Grålum, 1714
NorwayActive - Recruiting
Investigational Site (437)
Trondheim, 7030
NorwayActive - Recruiting
Investigational Site (436)
Barcelona, 08003
SpainActive - Recruiting
Investigational Site (429)
Burgos, 9006
SpainActive - Recruiting
Investigational Site (430)
Madrid, 28007
SpainActive - Recruiting
Investigational Site (425)
Murcia, 30008
SpainActive - Recruiting
Investigational Site (426)
Murcia, 30008
SpainActive - Recruiting
Investigational Site (427)
Seville, 41013
SpainActive - Recruiting
Investigational Site (415)
Ankara, 06200
TurkeyCompleted
Investigational Site (416)
Ankara, 06800
TurkeyCompleted
Investigational Site (418)
Istanbul, 34718
TurkeyCompleted
Investigational Site (442)
Leeds, SE1 9RT
United KingdomActive - Recruiting
Investigational Site (439)
London, E1 1BB
United KingdomActive - Recruiting
Investigational Site (440)
London, W12 0HS
United KingdomActive - Recruiting
Investigational Site (441)
London, SE1 9RT
United KingdomActive - Recruiting
Investigational Site (230)
Los Angeles, California 90033
United StatesActive - Recruiting
Investigational Site (401)
Washington, District of Columbia 20007
United StatesActive - Recruiting
Investigational Site (419)
Cooper City, Florida 33024
United StatesActive - Recruiting
Investigational Site (425)
Miami, Florida 33143
United StatesActive - Recruiting
Investigational Site (219)
Iowa City, Iowa 52242
United StatesActive - Recruiting
Investigational Site (435)
Columbia, Maryland 21044
United StatesActive - Recruiting
Investigational Site (422)
Bronx, New York 10469
United StatesActive - Recruiting
Investigational site (405)
Lake Success, New York 11042
United StatesActive - Recruiting
Investigational Site (423)
New Hyde Park, New York 11040
United StatesActive - Recruiting
Investigational Site (404)
New York, New York 10065
United StatesActive - Recruiting
Investigational Site (421)
New York, New York 10028
United StatesActive - Recruiting
Investigational Site (420)
Port Jefferson Station, New York 11776
United StatesSite Not Available
Investigational Site (420)
Shirley, New York 11967
United StatesActive - Recruiting
Investigational Site (414)
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Investigational Site (402)
Greenville, North Carolina 27834
United StatesActive - Recruiting
Investigational Site (411)
Seattle, Washington 98109
United StatesActive - Recruiting
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