Phase
Condition
White Cell Disorders
Thrombocytopenic
Dysfunctional Uterine Bleeding
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
AustraliaSite Not Available
Investigational Site (519)
Concord, 2139
AustraliaSite Not Available
Investigational Site (517)
Douglas, 4814
AustraliaSite Not Available
Investigational Site (413)
Liverpool, 2170
AustraliaSite Not Available
Investigational Site (407)
West Perth, 6005
AustraliaSite Not Available
Investigational Site (409)
Westmead, 2145
AustraliaSite Not Available
Investigational Site (434)
Vienna, 1090
AustriaSite Not Available
Investigational Site (406)
Greenfield Park, J4V2H1
CanadaSite Not Available
Investigational Site (403)
Hamilton, L8S 4K1
CanadaSite Not Available
Investigational Site (444)
Toronto, M5B 1W8
CanadaSite Not Available
Investigational Site (438)
Essen, 45147
GermanySite Not Available
Investigational Site (432)
Meldola, 47014
ItalySite Not Available
Investigational Site (428)
Milan, 20122
ItalySite Not Available
Investigational Site (431)
Novara, 28100
ItalySite Not Available
Investigational Site (443)
Trieste, 34128
ItalySite Not Available
Investigational Site (433)
Grålum, 1714
NorwaySite Not Available
Investigational Site (437)
Trondheim, 7030
NorwaySite Not Available
Investigational Site (436)
Barcelona, 08003
SpainSite Not Available
Investigational Site (429)
Burgos, 9006
SpainSite Not Available
Investigational Site (430)
Madrid, 28007
SpainSite Not Available
Investigational Site (425)
Murcia, 30008
SpainActive - Recruiting
Investigational Site (426)
Murcia, 30008
SpainSite Not Available
Investigational Site (427)
Seville, 41013
SpainSite Not Available
Investigational Site (415)
Ankara, 06200
TurkeySite Not Available
Investigational Site (416)
Ankara, 06800
TurkeySite Not Available
Investigational Site (418)
Istanbul, 34718
TurkeySite Not Available
Investigational Site (442)
Leeds, SE1 9RT
United KingdomSite Not Available
Investigational Site (439)
London, E1 1BB
United KingdomSite Not Available
Investigational Site (440)
London, W12 0HS
United KingdomSite Not Available
Investigational Site (441)
London, SE1 9RT
United KingdomSite Not Available
Investigational Site (230)
Los Angeles, California 90033
United StatesSite Not Available
Investigational Site (401)
Washington, District of Columbia 20007
United StatesSite Not Available
Investigational Site (419)
Cooper City, Florida 33024
United StatesSite Not Available
Investigational Site (425)
Miami, Florida 33143
United StatesSite Not Available
Investigational Site (219)
Iowa City, Iowa 52242
United StatesSite Not Available
Investigational Site (435)
Columbia, Maryland 21044
United StatesSite Not Available
Investigational Site (422)
Bronx, New York 10469
United StatesSite Not Available
Investigational site (405)
Lake Success, New York 11042
United StatesSite Not Available
Investigational Site (423)
New Hyde Park, New York 11040
United StatesSite Not Available
Investigational Site (404)
New York, New York 10065
United StatesSite Not Available
Investigational Site (421)
New York, New York 10028
United StatesSite Not Available
Investigational Site (420)
Port Jefferson Station, New York 11776
United StatesSite Not Available
Investigational Site (420)
Shirley, New York 11967
United StatesSite Not Available
Investigational Site (414)
Charlotte, North Carolina 28204
United StatesSite Not Available
Investigational Site (402)
Greenville, North Carolina 27834
United StatesSite Not Available
Investigational Site (411)
Seattle, Washington 98109
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.