A Phase 2a study evaluating BIVV020 in adults with persistent/chronic immune thrombocytopenia (ITP)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 12

Inclusion Criteria

Male and female participants =18 years of age at the time of signing the
informed consent
- Confirmed diagnosis of primary ITP; for participants who previously
received sutimlimab in study TDR16218 (NCT03275454), a response to
sutimlimab must have been obtained, as defined by platelet count =30 ×
10^9/L on 2 visits at least 7 days apart
- For participants who have not previously received sutimlimab:
persistent/chronic ITP (ITP lasting for =6 months) and all the following
conditions:
a) Platelet count =30 × 10^9/L on 2 occasions at least 5 days apart during
the Screening Period;
b) Lack of an adequate platelet count response (as defined by maintenance of sustained platelet count =30 × 109/L in the absence of bleeding) to at least 2 ITP treatments, 1 of which was a thrombopoietin
receptor agonist. Other ITP treatments include: IVIg, anti-D immunoglobulin, corticosteroids, splenectomy, rituximab, cyclophosphamide, azathioprine, danazol, cyclosporin A, mycophenolate
mofetil, or fostamatinib.
c) If receiving weekly thrombopoietin receptor agonist dosing, the last
dose must have been administered =7 days before the first dose of
BIVV020. If receiving daily thrombopoietin receptor agonist dosing, the
last dose must have been administered =24 hours before the first dose of
BIVV020
d) If applicable, concurrent administration of ITP medications (eg.
corticosteroids, IVIg, azathioprine, danazol, cyclosporin A, mycophenolate
mofetil, or thrombopoietin receptor agonists) is acceptable provided the
patient has been on a stable dose for at least 1 month.
e) If previously dosed with rituximab, the last dose of rituximab must have
been administered at least 12 weeks before the first dose of BIVV020
- Documented vaccinations against encapsulated bacterial pathogens
(Neisseria meningitidis, including serogroup B where available,
Haemophilus influenzae, and Streptococcus pneumoniae) within 5 years
of enrollment
- Contraceptive use for women of childbearing potential and men who are
sexually active with a female partner of childbearing potential
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
- Clinically significant medical history or ongoing chronic illness that
would jeopardize the safety of the participant or compromise the quality of
the data derived from his/her participation in the study
- Clinical diagnosis of SLE
- Clinically relevant infection within the month prior to enrollment
- History of venous or arterial thrombosis within the year prior to
enrollment
- Secondary ITP from any cause including lymphoma, chronic
lymphocytic leukemia, and drug-induced thrombocytopenia
- Positive hepatitis B surface antigen (HBsAg) or active HCV
infection
- HIV infection
- Pregnant or lactating women
- Hemoglobin level <10 g/dL

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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