A multicenter, Phase 2a, open-label, non-randomized study evaluating the efficacy, safety, and tolerability of BIVV020 in adults with persistent/chronic immune thrombocytopenia (ITP)

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 × 10^9/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

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