New drug BIVV020 shows promise for chronic ITP in small trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. Platelet count ≤30 × 10\^9/L on 2 occasions at least 5 days apart during the Screening Period; 2. 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. 3. 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 4. If applicable, concurrent administration of ITP medications (eg. corticosteroids, IVIg, azathioprine, danazol, cyclosporin A, mycophenolate mofetil, or thrombopoietin receptor agonists) is acceptable provided the participant has been on a stable dose for at least 1 month. 5. 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 were sexually active with a female partner of childbearing potential Exclusion criteria: Participants were 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 The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.