A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)

NCT ID: NCT04669600

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-04
• Study Completion Date: 2023-02-07

Brief Summary

Primary Objective:

• To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistent/chronic immune thrombocytopenia (ITP)

Secondary Objectives:

• To assess the safety and tolerability of BIVV020
• To assess the pharmacokinetics of BIVV020
• To assess the response rate of treatment with BIVV020
• To assess the time to response
• To assess the effect of treatment with BIVV020 on the requirement for rescue ITP therapy
• To assess the immunogenicity of BIVV020

Detailed Description

Study duration:

• Screening period: up to 56 days
• Transition period between last sutimlimab dose and first dose of BIVV020 (for participants who were previously receiving sutimlimab): 14 days, included as part of the 56-day Screening period. Treatment duration: Minimum 52 weeks.

Visit frequency:

• Day 1
• Day 4
• Weeks 1 to 6: Weekly
• Weeks 7 to 12: Every other week
• Weeks 13 to 24: Every 4 weeks
• Weeks 25+: At least every 8 weeks
• End of Study visit: 22 weeks after the last dose of BIVV020

Conditions

Immune Thrombocytopenia (ITP)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAR445088

Participants received SAR445088 (BIVV020).

Group Type: EXPERIMENTAL

SAR445088 (BIVV020)

Intervention Type: DRUG

Pharmaceutical form:solution for injection

Interventions

SAR445088 (BIVV020)

Pharmaceutical form:solution for injection

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioverativ, a Sanofi company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number :8400001

Washington D.C., District of Columbia, United States

Investigational Site Number :8400002

Tamarac, Florida, United States

Investigational Site Number :2030002

Ostrava - Poruba, , Czechia

Investigational Site Number :2760001

Essen, , Germany

Investigational Site Number :5280001

Leiden, , Netherlands

Investigational Site Number :7240002

A Coruña, A Coruña [La Coruña], Spain

Investigational Site Number :7240001

Palma de Mallorca, , Spain

Investigational Site Number :7240003

Seville, , Spain

Investigational Site Number :8260002

London, London, City of, United Kingdom

Countries

United States; Czechia; Germany; Netherlands; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25319&tenant=MT_SNY_9011

PDY16894 Plain Language Results Summary

Other Identifiers

2020-004162-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1253-2343

Identifier Type: OTHER

Identifier Source: secondary_id

PDY16894

Identifier Type: -

Identifier Source: org_study_id