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

NCT04669600 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: PDY168942020-004162-18U1111-1253-2343
• Study Type: interventional
• Target: 12
• Locations: 6 countries
• Sites: 9

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

Conditions

Immune Thrombocytopenia (ITP)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Durable Platelet Response

  A naive participant was a participant who did not use sutimlimab prior to enrollment. A switcher was a participant who used sutimlimab prior to enrollment. A naive participant was a responder if the platelet count was \>=50 × 10\^9/liter (L) at \>=50 percent (%) of scheduled visits, or for participants with baseline platelet count \<15 × 10\^9/L, a \>=20 × 10\^9/L increase in platelet count from baseline at \>=50% of scheduled visits, without receiving rescue immune thrombocytopenia (ITP) therapy. A switcher was a responder if the maintenance platelet count was \>=30 × 10\^9/L at \>=50% of scheduled visits, without receiving rescue ITP therapy.

  From Week 3 to Week 24

Secondary Outcomes (10)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (SAE)

  From first study treatment administration (Day 1) up to Week 103

• Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematology

  On Days 1, 15, 29, at Weeks 8, 12, 24, and then every 8 weeks until the end of study (EOS) (Week 103)

• Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Clinical Chemistry

  On Days 1, 15, 29, Weeks 8, 12 and 24, then every 8 weeks until the EOS (Week 103)

• Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Coagulation

  On Days 1, 15, 29, Weeks 8, 12 and 24, then every 8 weeks until the EOS (Week 103)

• Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Urinalysis

  On Days 1, 15, 29, Weeks 8, 12 and 24, then every 8 weeks until the EOS (Week 103)

Study Arms (1)

SAR445088

EXPERIMENTAL

Participants received SAR445088 (BIVV020).

Drug: SAR445088 (BIVV020)

Interventions

SAR445088 (BIVV020) DRUG

Pharmaceutical form:solution for injection

SAR445088

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Platelet count ≤30 × 10\^9/L on 2 occasions at least 5 days apart during the Screening Period;
• 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.
• 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
• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioverativ, a Sanofi company: lead

Study Sites (9)

Investigational Site Number :8400001

Washington D.C., District of Columbia, 20007, United States

Location

Investigational Site Number :8400002

Tamarac, Florida, 33321, United States

Location

Investigational Site Number :2030002

Ostrava - Poruba, 70852, Czechia

Location

Investigational Site Number :2760001

Essen, 45147, Germany

Location

Investigational Site Number :5280001

Leiden, 2333 ZA, Netherlands

Location

Investigational Site Number :7240002

A Coruña, A Coruña [La Coruña], 15006, Spain

Location

Investigational Site Number :7240001

Palma de Mallorca, 07120, Spain

Location

Investigational Site Number :7240003

Seville, 41013, Spain

Location

Investigational Site Number :8260002

London, London, City of, W12 0HS, United Kingdom

Location

Related Links

• PDY16894 Plain Language Results Summary

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

8006331610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: February 4, 2021
• Primary Completion: February 15, 2022
• Study Completion: February 7, 2023
• Last Updated: September 10, 2025
• Results First Posted: February 22, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); CZ (1); NL (1); DE (1); US (2); ES (3)