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

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ClinicalTrials.gov Identifier: NCT04669600
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : June 4, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Bioverativ, a Sanofi company )

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

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia (ITP) Drug: BIVV020 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : February 4, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: BIVV0020
All eligible participants will receive BIVV020 for at least 52 weeks.
Drug: BIVV020
Pharmaceutical form:solution for injection




Primary Outcome Measures :
  1. Proportion of participants with a durable platelet response [ Time Frame: Week 3 to Week 24 ]

    Durable platelet response is defined for naïve participants as the proportion of participants with a platelet count ≥50 × 109/L at ≥50% of scheduled visits, or for participants with baseline platelet count <15 × 109/L, a ≥20 × 109/L increase in platelet count from baseline at ≥50% of scheduled visits, without receiving rescue ITP therapy, as assessed from Week 3 to Week 24.

    Durable platelet response is defined for participants who previously received sutimlimab as maintenance of platelet count ≥30 × 109/L at ≥50% of scheduled visits, without receiving rescue ITP therapy, as assessed from Week 3 to Week 24.



Secondary Outcome Measures :
  1. Number of participants with treatment emergent adverse events [ Time Frame: Week 52 ]
  2. Plasma concentrations of BIVV020 [ Time Frame: Week 52 ]
  3. Response rate of treatment with BIVV020 [ Time Frame: Weeks 24 and 52 ]
    Response rate at Weeks 24 and 52, defined as a platelet count ≥50 × 109/L and a greater than 2-fold increase from baseline, measured on 2 occasions at least 7 days apart, with the absence of bleeding (bleeding is defined as bleeding with a score ≥2 on the WHO bleeding scale), and the lack of combination ITP therapy during this period.

  4. Time to first platelet response [ Time Frame: Baseline to Week 52 ]
    Time from baseline to first platelet response, defined as greater than or equal to each of the following values: 50 × 109/L and 100 × 109/L (confirmed by 2 measurements at least 7 days apart)

  5. Proportion of patients who did not require rescue therapy for an acute episode of thrombocytopenia after Week 3 [ Time Frame: From Week 3 to Week 52 ]
  6. Number of participants with incidence and titer (if relevant) of anti-BIVV020 antibodies [ Time Frame: Week 24, Week 52 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 patient 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 are sexually active with a female partner of childbearing potential

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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669600


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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United States, District of Columbia
Investigational Site Number 8400001 Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Investigational Site Number 8400002 Recruiting
Tamarac, Florida, United States, 33321
Czechia
Investigational Site Number 2030002 Recruiting
Ostrava, Czechia, 70852
Germany
Investigational Site Number 2760001 Recruiting
Essen, Germany, 45147
Netherlands
Investigational Site Number 5280001 Recruiting
Leiden, Netherlands, 2333 ZA
Spain
Investigational Site Number 7240002 Recruiting
La Coruña, Spain, 15006
Investigational Site Number 7240001 Recruiting
Palma De Mallorca, Spain, 07120
Investigational Site Number 7240003 Recruiting
Sevilla, Spain, 41013
United Kingdom
Investigational Site Number 8260001 Recruiting
London, United Kingdom, WC1E 6BT
Sponsors and Collaborators
Bioverativ, a Sanofi company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Bioverativ, a Sanofi company
ClinicalTrials.gov Identifier: NCT04669600    
Other Study ID Numbers: PDY16894
2020-004162-18 ( EudraCT Number )
U1111-1253-2343 ( Other Identifier: UTN )
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombocytopenia
Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations