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Trial record 21 of 55 for:    Recruiting Studies | Immune Thrombocytopenia

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 : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Bioverativ, a Sanofi company )

Tracking Information
First Submitted Date  ICMJE December 9, 2020
First Posted Date  ICMJE December 17, 2020
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE February 4, 2021
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2020)
  • Number of participants with treatment emergent adverse events [ Time Frame: Week 52 ]
  • Plasma concentrations of BIVV020 [ Time Frame: Week 52 ]
  • 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.
  • 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)
  • 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 ]
  • Number of participants with incidence and titer (if relevant) of anti-BIVV020 antibodies [ Time Frame: Week 24, Week 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)
Official Title  ICMJE 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)
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Immune Thrombocytopenia (ITP)
Intervention  ICMJE Drug: BIVV020
Pharmaceutical form:solution for injection
Study Arms  ICMJE Experimental: BIVV0020
All eligible participants will receive BIVV020 for at least 52 weeks.
Intervention: Drug: BIVV020
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 9, 2020)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04669600
Other Study ID Numbers  ICMJE PDY16894
2020-004162-18 ( EudraCT Number )
U1111-1253-2343 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/
Responsible Party Sanofi ( Bioverativ, a Sanofi company )
Study Sponsor  ICMJE Bioverativ, a Sanofi company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP