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A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04269551
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Bioverativ, a Sanofi company )

Tracking Information
First Submitted Date  ICMJE January 29, 2020
First Posted Date  ICMJE February 17, 2020
Last Update Posted Date May 18, 2021
Actual Study Start Date  ICMJE June 15, 2020
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2020)
Assessment of adverse events (AEs) [ Time Frame: Screening to Day 106 ]
Number of participants with adverse events (AEs)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2020)
  • Mean change from baseline in bilirubin over time [ Time Frame: Day 1 to Day 106 ]
    Assessment of total bilirubin
  • Mean change from baseline in hemoglobin over time [ Time Frame: Day 1 to Day 106 ]
    Assessment of hemoglobin
  • Complement System Classical Pathway Levels as Measured by WIESLAB Assay [ Time Frame: Day 1 to Day 106 ]
    Inhibition by BIVV020 of the complement system classical pathway measured by the WIESLAB assay
  • Complement System Alternative Pathway Levels as Measured by WIESLAB Assay [ Time Frame: Day 1 to Day 106 ]
    Effect of BIVV0020 on the complement system alternative pathway measured by the WIESLAB assay
  • Total Complement (CH50) Levels [ Time Frame: Day 1 to Day 106 ]
    Complement CH50 is a blood test that helps us determine whether protein abnormalities and deficiencies in the complement system are responsible for any increase in autoimmune activity. It will be assessed using complement assays.
  • Total Complement Factor C4 Levels [ Time Frame: Day 1 to Day 106 ]
    Total C4 Levels will be assessed in plasma using complement assays
  • PK parameter: Cmax [ Time Frame: Day 1 to Day 106 ]
    Observed maximum plasma concentration
  • PK parameter: tmax [ Time Frame: Day 1 to Day 106 ]
    Observed first time to reach Cmax
  • PK parameter: AUClast [ Time Frame: Day 1 to Day 106 ]
    Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
  • PK parameter: AUC0-∞ [ Time Frame: Day 1 to Day 106 ]
    Calculated area under the plasma concentration versus time curve extrapolated to infinity
  • Number of participants with anti-BIVV antibodies [ Time Frame: Day 1 to Day 106 ]
    Observed number of participants with BIVV020 antibodies
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 Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease
Official Title  ICMJE A Multicenter, Phase 1b, Open Label, Nonrandomized, Single Dose Study Evaluating the Safety, Tolerability and Activity of BIVV020 in Adults With Cold Agglutinin Disease
Brief Summary

Primary Objective:

To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020

Secondary Objectives:

To assess, in participants with cold agglutinin disease, after a single dose of intravenous (IV) BIVV020:

  • The effect of BIVV020 on complement mediated hemolysis
  • The pharmacodynamics (PD) of BIVV020 relating to complement inhibition
  • The pharmacokinetics (PK) of BIVV020
  • The immunogenicity of BIVV020
Detailed Description Up to 23 weeks (screening period up to 8 weeks, treatment period 15 weeks)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autoimmune Haemolytic Anaemia
Intervention  ICMJE Drug: BIVV020
Pharmaceutical form:solution for injection Route of administration: intravenous
Study Arms  ICMJE Experimental: BIVV020 IV
Single administration dose 1, plus two optional doses of BIVV020 administered intravenously.
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: February 12, 2020)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Male and/or female patients, ≥ 18 years of age with cold agglutinin disease as defined by:

    1. Chronic hemolysis per Investigator's judgement,
    2. Polyspecific direct antiglobulin test (DAT) positive,
    3. Monospecific DAT strongly positive for C3d,
    4. Cold agglutinin (CAg) titer ≥ 64 at 4 C; and,
    5. IgG DAT ≤1+.
  • A hemoglobin level ≤11 mg/dL.
  • A total bilirubin level above the normal reference range that is thought to be due to hemolysis.
  • Documented vaccinations against encapsulated bacterial pathogens (Neisseria meningitidis, including serogroup B meningococcus and Streptococcus pneumoniae) within five years of screening or willing to complete protocol specified vaccinations.
  • Having given written informed consent prior to undertaking any study-related procedure.

Exclusion criteria:

  • Cold agglutinin syndrome secondary to infection, rheumatologic disease, or known high grade hematologic malignancy, or known solid organ tumor.
  • Clinically relevant infection of any kind within one month preceding screening.
  • Treatment with anti-CD20 monotherapy within three months or anti CD20 combination therapies within six months prior to screening.
  • Concurrent treatment with systemic immunosuppressive agents targeting B- or T-cell function and/or cytotoxic agents within 3 months prior to screening. Concurrent treatment with other systemic immunosuppressants within 5.5 half-lives of the drug prior to screening.
  • Any specific complement system inhibitor within three months prior to screening.
  • Concurrent treatment with systemic corticosteroids other than a stable daily dose equivalent to ≤10 mg/day prednisone within three months prior to screening.
  • If female, pregnant or lactating.

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 Canada,   Germany,   Italy,   Netherlands,   Norway,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04269551
Other Study ID Numbers  ICMJE PDY16370
2019-001844-22 ( EudraCT Number )
U1111-1233-0831 ( 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 March 2021

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