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Trial record 1 of 1 for:    M254
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Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients

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: NCT03866577
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE February 12, 2019
First Posted Date  ICMJE March 7, 2019
Last Update Posted Date December 16, 2020
Actual Study Start Date  ICMJE January 28, 2019
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Number and Severity of Adverse Events (AEs) - Part A [ Time Frame: Up to approximately Day 29 ]
  • Frequency of Clinically Significant Abnormalities in Clinical Safety Laboratory Values - Part A [ Time Frame: Up to approximately Day 29 ]
  • Shift From Baseline in Clinically Significant Abnormalities for Clinical Safety Laboratory Values - Part A [ Time Frame: Up to approximately Day 29 ]
  • Frequency of Clinically Significant Abnormalities in Vital Signs - Part A [ Time Frame: Up to approximately Day 29 ]
  • Shift From Baseline in Clinically Significant Abnormalities for Vital Signs - Part A [ Time Frame: Up to approximately Day 29 ]
  • Frequency of Clinically Significant Abnormalities in Electrocardiograms (ECGs) - Part A [ Time Frame: Up to approximately Day 29 ]
  • Shift From Baseline in Clinically Significant Abnormalities for Electrocardiograms (ECGs) - Part A [ Time Frame: Up to approximately Day 29 ]
  • Number and Severity of AEs - Part B [ Time Frame: Up to approximately Day 29 ]
  • Frequency of Clinically Significant Abnormalities in Clinical Safety Laboratory Values - Part B [ Time Frame: Up to approximately Day 29 ]
  • Shift From Baseline in Clinically Significant Abnormalities for Clinical Safety Laboratory Values - Part B [ Time Frame: Up to approximately Day 29 ]
  • Frequency of Clinically Significant Abnormalities in Vital Signs - Part B [ Time Frame: Up to approximately Day 29 ]
  • Shift From Baseline in Clinically Significant Abnormalities for Vital Signs - Part B [ Time Frame: Up to approximately Day 29 ]
  • Frequency of Clinically Significant Abnormalities in ECGs - Part B [ Time Frame: Up to approximately Day 29 ]
  • Shift From Baseline in Clinically Significant Abnormalities for ECGs - Part B [ Time Frame: Up to approximately Day 29 ]
  • Number and Severity of AEs - Part C [ Time Frame: Up to approximately Day 29 ]
  • Frequency of Clinically Significant Abnormalities in Clinical Safety Laboratory Values - Part C [ Time Frame: Up to approximately Day 29 ]
  • Shift From Baseline in Clinically Significant Abnormalities for Clinical Safety Laboratory Values - Part C [ Time Frame: Up to approximately Day 29 ]
  • Frequency of Clinically Significant Abnormalities in Vital Signs - Part C [ Time Frame: Up to approximately Day 29 ]
  • Shift From Baseline in Clinically Significant Abnormalities for Vital Signs - Part C [ Time Frame: Up to approximately Day 29 ]
  • Frequency of Clinically Significant Abnormalities in ECGs - Part C [ Time Frame: Up to approximately Day 29 ]
  • Shift From Baseline in Clinically Significant Abnormalities for ECGs - Part C [ Time Frame: Up to approximately Day 29 ]
  • Measurement of Changes in Platelet Counts After M254 Administration Compared to IVIg - Part C [ Time Frame: Baseline to approximately Day 29 ]
  • Number and Severity of AEs - Part D [ Time Frame: Up to approximately Day 71 ]
  • Frequency of Clinically Significant Abnormalities in Clinical Safety Laboratory Values - Part D [ Time Frame: Up to approximately Day 71 ]
  • Shift From Baseline in Clinically Significant Abnormalities for Clinical Safety Laboratory Values - Part D [ Time Frame: Up to approximately Day 71 ]
  • Frequency of Clinically Significant Abnormalities in Vital Signs - Part D [ Time Frame: Up to approximately Day 71 ]
  • Shift From Baseline in Clinically Significant Abnormalities for Vital Signs - Part D [ Time Frame: Up to approximately Day 71 ]
  • Frequency of Clinically Significant Abnormalities in ECGs - Part D [ Time Frame: Up to approximately Day 71 ]
  • Shift From Baseline in Clinically Significant Abnormalities for ECGs - Part D [ Time Frame: Up to approximately Day 71 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Maximum Plasma Concentration (Cmax) of M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  • Time to Maximum Plasma Concentration (Tmax) of M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  • Area Under the Concentration-time Curve From Zero to Time of Last Measurable Concentration Area [AUC(0 last)] of M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  • Area Under the Concentration-time Curve From Zero to Infinity [AUC(0 ∞)] of M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  • Volume of Distribution (Vd) of M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  • Clearance of Drug (CL) M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  • Mean Residence Time (MRT) of M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  • Apparent Terminal-phase Half-life (t½) of M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  • Cmax of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  • Tmax of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  • AUC(0 last) of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  • AUC(0 ∞) of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  • Vd of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  • CL of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  • MRT of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  • t½ of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  • Measurements of Changes in Platelet Counts After M254 Administration - Part D [ Time Frame: Baseline to approximately Day 71 ]
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 Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients
Official Title  ICMJE A 4-part Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of M254 in Healthy Volunteers and in Patients With Immune Thrombocytopenic Purpura
Brief Summary The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic purpura (ITP) patients. The pharmacodynamics of the drug will be measured as platelet response in patients with ITP.
Detailed Description The Part A of the study is currently not accepting healthy volunteers as the recruitment for the part A has completed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Masking Description:

Part A: Double (Subject, Investigator);

Part B, C, and D: Open Label Investigations

Primary Purpose: Treatment
Condition  ICMJE Immune Thrombocytopenic Purpura (ITP)
Intervention  ICMJE
  • Biological: Biological: M254
    M254 administered as intravenous infusion
  • Drug: Placebo
    Placebo administered as intravenous infusion
  • Biological: Intravenous immunoglobulin (IVIg)
    IVIg administered as intravenous infusion
Study Arms  ICMJE
  • Experimental: Part A
    Healthy volunteers will receive a single ascending dose of M254 or placebo
    Interventions:
    • Biological: Biological: M254
    • Drug: Placebo
  • Experimental: Part B
    Immune thrombocytopenic purpura (ITP) patients will receive a single ascending dose of M254 followed by IVIg
    Interventions:
    • Biological: Biological: M254
    • Biological: Intravenous immunoglobulin (IVIg)
  • Experimental: Part C
    ITP patients will receive a single dose of M254 or IVIg, followed by a single dose of the other drug approximately 28 days later
    Interventions:
    • Biological: Biological: M254
    • Biological: Intravenous immunoglobulin (IVIg)
  • Experimental: Part D
    ITP patients will receive repeated doses of M254
    Intervention: Biological: Biological: M254
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: March 5, 2019)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Criteria for Healthy Volunteers: Subject must be between the ages of 18 and 55 years; healthy as indicated by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram, and all abnormal findings are assessed as not clinically significant by the Investigator; not pregnant or breastfeeding; and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.

Key Criteria for Immune Thrombocytopenic Purpura (ITP) Patients: Patient must be aged ≥18 years and diagnosed with ITP at least 3 months prior to screening, stable maintenance therapy for at least 4 weeks prior to the first study visit, not pregnant or breastfeeding, and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Momenta General Queries +1 617-491-9700 ClinicalTrialInfo@momentapharma.com
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Hungary,   Italy,   Netherlands,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03866577
Other Study ID Numbers  ICMJE MOM-M254-001
2018-003534-32 ( EudraCT Number )
Has Data Monitoring Committee Yes
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: No
Responsible Party Momenta Pharmaceuticals, Inc.
Study Sponsor  ICMJE Momenta Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Momenta General Queries Momenta Pharmaceuticals, Inc.
PRS Account Momenta Pharmaceuticals, Inc.
Verification Date December 2020

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