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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenic Purpura (ITP) Biological: Biological: M254 Drug: Placebo Biological: Intravenous immunoglobulin (IVIg) Phase 1 Phase 2

Detailed Description:
The Part A of the study is currently not accepting healthy volunteers as the recruitment for the part A has completed.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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
Official Title: 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
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A
Healthy volunteers will receive a single ascending dose of M254 or placebo
 Biological: Biological: M254
M254 administered as intravenous infusion

Drug: Placebo
Placebo administered as intravenous infusion
Experimental: Part B
Immune thrombocytopenic purpura (ITP) patients will receive a single ascending dose of M254 followed by IVIg
 Biological: Biological: M254
M254 administered as intravenous infusion

Biological: Intravenous immunoglobulin (IVIg)
IVIg administered as intravenous infusion
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
 Biological: Biological: M254
M254 administered as intravenous infusion

Biological: Intravenous immunoglobulin (IVIg)
IVIg administered as intravenous infusion
Experimental: Part D
ITP patients will receive repeated doses of M254
 Biological: Biological: M254
M254 administered as intravenous infusion


Outcome Measures
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Primary Outcome Measures :
  1. Number and Severity of Adverse Events (AEs) - Part A [ Time Frame: Up to approximately Day 29 ]
  2. Frequency of Clinically Significant Abnormalities in Clinical Safety Laboratory Values - Part A [ Time Frame: Up to approximately Day 29 ]
  3. Shift From Baseline in Clinically Significant Abnormalities for Clinical Safety Laboratory Values - Part A [ Time Frame: Up to approximately Day 29 ]
  4. Frequency of Clinically Significant Abnormalities in Vital Signs - Part A [ Time Frame: Up to approximately Day 29 ]
  5. Shift From Baseline in Clinically Significant Abnormalities for Vital Signs - Part A [ Time Frame: Up to approximately Day 29 ]
  6. Frequency of Clinically Significant Abnormalities in Electrocardiograms (ECGs) - Part A [ Time Frame: Up to approximately Day 29 ]
  7. Shift From Baseline in Clinically Significant Abnormalities for Electrocardiograms (ECGs) - Part A [ Time Frame: Up to approximately Day 29 ]
  8. Number and Severity of AEs - Part B [ Time Frame: Up to approximately Day 29 ]
  9. Frequency of Clinically Significant Abnormalities in Clinical Safety Laboratory Values - Part B [ Time Frame: Up to approximately Day 29 ]
  10. Shift From Baseline in Clinically Significant Abnormalities for Clinical Safety Laboratory Values - Part B [ Time Frame: Up to approximately Day 29 ]
  11. Frequency of Clinically Significant Abnormalities in Vital Signs - Part B [ Time Frame: Up to approximately Day 29 ]
  12. Shift From Baseline in Clinically Significant Abnormalities for Vital Signs - Part B [ Time Frame: Up to approximately Day 29 ]
  13. Frequency of Clinically Significant Abnormalities in ECGs - Part B [ Time Frame: Up to approximately Day 29 ]
  14. Shift From Baseline in Clinically Significant Abnormalities for ECGs - Part B [ Time Frame: Up to approximately Day 29 ]
  15. Number and Severity of AEs - Part C [ Time Frame: Up to approximately Day 29 ]
  16. Frequency of Clinically Significant Abnormalities in Clinical Safety Laboratory Values - Part C [ Time Frame: Up to approximately Day 29 ]
  17. Shift From Baseline in Clinically Significant Abnormalities for Clinical Safety Laboratory Values - Part C [ Time Frame: Up to approximately Day 29 ]
  18. Frequency of Clinically Significant Abnormalities in Vital Signs - Part C [ Time Frame: Up to approximately Day 29 ]
  19. Shift From Baseline in Clinically Significant Abnormalities for Vital Signs - Part C [ Time Frame: Up to approximately Day 29 ]
  20. Frequency of Clinically Significant Abnormalities in ECGs - Part C [ Time Frame: Up to approximately Day 29 ]
  21. Shift From Baseline in Clinically Significant Abnormalities for ECGs - Part C [ Time Frame: Up to approximately Day 29 ]
  22. Measurement of Changes in Platelet Counts After M254 Administration Compared to IVIg - Part C [ Time Frame: Baseline to approximately Day 29 ]
  23. Number and Severity of AEs - Part D [ Time Frame: Up to approximately Day 71 ]
  24. Frequency of Clinically Significant Abnormalities in Clinical Safety Laboratory Values - Part D [ Time Frame: Up to approximately Day 71 ]
  25. Shift From Baseline in Clinically Significant Abnormalities for Clinical Safety Laboratory Values - Part D [ Time Frame: Up to approximately Day 71 ]
  26. Frequency of Clinically Significant Abnormalities in Vital Signs - Part D [ Time Frame: Up to approximately Day 71 ]
  27. Shift From Baseline in Clinically Significant Abnormalities for Vital Signs - Part D [ Time Frame: Up to approximately Day 71 ]
  28. Frequency of Clinically Significant Abnormalities in ECGs - Part D [ Time Frame: Up to approximately Day 71 ]
  29. Shift From Baseline in Clinically Significant Abnormalities for ECGs - Part D [ Time Frame: Up to approximately Day 71 ]

Secondary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  2. Time to Maximum Plasma Concentration (Tmax) of M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  3. 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 ]
  4. 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 ]
  5. Volume of Distribution (Vd) of M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  6. Clearance of Drug (CL) M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  7. Mean Residence Time (MRT) of M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  8. Apparent Terminal-phase Half-life (t½) of M254 - Part A, B, and C [ Time Frame: Day 1 to Day 29 ]
  9. Cmax of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  10. Tmax of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  11. AUC(0 last) of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  12. AUC(0 ∞) of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  13. Vd of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  14. CL of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  15. MRT of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  16. t½ of M254 - Part D [ Time Frame: Day 1 to Day 71 ]
  17. Measurements of Changes in Platelet Counts After M254 Administration - Part D [ Time Frame: Baseline to approximately Day 71 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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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): NCT03866577


Contacts
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Contact: Momenta General Queries +1 617-491-9700 ClinicalTrialInfo@momentapharma.com

Locations
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United States, California
Momenta Investigational Site Not yet recruiting
Los Angeles, California, United States, 90089
United States, Florida
Momenta Investigational Site Recruiting
Miami Lakes, Florida, United States, 33176
Momenta Investigational Site Recruiting
Saint Petersburg, Florida, United States, 33701
United States, North Carolina
Momenta Investigational Site Not yet recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Momenta Investigational Site Recruiting
Cleveland, Ohio, United States, 44106
Momenta Investigational Site Not yet recruiting
Cleveland, Ohio, United States, 44195
Belgium
Momenta Investigational Site Recruiting
Yvoir, Namur, Belgium, 5530
France
Momenta Investigational Site Withdrawn
Le Mans Cedex 9, Pays De La Loire, France, 72037
Germany
Momenta Investigational Site Withdrawn
Aschaffenburg, Bayern, Germany, 63739
Hungary
Momenta Investigational Site Recruiting
Pecs, Baranya, Hungary, 7643
Momenta Investigational Site Recruiting
Debrecen, Hajdu-Bihar, Hungary, 4032
Momenta Investigational Site Recruiting
Kaposvar, Somogy, Hungary, 7400
Italy
Momenta Investigational Site Recruiting
San Giovanni Rotondo, Foggia, Italy, 71013
Momenta Investigational Site Recruiting
Meldola, Forli-Cesena, Italy, 47014
Momenta Investigational Site Recruiting
Reggio emilia, Reggio Nella Emilia, Italy, 42123
Momenta Investigational Site Recruiting
Ravenna, Italy, 48100
Momenta Investigational Site Recruiting
Roma, Italy, 86100
Netherlands
Momenta Investigational Site Recruiting
Groningen, Netherlands, 9713 GZ
Momenta Investigational Site Completed
Groningen, Netherlands, 9728 NZ
Poland
Momenta Investigational Site Recruiting
Wroclaw, Dolnoslaskie, Poland, 50-367
Momenta Investigational Site Recruiting
Lublin, Lubelskie, Poland, 20-001
Momenta Investigational Site Recruiting
Chorzow, Slaskie, Poland, 41-503
Momenta Investigational Site Recruiting
Poznan, Wielkopolskie, Poland, 61-828
Momenta Investigational Site Recruiting
Opole, Poland, 45-061
Spain
Momenta Investigational Site Recruiting
Barcelona, Spain, 08035
Momenta Investigational Site Recruiting
Burgos, Spain, 09006
Momenta Investigational Site Recruiting
Malaga, Spain, 29010
Momenta Investigational Site Recruiting
Murcia, Spain, 30008
Momenta Investigational Site Recruiting
Salamanca, Spain, 37007
Momenta Investigational Site Recruiting
Valencia, Spain, 46017
Sponsors and Collaborators
Momenta Pharmaceuticals, Inc.
Investigators
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Study Director: Momenta General Queries Momenta Pharmaceuticals, Inc.
More Information
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Responsible Party: Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03866577    
Other Study ID Numbers: MOM-M254-001
2018-003534-32 ( EudraCT Number )
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Momenta Pharmaceuticals, Inc.:
Immune thrombocytopenic purpura
Healthy subjects
M254
Intravenous immunoglobulin (IVIg)
Additional relevant MeSH terms:
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Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
 Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs