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Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients

NCT ID: NCT03866577

Last Updated: 2025-05-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-21

Study Completion Date

2021-06-09

Brief Summary

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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.

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Detailed Description

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The Part A of the study is currently not accepting healthy volunteers as the recruitment for the part A has completed.

Conditions

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Immune Thrombocytopenic Purpura (ITP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Part A: Double (Subject, Investigator);

Part B, C, and D: Open Label Investigations

Study Groups

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Part A

Healthy volunteers will receive a single ascending dose of M254 or placebo

Group Type EXPERIMENTAL

Biological: M254

Intervention Type BIOLOGICAL

M254 administered as intravenous infusion

Placebo

Intervention Type DRUG

Placebo administered as intravenous infusion

Part B

Immune thrombocytopenic purpura (ITP) patients will receive a single ascending dose of M254 followed by IVIg

Group Type EXPERIMENTAL

Biological: M254

Intervention Type BIOLOGICAL

M254 administered as intravenous infusion

Intravenous immunoglobulin (IVIg)

Intervention Type BIOLOGICAL

IVIg administered as intravenous infusion

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

Group Type EXPERIMENTAL

Biological: M254

Intervention Type BIOLOGICAL

M254 administered as intravenous infusion

Intravenous immunoglobulin (IVIg)

Intervention Type BIOLOGICAL

IVIg administered as intravenous infusion

Part D

ITP patients will receive repeated doses of M254

Group Type EXPERIMENTAL

Biological: M254

Intervention Type BIOLOGICAL

M254 administered as intravenous infusion

Interventions

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Biological: M254

M254 administered as intravenous infusion

Intervention Type BIOLOGICAL

Placebo

Placebo administered as intravenous infusion

Intervention Type DRUG

Intravenous immunoglobulin (IVIg)

IVIg administered as intravenous infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Momenta Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Momenta General Queries

Role: STUDY_DIRECTOR

Momenta Pharmaceuticals, Inc.

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Oncology Institute of Hope and Innovation

Whittier, California, United States

Site Status

Lakes Research

Miami Lakes, Florida, United States

Site Status

University of South Florida

St. Petersburg, Florida, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Taussig Cancer Insititute Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Ucl de Mont-Godinne

Yvoir, , Belgium

Site Status

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Site Status

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, , Hungary

Site Status

Pecsi Tudomanyegyetem

Pécs, , Hungary

Site Status

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, , Italy

Site Status

Azienda Unita Sanitaria Locale di Ravenna

Ravenna, , Italy

Site Status

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, , Italy

Site Status

Policlinico Universitario Agostino Gemelli

Roma, , Italy

Site Status

Ospedale 'Casa Sollievo della Sofferenza' - U.O. Ematologia-

San Giovanni Rotondo, , Italy

Site Status

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Site Status

PRA Health Sciences

Groningen, , Netherlands

Site Status

Silesian Healthy Blood Clinic

Chorzów, , Poland

Site Status

Samodzielny Publiczny Szpital Kliniczny Nr 1

Lublin, , Poland

Site Status

Szpital Wojewodzki w Opolu

Opole, , Poland

Site Status

Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSW w Poznaniu im prof Ludwika Bierkowskiego

Poznan, , Poland

Site Status

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, , Poland

Site Status

Hosp Univ Vall D Hebron

Barcelona, , Spain

Site Status

Hosp. Univ. de Burgos

Burgos, , Spain

Site Status

Hosp. Regional. Carlos Haya

Málaga, , Spain

Site Status

Hosp. Gral. Univ. J.M. Morales Meseguer

Murcia, , Spain

Site Status

Hosp Clinico Univ de Salamanca

Salamanca, , Spain

Site Status

Hosp. Univ. Dr. Peset

Valencia, , Spain

Site Status

Countries

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United States Belgium Hungary Italy Netherlands Poland Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018-003534-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MOM-M254-001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108979

Identifier Type: -

Identifier Source: org_study_id

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