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Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia

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: NCT04119050
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.

Brief Summary:
The main purpose of this study is to evaluate the efficacy of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).

Condition or disease Intervention/treatment Phase
Warm Autoimmune Hemolytic Anemia Drug: M281 Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study
Actual Study Start Date : February 25, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: M281 administered every 4 weeks Drug: M281
M281 injection administered as intravenous infusion
Other Name: Nipocalimab

Experimental: M281 administered every 2 weeks Drug: M281
M281 injection administered as intravenous infusion
Other Name: Nipocalimab

Experimental: Placebo administered every 2 weeks Drug: Placebo
Placebo administered as intravenous infusion




Primary Outcome Measures :
  1. Number of Participants That Attain Hemoglobin (Hgb) Response [ Time Frame: Up to Week 20 ]

Secondary Outcome Measures :
  1. Percentage of Participants That Achieve any Reduction in the Daily Dose of Corticosteroids While Maintaining Hgb Response [ Time Frame: Baseline (Day 1, Week 0) through 24 weeks ]
  2. Percent Reduction in Daily Corticosteroid Dose [ Time Frame: Baseline (Day 1, Week 0) through 24 weeks ]
  3. Hgb Range at Steady State [ Time Frame: Baseline (Day 1, Week 0) through 24 weeks ]
    It will be estimated using a model-based longitudinal analysis of Hgb/hemolysis parameters in relationship to IgG level and dose regimen.

  4. Percentage of Participants With Hgb Within the Normal Range for Their Gender [ Time Frame: Baseline (Day 1, Week 0) through Week 16 and Week 24 ]
  5. Change From Baseline in Hgb [ Time Frame: Baseline (Day 1, Week 0) through Week 16 and Week 24 ]
  6. Percentage of Participants who Experience at Least a 2 g/dL Increase in Hgb From Baseline and Normalization of Lactate Dehydrogenase and Haptoglobin [ Time Frame: Baseline (Day 1, Week 0) through Week 24 ]
  7. Mean Time During Which the Primary Endpoint is Maintained [ Time Frame: Baseline (Day 1, Week 0) through Week 24 ]
  8. Change From Baseline in the Total Score From the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale [ Time Frame: Baseline (Day 1, Week 0) through Week 24 ]


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:   No
Criteria

Inclusion criteria:

  • Male or female ≥18 years of age
  • Participants diagnosed with primary or secondary warm autoimmune hemolytic anemia (wAIHA)
  • Participants must be able to understand and voluntarily provide written informed consent to participate in the study and comply with all study procedures

Exclusion criteria:

  • Participants must not be pregnant or breastfeeding
  • Participants must not have other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate

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): NCT04119050


Contacts
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Contact: Momenta General Queries +1 617-715-5094 ClinicalTrialInfo@momentapharma.com

Locations
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United States, California
Momenta Investigational Site Recruiting
Los Angeles, California, United States, 90033
Momenta Investigational Site Recruiting
Riverside, California, United States, 92501
Momenta Investigational Site Recruiting
Whittier, California, United States, 90603
United States, Florida
Momenta Investigational Site Recruiting
Jacksonville, Florida, United States, 32207
Momenta Investigational Site Recruiting
Miami, Florida, United States, 33014
United States, Illinois
Momenta Investigational Site Recruiting
Chicago, Illinois, United States, 60612
United States, Michigan
Momenta Investigational Site Suspended
Novi, Michigan, United States, 48377
United States, New York
Momenta Investigational Site Recruiting
Bronx, New York, United States, 10467
United States, North Carolina
Momenta Investigational Site Recruiting
Greenville, North Carolina, United States, 27834
United States, Ohio
Momenta Investigational Site Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Momenta Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Utah
Momenta Investigational Site Recruiting
Salt Lake City, Utah, United States, 84132
United States, Washington
Momenta Investigational Site Recruiting
Tacoma, Washington, United States, 98405
United States, Wisconsin
Momenta Investigational Site Suspended
Madison, Wisconsin, United States, 53705
Germany
Momenta Investigational Site Recruiting
Berlin, Germany, 10707
Momenta Investigational Site Recruiting
Munchen, Germany, 80634
Italy
Momenta Investigational Site Recruiting
Novara, Italy, 28100
Poland
Momenta Investgational Site Recruiting
Opole, Opolskie, Poland, 46-020
Momenta Investigational Site Recruiting
Białystok, Poland, 15-732
Spain
Momenta Investigational Site Recruiting
Palma de Mallorca, Baleares, Spain, 07198
Momenta Investigational Site Recruiting
Cordoba, Córdoba, Spain, 14004
Momenta Investigational Site #1 Recruiting
Málaga, Malaga, Spain, 29010
Momenta Investigational Site Recruiting
València, Valencia, Spain, 46026
Momenta Investigational Site Recruiting
Madrid, Spain, 28031
Momenta Investigational Site Recruiting
Madrid, Spain, 28034
Momenta Investigational Site Suspended
Madrid, Spain, 28041
Momenta Investigational Site Suspended
Madrid, Spain, 28046
Momenta Investigational Site Suspended
Madrid, Spain, 28223
Momenta Investigational Site #2 Suspended
Malaga, Spain, 29010
Momenta Investigational Site Recruiting
Sevilla, Spain, 41013
Momenta Investigational Site Recruiting
Zaragoza, Spain, 50009
Ukraine
Momenta Investigational Site Recruiting
Cherkasy, Ukraine, 18009
Momenta Investigational Site Recruiting
Dnipro, Ukraine, 49027
Momenta Investigational Site Recruiting
Kyiv, Ukraine, 04112
Momenta Investigational Site Suspended
Ternopil, Ukraine, 46002
Sponsors and Collaborators
Momenta Pharmaceuticals, Inc.
Investigators
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Study Director: Momenta General Queries Momenta Pharmaceuticals, Inc.
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Responsible Party: Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04119050    
Other Study ID Numbers: MOM-M281-006
2019-000720-17 ( EudraCT Number )
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 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.:
Warm Autoimmune Hemolytic Anemia
M281
wAIHA
Nipocalimab
Additional relevant MeSH terms:
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Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hemolysis
Hematologic Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases