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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 : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.

Study Description
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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

Study Design
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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

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
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): NCT04119050


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

Locations
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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: NCT04119050    
Other Study ID Numbers: MOM-M281-006
2019-000720-17 ( EudraCT Number )
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
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