Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
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ClinicalTrials.gov Identifier: NCT04119050 |
Recruitment Status :
Recruiting
First Posted : October 8, 2019
Last Update Posted : January 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Warm Autoimmune Hemolytic Anemia | Drug: M281 Drug: Placebo | Phase 2 Phase 3 |
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 |

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 |
- Number of Participants That Attain Hemoglobin (Hgb) Response [ Time Frame: Up to Week 20 ]
- 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 ]
- Percent Reduction in Daily Corticosteroid Dose [ Time Frame: Baseline (Day 1, Week 0) through 24 weeks ]
- 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.
- 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 ]
- Change From Baseline in Hgb [ Time Frame: Baseline (Day 1, Week 0) through Week 16 and Week 24 ]
- 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 ]
- Mean Time During Which the Primary Endpoint is Maintained [ Time Frame: Baseline (Day 1, Week 0) through Week 24 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | Momenta General Queries | Momenta Pharmaceuticals, Inc. |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Warm Autoimmune Hemolytic Anemia M281 wAIHA Nipocalimab |
Anemia Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Hemolysis |
Hematologic Diseases Pathologic Processes Autoimmune Diseases Immune System Diseases |