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Trial record 3 of 6 for:    M281

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.

Tracking Information
First Submitted Date  ICMJE September 18, 2019
First Posted Date  ICMJE October 8, 2019
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE February 25, 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2019)
Number of Participants That Attain Hemoglobin (Hgb) Response [ Time Frame: Up to Week 20 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
Official Title  ICMJE Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study
Brief Summary The main purpose of this study is to evaluate the efficacy of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Warm Autoimmune Hemolytic Anemia
Intervention  ICMJE
  • Drug: M281
    M281 injection administered as intravenous infusion
    Other Name: Nipocalimab
  • Drug: Placebo
    Placebo administered as intravenous infusion
Study Arms  ICMJE
  • Experimental: M281 administered every 4 weeks
    Intervention: Drug: M281
  • Experimental: M281 administered every 2 weeks
    Intervention: Drug: M281
  • Experimental: Placebo administered every 2 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 4, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Momenta General Queries +1 617-715-5094 ClinicalTrialInfo@momentapharma.com
Listed Location Countries  ICMJE Czechia,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Poland,   Spain,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04119050
Other Study ID Numbers  ICMJE MOM-M281-006
2019-000720-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Momenta Pharmaceuticals, Inc.
Study Sponsor  ICMJE Momenta Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Momenta General Queries Momenta Pharmaceuticals, Inc.
PRS Account Momenta Pharmaceuticals, Inc.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP