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

Overview

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

Full Title of Study: “Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2021

Interventions

  • Drug: M281
    • M281 injection administered as intravenous infusion
  • Drug: Placebo
    • Placebo administered as intravenous infusion

Arms, Groups and Cohorts

  • Experimental: M281 administered every 4 weeks
  • Experimental: M281 administered every 2 weeks
  • Experimental: Placebo administered every 2 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants That Attain Hemoglobin (Hgb) Response
    • Time Frame: Up to Week 20

Secondary Measures

  • 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

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Momenta Pharmaceuticals, Inc.
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Momenta General Queries, Study Director, Momenta Pharmaceuticals, Inc.
    • Overall Contact(s)
      • Momenta General Queries, +1 617-715-5094, ClinicalTrialInfo@momentapharma.com

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.