Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male or female ≥18 years of age - Have been diagnosed with warm autoimmune hemolytic anemia (wAIHA) for at least 3 months, and are currently receiving treatment for wAIHA or have previously received treatment for wAIHA (treatment-naive patients are not eligible) - 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 - Have cold antibody autoimmune hemolytic anemia (AIHA), cold agglutinin syndrome, mixed type (that is, warm and cold) AIHA, or paroxysmal cold hemoglobinuria

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
M281 administered every 4 weeks (double-blind period)
Participants will receive M281 administered every 4 weeks alternating with placebo every 4 weeks during the 24 weeks double-blind period.
  • Drug: M281
    M281 injection administered as intravenous infusion
    Other names:
    • Nipocalimab, JNJ-80202135
  • Drug: Placebo
    Placebo administered as intravenous infusion
Experimental
M281 administered every 2 weeks (double-blind period)
Participants will receive M281 administered every 2 weeks during the 24 weeks double-blind period.
  • Drug: M281
    M281 injection administered as intravenous infusion
    Other names:
    • Nipocalimab, JNJ-80202135
Experimental
Placebo administered every 2 weeks (double-blind period)
Participants will receive M281 matching placebo administered every 2 weeks during the 24 weeks double-blind period.
  • Drug: Placebo
    Placebo administered as intravenous infusion
Experimental
M281 administered every 4 weeks (open-label extension period)
Participants will receive M281 administered every 4 weeks during the 28 weeks open-label extension period.
  • Drug: M281
    M281 injection administered as intravenous infusion
    Other names:
    • Nipocalimab, JNJ-80202135
Experimental
M281 administered every 2 weeks (open-label extension period)
Participants will receive M281 administered every 2 weeks during the 28 weeks open-label extension period.
  • Drug: M281
    M281 injection administered as intravenous infusion
    Other names:
    • Nipocalimab, JNJ-80202135

Recruiting Locations

Tulane University School of Medicine
New Orleans, Louisiana 70112

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
JNJ.CT@sylogent.com

Detailed Description

The study consists of a 24-week double-blind, placebo control period, a 28-week open-label extension period and an 8-week follow-up period. Eligible participants will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.