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Monoclonal Antibodies

M281 for Autoimmune Hemolytic Anemia

Phase 2 & 3

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants greater than or equal to (>=)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 participants are not eligible)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 1, week 0) and at week 24

Awards & highlights

Study Summary

This trial will study whether M281 is effective and safe in people with wAIHA.

Who is the study for?

Adults over 18 with warm autoimmune hemolytic anemia (wAIHA) who are currently or previously treated for wAIHA can join. Those with cold antibody AIHA, mixed type AIHA, or paroxysmal cold hemoglobinuria cannot participate. Pregnant or breastfeeding individuals and those with other significant health issues are also excluded.Check my eligibility

What is being tested?

The trial is testing the effectiveness and safety of a medication called M281 in adults with wAIHA compared to a placebo. Participants will either receive M281 or a placebo to determine if M281 improves their condition.See study design

What are the potential side effects?

While specific side effects of M281 aren't listed here, common side effects in trials may include reactions at the injection site, headaches, nausea, fatigue, and potential immune system responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been treated for warm autoimmune hemolytic anemia for over 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1, week 0) and at week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1, week 0) and at week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1, week 0) and at week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Achieving Durable Response of Improvement in Hemoglobin (Hgb)

Secondary outcome measures

Absolute Change from Baseline in Average Daily Dose of Prednisone or Equivalent

Change From Baseline in EuroQol 5-dimension 5-level ( EQ-5D-5L) Scale Score

Change From Baseline in Hemolytic Marker - Haptoglobin

+19 more

Side effects data

From 2020 Phase 2 trial • 68 Patients • NCT03772587

21%

Rash

14%

Urinary Tract Infection

14%

Diarrhoea

14%

Oedema Peripheral

14%

Nasopharyngitis

Malaise

Asymptomatic Bacteriuria

Peripheral Swelling

Musculoskeletal Chest Pain

Vision Blurred

Vomiting

Glucose Tolerance Impaired

Eyelid Ptosis

Headache

Lymphocyte Count Decreased

Brachiocephalic Vein Thrombosis

Rash Erythematous

Herpes Zoster

Hypothyroidism

Skin Swelling

Thrombocytopenia

Abdominal Pain Upper

Nausea

Vessel Puncture Site Pruritus

Vessel Puncture Site Swelling

Cellulitis

Conjunctivitis

Blood Pressure Increased

Neutrophil Percentage Increased

Hypophosphataemia

Back Pain

Muscle Spasms

Muscle Twitching

Cough

Dysphonia

Erythema

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Nipocalimab 60 mg/kg (Q2W)

Placebo

Nipocalimab 5 Milligrams/Kilogram (mg/kg)

Nipocalimab 30 mg/kg

Nipocalimab 60 mg/kg

Trial Design

5Treatment groups

Experimental Treatment

Group I: Placebo administered every 2 weeks (double-blind period)Experimental Treatment1 Intervention

Participants will receive M281 matching placebo administered every 2 weeks during the 24 weeks double-blind period.

Group II: M281 administered every 4 weeks (open-label extension period)Experimental Treatment1 Intervention

Participants will receive M281 administered every 4 weeks during the 144 weeks open-label extension period.

Group III: M281 administered every 4 weeks (double-blind period)Experimental Treatment2 Interventions

Participants will receive M281 administered every 4 weeks alternating with placebo every 4 weeks during the 24 weeks double-blind period.

Group IV: M281 administered every 2 weeks (open-label extension period)Experimental Treatment1 Intervention

Participants will receive M281 administered every 2 weeks during the 144 weeks open-label extension period.

Group V: M281 administered every 2 weeks (double-blind period)Experimental Treatment1 Intervention

Participants will receive M281 administered every 2 weeks during the 24 weeks double-blind period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

M281

2016

Completed Phase 2

~120

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,197 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,794 Total Patients Enrolled

Media Library

M281 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04119050 — Phase 2 & 3

Autoimmune Hemolytic Anemia Research Study Groups: M281 administered every 4 weeks (double-blind period), M281 administered every 2 weeks (open-label extension period), M281 administered every 4 weeks (open-label extension period), M281 administered every 2 weeks (double-blind period), Placebo administered every 2 weeks (double-blind period)

Autoimmune Hemolytic Anemia Clinical Trial 2023: M281 Highlights & Side Effects. Trial Name: NCT04119050 — Phase 2 & 3

M281 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04119050 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different sites can people participate in this clinical trial?

"Currently, patients are being accepted at Heme Onc Call in Cooper City, Florida, University of Florida in Gainesville, Washington, University of South Florida Health in Tacoma, Michigan and 20 other locations."

Answered by AI

Are participants still being recruited for this research project?

"This clinical trial, which was originally posted on 2019-10-24 and was last edited on 2022-10-25, is currently looking for candidates, as reported on clinicaltrials.gov."

Answered by AI

What is the sample size for this clinical research?

"One hundred and eleven research participants are needed for this project. These individuals must meet the pre-specified inclusion criteria. The trial is running out of multiple sites, like Heme Onc Call in Cooper City, Florida and University of Florida in Gainesville, Washington."

Answered by AI

Is this research novel in any way?

"Right now, 5 different clinical trials are ongoing for M281 in 103 cities 33 countries. The first study took place in 2019. That particular 111-person Phase 2 & 3 study was sponsored by Janssen Research & Development, LLC and completed drug approval in 2019. Since then, 18242 more studies have been conducted."

Answered by AI

Could you please provide a list of other experiments that have used M281?

"At this time, there are a total of 5 clinical trials underway that are investigating the efficacy of M281. Two of these trials are in Phase 3. Most of the trials for M281 are located in Petaling Jaya, California, but there are a total of 628 trial sites across the globe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04119050.

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