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

Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension

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

Study Overview

• Status: Recruiting
• Conditions: Warm Autoimmune Hemolytic Anemia
• Intervention / Treatment: Drug: M281; Drug: Placebo

Detailed Description

The study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. 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.

• Study Type: Interventional
• Enrollment (Estimated): 111
• Phase: Phase 2; Phase 3

Expanded Access

Temporarily not available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Brazil
  • Botucatu, Brazil, 18610-070
    • Completed
    • Hospital das Clínicas da Faculdade de Medicina de Botucatu
  • Brasilia, Brazil, 71681-603
    • Recruiting
    • Impar Servicos Hospitalares S/A - Hospital Brasilia
  • Campinas, Brazil, 13083-887
    • Recruiting
    • CTO Centro de Tratamento Oncologico Unidade Belem
  • Goiânia, Brazil, 74605-020
    • Recruiting
    • Hospital das Clínicas da Universidade Federal de Goiás
  • Niterói, Brazil, 24020-096
    • Recruiting
    • Complexo Hospitalar de Niteroi
  • Recife, Brazil, 50040-000
    • Recruiting
    • Oncoclinicas - Unidade OC Oncoclinicas Multihemo Ilha do Leite
  • Salvador, Brazil, 40170-110
    • Completed
    • Núcleo de Oncologia da Bahia
  • Salvador, Brazil, 41253-190
    • Completed
    • Hospital Sao Rafael
  • Santo Andre, Brazil, 09060-870
    • Recruiting
    • Hospital Santa Marcelina
  • Santo Andre, Brazil, 09060 650
    • Completed
    • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
  • Sao Jose Do Rio Preto, Brazil, 15090 000
    • Completed
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
  • Sao Paulo, Brazil, 05403 000
    • Recruiting
    • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • Sao Paulo, Brazil, 01308-050
    • Recruiting
    • Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
  • Sao Paulo, Brazil, 04024-002
    • Completed
    • Universidade Federal de Sao Paulo
• China
  • Beijing Shi, China, 100020
    • Recruiting
    • Beijing Chao-Yang Hospital, Capital Medical University
  • Beijing Shi, China, 100044
    • Completed
    • Peking University People s Hospital
  • Changchun, China, 130021
    • Completed
    • The First Hospital of Jilin University
  • Chengdu, China, 610041
    • Recruiting
    • West China Hospital of Sichuan University
  • Guangzhou Shi, China, 510180
    • Recruiting
    • Guangzhou First Municipal People's Hospital
  • Haikou, China, 570311
    • Completed
    • Hainan General Hospital
  • Hangzhou, China, 310003
    • Recruiting
    • First Affiliated Hospital Medical School of Zhejiang University
  • Lanzhou, China, 730030
    • Completed
    • Lanzhou University Second Hospital
  • Nanjing, China, 210029
    • Recruiting
    • Jiangsu Province Hospital
  • Nantong, China, 226001
    • Recruiting
    • Affiliated hospital of Nantong University
  • ShangHai, China, 200032
    • Completed
    • Shanghai Zhongshan Hospital
  • Shanghai, China, 200040
    • Recruiting
    • Huashan Hospital Affiliated to Fudan University
  • Suzhou, China, 215006
    • Recruiting
    • The First Affiliated Hospital Of Soochow University
  • Tianjin, China, 300052
    • Recruiting
    • Tianjin Medical University General Hospital
  • Wuhan, China, 430022
    • Recruiting
    • Union Hospital Tongji Medical College of Huazhong University of Science and Technology
  • Xi'An, China, 710061
    • Recruiting
    • The First Affiliated Hospital of Xian Jiaotong University
• Czechia
  • Brno, Czechia, 625 00
    • Recruiting
    • Fakultni nemocnice Brno
  • Praha 10, Czechia, 100 34
    • Completed
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha 2, Czechia, 128 00
    • Completed
    • Ustav hematologie a krevni transfuze
• Egypt
  • Alexandria, Egypt, 21131
    • Recruiting
    • Alexandria University Hospital
  • Cairo, Egypt, 11211
    • Recruiting
    • Cairo University
  • Cairo, Egypt, 1181
    • Recruiting
    • Ain Shams University Hospital
  • Cairo, Egypt, 11976
    • Recruiting
    • National Cancer Institute
  • Cairo, Egypt, 12655
    • Completed
    • Nasser institute Hospital
  • Mansoura, Egypt, 35516
    • Completed
    • Mansoura University Hospital
• France
  • Brest Cedex 2, France, 29609
    • Completed
    • ICH Hopital A. Morvan
  • Dijon, France, 21000
    • Recruiting
    • CHU Dijon Bourgogne
  • La Tronche, France, 38700
    • Recruiting
    • CHU Grenoble
  • Nantes, France, 44093
    • Recruiting
    • CHU NANTES - Hôtel Dieu
  • Poitiers, France, 86021
    • Recruiting
    • CHU de Poitiers
  • Rennes, France, 35200
    • Recruiting
    • CHRU Hopital Sud
• Germany
  • Berlin, Germany, 10707
    • Recruiting
    • Onkologische Schwerpunktpraxis
  • Essen, Germany, 45147
    • Recruiting
    • Universitätsklinikum Essen
  • München, Germany, 80634
    • Completed
    • Rotkreuzklinikum München
• Greece
  • Athens, Greece, 11527
    • Completed
    • Laiko General Hospital of Athens
  • Athens, Greece, 115 27
    • Completed
    • General Hospital of Athens 'G. Gennimatas'
  • Athens, Greece, 12462
    • Completed
    • Attikon University General Hospital of Attica
  • Larissa, Greece, 41110
    • Completed
    • University Hospital of Larissa
  • Patras, Greece, 26504
    • Completed
    • University General Hospital of Rio Patras
  • Thessaloniki, Greece, 54636
    • Completed
    • University General Hospital of Thessaloniki
• Hungary
  • Budapest, Hungary, 1083
    • Recruiting
    • Semmelweis Egyetem
  • Budapest, Hungary, 1097
    • Recruiting
    • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
  • Debrecen, Hungary, 4032
    • Recruiting
    • Debreceni Egyetem Klinikai Kozpont
  • Gyõr, Hungary, 9023
    • Recruiting
    • Petz Aladar Megyei Oktato Korhaz
  • Kaposvar, Hungary, 7400
    • Completed
    • Somogy Megyei Kaposi Mór Oktató Kórház
• Israel
  • Afula, Israel, 1834111
    • Recruiting
    • Ha'Emek Medical Center
  • Beer Sheva, Israel, 8410101
    • Recruiting
    • Soroka Medical Center
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 9112001
    • Completed
    • Hadassah Medical Center
  • Kiryat Tzanz, Israel, 4244916
    • Recruiting
    • Hospital Sanz Medical Center Laniado Hospital
  • Petach Tikvah, Israel, 49100
    • Recruiting
    • Rabin Medical Center, Beilinson Hospital
  • Tel Aviv, Israel, 64239
    • Recruiting
    • Tel Aviv Sourasky Medical Center
• Italy
  • Ascoli Piceno, Italy, 63100
    • Completed
    • PO C e G Mazzoni AST Ascoli Piceno
  • Brescia, Italy, 25123
    • Completed
    • ASST Spedali Civili di Brescia
  • Catania, Italy, 95125
    • Recruiting
    • AOU Policlinico G Rodolico S Marco
  • Catania, Italy, 95122
    • Completed
    • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
  • Firenze, Italy, 50134
    • Completed
    • Azienda Ospedaliero Universitaria Careggi
  • Milan, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Monza, Italy, 20900
    • Completed
    • Fondazione IRCCS San Gerardo dei Tintori
  • Novara, Italy, 28100
    • Recruiting
    • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
  • Roma, Italy, 00161
    • Completed
    • Umberto I Policlinico di Roma
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A Gemelli IRCCS
  • Torino, Italy, 10126
    • Completed
    • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
  • Vicenza, Italy, 36100
    • Completed
    • Azienda Ulss 8 Berica- Ospedale Di Vicenza
• Japan
  • Fukushima, Japan, 960 1295
    • Completed
    • Fukushima Medical University Hospital
  • Iruma-gun, Japan, 350-0495
    • Recruiting
    • Saitama Medical University Hospital
  • Kanagawa, Japan, 216 8511
    • Completed
    • St Marianna University Hospital
  • Kitakyusyu-Shi, Japan, 806-8501
    • Completed
    • Japan Community Health care Organization Kyushu Hospital
  • Kofu-Shi, Japan, 400-0027
    • Recruiting
    • Yamanashi Prefectural Central Hospital
  • Ogaki, Japan, 503-8502
    • Completed
    • Ogaki Municipal Hospital
  • Sapporo, Japan, 060-8543
    • Completed
    • Sapporo Medical University Hospital
  • Sendai, Japan, 980 8574
    • Recruiting
    • Tohoku University Hospital
  • Suita, Japan, 565 0871
    • Recruiting
    • Osaka University Hospital
  • Toyama, Japan, 930 8550
    • Completed
    • Toyama Prefectural Central Hospital
  • Wakayama, Japan, 641 8510
    • Recruiting
    • Wakayama Medical University Hospital
  • Yonago, Japan, 683-8504
    • Recruiting
    • Tottori University Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 41944
    • Completed
    • Kyungpook National University Hospital
  • Daejeon, Korea, Republic of, 35015
    • Completed
    • Chungnam National University Hospital
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 138-040
    • Recruiting
    • Asan Medical Center
• Malaysia
  • Ampang, Malaysia, 68000
    • Recruiting
    • Hospital Ampang
  • Johor Bahru, Malaysia, 80100
    • Completed
    • Hospital Sultanah Aminah
  • Kota Kinabalu, Malaysia, 88200
    • Completed
    • Hospital Queen Elizabeth
  • Kuala Lumpur, Malaysia, 50603
    • Completed
    • University Malaya Medical Centre
  • Kuantan, Malaysia, 25100
    • Completed
    • Hospital Tengku Ampuan Afzan
  • Kuching, Malaysia, 93586
    • Recruiting
    • Hospital Umum Sarawak
  • Petaling Jaya, Malaysia, 47500
    • Completed
    • Sunway Medical Centre
• Netherlands
  • Amsterdam, Netherlands, 1081 HV Amsterdam
    • Recruiting
    • Amsterdam Universitair Medische Centra Locatie Vrije Universiteit Medisch Centrum
  • Amsterdam, Netherlands, 1105 AZ
    • Completed
    • Academic Medical Centre Amsterdam
  • Maastricht, Netherlands, 6229 HX
    • Completed
    • Maastricht Universitair Medisch Centrum
• Poland
  • Bialystok, Poland, 15-732
    • Recruiting
    • Interhem
  • Gdansk, Poland, 80-214
    • Completed
    • Klinika Hematologii i Transplantologii, UCK
  • Katowice, Poland, 40 519
    • Recruiting
    • Pratia Onkologia Katowice
  • Lodz, Poland, 93 510
    • Recruiting
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
  • Opole, Poland, 45-061
    • Completed
    • Szpital Wojewodzki w Opolu
  • Warszawa, Poland, 02-172
    • Recruiting
    • MTZ Clinical Research Powered by Pratia
• Spain
  • Alcalá de Henares, Spain, 28805
    • Recruiting
    • Hosp. Univ. Principe de Asturias
  • Badalona, Spain, 08916
    • Recruiting
    • Hosp. Univ. Germans Trias I Pujol
  • Barcelona, Spain, 08036
    • Recruiting
    • Hosp Clinic de Barcelona
  • Burgos, Spain, 09006
    • Completed
    • Complejo Asistencial Univ. de Burgos
  • Córdoba, Spain, 14004
    • Recruiting
    • Hosp Reina Sofia
  • Las Palmas de Gran Canaria, Spain, 35010
    • Completed
    • Hosp. Univ. de Gran Canaria Dr. Negrin
  • Madrid, Spain, 28034
    • Recruiting
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28041
    • Recruiting
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28046
    • Recruiting
    • Hosp. Univ. La Paz
  • Madrid, Spain, 28031
    • Recruiting
    • Hosp. Univ. Infanta Leonor
  • Madrid, Spain, 28040
    • Completed
    • Hospital Clinico San Carlos
  • Majadahonda, Spain, 28222
    • Recruiting
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Málaga, Spain, 29010
    • Recruiting
    • Hosp. Virgen Del Rocio
  • Málaga, Spain, 29010
    • Completed
    • Hosp Regional Univ de Malaga
  • Málaga, Spain, 29010
    • Completed
    • Hosp Virgen de La Victoria
  • Palma de Mallorca, Spain, 07198
    • Completed
    • Hosp. Son Llatzer
  • Pamplona, Spain, 31008
    • Recruiting
    • Clinica Univ. de Navarra
  • Pozuelo de Alarcon, Spain, 28223
    • Recruiting
    • Hosp. Quiron Madrid Pozuelo
  • Valencia, Spain, 46026
    • Recruiting
    • Hosp. Univ. I Politecni La Fe
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hosp. Univ. Miguel Servet
• Ukraine
  • Cherkassy, Ukraine, 18009
    • Completed
    • Cherkassy Regional Oncology Dispensary, Department of Hematology
  • Dnipro, Ukraine, 49102
    • Completed
    • Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
  • Kyiv, Ukraine, 02091
    • Terminated
    • Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
  • Kyiv, Ukraine, 04112
    • Terminated
    • Kyiv City Clinical Hospital #9, Department of infectious diseases
  • Ternopil, Ukraine, 46002
    • Terminated
    • Ternopil University Hospital of Ternopil Regional Council
• United Kingdom
  • Leeds, United Kingdom, LF9 7TF
    • Recruiting
    • Leeds Teaching Hospitals NHS Trust
  • Liverpool, United Kingdom, L7 8XP
    • Recruiting
    • Liverpool University Hospitals NHS Foundation Trust
  • London, United Kingdom, E1 2ES
    • Recruiting
    • Barts Health Nhs Trust
  • Oxford, United Kingdom, OX3 7LE
    • Recruiting
    • Oxford University Hospitals NHS Foundation Trust
  • Plymouth, United Kingdom, PL6 8DH
    • Recruiting
    • University Hospitals Plymouth NHS Trust
  • Southampton, United Kingdom, SO166YD
    • Recruiting
    • University Hospital Southampton NHS Foundation Trust
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Completed
      • MemorialCare Medical Group
    • Los Angeles, California, United States, 90033
      • Completed
      • University of Southern California
    • Riverside, California, United States, 92501
      • Completed
      • Compassionate Cancer Care
    • Whittier, California, United States, 90603
      • Completed
      • American Institute of Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Completed
      • University of Colorado Anschutz Medical Campus
  • Florida
    • Cooper City, Florida, United States, 33024
      • Completed
      • GNP Research
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida College of Medicine
    • Jacksonville, Florida, United States, 32204
      • Completed
      • 21st Century Oncology
    • Miami Lakes, Florida, United States, 33014
      • Completed
      • Lakes Research
    • Orlando, Florida, United States, 32804
      • Completed
      • AdventHealth Cancer Institute
    • Saint Petersburg, Florida, United States, 33701
      • Completed
      • Children's Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Completed
      • Rush University Medical Center
  • Kansas
    • Merriam, Kansas, United States, 66204
      • Completed
      • Alliance for Multispeciality Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Completed
      • Tulane University School of Medicine
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Completed
      • Henry Ford Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Completed
      • Research Medical Center
  • New York
    • Lake Success, New York, United States, 11042
      • Completed
      • Monter Cancer Center
    • Lake Success, New York, United States, 11042
      • Completed
      • Montefiore Medical Center
    • Nyack, New York, United States, 10960
      • Recruiting
      • Hematology Oncology Associates of Rockland
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
    • Greenville, North Carolina, United States, 27834
      • Recruiting
      • East Carolina University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Completed
      • Taussig Cancer Insititute Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Completed
      • The Ohio State University- James Cancer Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Completed
      • Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15224
      • Completed
      • West Penn Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Completed
      • University of Utah
  • Washington
    • Tacoma, Washington, United States, 98405
      • Completed
      • Northwest Medical Specialists
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Completed
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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)
• 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 been diagnosed with cold antibody autoimmune hemolytic anemia (AIHA), cold agglutinin syndrome, mixed type (that is, warm and cold) AIHA, or paroxysmal cold hemoglobinuria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 144 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 144 weeks open-label extension period.	Drug: M281; M281 injection administered as intravenous infusion; Other Names: Nipocalimab, JNJ-80202135

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Achieving Durable Response of Improvement in Hemoglobin (Hgb)	Up to Week 20 of the double-blind period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Total Score From the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale at the Time of Durable Response	The FACIT-Fatigue is a self-administered 13-item questionnaire that assess patient-reported fatigue associated with chronic illness therapy. It assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement.	Baseline (Day 1, Week 0) through Week 24
Change From Baseline in the Total Score From the FACIT-Fatigue Scale at the end of the Double-blind Period (Week 24)	The FACIT-Fatigue is a self-administered 13-item questionnaire that assess patient-reported fatigue associated with chronic illness therapy. It assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement.	Baseline (Day 1, Week 0) through Week 24 of the double-blind period
Change from Baseline in Average Daily Dose of Prednisone or Equivalent	Change from baseline in average daily dose of prednisone or equivalent at week 24 among participants on prednisone or equivalent at baseline will be reported.	Baseline (Day 1, Week 0) and at Week 24
Number of Participants That Simultaneously Attain Normal Lactate Dehydrogenase, Haptoglobin, and Indirect Bilirubin Levels at a Minimum of 3 Consecutive Visits After Baseline		Baseline (Day 1, Week 0) through Week 24
Percentage of Participants who Experience at Least a 2 g/dL Increase in Hgb From Baseline and Normalization of Lactate Dehydrogenase, Haptoglobin, and Indirect Bilirubin at any Time During the Study		Baseline (Day 1, Week 0) through Week 24
Percentage of Participants who Experience at Least a 2 g/dL Increase in Hgb From Baseline and Normalization of Lactate Dehydrogenase, Haptoglobin, and Indirect Bilirubin at 3 Consecutive Visits		Baseline (Day 1, Week 0) through Week 24
Percentage of Participants who Achieve the Durable Response in Improvement of Hgb During the Double-blind Period and Maintain that Response for Up to 24 Weeks, Without the Need of Rescue Therapy	Percentage of participants who achieve the durable response in improvement of Hgb during the double-blind period and maintain that response for up to 24 weeks, without the need of rescue therapy will be reported.	Up to 24 weeks
Change From Baseline in Hgb Concentration		Baseline (Day 1, Week 0) through Week 24
Change From Baseline in Reticulocyte Count		Baseline (Day 1, Week 0) through Week 24
Change From Baseline in Hemolytic Marker - Lactate Dehydrogenase		Baseline (Day 1, Week 0) through Week 24
Change From Baseline in Hemolytic Marker - Haptoglobin		Baseline (Day 1, Week 0) through Week 24
Change From Baseline in Hemolytic Marker - Indirect Bilirubin		Baseline (Day 1, Week 0) through Week 24
Time to Hgb Response		Baseline (Day 1, Week 0) through Week 24
Mean Time During Which the Primary Endpoint is Maintained		Baseline (Day 1, Week 0) through Week 24
Change From Baseline in the Total Score, Item Scores, and Impact and Experience Domains From the FACIT-Fatigue Scale	The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement.	Baseline (Day 1, Week 0) through Week 24 of the double-blind period
Change From Baseline in EuroQol 5-dimension 5-level ( EQ-5D-5L) Scale Score	The EQ-5D-5L quality of life questionnaire will be used to assess health related quality of life status. The 5 dimensions are mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension is rated by the patient on a 5 level scale (no problems, slight problems, moderate problems, severe problems, extreme problems).	Baseline (Day 1, Week 0) through Week 24
Change From Baseline in Medical Outcomes Study Short Form 36 Item Health Survey Version 2 Acute (SF-36v2) Score	The SF-36v2 will be used to assess general quality of life. The 36 items on the SF-36 health survey encompass the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 8 domains can be aggregated into 2 summary scales that reflect physical and mental health: a physical component summary (PCS) and a mental component summary (MCS). Responses to all items are rated on a 3-, 5- or 6-point Likert scale. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement.	Baseline (Day 1, Week 0) through Week 24
Change From Baseline in Patient Global Impression of Severity (PGIS)	The PGIS will be used to assess the severity of warm autoimmune hemolytic anemia (wAIHA) fatigue symptoms. The PGIS is a 5-point response scale. Participant will be asked to rate their fatigue over the past 7 days using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe.	Baseline (Day 1, Week 0) through Week 24
Patient-reported Status As Assessed by Patient Global Impression of Change (PGIC) Scale Score	The PGIC will assess if there has been an improvement or decline in patient-reported status since the beginning of the treatment. The PGIC is a 7-point response scale. Participants will be asked to rate their current fatigue as compared to when they started the study, using the following 7-point scale: 1 = Much better, 2 = Moderately better, 3 = A little better, 4 = No change, 5 = A little worse, 6 = Moderately worse, and 7 = Much worse.	At Week 24
Hgb Range at Steady State	It will be estimated using a model-based longitudinal analysis of Hgb/hemolysis parameters in relationship to IgG level and dose regimen.	Baseline (Day 1, Week 0) through Week 24
Absolute Change from Baseline in Average Daily Dose of Prednisone or Equivalent	Absolute change from baseline in average daily dose of prednisone or equivalent at Week 24 among all participants will be reported.	Baseline (Day 1, Week 0) and at Week 24
Percentage of participants who Achieve Corticosteroid Reduction to less than or equal to (<=) 7.5 milligrams per day (mg/day) of Oral Prednisone (or Equivalent), Among Participants with Prednisone or Equivalent greater than (>) 7.5 mg/day at Baseline	Percentage of participants who achieve corticosteroid reduction to <= 7.5 mg/day of oral prednisone (or equivalent) at Week 24 of the double-blind period, among participants with prednisone or equivalent >7.5 mg/day at baseline will be reported.	At Week 24

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General Publications

• Liu AP, Cheuk DK. Disease-modifying treatments for primary autoimmune haemolytic anaemia. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012493. doi: 10.1002/14651858.CD012493.pub2.

Helpful Links

• ENERGY website link
• Participant recruitment poster

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Estimated): March 20, 2025
• Study Completion (Estimated): April 10, 2028

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Estimated): January 10, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: wAIHA; Warm Autoimmune Hemolytic Anemia; M281 (Nipocalimab); JNJ-80202135
• Additional Relevant MeSH Terms: Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Hematologic Diseases; Anemia; Hemolysis; Anemia, Hemolytic; Anemia, Hemolytic, Autoimmune
• Other Study ID Numbers: CR108987; 2019-000720-17 (EudraCT Number); MOM-M281-006 (Other Identifier: Janssen Research & Development, LLC); 2023-505321-14-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes