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Warm Autoimmune Hemolytic AnemiaPhase 2/3ENERGYNCT04119050

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

A Phase 2/3 study testing M281 in people with Warm Autoimmune Hemolytic Anemia, run by Janssen Research & Development, LLC at 171 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Warm Autoimmune Hemolytic Anemia
What is being tested?
M281
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
171 sitesin 19 countries
Study dates
15 Aug 2019to 1 Apr 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

171 sites in 19 countries.

171 sites in 19 countries

United States29 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Taussig Cancer Insititute Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University- James Cancer Hospital

    Columbus, Ohio, 43210

  • GNP Research

    Cooper City, Florida, 33024

  • Henry Ford Medical Center

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • MemorialCare Medical Group

    Fountain Valley, California, 92708

  • University of Florida College of Medicine

    Gainesville, Florida, 32610

  • East Carolina University

    Greenville, North Carolina, 27834

  • 21st Century Oncology

    Jacksonville, Florida, 32204

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Montefiore Medical Center

    Lake Success, New York, 11042

  • Monter Cancer Center

    Lake Success, New York, 11042

  • University of Southern California

    Los Angeles, California, 90033

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Alliance for Multispeciality Research

    Merriam, Kansas, 66204

  • Lakes Research

    Miami Lakes, Florida, 33014

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960

  • AdventHealth Cancer Institute

    Orlando, Florida, 32804

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Compassionate Cancer Care

    Riverside, California, 92501

  • University of Utah

    Salt Lake City, Utah, 84132

  • Children's Research Institute

    St. Petersburg, Florida, 33701

  • Northwest Medical Specialists

    Tacoma, Washington, 98405

  • American Institute of Research

    Whittier, California, 90603

Other trials in United States

Spain20 sites

  • Hosp. Univ. Principe de Asturias

    Alcalá de Henares, 28805

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Complejo Asistencial Univ. de Burgos

    Burgos, 09006

  • Hosp Reina Sofia

    Córdoba, 14004

  • Hosp. Univ. de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, 35010

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Hosp Regional Univ de Malaga

    Málaga, 29010

  • Hosp Virgen de La Victoria

    Málaga, 29010

  • Hosp. Virgen Del Rocio

    Málaga, 29010

  • Hosp. Son Llatzer

    Palma de Mallorca, 07198

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp. Quiron Madrid Pozuelo

    Pozuelo de Alarcón, 28223

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

  • Hosp. Univ. Miguel Servet

    Zaragoza, 50009

Other trials in Spain

China16 sites

  • Beijing Chao-yang Hospital, Capital Medical University

    Beijing, 100020

  • Peking University People's Hospital

    Beijing, 100044

  • The First Hospital of Jilin University

    Changchun, 130021

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180

  • Hainan General Hospital

    Haikou, 570311

  • First Affiliated Hospital Medical School of Zhejiang University

    Hangzhou, 310003

  • Lanzhou University Second Hospital

    Lanzhou, 730030

  • Jiangsu Province Hospital

    Nanjing, 210029

  • Affiliated Hospital of Nantong University

    Nantong, 226001

  • Shanghai Zhongshan Hospital

    Shanghai, 200032

  • Huashan Hospital affiliated to Fudan University

    Shanghai, 200040

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430022

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061

Other trials in China

Brazil14 sites

  • Hospital das Clínicas da Faculdade de Medicina de Botucatu

    Botucatu, 18610-070

  • Impar Servicos Hospitalares S/A - Hospital Brasilia

    Brasília, 71681-603

  • CTO Centro de Tratamento Oncologico Unidade Belem

    Campinas, 13083-887

  • Hospital Das Clinicas Da Universidade Federal De Goias

    Goiânia, 74605-020

  • Complexo Hospitalar de Niteroi

    Niterói, 24020-096

  • Oncoclinicas - Unidade OC Oncoclinicas Multihemo Ilha do Leite

    Recife, 50040-000

  • Nucleo de Oncologia da Bahia

    Salvador, 40170-110

  • Hospital Sao Rafael

    Salvador, 41253 190

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060 650

  • Hospital Santa Marcelina

    Santo André, 09060-870

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    São José do Rio Preto, 15090 000

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 050

  • Universidade Federal de Sao Paulo

    São Paulo, 04024-002

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403 000

Other trials in Brazil

Italy12 sites

  • PO C e G Mazzoni AST Ascoli Piceno

    Ascoli Piceno, 63100

  • ASST Spedali Civili di Brescia

    Brescia, 25123

  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi

    Catania, 95122

  • AOU Policlinico G Rodolico S Marco

    Catania, 95125

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900

  • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

    Novara, 28100

  • Umberto I Policlinico di Roma

    Roma, 00161

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

    Torino, 10126

  • Azienda Ulss 8 Berica- Ospedale Di Vicenza

    Vicenza, 36100

Other trials in Italy

Japan12 sites

  • Fukushima Medical University Hospital

    Fukushima, 960 1295

  • Saitama Medical University Hospital

    Iruma-gun, 350-0495

  • St Marianna University Hospital

    Kanagawa, 216 8511

  • Japan Community Health care Organization Kyushu Hospital

    Kitakyusyu-Shi, 806-8501

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-0027

  • Ogaki Municipal Hospital

    Ōgaki, 503-8502

  • Sapporo Medical University Hospital

    Sapporo, 060-8543

  • Tohoku University Hospital

    Sendai, 980 8574

  • Osaka University Hospital

    Suita, 565 0871

  • Toyama Prefectural Central Hospital

    Toyama, 930 8550

  • Wakayama Medical University Hospital

    Wakayama, 641 8510

  • Tottori University Hospital

    Yonago, 683-8504

Other trials in Japan

Israel8 sites

  • Ha'Emek Medical Center

    Afula, 1834111

  • Soroka Medical Center

    Beersheba, 8410101

  • Rambam Health Care Campus

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Hospital Sanz Medical Center Laniado Hospital

    Kiryat Tzanz, 4244916

  • Rabin Medical Center, Beilinson Hospital

    Petach Tikvah, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Malaysia7 sites

  • Hospital Ampang

    Ampang, 68000

  • Hospital Sultanah Aminah

    Johor Bharu, 80100

  • Hospital Queen Elizabeth

    Kota Kinabalu, 88200

  • University Malaya Medical Centre

    Kuala Lumpur, 50603

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Hospital Umum Sarawak

    Kuching, 93586

  • Sunway Medical Centre

    Petaling Jaya, 47500

Other trials in Malaysia

Egypt6 sites

  • Mansoura University Hospital

    Al Mansurah, 35516

  • Alexandria University

    Alexandria, 21561

  • Cairo university

    Cairo, 11211

  • National Cancer Institute Cairo

    Cairo, 11796

  • Ain Shams University Hospital

    Cairo, 1181

  • Nasser Institute Hospital for Research and Treatment

    Cairo, 12655

Other trials in Egypt

France6 sites

  • CHRU Hopital Amiens Picardie Sud

    Amiens, 80054

  • ICH Hopital A. Morvan

    Brest, 29609

  • CHU Dijon Bourgogne

    Dijon, 21000

  • CHU Grenoble

    La Tronche, 38700

  • CHU Nantes - Hotel Dieu

    Nantes, 44093

  • CHU De Poitiers

    Poitiers, 86021

Other trials in France

Greece6 sites

  • General Hospital of Athens G Gennimatas

    Athens, 115 27

  • Laiko General Hospital of Athens

    Athens, 11527

  • Attikon University General Hospital of Attica

    Athens, 12462

  • University Hospital Of Larissa

    Larissa, 41110

  • University General Hospital of Rio Patras

    Pátrai, 26504

  • University General Hospital of Thessaloniki

    Thessaloniki, 54636

Other trials in Greece

Poland6 sites

  • Interhem

    Bialystok, 15-732

  • Klinika Hematologii i Transplantologii, UCK

    Gdansk, 80-214

  • Pratia Onkologia Katowice

    Katowice, 40 519

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

    Lodz, 93 510

  • Szpital Wojewodzki w Opolu

    Opole, 45-061

  • MTZ Clinical Research Powered by Pratia

    Warsaw, 02-172

Other trials in Poland

United Kingdom6 sites

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LF9 7TF

  • Liverpool University Hospitals NHS Foundation Trust

    Liverpool, L7 8XP

  • Barts Health NHS Trust

    London, E1 2ES

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO166YD

Other trials in United Kingdom

Hungary5 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Petz Aladar Megyei Oktato Korhaz

    Gyõr, 9023

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

Other trials in Hungary

Ukraine5 sites

  • Cherkassy Regional Oncology Dispensary, Department of Hematology

    Cherkassy, 18009

  • Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

    Dnipro, 49102

  • Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

    Kyiv, 02091

  • Kyiv City Clinical Hospital #9, Department of infectious diseases

    Kyiv, 04112

  • Ternopil University Hospital of Ternopil Regional Council

    Ternopil, 46002

Other trials in Ukraine

South Korea4 sites

  • Kyungpook National University Hospital

    Daegu, 41944

  • Chungnam National University Hospital

    Daejeon, 35015

  • Samsung Medical Center

    Seoul, 06351

  • Asan Medical Center

    Seoul, 138-040

Other trials in South Korea

Czechia3 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Ustav Hematologie A Krevni Transfuze

    Prague, 128 00

Other trials in Czechia

Germany3 sites

  • Onkologische Schwerpunktpraxis

    Berlin, 10707

  • Universitatsklinikum Essen

    Essen, 45147

  • Rotkreuzklinikum München

    München, 80634

Other trials in Germany

Netherlands3 sites

  • Amsterdam Universitair Medische Centra Locatie Vrije Universiteit Medisch Centrum

    Amsterdam, 1081 HV Amsterdam

  • Academic Medical Centre Amsterdam

    Amsterdam, 1105 AZ

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX

Other trials in Netherlands

About this study

Official title: 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).

Read the 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.

Being tested
M281, Placebo
Keywords
Warm Autoimmune Hemolytic Anemia, M281 (Nipocalimab), wAIHA, JNJ-80202135

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M281Drug

    Also called Nipocalimab, JNJ-80202135

    M281 injection administered as intravenous infusion

  • PlaceboDrug

    Placebo administered as intravenous infusion

Study groups in NCT04119050
Study groupRoleWhat they receive
M281 administered every 4 weeks (double-blind period)ExperimentalParticipants will receive M281 administered every 4 weeks alternating with placebo every 4 weeks during the 24 weeks double-blind period.
Receives: Drug: M281; Drug: Placebo
M281 administered every 2 weeks (double-blind period)ExperimentalParticipants will receive M281 administered every 2 weeks during the 24 weeks double-blind period.
Receives: Drug: M281
Placebo administered every 2 weeks (double-blind period)ExperimentalParticipants will receive M281 matching placebo administered every 2 weeks during the 24 weeks double-blind period.
Receives: Drug: Placebo
M281 administered every 4 weeks (open-label extension period)ExperimentalParticipants will receive M281 administered every 4 weeks during the 144 weeks open-label extension period.
Receives: Drug: M281
M281 administered every 2 weeks (open-label extension period)ExperimentalParticipants will receive M281 administered every 2 weeks during the 144 weeks open-label extension period.
Receives: Drug: M281

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to Week 20 of the double-blind period

Secondary outcomes (22)

  1. 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.

    Measured: Baseline (Day 1, Week 0) through Week 24

  2. 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.

    Measured: Baseline (Day 1, Week 0) through Week 24 of the double-blind period

  3. 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.

    Measured: Baseline (Day 1, Week 0) and at Week 24

  4. Number of Participants That Simultaneously Attain Normal Lactate Dehydrogenase, Haptoglobin, and Indirect Bilirubin Levels at a Minimum of 3 Consecutive Visits After Baseline

    Measured: Baseline (Day 1, Week 0) through Week 24

  5. 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

    Measured: Baseline (Day 1, Week 0) through Week 24

  6. 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

    Measured: Baseline (Day 1, Week 0) through Week 24

  7. 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.

    Measured: Up to 24 weeks

  8. Change From Baseline in Hgb Concentration

    Measured: Baseline (Day 1, Week 0) through Week 24

  9. Change From Baseline in Reticulocyte Count

    Measured: Baseline (Day 1, Week 0) through Week 24

  10. Change From Baseline in Hemolytic Marker - Lactate Dehydrogenase

    Measured: Baseline (Day 1, Week 0) through Week 24

  11. Change From Baseline in Hemolytic Marker - Haptoglobin

    Measured: Baseline (Day 1, Week 0) through Week 24

  12. Change From Baseline in Hemolytic Marker - Indirect Bilirubin

    Measured: Baseline (Day 1, Week 0) through Week 24

  13. Time to Hgb Response

    Measured: Baseline (Day 1, Week 0) through Week 24

  14. Mean Time During Which the Primary Endpoint is Maintained

    Measured: Baseline (Day 1, Week 0) through Week 24

  15. 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.

    Measured: Baseline (Day 1, Week 0) through Week 24 of the double-blind period

  16. 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).

    Measured: Baseline (Day 1, Week 0) through Week 24

  17. 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.

    Measured: Baseline (Day 1, Week 0) through Week 24

  18. 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.

    Measured: Baseline (Day 1, Week 0) through Week 24

  19. 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.

    Measured: At Week 24

  20. 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.

    Measured: Baseline (Day 1, Week 0) through Week 24

  21. 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.

    Measured: Baseline (Day 1, Week 0) and at Week 24

  22. 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.

    Measured: At Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2019
  2. Study start15 Aug 2019
  3. Primary completion2 Feb 2025
  4. Study completion1 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04119050
Sponsor's protocol ID
CR108987
Other IDs
MOM-M281-006, 2019-000720-17, 2023-505321-14-00, 2023, 2019
Acronym
ENERGY
Status last verified
Aug 2026
First submitted
18 Sep 2019
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Publications

  • Fattizzo B, Murakhovskaya I, Ueda Y, Schlichting D, Sweet KM, Zelasky M, Craig J, Liva SG, Leu JH, Ling LE, Pease S, Anakor A, Shu C. Nipocalimab for warm autoimmune hemolytic anemia: results from the phase 2/3 randomized, double-blind ENERGY study. Blood. 2026 Aug 28:blood.2026034036. doi: 10.1182/blood.2026034036. Online ahead of print.

    PubMed 42664110

  • 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.

    PubMed 33786812

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing M281 in people with Warm Autoimmune Hemolytic Anemia, run by Janssen Research & Development, LLC at 171 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in United States, Spain, China, Brazil, Italy and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Durable Response of Improvement in Hemoglobin (Hgb) (time frame: Up to Week 20 of the double-blind period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04119050, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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