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

Primary Purpose

Warm Autoimmune Hemolytic Anemia

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
M281
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warm Autoimmune Hemolytic Anemia focused on measuring Warm Autoimmune Hemolytic Anemia, M281 (Nipocalimab), wAIHA, JNJ-80202135

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MemorialCare Medical GroupRecruiting
  • University of Southern CaliforniaRecruiting
  • Compassionate Cancer Care Medical GroupRecruiting
  • American Institute of Research
  • University of Colorado - Anschutz Medical CampusRecruiting
  • Heme Onc CallRecruiting
  • University of Florida Health JacksonvilleRecruiting
  • 21st Century Oncology
  • Lakes Research
  • Children's Research InstituteRecruiting
  • Rush University Medical Center
  • Tulane University School of MedicineRecruiting
  • Henry Ford Medical Center
  • Research Medical CenterRecruiting
  • Montefiore Medical CenterRecruiting
  • Monter Cancer Center
  • East Carolina University-School of MedicineRecruiting
  • Scotland Cancer Treatment Center - Duke Cancer NetworkRecruiting
  • Taussig Cancer Insititute - Cleveland ClinicRecruiting
  • The Ohio State University- James Cancer HospitalRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Hospital of the University of PennsylvaniaRecruiting
  • West Penn Hospital
  • University of Utah
  • NorthWest Medical Specialties, PLLCRecruiting
  • University of Wisconsin Carbone Cancer Center
  • Beijing Chao-yang Hospital, Capital Medical UniversityRecruiting
  • Peking University People's HospitalRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Guangzhou First Municipal People's HospitalRecruiting
  • Hainan General HospitalRecruiting
  • First Affiliated Hospital, Medical School of Zhejiang UniversityRecruiting
  • Lanzhou University Second HospitalRecruiting
  • Jiangsu Province HospitalRecruiting
  • Affiliated Hospital of Nantong UniversityRecruiting
  • Huashan Hospital affiliated to Fudan UniversityRecruiting
  • Shanghai Zhongshan HospitalRecruiting
  • The First Affiliated Hospital of Soochow UniversityRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • Wuhan Union HospitalRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Fakultni nemocnice BrnoRecruiting
  • Fakultni nemocnice Kralovske VinohradyRecruiting
  • Ustav Hematologie A Krevni TransfuzeRecruiting
  • CHRU Hopital SudRecruiting
  • ICH Hopital A. Morvan
  • CHU Dijon BourgogneRecruiting
  • CHU GrenobleRecruiting
  • CHU Nantes - Hotel DieuRecruiting
  • CHU De PoitiersRecruiting
  • Onkologische SchwerpunktpraxisRecruiting
  • Universitatsklinikum EssenRecruiting
  • Rotkreuzklinikum München
  • General Hospital of Athens 'G. Gennimatas'Recruiting
  • Laiko General Hospital of Athens
  • Attikon University General Hospital of AtticaRecruiting
  • University Hospital Of LarissaRecruiting
  • University General Hospital of Rio PatrasRecruiting
  • University General Hospital of ThessalonikiRecruiting
  • Semmelweis EgyetemRecruiting
  • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László TelephelyRecruiting
  • Debreceni Egyetem Klinikai KozpontRecruiting
  • Petz Aladar Megyei Oktato KorhazRecruiting
  • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Ha'Emek Medical CenterRecruiting
  • Soroka Medical CenterRecruiting
  • Rambam Health Care CampusRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • Rabin Medical Center, Beilinson HospitalRecruiting
  • Laniado HospitalRecruiting
  • Rabin Medical Center, Beilinson HospitalRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting
  • Ospedale MazzonlRecruiting
  • ASST Spedali Civili BresciaRecruiting
  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione GaribaldiRecruiting
  • Azienda Ospedaliero Univ. Policlinico Gaspare RodolicoRecruiting
  • Careggi University HospitalRecruiting
  • Policlinico di MilanoRecruiting
  • San Gerardo HospitalRecruiting
  • Università del Piemonte Orientale - Ospedale Maggiore della Carità di NovaraRecruiting
  • Umberto I Policlinico di Roma
  • Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'Recruiting
  • Ospedale San BortoloRecruiting
  • Fukushima Medical University HospitalRecruiting
  • Saitama Medical University HospitalRecruiting
  • St.Marianna University HospitalRecruiting
  • Japan Community Health care Organization Kyushu HospitalRecruiting
  • Yamanashi Prefectural Central HospitalRecruiting
  • Ogaki Municipal HospitalRecruiting
  • Sapporo Medical University HospitalRecruiting
  • Tohoku University HospitalRecruiting
  • Osaka University HospitalRecruiting
  • Toyama Prefectural Central HospitalRecruiting
  • Wakayama Medical University HospitalRecruiting
  • Tottori University HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Chungnam National University HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Asan Medical CenterRecruiting
  • Hospital AmpangRecruiting
  • Hospital Sultan IsmailRecruiting
  • Hospital Queen ElizabethRecruiting
  • University Malaya Medical CentreRecruiting
  • Hospital Tengku Ampuan AfzanRecruiting
  • Sunway Medical CentreRecruiting
  • Academic Medical Centre AmsterdamRecruiting
  • Haga ziekenhuisRecruiting
  • Maastricht Universitair Medisch Centrum
  • InterhemRecruiting
  • Klinika Hematologii i Transplantologii, UCK
  • Pratia Onkologia KatowiceRecruiting
  • Szpital Wojewodzki w OpoluRecruiting
  • MTZ Clinical Research Powered by PratiaRecruiting
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w LodziRecruiting
  • Hosp. Univ. Principe de AsturiasRecruiting
  • Hosp. Univ. Germans Trias I PujolRecruiting
  • Hosp. Clinic I Provincial de BarcelonaRecruiting
  • Complejo Asistencial Univ. de Burgos
  • Hosp. Reina SofiaRecruiting
  • Hosp. Univ. de Gran Canaria Dr. Negrin
  • Hosp. Univ. Infanta LeonorRecruiting
  • Hosp. Univ. Ramon Y CajalRecruiting
  • Hospital Clinico San CarlosRecruiting
  • Hosp. Univ. 12 de OctubreRecruiting
  • Hosp. Univ. La PazRecruiting
  • Hospital Universitario Puerta de Hierro MajadahondaRecruiting
  • Hosp. Regional Univ. de Malaga
  • Hosp. Virgen de La VictoriaRecruiting
  • Hosp. Virgen Del RocioRecruiting
  • Hosp. Son LlatzerRecruiting
  • Clinica Univ. de NavarraRecruiting
  • Hosp. Quiron Madrid PozueloRecruiting
  • Hosp. Univ. I Politecni La FeRecruiting
  • Hosp. Univ. Miguel ServetRecruiting
  • Cherkassy Regional Oncology Dispensary, Department of Hematology
  • Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
  • Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
  • Kyiv City Clinical Hospital #9, Department of infectious diseases
  • Ternopil University Hospital of Ternopil Regional Council
  • Leeds Teaching Hospitals NHS TrustRecruiting
  • Royal Liverpool University HospitalRecruiting
  • Barts Health NHS TrustRecruiting
  • Oxford University Hospitals NHS Foundation TrustRecruiting
  • University Hospitals Plymouth NHS TrustRecruiting
  • University Hospital Southampton NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

M281 administered every 4 weeks (double-blind period)

M281 administered every 2 weeks (double-blind period)

Placebo administered every 2 weeks (double-blind period)

M281 administered every 4 weeks (open-label extension period)

M281 administered every 2 weeks (open-label extension period)

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
Number of Participants That Simultaneously Attain Normal Lactate Dehydrogenase, Haptoglobin, and Indirect Bilirubin Levels at a Minimum of 3 Consecutive Visits After Baseline
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
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
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.
Change From Baseline in Hgb Concentration
Change From Baseline in Reticulocyte Count
Change From Baseline in Hemolytic Marker - Lactate Dehydrogenase
Change From Baseline in Hemolytic Marker - Haptoglobin
Change From Baseline in Hemolytic Marker - Indirect Bilirubin
Time to Hgb Response
Mean Time During Which the Primary Endpoint is Maintained
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.
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).
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 18, 2019
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04119050
Brief Title
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2019 (Actual)
Primary Completion Date
March 20, 2025 (Anticipated)
Study Completion Date
April 10, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warm Autoimmune Hemolytic Anemia
Keywords
Warm Autoimmune Hemolytic Anemia, M281 (Nipocalimab), wAIHA, JNJ-80202135

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
M281 administered every 4 weeks (double-blind period)
Arm Type
Experimental
Arm Description
Participants will receive M281 administered every 4 weeks alternating with placebo every 4 weeks during the 24 weeks double-blind period.
Arm Title
M281 administered every 2 weeks (double-blind period)
Arm Type
Experimental
Arm Description
Participants will receive M281 administered every 2 weeks during the 24 weeks double-blind period.
Arm Title
Placebo administered every 2 weeks (double-blind period)
Arm Type
Experimental
Arm Description
Participants will receive M281 matching placebo administered every 2 weeks during the 24 weeks double-blind period.
Arm Title
M281 administered every 4 weeks (open-label extension period)
Arm Type
Experimental
Arm Description
Participants will receive M281 administered every 4 weeks during the 144 weeks open-label extension period.
Arm Title
M281 administered every 2 weeks (open-label extension period)
Arm Type
Experimental
Arm Description
Participants will receive M281 administered every 2 weeks during the 144 weeks open-label extension period.
Intervention Type
Drug
Intervention Name(s)
M281
Other Intervention Name(s)
Nipocalimab, JNJ-80202135
Intervention Description
M281 injection administered as intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered as intravenous infusion
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Durable Response of Improvement in Hemoglobin (Hgb)
Time Frame
Up to Week 20 of the double-blind period
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
Change From Baseline in the Total Score From the FACIT-Fatigue Scale at the end of the Double-blind Period (Week 24)
Description
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.
Time Frame
Baseline (Day 1, Week 0) through Week 24 of the double-blind period
Title
Change from Baseline in Average Daily Dose of Prednisone or Equivalent
Description
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.
Time Frame
Baseline (Day 1, Week 0) and at Week 24
Title
Number of Participants That Simultaneously Attain Normal Lactate Dehydrogenase, Haptoglobin, and Indirect Bilirubin Levels at a Minimum of 3 Consecutive Visits After Baseline
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
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
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
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
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
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
Description
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.
Time Frame
Up to 24 weeks
Title
Change From Baseline in Hgb Concentration
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
Change From Baseline in Reticulocyte Count
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
Change From Baseline in Hemolytic Marker - Lactate Dehydrogenase
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
Change From Baseline in Hemolytic Marker - Haptoglobin
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
Change From Baseline in Hemolytic Marker - Indirect Bilirubin
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
Time to Hgb Response
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
Mean Time During Which the Primary Endpoint is Maintained
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
Change From Baseline in the Total Score, Item Scores, and Impact and Experience Domains From the FACIT-Fatigue Scale
Description
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.
Time Frame
Baseline (Day 1, Week 0) through Week 24 of the double-blind period
Title
Change From Baseline in EuroQol 5-dimension 5-level ( EQ-5D-5L) Scale Score
Description
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).
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
Change From Baseline in Medical Outcomes Study Short Form 36 Item Health Survey Version 2 Acute (SF-36v2) Score
Description
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.
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
Change From Baseline in Patient Global Impression of Severity (PGIS)
Description
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.
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
Patient-reported Status As Assessed by Patient Global Impression of Change (PGIC) Scale Score
Description
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.
Time Frame
At Week 24
Title
Hgb Range at Steady State
Description
It will be estimated using a model-based longitudinal analysis of Hgb/hemolysis parameters in relationship to IgG level and dose regimen.
Time Frame
Baseline (Day 1, Week 0) through Week 24
Title
Absolute Change from Baseline in Average Daily Dose of Prednisone or Equivalent
Description
Absolute change from baseline in average daily dose of prednisone or equivalent at Week 24 among all participants will be reported.
Time Frame
Baseline (Day 1, Week 0) and at Week 24
Title
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
Description
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.
Time Frame
At Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
MemorialCare Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Compassionate Cancer Care Medical Group
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Individual Site Status
Recruiting
Facility Name
American Institute of Research
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Completed
Facility Name
University of Colorado - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Heme Onc Call
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida Health Jacksonville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Name
21st Century Oncology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Individual Site Status
Completed
Facility Name
Lakes Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Completed
Facility Name
Children's Research Institute
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Completed
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Completed
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Name
Monter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Completed
Facility Name
East Carolina University-School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Name
Scotland Cancer Treatment Center - Duke Cancer Network
City
Laurinburg
State/Province
North Carolina
ZIP/Postal Code
28352
Country
United States
Individual Site Status
Recruiting
Facility Name
Taussig Cancer Insititute - Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University- James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Completed
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Completed
Facility Name
NorthWest Medical Specialties, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Completed
Facility Name
Beijing Chao-yang Hospital, Capital Medical University
City
Beijing Shi
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University People's Hospital
City
Beijing Shi
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital of Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Guangzhou First Municipal People's Hospital
City
Guangzhou Shi
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Name
Hainan General Hospital
City
Haikou
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital, Medical School of Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
ZIP/Postal Code
226001
Country
China
Individual Site Status
Recruiting
Facility Name
Huashan Hospital affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Zhongshan Hospital
City
ShangHai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430023
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'An
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Ustav Hematologie A Krevni Transfuze
City
Praha 2
ZIP/Postal Code
128 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CHRU Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Name
ICH Hopital A. Morvan
City
Brest Cedex 2
ZIP/Postal Code
29609
Country
France
Individual Site Status
Completed
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Nantes - Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
CHU De Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Name
Onkologische Schwerpunktpraxis
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Rotkreuzklinikum München
City
München
ZIP/Postal Code
80634
Country
Germany
Individual Site Status
Completed
Facility Name
General Hospital of Athens 'G. Gennimatas'
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Name
Laiko General Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Completed
Facility Name
Attikon University General Hospital of Attica
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital Of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital of Rio Patras
City
Patras
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Gyõr
ZIP/Postal Code
9023
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Completed
Facility Name
Ha'Emek Medical Center
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Individual Site Status
Recruiting
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Laniado Hospital
City
Netanya
ZIP/Postal Code
4244916
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Petach Tikvah
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
Ospedale Mazzonl
City
Ascoli Piceno
ZIP/Postal Code
63100
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Spedali Civili Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi
City
Catania
ZIP/Postal Code
95122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Careggi University Hospital
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico di Milano
City
Milano
ZIP/Postal Code
21022
Country
Italy
Individual Site Status
Recruiting
Facility Name
San Gerardo Hospital
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Umberto I Policlinico di Roma
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Completed
Facility Name
Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'
City
Roma
ZIP/Postal Code
168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Bortolo
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University Hospital
City
Iruma-gun
ZIP/Postal Code
350-0495
Country
Japan
Individual Site Status
Recruiting
Facility Name
St.Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japan Community Health care Organization Kyushu Hospital
City
Kitakyusyu-Shi
ZIP/Postal Code
806-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu-Shi
ZIP/Postal Code
400-0027
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ogaki Municipal Hospital
City
Ogaki
ZIP/Postal Code
503-8502
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo Medical University Hospital
City
Sapporo
ZIP/Postal Code
060-8543
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka University Hospital
City
Suita
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toyama Prefectural Central Hospital
City
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tottori University Hospital
City
Yonago
ZIP/Postal Code
683-8504
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-040
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital Ampang
City
Ampang
ZIP/Postal Code
68000
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Sultan Ismail
City
Johor Bahru
ZIP/Postal Code
80100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Queen Elizabeth
City
Kota Kinabalu
ZIP/Postal Code
88200
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Tengku Ampuan Afzan
City
Kuantan
ZIP/Postal Code
25100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Sunway Medical Centre
City
Petaling Jaya
ZIP/Postal Code
47500
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Academic Medical Centre Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Haga ziekenhuis
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht Universitair Medisch Centrum
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Completed
Facility Name
Interhem
City
Bialystok
ZIP/Postal Code
15-732
Country
Poland
Individual Site Status
Recruiting
Facility Name
Klinika Hematologii i Transplantologii, UCK
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Completed
Facility Name
Pratia Onkologia Katowice
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Wojewodzki w Opolu
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Individual Site Status
Recruiting
Facility Name
MTZ Clinical Research Powered by Pratia
City
Warszawa
ZIP/Postal Code
02-172
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
City
Łódź
ZIP/Postal Code
93-510
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Principe de Asturias
City
Alcalá de Henares
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Asistencial Univ. de Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Individual Site Status
Completed
Facility Name
Hosp. Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. de Gran Canaria Dr. Negrin
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Completed
Facility Name
Hosp. Univ. Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Regional Univ. de Malaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Completed
Facility Name
Hosp. Virgen de La Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Virgen Del Rocio
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Son Llatzer
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Quiron Madrid Pozuelo
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. I Politecni La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Cherkassy Regional Oncology Dispensary, Department of Hematology
City
Cherkassy
ZIP/Postal Code
18009
Country
Ukraine
Individual Site Status
Completed
Facility Name
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Individual Site Status
Completed
Facility Name
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Kyiv City Clinical Hospital #9, Department of infectious diseases
City
Kyiv
ZIP/Postal Code
04112
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Ternopil University Hospital of Ternopil Regional Council
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LF9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospitals Plymouth NHS Trust
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
ZIP/Postal Code
SO166YD
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33786812
Citation
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.
Results Reference
derived
Links:
URL
https://energywarmanemiastudy.com
Description
Link to Recruitment Website
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&amp;parentIdentifier=CR108987&amp;attachmentIdentifier=b509c2dc-edca-4931-9563-29144a9c45f3&amp;fileName=CR108987_Energy_Study_Patient_Poster.pdf&amp;versionIdentifier=
Description
Energy Study Patient Poster

Learn more about this trial

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

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