Warm Autoimmune Hemolytic Anemia
Conditions
Interventions
M281 : M281 injection administered as intravenous infusion :
Participants will receive M281 administered every 4weeks alternating with placebo every 4 weeks during the 24 weeks double-blind period.
Sponsors
Nishikawa Kazuko
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving Durable Response of Improvement in Hemoglobin (Hgb) : Up to Week 20 of the double-blind period | — |
Secondary
| Measure | 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 : Baseline (Day 1, Week 0) through 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 the Total Score From the FACIT-Fatigue Scale at the end of the Double-blind Period (Week 24) : Baseline (Day 1, Week 0) through Week 24 of the double-blind period : 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 : Baseline (Day 1, Week 0) and at Week 24 : 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 : 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 Ind | — |
Countries
Brazil, China, Czech Republic, Egypt, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic Of, Malaysia, Mexico, Netherlands, Poland, Spain, United Kingdom Of Great BritainAnd Northern Irelan, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed