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

Efficacy of nipocalimab in patients with warm autoimmune hemolytic anemia (wAIHA) Durable response in improvement in hemoglobin (Hgb), defined as attainment of the following at 3 consecutive visits, where at least the first is at or before Week 16, without the need of rescue therapy: 1- Hgb concentration greater than or equal to10 g/dL AND 2- An increase from baseline in Hgb greater than or equal to 2 g/dL Durable response in improvement in hemoglobin (Hgb), defined as attainment of the following at 3 consecutive visits, where at least the first is at or before Week 16, without the need of rescue therapy: 1- Hgb concentration greater than or equal to10 g/dL AND 2- An increase from baseline in Hgb greater than or equal to 2 g/dL -Change from baseline in the total score from the Functional Assessment of Chronic Illness Therapy-Fatigue (FACITFatigue) Scale at the end of the double-blind period -Simultaneous attainment of normal lactate dehydrogenase (LDH), AND normal haptoglobin, AND normal indirect bilirubin levels at a minimum of 3 consecutive visits after baseline -Percent reduction from baseline in daily dose of prednisone or equivalent at week 24 among patients on prednisone or equivalent at baseline -Hgb range at steady state (estimated using a model-based longitudinal analysis of Hgb/hemolysis parameters in relationship to IgG level and dose regimen) -Hemoglobin concentration, reticulocyte count, hemolytic markers, and change from baseline in these parameters through Week 16 of the double-blind period -Hemoglobin concentration, reticulocyte count, hemolytic markers, and change from baseline throughout the study -Attainment of the following at any time during the study: An increase from baseline in Hgb of greater than or equal to 2 g/dL AND normal LDH, haptoglobin, and indirect bilirubin levels - Attainment of the above at 3 consecutive visits -Time to response defined as the first time point at which the criteria for the primary efficacy endpoint are met - Duration from the first time point at which the durable response criteria for the primary efficacy endpoint are met until the time point at which it is no longer met -Change from baseline in the total score from the FACIT-Fatigue Scale at the time of durable response - Change from baseline in the total score and item scores from the FACIT-Fatigue Scale during the double-blind period and open-label extension (OLE) -EuroQol 5-dimension, 5-level (EQ-5D-5L) quality of life questionnaire, Medical Outcomes Study Short Form 36-Item health survey (SF-36), patient global impression of severity (PGIS), patient global impression of change (PGIC), and FACIT-Fatigue Scale

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Medical Research
• Age: - 99 Years
• Gender: All