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
Recruiting
99 years and younger
All
Phase
2
2 participants needed
1 Location
Brief description of study
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
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Medical Research
-
Age: - 99 Years
-
Gender: All
Updated on
11 Jan 2023.
Study ID: 850609
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