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Active Not Recruiting
NCT05648968
A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia
Conditions: Warm Autoimmune Hemolytic Anemia (wAIHA)
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 90
Sponsor: Novartis Pharmaceuticals
Location: Michigan Center of Medical Research Farmington Hills Michigan
Summary
The purpose of this study is to evaluate efficacy and safety of ianalumab compared to placebo in patients with warm autoimmune hemolytic anemia, who failed at least one line of treatment.
Eligibility Criteria
Key Inclusion Criteria:
* 18 years and older at time of signing consent
* Patients with primary or secondary wAIHA documented by positive direct antiglobulin test specific for anti-IgG or anti-IgA, who had an insufficient response to, or relapsed after at least one line of treatment, including patients with steroid resistance, dependence or intolerance
* Hemoglobin concentration at screening and at Week 1 \>=5 g/dL and \
Source: ClinicalTrials.gov (NCT05648968). StuddyBuddy aggregates publicly available trial information.
