Health Condition 1: D591- Other autoimmune hemolytic anemias
Conditions
Interventions
Intervention1: ianalumab: Arm A (investigational): ianalumab at 3 mg/kg dose, intravenously, every 4 weeks (4 doses in total)
Intervention2: ianalumab: Arm B (investigational): ianalumab at 9 mg/kg d
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Written informed consent form (ICF) must be obtained prior to any screening assessments Male or female participants aged 18 years and older on the day of signing the ICF Participants with primary or secondary wAIHA (previously documented by positive direct antiglobulin test (DAT) 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 below 10 g/dL, associated with presence of symptoms related to anemia. The dose of supportive care must be stable for at least 4 weeks prior randomization
Exclusion criteria
Exclusion criteria: Patients with wAIHA secondary to hematologic disease involving bone marrow or other immunologic disease requiring immunosuppressant or presence of other forms of AIHA (cold or intermediate), Evanâ??s Syndrome or other cytopenias Prior use of B-cell depleting therapy within 12 weeks prior randomization Active viral, bacterial or other infections (including tuberculosis or SARS-CoV-2) Known history of primary or secondary immunodeficiency, or a positive human immune deficiency virus (HIV) or positivity for hepatitis C virus (HCV) or hepatitis B virus (HBV) Live or live-attenuated vaccination within 4 weeks before randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| demonstrate that either dose of ianalumab induces durable hemoglobin (Hb) response compared to placebo in patients with wAIHATimepoint: increased Hb for at least two consecutive (q2w, every other week) assessments) between Week 9 and Week 17 | — |
Secondary
| Measure | Time frame |
|---|---|
| time to durableTimepoint: durable response, to first response, to first complete response- every week;quality of response in each treatment groupTimepoint: Response rate, complete response rate & hemoglobin level-every week;need for rescue treatments in each treatment groupTimepoint: Number and proportion of participants that receive rescue treatment overall;safety profileTimepoint: Frequency of adverse events (AEs);characterize the pharmacokinetics (PK)Timepoint: Ianalumab concentration in serum;immunogenicity against ianalumabTimepoint: titer of anti-drug antibodies (ADA) in serum over time;quality of life (QoL) in each treatment groupTimepoint: Patient Reported Outcomes (PROs) | — |
Countries
Australia, China, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Singapore, Taiwan, Thailand, United Kingdom, United States of America
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed