A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia

Part of paid clinical trials in Farmington Hills, Michigan.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05648968
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Warm Autoimmune Hemolytic Anemia (wAIHA)

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ianalumab — BIOLOGICAL
    i.v. infusion, prepared from concentrate solution
  • Placebo — DRUG
    i.v. infusion, prepared from matching placebo

Study Details

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.

Key Dates

Start date
Dec 30, 2022
Status verified
Jun 2026
Primary completion
Feb 20, 2026
Completion
Dec 19, 2028

Study Design

Enrollment
90 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ianalumab low dose
    Participants will receive low dose ianalumab intravenously
  • Experimental: Ianalumab high dose
    Participants will receive high dose ianalumab intravenously
  • Placebo Comparator: Placebo
    Participants will receive placebo intravenously

Primary Outcome Measure

Binary variable indicating whether a patient achieves a durable response [ Time Frame: Randomization to Week 25 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Michigan Center of Medical ResearchFarmington HillsMichigan48334-
University of Minnesota Med CenterMinneapolisMinnesota55455-
Fred Hutchinson Cancer CenterSeattleWashington98109-

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By research site
Michigan Center of Medical Research· Farmington Hills, MIUniversity of Minnesota Med Center· Minneapolis, MNFred Hutchinson Cancer Center· Seattle, WA