MedTrace Logo

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

NCT05648968 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • Warm Autoimmune Hemolytic Anemia (wAIHA)

Interventions

BIOLOGICAL

Ianalumab

i.v. infusion, prepared from concentrate solution

DRUG

Placebo

i.v. infusion, prepared from matching placebo

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-30
Primary Completion
2026-02-20
Completion
2028-12-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • China
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Singapore
  • Spain
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05648968 on ClinicalTrials.gov