A Phase 3, Randomized, Double-blind, Study to Assess Efficacy and Safety of Ianalumab (VAY736) Versus Placebo in Warm Autoimmune Hemolytic Anemia (wAIHA) Patients Who Failed at Least One Line of Treatment

Status: Recruiting
Location: See all (89) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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 \<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 to randomization into the study

Locations
United States
Colorado
University of Colorado Anschutz
WITHDRAWN
Aurora
Florida
Napa Research
WITHDRAWN
Margate
Illinois
NorthShore University Health System
WITHDRAWN
Evanston
Indiana
Parkview Research Center
WITHDRAWN
Fort Wayne
Michigan
Michigan Center of Medical Research
ACTIVE_NOT_RECRUITING
Farmington Hills
Minnesota
University of Minnesota Med Center
ACTIVE_NOT_RECRUITING
Minneapolis
North Carolina
Brody School of Medicine
WITHDRAWN
Greenville
New Jersey
Summit Health
WITHDRAWN
Florham Park
Inspira Medical Cent Mullica Hill
WITHDRAWN
Mullica Hill
New York
Montefiore Medical Center
WITHDRAWN
The Bronx
Ohio
Gabrail Cancer Center
RECRUITING
Canton
STAT Research Inc
WITHDRAWN
Dayton
Texas
Texas Oncology-Baylor Scott and White
WITHDRAWN
Dallas
Baylor College Of Medicine
WITHDRAWN
Houston
Washington
Fred Hutchinson Cancer Center
ACTIVE_NOT_RECRUITING
Seattle
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Buenos Aires
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Caba
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Caba
Australia
Novartis Investigative Site
RECRUITING
Fitzroy
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Garran
Novartis Investigative Site
RECRUITING
Melbourne
China
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Dalian
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Guangzhou
Novartis Investigative Site
COMPLETED
Hangzhou
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kunming
Novartis Investigative Site
WITHDRAWN
Suzhou
Novartis Investigative Site
RECRUITING
Tianjin
Novartis Investigative Site
RECRUITING
Tianjin
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Wuhan
France
Novartis Investigative Site
WITHDRAWN
Blois
Novartis Investigative Site
WITHDRAWN
Caen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Créteil
Novartis Investigative Site
WITHDRAWN
Le Mans
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lille
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Nantes
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Nice
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Toulouse
Novartis Investigative Site
WITHDRAWN
Vandœuvre-lès-nancy
Germany
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Dresden
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Essen
Novartis Investigative Site
RECRUITING
Frankfurt Am Main
Novartis Investigative Site
COMPLETED
Giessen
Novartis Investigative Site
WITHDRAWN
Greifswald
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Hanover
Hungary
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Debrecen
India
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Hyderabad
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lucknow
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Madurai
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
New Delhi
Israel
Novartis Investigative Site
WITHDRAWN
Afula
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kfar Saba
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Petah Tikva
Novartis Investigative Site
WITHDRAWN
Ẕerifin
Italy
Novartis Investigative Site
RECRUITING
Avellino
Novartis Investigative Site
RECRUITING
Bari
Novartis Investigative Site
RECRUITING
Bassano Del Grappa
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Milan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Milan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Novara
Japan
Novartis Investigative Site
WITHDRAWN
Aomori
Novartis Investigative Site
WITHDRAWN
Fukuoka
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Gifu
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Isehara
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Itabashi-ku
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kobe
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Matsuyama
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Narita
Novartis Investigative Site
COMPLETED
Shinjuku Ku
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Suita
Novartis Investigative Site
WITHDRAWN
Yamagata
Malaysia
Novartis Investigative Site
WITHDRAWN
George Town
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
George Town
Novartis Investigative Site
COMPLETED
Johor Bahru
Novartis Investigative Site
WITHDRAWN
Kuala Lumpur
Novartis Investigative Site
WITHDRAWN
Kuala Selangor
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kuching
Romania
Novartis Investigative Site
WITHDRAWN
Bucharest
Singapore
Novartis Investigative Site
COMPLETED
Singapore
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Singapore
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Murcia
Taiwan
Novartis Investigative Site
WITHDRAWN
Taoyuan District
Thailand
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bangkok
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bangkok
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Chiang Mai
United Kingdom
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Birmingham
Novartis Investigative Site
RECRUITING
Leeds
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
London
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2022-12-30
Estimated Completion Date: 2029-05-02
Participants
Target number of participants: 90
Treatments
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
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov