Last updated 15 days ago
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
111 patients around the world
Available in United States, Brazil, Spain
The study consists of a 24-week double-blind, placebo control period, a 144-week
open-label extension period and follow-up period of 8 weeks after last study drug
administration. Eligible participants will be randomized to placebo or nipocalimab (2
dose levels) during the double-blind period and nipocalimab (2 dose levels) during the
open-label extension period.
Janssen Research & Development, LLC
40Research sites
111Patients around the world
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Participants greater than or equal to (>=)18 years of ageHave been diagnosed with warm autoimmune hemolytic anemia (wAIHA) for at least 3 months, and are currently receiving treatment for wAIHA or have previously received treatment for wAIHA (treatment-naive participants are not eligible)Participants must be able to understand and voluntarily provide written informed consent to participate in the study and comply with all study procedures
- Participants must not be pregnant or breastfeedingParticipants must not have other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participateHave been diagnosed with cold antibody autoimmune hemolytic anemia (AIHA), cold agglutinin syndrome, mixed type (that is, warm and cold) AIHA, or paroxysmal cold hemoglobinuria
Sites
Oncológica do Brasil
Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
Hospital Brasília
Hospital das Clínicas da Universidade Federal de Goiás - UFG
Complexo Hospitalar de Niterói - CHN
Multihemo - Oncoclínicas
Clínica Oncológica - CLION
Hospital Sao Rafael
Centro de Estudos e Pesquisas de Hematologia e Oncologia - CEPHO
Fundação Faculdade Regional de Medicina de São José do Rio Preto
StudyENERGY
SponsorJanssen Research & Development, LLC
Study typeInterventional
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04119050
