An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias (RUBY-4)
Research type
Research Study
Full title
Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects with Autoimmune Cytopenias (RUBY-4)
IRAS ID
1009463
Contact name
Jeanne Paine
Contact email
Sponsor organisation
Alpine Immune Sciences Inc.
Eudract number
2023-507067-19
Clinicaltrials.gov Identifier
Research summary
An autoimmune disease occurs when the immune (defence) system treats healthy parts of the body as if they are foreign and attacks them. Cytopenia is a condition characterised by low number of cells in the blood. In autoimmune cytopenias a type of white blood cell, called a plasma cell begins making a type of protein called antibodies that attack the body’s own platelets or red blood cells, this makes people sick. There are different types of autoimmune cytopenias, including idiopathic thrombocytopenia (ITP), warm autoimmune hemolytic anemia (wAIHA), and cold agglutinin disease (CAD). Povetacicept is a new medicine being tested in people with ITP, wAIHA, or CAD who have received other treatments for their disease. Povetacicept is thought to work by stopping some proteins involved in the growth of plasma cells, lowering the number of plasma cells in the body, so less will be available to attack the body’s own platelets or red blood cells.\nThis study is open-label meaning that both doctors and participants know which drug is being administered. The study is funded by biopharmaceutical company Alpine, and it will be conducted in selected NHS Trust hospitals. The main purpose is to test if there are any unwanted side effects of povetacicept and to see how well this medication works in people with autoimmune cytopenias. It is expected that the study will last 3 years, and approximately 126 participants across 40 sites internationally are expected to take part. The study includes a Screening, Treatment, Optional Treatment Extension, and Follow-up Period. Everyone who participates will receive 6 doses of povetacicept. At the end of the Treatment Period (24 weeks), participants will decide with the study doctor if they should be in the optional Treatment Extension Period and receive 6 more doses of povetacicept (24 weeks). Participants will complete an end-of-study visit and follow-up visits for safety monitoring. Total participation will be approximately 36 or 60 weeks.
REC name
London - City & East Research Ethics Committee
REC reference
24/LO/0078
Date of REC Opinion
16 Feb 2024
REC opinion
Further Information Favourable Opinion