PHOENYCS FLY
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
IRAS ID
1004749
Contact name
Marie-Alix Bonny
Contact email
Sponsor organisation
UCB BIOPHARMA SRL
Eudract number
2019-003407-35
Clinicaltrials.gov Identifier
Research summary
Systemic lupus erythematosus (SLE) is a long-term (chronic) disease that leads to inflammation in the body that’s caused by the body’s immune system attacking its own healthy organs. Although some patients have active symptoms all the time, it often has a relapsing-remitting effect meaning the symptoms are at times worse (in relapse) and other times are improved or gone (in remission). \nWith current treatments for SLE, the majority of patients develop tissue and organ damage over time due to a lack of being able to control disease activity, or due to harmful side effects of the medications. \nThe aim of this study is to see if the investigational drug (not approved for sale) dapirolizumab pegol (DZP), when used in addition to current SLE medication, can improve the disease over a period of 48 weeks, for patients with both active and frequently relapsed-remitting SLE. The effectiveness of DZP will be compared against a placebo (study drug that contains no medicinal ingredient).\nDZP is a type of molecule called an antibody. They help the immune system to fight infections by attaching to foreign molecules in the body called antigens. DZP attaches to molecules called CD40 ligand (CD40L) found of the surface of certain cells that are involved in communication within the immune system. By doing this, it stops the communication and therefore stops the inflammation in the body. \nDZP is a liquid drug that will be given intravenously (in a vein). Evidence from previous studies has shown that DZP, when used in combination with standard medications, is more effective than using standard medications alone in patients with active or relapsed-remitting SLE. \nThe study will include approximately 450 participants across approximately 280 sites in around 31 countries worldwide. This research is being sponsored by UCB Biopharma SRL.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0068
Date of REC Opinion
21 Apr 2022
REC opinion
Further Information Favourable Opinion