myOpportunITy 2
Research type
Research Study
Full title
A phase 3 multicentre, double-blind, randomised, placebo-controlled study to evaluate the efficacy, safety, and tolerability of Rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)
IRAS ID
278155
Contact name
Quentin Hill
Contact email
Sponsor organisation
UCB Biopharma SRL
Eudract number
2019-003451-11
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
143499, IND Number
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Research Summary
Immune thrombocytopenia (ITP) is a clinical disorder which causes a decrease number of platelets (a type of cell that helps blood to clot) in the blood. People who have ITP tend to bleed often, develop rashes of purple spots (purpura) on the skin due to blood accumulation under the skin (or develop small red/purple spots (petechiae) caused by bleeding from small blood vessels into the skin.\n\nMost often, ITP is caused when people develop autoantibodies against proteins on the surface of the platelet (referred to as antigens). Autoantibody formation mean that their bodies produce a certain protein normally involved in the immune response against foreign particles such as bacteria and viruses, but in ITP this protein is targeted towards the body’s own cells, in this case, platelets. The antibodies against platelets are called pathogenic IgG autoantibodies. The presence of these autoantibody reduces the number of platelets in the blood and can lead to ITP.\n\nTreatments aimed at reducing the quantity of these autoantibodies, are being used to treat autoimmune diseases including ITP. The primary goal for treatment of ITP is to achieve a platelet count that prevents major bleeding.\n\nRozanolixizumab is being developed to reduce the amount of pathogenic IgG autoantibodies and is targeted to a specific step in the pathway that recycles and maintains pathogenic IgG autoantibodies. Rozanolixizumab was designed to block this step, leading to less pathogenic IgG autoantibodies resulting in increased platelet numbers.\n\nThis study is one of 2 needed to establish whether rozanolixizumab is able to produce the desired effect on platelets and compare the safety of rozanolixizumab over placebo (dummy drug) in study participants with primary ITP who have failed or were intolerant to at least one prior ITP therapy and who require an increase and sustained effect in their platelet counts.
Summary of Results
This Plain Language Summary of Study Results will be disclosed on https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbc7HpuNAp8zv5-2FZAR9YCy6VMNbtqwp5CnAiDUowO5tjPW4JCbHIhYccwjYMSN14EOhcb8EiQ4M4Oi6qLU-2BDxALnxipIS2PCv4xy-2F1TxjnUpDRr-4_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJkbSpQ20Xsi8ls8GHUcnnTFT0qeaHVKHajlyNWt743JkLG7V-2FcTOyP9PVLXZc2TtBKCi240Hb1sbrXXaletvLLHMsBvBbc7hZ07rO-2B0oI1eUyNl2APVrtgSMO8UdyjBfkwYiB9HCh4hKOXzNTt5d6HAl9Or4X8M8anyhPXcxWnrg-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C45bbeefd5c3a49594b1408db4d705142%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638188917010047559%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=PuiJLB43hvT%2BjbGiUVzUxKXizqWOgTU%2FUhI%2FYceLfec%3D&reserved=0 once the clinical results are made available on https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfbzSmdWCVTTDSfM-2Bp8ODc89J4A4_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJkbSpQ20Xsi8ls8GHUcnnTyyNaY7R2nUwPPZEwXYd0R-2F1LQ7elu7PWmlukNiianclbdxZcMPHxoRWmcNLwKKL0ERq9gN5oNKIO82tNPGYg6pr8g-2FFp2atTwPE2Egd6fcRpkTj4O-2Bj3DtTmtTxgLPeL-2FgoHMOyMVs3nwlP87wL-2Fhw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C45bbeefd5c3a49594b1408db4d705142%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638188917010047559%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=pF3isBsPNGd%2FbdoODXC2UB6DRFWiibR1%2BM9Cjwrjv%2FA%3D&reserved=0 and other registries.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
20/EE/0077
Date of REC Opinion
20 Apr 2020
REC opinion
Further Information Favourable Opinion