* Safety of rozanolixizumab given by manual injection or syringe driver
Research type
Research Study
Full title
A randomised, participant-blind, investigator-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of rozanolixizumab administered subcutaneously via manual push versus syringe driver to healthy participants (20-019)
IRAS ID
294895
Contact name
Shikiko Watanabe
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2020-005973-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary
The study medicine (rozanolixizumab) is an experimental treatment for certain types of autoimmune diseases. Normally, the immune system defends the body from harmful substances (such as infections) by making proteins called antibodies – the antibodies stick to and destroy the harmful substances. But in patients with autoimmune diseases, the immune system makes antibodies to attack healthy parts of the body.
The study medicine is a type of protein called a ‘monoclonal antibody’, which is made specifically for use in humans. The study medicine blocks a substance called FcRn, which reduces the blood levels of harmful antibodies that cause certain autoimmune diseases. We hope the study medicine will be more effective, and have fewer side effects, than existing treatments for autoimmune diseases.
In this study, we’ll test single doses of the study medicine, given by injection under the skin of the abdomen. Depending on the group the study medicine will either be injected by a mechanical pump (called a syringe driver), or a nurse will place the needle under the skin and the participant will be asked to manually push the syringe of study medicine at a speed they are comfortable with. We aim to better understand the injection methods by studying the blood levels of the study medicine and how the body reacts to it
We’ll give 32 healthy men and women, aged 18–65, a single dose of the study medicine or placebo. Participants will be split into groups based on their weight.
We’ll screen participants up to 4 weeks before they start the study. Participants will take 8 weeks to finish the study. They’ll stay on the ward for 5 nights and make up to 9 outpatient visits.
A pharmaceutical company (UCB) is funding the study.
The study will take place at 1 centre in London.
Summary of Results
The lay summary of study results will be posted on https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbc7HpuNAp8zv5-2FZAR9YCy6VMNbtqwp5CnAiDUowO5tjPW4JCbHIhYccwjYMSN14EOhcb8EiQ4M4Oi6qLU-2BDxALnxipIS2PCv4xy-2F1TxjnUpDUp-v_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIE45DgPlWPROToJDK-2B13GOKto1JiRhuxPQwoXRJeGbq7lGjx-2BSMw402o5ni1p8wGDvWF5Qk3WTVD65qgA-2Foxnxo9A5wKXTMHCRhHqlZSoMdejotiwaE0pVhXwkzjx6XC1TS1Ae-2F6DLOVlGg24-2FiOcUnycQjmcrVbWzbNG-2B4La68w-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C86471129f57e4bdd37bc08db3aaacfbc%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638168277531352097%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=YO0Vl45rCTrAD3UgtS6CAaaqBbPz2Rl2Xvwv56Ss20w%3D&reserved=0 once the clinical results are made available on clinicaltrials.gov and other registries.
REC name
London - Riverside Research Ethics Committee
REC reference
21/FT/0022
Date of REC Opinion
1 Mar 2021
REC opinion
Favourable Opinion