LITMUS v1.0
Research type
Research Study
Full title
Low-dose Interleukin-2 for Treg Expansion after induction therapies in Multiple Sclerosis (LITMUS)
IRAS ID
300567
Contact name
Joanne Jones
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Multiple sclerosis (MS) is an autoimmune disease in which the patient’s own immune system attacks their brain and spinal cord causing damage and disability.
Alemtuzumab and cladribine are licensed treatments for MS that work by depleting immune cells, including the MS-causing cells. The immune system is then allowed to grow back. These treatments are known as induction therapies as there is no need for continuous medication.
Alongside MS-causing cells, both alemtuzumab and cladribine deplete T-regulatory cells (Tregs). Tregs are very important immune cells, as they help keep the rest of the immune system under control, preventing autoimmunity.
The purpose of this study is to test whether low doses of a drug called Proleukin can selectively expand Tregs in individuals with MS who have been treated with alemtuzumab or cladribine as part of their routine medical care. Increasing Tregs after alemtuzumab could improve its safety, as 4 out of 10 patients develop a new autoimmune disease (mainly affecting the thyroid gland) after treatment.
Increasing Tregs after cladribine could improve its efficacy as 1 in 4 patients get more MS attacks after treatment.Proleukin is the drug version of a naturally occurring immune cell growth factor called Interleukin-2 (IL-2). When given at very low doses, IL-2 has been shown to selectively increase Treg numbers in humans in a variety of settings other than MS (such as diabetes, lupus, and vasculitis) and it has been shown to be very safe.
In this study, participants will be given 6 subcutaneous injections (i.e. injections under the skin) of low-dose IL-2 over a 3 week period, and provide blood samples to measure Tregs. We do not expect any clinical benefits over this very short time frame. This is purely a mechanistic study, the read out of which will be Treg frequency before and after treatment.
REC name
Wales REC 7
REC reference
21/WA/0378
Date of REC Opinion
7 Dec 2021
REC opinion
Further Information Favourable Opinion