REASCENT
Research type
Research Study
Full title
REASCENT trial: A proof of principle trial to treat active Systemic sclerosis via interferon inhibition
IRAS ID
1005954
Contact name
Francesco Del Galdo
Contact email
Sponsor organisation
University of Leeds
Eudract number
2022-001985-37
Research summary
Systemic Sclerosis (SSc) is a rare autoimmune condition that can affect a patient's whole body. An autoimmune disease occurs when a person’s immune system attacks their own body by mistake, in SSc this activity can lead to scarring of the organs.
SSc is a life-long condition that can involve the skin, joints, lung, heart, kidneys, blood vessels and the digestive system. Patients may experience many complications as well as a decreased quality of life. Though there has been progress in the understanding of SSc, to date, there are no approved disease-modifying treatments for SSc, making this area of research a deeply unmet clinical need.
Scientific research suggests that a protein called Type I interferon (Type I IFN), could play a major role in SSc. Measuring the amount of Type I IFN in a patient’s blood could be crucial and levels of Type I IFN activity has been linked to how SSc presents clinically, for example, which organs are affected.
The REASCENT trial, led by Professor Francesco del Galdo, is a phase 2b, single arm, open label, proof of principle trial to evaluate the efficacy and safety of anifrolumab. Anifrolumab (Astra Zeneca AB) is a new drug that blocks Type I IFN and is currently licensed in the UK to treat another disease involving Type I IFN, systemic lupus erythematosus.
We will enroll up to 35 participants, diagnosed with SSc, who have poor hand function, from the active observational study, STRIKE (IRAS ID 178638). Those who consent to participate in REASCENT will receive anifrolumab 300 mg intravenously on a monthly basis, for a period of 52 weeks. The final infusion will receive their anifrolumab infusion on week 48.
REC name
London - Central Research Ethics Committee
REC reference
25/LO/0482
Date of REC Opinion
26 Sep 2025
REC opinion
Further Information Favourable Opinion