RecruitingPhase IIInterventional

REASCENT trial: a proof of principle trial to treat active systemic sclerosis via interferon inhibition

Systemic sclerosis is a rare, lifelong autoimmune condition. It happens when the body's immune system mistakenly attacks healthy tissue, causing hard, scarred patches on the skin and damage to internal organs. There are currently no approved treatments that can slow down or stop the disease itself. In this clinical trial, doctors in Leeds are testing a medicine called anifrolumab (brand name Saphnelo). This drug works by blocking a specific immune protein called Type I interferon, which is thought to drive tissue scarring. Anifrolumab is already used in the UK for lupus. Up to 35 adults with systemic sclerosis that affects their hands will receive the medicine through a drip once a month for about a year. Researchers will closely check whether the treatment is safe, well tolerated, and helpful for daily hand movement and overall health.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

University of Leeds

Enrolment target

Start

27 Sep 2025

Estimated completion

31 Aug 2028

Systemic sclerosis

What is this study about?

Systemic sclerosis, sometimes called scleroderma, is a rare autoimmune condition where your immune system attacks healthy tissues by mistake. Over time, this leads to inflammation and thick, scarred tissue that can affect the skin, joints, blood vessels, and vital organs like the lungs and heart. Many people find that skin tightening makes everyday tasks difficult, particularly when it affects their hands. Right now, there are no approved treatments in the UK that directly alter the course of the disease.

Scientists have discovered that a protein in our immune system, called Type I interferon, may play a major part in driving this tissue damage. When levels of this protein are too high, the body produces too much scar tissue. The REASCENT study is exploring whether a medicine called anifrolumab can help. Anifrolumab blocks this protein to help calm inflammation. It is already safely used in the UK to treat lupus, another autoimmune condition linked to the same protein.

In this trial, doctors want to see if giving anifrolumab to people with systemic sclerosis can safely ease symptoms and protect against further scarring. Because this is a proof-of-principle study, all participants will receive the real medicine rather than a dummy drug (placebo). The results will help doctors understand whether this treatment could become a much-needed new option for people living with the condition.

Key takeaways

REASCENT is testing whether anifrolumab, a drug approved for lupus, can treat systemic sclerosis.
Up to 35 adults aged 18 to 70 with hand difficulties will take part through the University of Leeds.
Everyone in the trial receives the study medicine as a monthly hospital drip for about one year.
Common side effects include mild respiratory infections, cold symptoms, and temporary redness at the drip site.
Taking part is voluntary, and you can stop at any time without your usual care being affected.

Who may be eligible?

This study is looking for up to 35 adults aged between 18 and 70 who have been diagnosed with systemic sclerosis. To take part, participants must already be enrolled in an ongoing UK observational study called STRIKE. Because the trial focuses on daily movement, people joining must have noticeable difficulties with their hand function caused by the condition.

Participants need to weigh at least 40 kg (about 6 stone 4 lbs) and be up to date with their COVID-19 vaccinations. If you are taking standard immune-suppressing medications, you must have been on a stable, unchanged dose for at least six months before joining. If you do not take these medications, you will need to remain off them during the study.

Because the effects of the study drug on an unborn baby are unknown, pregnant or breastfeeding women cannot take part. Anyone who could become pregnant, as well as sexually active male participants, must agree to use reliable contraception throughout the study and for several months after the final dose.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am between 18 and 70 years old.
I have a confirmed diagnosis of systemic sclerosis (scleroderma).
I experience noticeable stiffness, pain, or limited movement in my hands.
I weigh at least 40 kg (about 6 stone 4 lbs).
I am currently taking part in the UK STRIKE observational study.
I am willing to use reliable contraception during the trial and for several months afterwards.

Answer every question to see your result.

What does participation involve?

Taking part in the REASCENT study lasts for around one year (52 weeks). During this time, you will receive anifrolumab as an intravenous infusion (a gentle drip into a vein in your arm). The infusion takes about 30 minutes, and the clinic team will monitor you for one to two hours afterwards to ensure you feel well. These treatments take place once every four weeks at the hospital, with the final dose given at week 48.

At your visits, the research team will carry out health checks, including physical examinations, tests to measure your hand mobility, and blood samples. Where possible, research blood tests will be combined with routine tests to save extra needle pricks. You will also have a screening chest X-ray to check your lungs before starting. You will attend regular hospital appointments beyond standard NHS care, giving you frequent, dedicated access to specialists who will monitor your health throughout.

Potential risks and benefits

You may not experience any direct medical benefit from taking part, though your hand function and symptoms might improve, and you will receive regular specialist monitoring. The study drug can cause side effects. Common ones include mild chest or head colds, bronchitis, shingles, and skin reactions near the drip site (such as redness, itching, or swelling). Because the drug dampens parts of your immune defence, you could pick up infections more easily. Blood tests can cause minor bruising, and a chest X-ray involves a very small amount of radiation. You are completely free to leave the trial at any point, and choosing to do so will not affect your standard NHS care.

Locations (1)

Chapel Allerton Hospital
Approximate
Leeds, England

Common questions

What is anifrolumab, and is it a new drug?

Anifrolumab is a targeted treatment that calms an overactive immune protein. It is already approved in the UK for treating lupus, but doctors are now testing whether it can also help systemic sclerosis.

Will I receive a dummy treatment (placebo)?

No. REASCENT is an 'open-label' trial, meaning every person who takes part receives the active trial drug. There is no placebo group.

How is the medicine given?

It is given as a drip into a vein in your arm once a month. Each infusion takes about 30 minutes, followed by a short rest period so nurses can check on you.

Can I take part if I am planning a family?

No. Because the medicine could harm an unborn child, both men and women taking part must use effective contraception during the study and for 18 weeks after the final dose.

Can I leave the study if I change my mind?

Yes. Participation is entirely voluntary. You can withdraw at any time without giving a reason, and your regular NHS medical care will continue as normal.

How to find out more

Francesco Del Galdo

f.delgaldo@leeds.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.