Lupus UK received a fee from BMS for the time spent to create this article. BMS checked the article to make sure the facts were correct, but Lupus UK had editorial control and remain independent of BMS.

New lupus treatment trial recruiting now!

A new trial is assessing whether a type of immunosuppressant treatment may be more effective for people with Systemic Lupus Erythematosus (SLE) than standard treatment.

 

What is this study about?

This study is a “Phase 3” trial. A Phase 3 trial is a larger trial with more people to see how a treatment works when you compare it to current treatments. Treatments in a Phase 3 trial have already been through trials with smaller amounts of people to start investigating if they are safe and effective, and what the right dose might be (Phases 1 and 2).

This trial is being done by a pharmaceutical company called Bristol Myers Squibb (BMS), who are testing a type of immunosuppressant treatment. BMS are conducting trials to see if it could be safe and effective to treat SLE.

The trial is being conducted in different countries, including the UK. The UK sites are in London, Middlesbrough, and Oxford.

Who can take part?

People may be able to take part if they are:

• Aged 18 or over.
• Have had a diagnosis of SLE for at least 24 weeks (approximately 5.5 months)
• Have moderate to severe SLE
• Are not pregnant, not planning to become pregnant during the study, and willing to use effective contraception during the study.

The detailed list of eligibility criteria would be discussed with you to check you are able and happy to take part.

What will happen if I take part?

Before you signed up, you would be given full details of what the study involves to make sure you were happy to continue. If you took part, you would be in the study for just over a year. It would include three separate parts:

1. Screening (4 weeks)
This would involve one or more visits to the study site for tests to check if you are eligible to take part in the study. This includes blood tests and a medical assessment.

2. Treatment (52 weeks, or one year)
At the beginning of the treatment phase, you would be randomly assigned to either receive the treatment or the placebo. A placebo is a substance that looks exactly like the treatment, but it doesn’t have any active ingredients so doesn’t have any effect. You and your doctors are not allowed to know which group you have been assigned to.

In both groups, you would be given a tablet to take twice a day for the year of the study. You would also visit the study site at least once a month for monitoring. This may include a medical assessment, questionnaires, and blood or urine tests.

You would keep taking your usual medications during the trial, but your dose of steroids may be adjusted in the second month of the study (if you already take them).

3. Safety follow-up (4 weeks) or long-term trial (2 years)
After the study is completed, all participants (including those who received the placebo) may be invited to take part in a long-term trial for another 2 years. On the long-term trial, all participants would receive treatment and you would be monitored. This part of the study is optional and full details would be discussed before you needed to decide whether to take part.

If you did not want to take part in the long-term trial or your doctor felt it was not suitable for you, you would then have a safety follow-up of 4 weeks. This would include at least one study site visit for a medical assessment and blood and urine tests. You would not take any more of the trial treatment during this follow-up.

Are there any risks to taking part?
The study team would talk through all potential risks to make sure you understand them before you decide whether to take part. The main risk of taking part is potential for side effects of the treatment, which may include increased risk of infection, acne-like rashes, and ulcers. Though some of the side effects were learnt about in earlier trials, it is possible there are other side effects the researchers do not know about yet. It is not known if the treatment has any risks during pregnancy or breastfeeding.

How do I find out more?
If you are interested in finding out more, you can find more details on the Be Part of Research page and on the ClinicalTrials.gov page for the trial.

If you are interested in taking part, you can ask your doctor to contact: Clinical.Trials@bms.com for further details. People with lupus cannot refer themselves to the trial – it can only be through a healthcare professional