What next?
What next?
About this study
Systemic Sclerosis (SSc), also known as scleroderma, is an autoimmune disorder causing inflammation and scarring (fibrosis) that can affect multiple organs. Around 50% of people with SSc develop Interstitial Lung Disease (SSc-ILD).
People with SSc have higher levels of the blood marker Tumor necrosis factor-like cytokine 1A (TL1A), which promotes inflammation and fibrosis. Monoclonal antibodies, like PRA023, bind to TL1A reducing their ability to function in a way that damages the lungs and other organs.
ATHENA-SSc-ILD is a Phase 2 trial of a new drug, PRA023, for people with SSc-ILD.
The study aims to better understand the effect of the drug on the body and see if it reduces inflammation and scarring of the lungs, slowing progression of SSc-ILD.
There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.
A study involving people can be:
- Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
- Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).
There are 3 main phases of clinical trials:
- Phase 1 is the earliest stage of research, where there is often a focus on understanding if the treatment is safe or if it causes any side effects.
- Phase 2 still focuses on safety and side effects, but also tries to find out more about what is the best dose.
- Phase 3 often compares the new treatment to existing treatments or lookalike medications.
As drugs or interventions move into the different phases, the number of people taking part will increase. Not all studies will make it to the later phases, especially if the intervention is not found to be safe or effective in phase 1 and 2.
The recruitment aim is the number of people that researcher want to take part in the research study.
What is involved?
You will receive either the study drug PRA023, or a placebo, which does not contain any active ingredients. Both the study drug and placebo are given as a 'drip' (intravenous infusion) where a fluid is delivered into the body through a vein.
You will take part in the study for 50 weeks. Your body's reaction to the drug will be monitored, and you will be asked to have lung function tests, CT scans of the lung and complete questionnaires.
Summary of involvement
Either receiving the study drug or a placebo
Study duration of 50 weeks
Lung function tests
HRCT scans
Questionnaires
Can I take part?
You may be able to take part if you are over the age of 18 and have a confirmed diagnosis of systemic sclerosis with onset of the disease within the last 5 years.
In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see list below). Only the clinical trial team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point.
If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.
To find our more about other research opportunities visit our research finder main page.
Diagnosis of systemic sclerosis
Interstitial lung disease confirmed by CT scan
Stable dose of treatments such as nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX) or azathioprine
Able to provide informed consent
Strict lung function critera which will be assessed by the researchers
People who may be able to have children, who are not able to take highly effective forms of contraception
Airway obstruction or pulmonary arterial hypertension
Current diagnosis of another inflammatory connective tissue disease
Any active or previous infection within the past 3 months
Current smoker or previous smoking within the last 6 months
What difference could taking part make?
Taking part in this study would enable researchers to identify if the study drug is well tolerated and beneficial for people diagnosed with SSc-ILD.
Taking part in research has the potential to make a difference for people who have SSc-ILD now and for future generations.
Where does the study take place?
Study locations
London
Leeds
How to take part
If you are interested in taking part in this study, please speak to your healthcare team to express your interest in research that may be suitable for you to take part in.
Further information
The summary on this page provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.
If you have any questions about this research study, please speak to your medical team.
Clinicaltrials@prometheusbiosciences.comThis study is supported by
APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.
Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email research@actionpf.org