ATHENA-SSc-ILD: New drug called PRA023 for people with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD)

Upcoming study
Expected to open February 2022
This study is currently recruiting
Expected to close December 2025
This study is closed
This study closed in December 2025
We will update this page with study results when available.
Information on study results are included below
This study closed in December 2025
Ask your healthcare team about taking part in research

What next?

Original listing:

What next?

Original listing:

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.


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


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.

You may be able to join this study if all of these apply:

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

You will not be able to join the study of any of the following applies:

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



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.

This study is supported by

Prometheus Biosciences, Inc.
Study ID number:

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