CONQUEST Study

What is the CONQUEST study?

Over time, the CONQUEST study will research multiple investigational medicines as potential treatments for scleroderma. The study is currently researching 2 investigational medicines for systemic sclerosis associated interstitial lung disease (SSc-ILD) in parallel using 1 study plan. By sharing study resources, these investigational medicines may become available to patients faster. Additionally, a shared placebo increases the odds of each participant receiving the experimental treatment instead of a placebo. The Scleroderma Research Foundation will make the data collected on patients treated with placebo available to other researchers, helping to spur further research into the disease.

Research studies like the CONQUEST SSc-ILD clinical trial use investigational medicines because health and regulatory authorities have not yet approved them for public use.

Who can join the CONQUEST study?

Candidates with the following criteria may be able to join the study:

• Adults ages 18 or older
• SSc-ILD diagnosis
• SSc symptoms, not including Raynaud’s disease, that began within the past 5 years
• This study permits earlier onset of Raynaud’s disease

Other criteria apply

What can study participants expect?

CONQUEST study participation is about 1 year. You will travel to a study center periodically to take study tests. The following timeline is an estimate. Lengths may vary for some study groups.

1. Review & sign Informed Consent Forms

You must read and sign Informed Consent Forms (ICFs) before you receive study tests.

2. Confirm study requirements (4 weeks)

You will receive study tests to determine if you qualify for the study. This is called the Screening Period.

3. Receive study group assignment

If you qualify, you will be assigned at random to a study group for 1 of 2 investigational medicines.

4. Receive investigational medicine assignment

Within your study group, you will be assigned at random to receive either the investigational medicine or placebo.

5. Visit study center (52 weeks | 1 visit every 3-5 weeks)

Depending on your study group, you will visit the study center between 10 - 18 times to receive study tests.

6. Attend all follow-up visits

You will visit the study center to receive study tests that check your health and safety. Frequency of visits depends on the investigational medicine assigned.

Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.