PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease


About this study

The purpose of this study is to assess the safety, tolerability, and effectiveness of PRA023 in subjects with Systemic Sclerosis (SSc) with diffuse cutaneous disease and Interstitial Lung Disease (ILD). 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Confirmed diagnosis of systemic sclerosis with onset of disease ≤ 5 years ago.

- Diffuse cutaneous scleroderma

- Systemic sclerosis related interstitial lung disease confirmed by HRCT

- FVC ≥ 45% of predicted normal

- Diffusing capacity of lung for carbon monoxide (DLCO)≥ 45% of predicted normal

- Stable dosing of nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX) or
azathioprine, as well corticosteroids

- Able to provide written informed consent and understand and comply with the
requirements of the study

Exclusion Criteria:

- WOCBP and men with female partners of childbearing potential who are unwilling or
unable to use two highly effective methods of contraception to avoid pregnancy for the
entire study period and for up to 12 weeks after the last dose of study drug

- Airway obstruction per pulmonary function test (PFT) or clinically significant
pulmonary arterial hypertension

- Current clinical diagnosis of another inflammatory connective tissue disease

- Any active infections, a serious infection within the past 3 months, or chronic
bacterial infection

- Current smoker or smoking within 6 months of screening

- Subjects in the opinion of the investigator that are an an unacceptable risk for
participation in the study

- Subjects who meet the protocol criteria for important laboratory exclusion criteria

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 4/7/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Vivek Nagaraja, M.B.B.S., M.D.

Open for enrollment

Contact information:

Shan Luc-Kenney R.N.

(480) 301-9769

More information


Publications are currently not available

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