Clinical Trials

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.