Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)

• Status: Recruiting
• Trial end date: 2024-06-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of PRA023 in participants with SSc-ILD .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prometheus Biosciences, Inc.
• Collaborator: PPD

Criteria

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 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