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

About

Brief Summary

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

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Join this Trial

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Study Stats
Protocol No.
22-000144
Category
Rheumatology
Contact
Nancy Lopez
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05270668
For detailed technical eligibility, visit ClinicalTrials.gov.