A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (ATHENA-SSc-ILD)

  • STATUS
    Recruiting
  • End date
    Jun 28, 2024
  • participants needed
    100
  • sponsor
    Prometheus Biosciences, Inc.
Updated on 11 October 2022
methotrexate
carbon monoxide
azathioprine
progressive systemic sclerosis
interstitial lung disease

Summary

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

Details
Condition Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease
Treatment Placebo, PRA023 IV, Companion diagnostic ( CDx)
Clinical Study IdentifierNCT05270668
SponsorPrometheus Biosciences, Inc.
Last Modified on11 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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