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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05270668
Recruitment Status : Recruiting
First Posted : March 8, 2022
Last Update Posted : May 22, 2023
Sponsor:
Information provided by (Responsible Party):
Prometheus Biosciences, Inc.

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

Condition or disease Intervention/treatment Phase
Diffuse Cutaneous Systemic Sclerosis Interstitial Lung Disease Drug: PRA023 IV Device: Companion diagnostic ( CDx) Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : February 22, 2022
Estimated Primary Completion Date : March 29, 2024
Estimated Study Completion Date : June 28, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PRA023
PRA023 IV administered by IV infusion
 Drug: PRA023 IV
PRA023 administered at timepoints as directed by the protocol

Device: Companion diagnostic ( CDx)
CDx+ or CDx-
Placebo Comparator: Placebo
Placebo administered by IV infusion
 Device: Companion diagnostic ( CDx)
CDx+ or CDx-

Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of AE, SAE and AE leading to discontinuation [ Time Frame: Week 50 ]
    Safety and tolerability

  2. Annual change of forced vital capacity (FVC) [ Time Frame: Week 50 ]
    Comparison of annual rate of change in FVC


Secondary Outcome Measures :
  1. Change of FVC [ Time Frame: Week 50 ]
    Comparison of change in FVC

  2. Annual rate of change in percent predicted FVC [ Time Frame: Week 50 ]
    Comparison of annual rate of change in FVC in percent predicted

  3. Change in high-resolution computer tomography (HRCT) [ Time Frame: Week 50 ]
    Comparison of change in HRCT quantitative ILD

  4. Change in American College of Rheumatology Combined Response Index in Systemic Sclerosis (ACR CRISS) [ Time Frame: Week 50 ]
    Proportion of subjects with improvement of ACR CRISS


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05270668


Contacts
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Contact: Prometheus Biosciences +1-858-422-4300 Clinicaltrials@prometheusbiosciences.com

Locations
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Sponsors and Collaborators
Prometheus Biosciences, Inc.
Investigators
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Study Director: Prometheus Biosciences Clinical Trials Call Center
More Information
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Responsible Party: Prometheus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT05270668    
Other Study ID Numbers: PR200-104
2021-005206-10 ( EudraCT Number )
First Posted: March 8, 2022    Key Record Dates
Last Update Posted: May 22, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Prometheus Biosciences, Inc.:
ATHENA SSc-ILD
ATHENA
Diffuse Cutaneous Scleroderma
Interstitial Lung Disease
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
 Pathologic Processes
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases