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

Sponsor

Prometheus Biosciences, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05270668

Collaborator

(none)

100

Enrollment

Locations

Arms

28.2

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Feb 22, 2022

Anticipated Primary Completion Date :

Mar 29, 2024

Anticipated Study Completion Date :

Jun 28, 2024

Arms and Interventions

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

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

Primary Outcome Measures

Incidence of AE, SAE and AE leading to discontinuation [Week 50]
Safety and tolerability
Annual change of forced vital capacity (FVC) [Week 50]
Comparison of annual rate of change in FVC

Secondary Outcome Measures

Change of FVC [Week 50]
Comparison of change in FVC
Annual rate of change in percent predicted FVC [Week 50]
Comparison of annual rate of change in FVC in percent predicted
Change in high-resolution computer tomography (HRCT) [Week 50]
Comparison of change in HRCT quantitative ILD
Change in American College of Rheumatology Combined Response Index in Systemic Sclerosis (ACR CRISS) [Week 50]
Proportion of subjects with improvement of ACR CRISS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prometheus Biosciences Selected Site	Los Angeles	California	United States	90045
2	Prometheus Biosciences Selected Site	Denver	Colorado	United States	80206
3	Prometheus Biosciences Selected Site	Washington	District of Columbia	United States	20007
4	Prometheus Biosciences Selected Site	New Brunswick	New Jersey	United States	08901
5	Prometheus Biosciences Selected Site	Toledo	Ohio	United States	43614
6	Prometheus Biosciences Selected Site	Charleston	South Carolina	United States	29425
7	Prometheus Biosciences Selected Site	Houston	Texas	United States	77030
8	Prometheus Biosciences Selected Site	Fitzroy	Victoria	Australia
9	Prometheus Biosciences Selected Site	Liège		Belgium	4000
10	Prometheus Biosciences Selected Site	Bordeaux	Gironde	France	33076
11	Prometheus Biosciences Selected Site	Lille	Nord	France	59000
12	Prometheus Biosciences Selected Site	Paris		France	75014
13	Prometheus Biosciences Selected Site	Warszawa	Mazowieckie	Poland	02-665
14	Prometheus Biosciences Selected Site	Barcelona		Spain	08025
15	Prometheus Biosciences Selected Site	Barcelona		Spain	08035
16	Prometheus Biosciences Selected Site	Barcelona		Spain	08036
17	Prometheus Biosciences Selected Site	Madrid		Spain	28034
18	Prometheus Biosciences Selected Site	Madrid		Spain	28041
19	Prometheus Biosciences Selected Site	Valencia		Spain	46017
20	Prometheus Biosciences Selected Site	Zaragoza		Spain	50009