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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)

Primary Purpose

Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PRA023 IV
Companion diagnostic ( CDx)
Placebo
Sponsored by
Prometheus Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Cutaneous Systemic Sclerosis focused on measuring ATHENA SSc-ILD, ATHENA, Diffuse Cutaneous Scleroderma, Interstitial Lung Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected CenterRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Call CenterRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Call CenterRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Call CenterRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting
  • Prometheus Biosciences Selected SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRA023

Placebo

Arm Description

PRA023 IV administered by IV infusion

Placebo administered by IV infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2022
Last Updated
October 16, 2023
Sponsor
Prometheus Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05270668
Brief Title
Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)
Acronym
ATHENA-SSc-ILD
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
March 29, 2024 (Anticipated)
Study Completion Date
June 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prometheus Biosciences, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease
Keywords
ATHENA SSc-ILD, ATHENA, Diffuse Cutaneous Scleroderma, Interstitial Lung Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRA023
Arm Type
Experimental
Arm Description
PRA023 IV administered by IV infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered by IV infusion
Intervention Type
Drug
Intervention Name(s)
PRA023 IV
Intervention Description
PRA023 administered at timepoints as directed by the protocol
Intervention Type
Device
Intervention Name(s)
Companion diagnostic ( CDx)
Intervention Description
CDx+ or CDx-
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Incidence of AE, SAE and AE leading to discontinuation
Description
Safety and tolerability
Time Frame
Week 50
Title
Annual change of forced vital capacity (FVC)
Description
Comparison of annual rate of change in FVC
Time Frame
Week 50
Secondary Outcome Measure Information:
Title
Change of FVC
Description
Comparison of change in FVC
Time Frame
Week 50
Title
Annual rate of change in percent predicted FVC
Description
Comparison of annual rate of change in FVC in percent predicted
Time Frame
Week 50
Title
Change in high-resolution computer tomography (HRCT)
Description
Comparison of change in HRCT quantitative ILD
Time Frame
Week 50
Title
Change in American College of Rheumatology Combined Response Index in Systemic Sclerosis (ACR CRISS)
Description
Proportion of subjects with improvement of ACR CRISS
Time Frame
Week 50

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prometheus Biosciences
Phone
+1-858-422-4300
Email
Clinicaltrials@prometheusbiosciences.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences
Organizational Affiliation
Clinical Trials Call Center
Official's Role
Study Director
Facility Information:
Facility Name
Prometheus Biosciences Selected Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048-1804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
855-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224-6821
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2621
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
New York
State/Province
New York
ZIP/Postal Code
10021-4823
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Fitzroy
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1-858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Center
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1-858-422-4300
Facility Name
Prometheus Biosciences Call Center
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
1-858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
1-858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1-858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Bad Nauheim
State/Province
Hessen
ZIP/Postal Code
61231
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50931
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858 422 4300
Facility Name
Prometheus Biosciences Selected Site
City
Bad Doberan
ZIP/Postal Code
18209
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858 422 4300
Facility Name
Prometheus Biosciences Selected Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7632
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Kfar Saba
State/Province
HaMerkas
ZIP/Postal Code
44281
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Call Center
City
Nahariya
State/Province
HaZafon
ZIP/Postal Code
2210001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Petah tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Reggio Emilia
State/Province
Emilia-Romagne
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858 422 4300
Facility Name
Prometheus Biosciences Selected Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858 422 4300
Facility Name
Prometheus Biosciences Selected Site
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Oslo
ZIP/Postal Code
N-0372
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
53-439
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858 422 4300
Facility Name
Prometheus Biosciences Selected Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-637
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-665
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
1-858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-276
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Bytom
State/Province
Slaskie
ZIP/Postal Code
41-902
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Call Center
City
Poznań
State/Province
Wielkopolski
ZIP/Postal Code
61-293
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1-858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1-858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1-858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1-858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1-8858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1-858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1-858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Saint Gallen
State/Province
Sankt Gallen (de)
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Geneva
ZIP/Postal Code
1206
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300
Facility Name
Prometheus Biosciences Selected Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prometheus Biosciences Call Center
Phone
+1 858-422-4300

12. IPD Sharing Statement

Learn more about this trial

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

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