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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05270668




Registration number
NCT05270668
Ethics application status
Date submitted
27/02/2022
Date registered
8/03/2022

Titles & IDs
Public title
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)
Scientific title
A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7240/PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD)
Secondary ID [1] 0 0
PR200-104
Secondary ID [2] 0 0
7240-007
Universal Trial Number (UTN)
Trial acronym
ATHENA-SSc-ILD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Cutaneous Systemic Sclerosis 0 0
Interstitial Lung Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tulisokibart
Diagnosis / Prognosis - Companion diagnostic ( CDx)
Treatment: Drugs - Placebo

Experimental: Tulisokibart - Tulisokibart IV administered by IV infusion

Placebo comparator: Placebo - Placebo administered by IV infusion


Treatment: Drugs: Tulisokibart
Tulisokibart administered at timepoints as directed by the protocol

Diagnosis / Prognosis: Companion diagnostic ( CDx)
CDx+ or CDx-

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants who Experience an Adverse Event (AE)
Timepoint [1] 0 0
Up to Week 50
Primary outcome [2] 0 0
Number of Participants who Experience a Serious Adverse Event (SAE)
Timepoint [2] 0 0
Up to Week 50
Primary outcome [3] 0 0
Number of Participants who Discontinue due to an AE
Timepoint [3] 0 0
Up to Week 50
Primary outcome [4] 0 0
Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at Week 50
Timepoint [4] 0 0
Baseline and up to Week 50
Secondary outcome [1] 0 0
Change from Baseline in FVC at Week 50
Timepoint [1] 0 0
Baseline and Week 50
Secondary outcome [2] 0 0
Change from Baseline in High-Resolution Computer Tomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50
Timepoint [2] 0 0
Baseline and Week 50
Secondary outcome [3] 0 0
Percentage of Participants with an Improvement in the Revised Composite Response Index in Systemic Sclerosis (CRISS) Score at Week 50
Timepoint [3] 0 0
Baseline and Week 50
Secondary outcome [4] 0 0
Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 50
Timepoint [4] 0 0
Baseline and Week 50
Secondary outcome [5] 0 0
Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Quality of Life (QoL) Outcome at Week 50
Timepoint [5] 0 0
Baseline and Week 50

Eligibility
Key inclusion criteria
* Has confirmed diagnosis of systemic sclerosis with onset of disease = 5 years ago.
* Has diffuse cutaneous scleroderma
* Has 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
* If on background therapy, meets stable dosing requirements for nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX) OR azathioprine, and corticosteroids
* Women of childbearing potential are eligible to participate if not pregnant or breastfeeding and either willing to use an acceptable contraceptive method or sexually abstinent
* Able to provide written informed consent and understand and comply with the requirements of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has an airway obstruction per pulmonary function test (PFT) or clinically significant pulmonary arterial hypertension
* Has current clinical diagnosis of another inflammatory connective tissue disease
* Has any active infections, a serious infection within the past 3 months, or chronic bacterial infection
* Is a current smoker or smoking within 6 months of screening
* Has any concomitant medical conditions that, in the opinion of the investigator, might place them in unacceptable risk for participation in the study
* Meets the protocol criteria for important laboratory exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2028
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital ( Site 4050) - Adelaide
Recruitment hospital [2] 0 0
St Vincents Hospital Melbourne ( Site 4051) - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Santa Fe
Country [18] 0 0
Belgium
State/province [18] 0 0
Liege
Country [19] 0 0
Belgium
State/province [19] 0 0
Oost-Vlaanderen
Country [20] 0 0
Belgium
State/province [20] 0 0
Vlaams-Brabant
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Chile
State/province [23] 0 0
Araucania
Country [24] 0 0
Chile
State/province [24] 0 0
Region M. De Santiago
Country [25] 0 0
France
State/province [25] 0 0
Nord
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
Germany
State/province [27] 0 0
Baden-Wurttemberg
Country [28] 0 0
Germany
State/province [28] 0 0
Hessen
Country [29] 0 0
Germany
State/province [29] 0 0
Mecklenburg-Vorpommern
Country [30] 0 0
Germany
State/province [30] 0 0
Nordrhein-Westfalen
Country [31] 0 0
Hungary
State/province [31] 0 0
Baranya
Country [32] 0 0
Hungary
State/province [32] 0 0
Budapest
Country [33] 0 0
Hungary
State/province [33] 0 0
Debrecen
Country [34] 0 0
Israel
State/province [34] 0 0
Haifa
Country [35] 0 0
Israel
State/province [35] 0 0
Kfar Saba
Country [36] 0 0
Israel
State/province [36] 0 0
Nahariya
Country [37] 0 0
Israel
State/province [37] 0 0
Petach Tikvah
Country [38] 0 0
Israel
State/province [38] 0 0
Ramat-Gan
Country [39] 0 0
Israel
State/province [39] 0 0
Tel Aviv
Country [40] 0 0
Italy
State/province [40] 0 0
Lombardia
Country [41] 0 0
Italy
State/province [41] 0 0
Piemonte
Country [42] 0 0
Italy
State/province [42] 0 0
Firenze
Country [43] 0 0
Italy
State/province [43] 0 0
Genova
Country [44] 0 0
Italy
State/province [44] 0 0
Milano
Country [45] 0 0
Italy
State/province [45] 0 0
Reggio Emilia
Country [46] 0 0
Italy
State/province [46] 0 0
Roma
Country [47] 0 0
Netherlands
State/province [47] 0 0
Gelderland
Country [48] 0 0
Norway
State/province [48] 0 0
Oslo
Country [49] 0 0
Poland
State/province [49] 0 0
Dolnoslaskie
Country [50] 0 0
Poland
State/province [50] 0 0
Kujawsko-pomorskie
Country [51] 0 0
Poland
State/province [51] 0 0
Mazowieckie
Country [52] 0 0
Poland
State/province [52] 0 0
Podlaskie
Country [53] 0 0
Poland
State/province [53] 0 0
Slaskie
Country [54] 0 0
Poland
State/province [54] 0 0
Wielkopolskie
Country [55] 0 0
Spain
State/province [55] 0 0
Asturias
Country [56] 0 0
Spain
State/province [56] 0 0
Cataluna
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid, Comunidad De
Country [58] 0 0
Spain
State/province [58] 0 0
Barcelona
Country [59] 0 0
Spain
State/province [59] 0 0
Madrid
Country [60] 0 0
Spain
State/province [60] 0 0
Malaga
Country [61] 0 0
Spain
State/province [61] 0 0
Valencia
Country [62] 0 0
Spain
State/province [62] 0 0
Zaragoza
Country [63] 0 0
Switzerland
State/province [63] 0 0
Berne
Country [64] 0 0
Switzerland
State/province [64] 0 0
Sankt Gallen
Country [65] 0 0
Switzerland
State/province [65] 0 0
Geneve
Country [66] 0 0
Switzerland
State/province [66] 0 0
Zurich
Country [67] 0 0
Ukraine
State/province [67] 0 0
Kyivska Oblast
Country [68] 0 0
Ukraine
State/province [68] 0 0
Kyiv
Country [69] 0 0
United Kingdom
State/province [69] 0 0
London, City Of
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prometheus Biosciences
Address 0 0
Clinical Trials Call Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@msd.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05270668