Clinical trial NCT05270668: 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)
Official 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Diffuse Cutaneous Systemic Sclerosis
Interstitial Lung Disease
Keywords: ATHENA SSc-ILD
ATHENA
Diffuse Cutaneous Scleroderma
Interstitial Lung Disease
Lead sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2022-03-08
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

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

Primary outcomes:
measure: Number of Participants who Experience an Adverse Event (AE)
timeFrame: Up to Week 50
measure: Number of Participants who Experience a Serious Adverse Event (SAE)
timeFrame: Up to Week 50
measure: Number of Participants who Discontinue due to an AE
timeFrame: Up to Week 50
measure: Change from Baseline in the Annual Rate of Change in Forced Vital Capacity (FVC) at Week 50
timeFrame: Baseline and up to Week 50
Secondary outcomes:
measure: Change from Baseline in FVC at Week 50
timeFrame: Baseline and Week 50
measure: Change from Baseline in High-Resolution Computer Tomography (HRCT) Quantitative Interstitial Lung Disease - Whole Lung (QILD-WL) at Week 50
timeFrame: Baseline and Week 50
measure: Percentage of Participants with an Improvement in the Revised Composite Response Index in Systemic Sclerosis (CRISS) Score at Week 50
timeFrame: Baseline and Week 50
measure: Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 50
timeFrame: Baseline and Week 50
measure: Change from Baseline in Living with Pulmonary Fibrosis (L-PF) Quality of Life (QoL) Outcome at Week 50
timeFrame: Baseline and Week 50
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic - Scottsdale ( Site 4014)
state: Arizona
city: Los Angeles
country: United States
facility: Pacific Arthritis Care Center ( Site 4008)
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center ( Site 4010)
state: California
city: Los Angeles
country: United States
facility: UCLA School of Medicine ( Site 4006)
state: California
city: Palo Alto
country: United States
facility: Stanford Health Care ( Site 4009)
state: California
city: Denver
country: United States
facility: National Jewish Health Medical Center ( Site 4015)
state: Colorado
city: New Haven
country: United States
facility: Yale University ( Site 4017)
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital ( Site 4005)
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Asthma and Allergy Center [Baltimore, MD] ( Site 4018)
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital ( Site 4003)
state: Massachusetts
city: Boston
country: United States
facility: Boston University School of Medicine ( Site 4021)
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospital ( Site 4001)
state: Michigan
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School ( Site 4013)
state: New Jersey
city: New York
country: United States
facility: Hospital For Special Surgery ( Site 4020)
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation ( Site 4019)
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center ( Site 4002)
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center ( Site 4016)
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina - PPDS ( Site 4004)
state: South Carolina
city: Houston
country: United States
facility: UT Physicians Rheumatology ( Site 4007)
state: Texas
city: Milwaukee
country: United States
facility: Froedtert and Medical College of Wisconsin ( Site 4012)
state: Wisconsin
city: Caba
country: Argentina
facility: Consultorios Médicos Dr. Doreski ( Site 4800)
state: Buenos Aires
city: Munro
country: Argentina
facility: Clínica Privada Independencia ( Site 4802)
state: Buenos Aires
city: Rio Cuarto
country: Argentina
facility: Centro de Investigación Instituto Médico Río Cuarto ( Site 4801)
state: Cordoba
city: Rosario.
country: Argentina
facility: Instituto Medico de la Fundacion Estudios Clinicos ( Site 4803)
state: Santa Fe
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital ( Site 4050)
state: South Australia
city: Melbourne
country: Australia
facility: St Vincents Hospital Melbourne ( Site 4051)
state: Victoria
city: Gent
country: Belgium
facility: UZ Gent ( Site 4401)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 4402)
state: Vlaams-Brabant
city: Liège
country: Belgium
facility: CHU de Liege ( Site 4400)
state: Wallonne, Region
city: Edmonton
country: Canada
facility: University Of Alberta Hospital ( Site 4702)
state: Alberta
city: London
country: Canada
facility: St. Joseph's Health Care London ( Site 4701)
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital [Toronto, Canada] ( Site 4700)
state: Ontario
city: Temuco
country: Chile
facility: Centro de especialidades médicas Vanguardia ( Site 4850)
state: Araucania
city: Santiago
country: Chile
facility: BIOCINETIC Ltda ( Site 4854)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Investigacion Clinica UC CICUC ( Site 4855)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos CIEC ( Site 4851)
state: Region M. De Santiago
city: Vitacura
country: Chile
facility: Clinica Dermacross ( Site 4853)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS ( Site 4852)
state: Valparaiso
city: Bordeaux
country: France
facility: CHU de Bordeaux. Hopital Pellegrin ( Site 4202)
state: Nord
city: Lille
country: France
facility: Hôpital Claude Huriez ( Site 4200)
state: Nord
city: Paris
country: France
facility: Hopital Cochin ( Site 4203)
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg ( Site 4152)
state: Baden-Wurttemberg
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik-Forschungs-GmbH ( Site 4153)
state: Hessen
city: Hohenfelde B Bad Doberan
country: Germany
facility: Rheumazentrum am Krankenhaus Bad Doberan ( Site 4150)
state: Mecklenburg-Vorpommern
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln ( Site 4151)
state: Nordrhein-Westfalen
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem AOK ( Site 4250)
state: Baranya
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz ( Site 4252)
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet ( Site 4253)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 4251)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 4601)
city: Kfar Saba
country: Israel
facility: Meir Medical Center. ( Site 4604)
city: Nahariya
country: Israel
facility: Galilee Medical Center ( Site 4602)
city: Petach Tikvah
country: Israel
facility: Rabin Medical Center ( Site 4603)
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center ( Site 4605)
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center ( Site 4606)
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino ( Site 4304)
state: Piemonte
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi ( Site 4301)
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino ( Site 4305)
city: Milano
country: Italy
facility: IRCCS Osp. Maggiore Policlinico ( Site 4306)
city: Milano
country: Italy
facility: Ospedale San Raffaele di Milano ( Site 4307)
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo ( Site 4303)
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova ( Site 4300)
city: Roma
country: Italy
facility: Azienda Policlinico Umberto I ( Site 4302)
city: Ciudad de México
country: Mexico
facility: Centro de Investigación y Tratamiento Reumatológico S.C ( Site 4902)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: PanAmerican Clinical Research - Guadalajara ( Site 4900)
state: Jalisco
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center ( Site 4650)
state: Gelderland
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF. Rikshospitalet ( Site 4350)
city: Lima
country: Peru
facility: Instituto de Ginecologia y Reproduccion ( Site 4952)
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow ( Site 4455)
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy ( Site 4454)
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Centrum Medyczne Reuma Park NZOZ ( Site 4450)
state: Mazowieckie
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 4451)
state: Podlaskie
city: Bytom
country: Poland
facility: Szpital Specjalistyczny nr 1 w Bytomiu ( Site 4453)
state: Slaskie
city: Poznań
country: Poland
facility: Twoja Przychodnia Poznanskie Centrum Medyczne ( Site 4452)
state: Wielkopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site
state: Wielkopolskie
city: Oviedo
country: Spain
facility: Hospital Central de Asturias ( Site 4109)
state: Asturias
city: Barcelona
country: Spain
facility: HOSPITAL CLÍNIC DE BARCELONA ( Site 4105)
state: Cataluna
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre ( Site 4106)
state: Madrid, Comunidad De
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS ( Site 4107)
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau ( Site 4102)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal ( Site 4101)
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga ( Site 4104)
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset ( Site 4103)
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa ( Site 4100)
city: Bern
country: Switzerland
facility: Inselspital Bern ( Site 4502)
state: Berne
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen ( Site 4501)
state: Sankt Gallen
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve HUG ( Site 4503)
city: Zurich
country: Switzerland
facility: Universitaetsspital Zuerich ( Site 4500)
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital # 3 ( Site 4754)
state: Kyivska Oblast
city: Ternopil
country: Ukraine
facility: ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 4750)
state: Ternopilska Oblast
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Nat Med University n.a.M.Pyrogov,City Clinical Hospital #1 ( Site 4751)
state: Vinnytska Oblast
city: Kyiv
country: Ukraine
facility: Medical Center OK!Clinic+LLC International Institute of Clinical Research ( Site 4753)
city: Kyiv
country: Ukraine
facility: Institute of Rheumatology LLC ( Site 4752)
city: London
country: United Kingdom
facility: Royal Free Hospital ( Site 4550)
state: London, City Of
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital ( Site 4551)
Study officials:
affiliation: Clinical Trials Call Center
name: Prometheus Biosciences
role: STUDY_DIRECTOR
References: